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VIDEO: The effect of removing pregnancy drug category labeling
AUSTIN, TEX. – In a randomized survey, the Food and Drug Administration’s previous letter-category labeling of drugs for pregnant women made prescribers more likely to prescribe appropriate medication than the new labeling standards without the letters.
The FDA removed the letter categories A, B, C, D, and X in 2014 in the belief “that a narrative structure for pregnancy labeling is best able to capture and convey the potential risks of drug exposure based on animal or human data, or both,” as stated in the FDA ruling.
“The [old] FDA categories are actually based upon the evidence related to clinical trials or animal trials and known risks to the fetus or the mother. The categorizations really reflect the evidence that we have or the absence of evidence as to whether medications can be safely used during pregnancy,” Dr. Robinson explained in a video interview. But letters can be perceived as overall “grades,” even though they aren’t.
The researchers sought to evaluate the effect of the letters’ removal by surveying doctors at two centers in New York City and two annual specialty meetings from October 2015 to May 2016.
The survey “included demographic information, followed by four clinical vignettes. Each vignette described a pregnant woman and presented an indication for prescribing a particular drug which was FDA approved. Each vignette was followed by detailed drug information as found in the FDA-approved package insert with the new [Pregnancy and Lactation Labeling Rule] content and formatting,” Dr. Robinson said at the meeting.
The 162 survey respondents estimated their likelihood of prescribing given the information in the vignette. The respondents were randomized to see the letter category or not. Category X (positive evidence of risk that clearly outweighs potential benefits) was not included. For all four remaining categories, the respondents who were shown the letter category were more likely to prescribe. Category B was significantly affected in a mixed linear model, and both categories B and C were significantly affected in a multivariate model.
“The new system of revised labeling may be more ambiguous and present new challenges for clinical decision making that could result in decreased access to medications for pregnant women,” Dr. Robinson said.
Dr. Robinson and her coauthors reported no relevant disclosures.
SOURCE: Robinson A et al. ACOG 2018. Abstract OP5.
AUSTIN, TEX. – In a randomized survey, the Food and Drug Administration’s previous letter-category labeling of drugs for pregnant women made prescribers more likely to prescribe appropriate medication than the new labeling standards without the letters.
The FDA removed the letter categories A, B, C, D, and X in 2014 in the belief “that a narrative structure for pregnancy labeling is best able to capture and convey the potential risks of drug exposure based on animal or human data, or both,” as stated in the FDA ruling.
“The [old] FDA categories are actually based upon the evidence related to clinical trials or animal trials and known risks to the fetus or the mother. The categorizations really reflect the evidence that we have or the absence of evidence as to whether medications can be safely used during pregnancy,” Dr. Robinson explained in a video interview. But letters can be perceived as overall “grades,” even though they aren’t.
The researchers sought to evaluate the effect of the letters’ removal by surveying doctors at two centers in New York City and two annual specialty meetings from October 2015 to May 2016.
The survey “included demographic information, followed by four clinical vignettes. Each vignette described a pregnant woman and presented an indication for prescribing a particular drug which was FDA approved. Each vignette was followed by detailed drug information as found in the FDA-approved package insert with the new [Pregnancy and Lactation Labeling Rule] content and formatting,” Dr. Robinson said at the meeting.
The 162 survey respondents estimated their likelihood of prescribing given the information in the vignette. The respondents were randomized to see the letter category or not. Category X (positive evidence of risk that clearly outweighs potential benefits) was not included. For all four remaining categories, the respondents who were shown the letter category were more likely to prescribe. Category B was significantly affected in a mixed linear model, and both categories B and C were significantly affected in a multivariate model.
“The new system of revised labeling may be more ambiguous and present new challenges for clinical decision making that could result in decreased access to medications for pregnant women,” Dr. Robinson said.
Dr. Robinson and her coauthors reported no relevant disclosures.
SOURCE: Robinson A et al. ACOG 2018. Abstract OP5.
AUSTIN, TEX. – In a randomized survey, the Food and Drug Administration’s previous letter-category labeling of drugs for pregnant women made prescribers more likely to prescribe appropriate medication than the new labeling standards without the letters.
The FDA removed the letter categories A, B, C, D, and X in 2014 in the belief “that a narrative structure for pregnancy labeling is best able to capture and convey the potential risks of drug exposure based on animal or human data, or both,” as stated in the FDA ruling.
“The [old] FDA categories are actually based upon the evidence related to clinical trials or animal trials and known risks to the fetus or the mother. The categorizations really reflect the evidence that we have or the absence of evidence as to whether medications can be safely used during pregnancy,” Dr. Robinson explained in a video interview. But letters can be perceived as overall “grades,” even though they aren’t.
The researchers sought to evaluate the effect of the letters’ removal by surveying doctors at two centers in New York City and two annual specialty meetings from October 2015 to May 2016.
The survey “included demographic information, followed by four clinical vignettes. Each vignette described a pregnant woman and presented an indication for prescribing a particular drug which was FDA approved. Each vignette was followed by detailed drug information as found in the FDA-approved package insert with the new [Pregnancy and Lactation Labeling Rule] content and formatting,” Dr. Robinson said at the meeting.
The 162 survey respondents estimated their likelihood of prescribing given the information in the vignette. The respondents were randomized to see the letter category or not. Category X (positive evidence of risk that clearly outweighs potential benefits) was not included. For all four remaining categories, the respondents who were shown the letter category were more likely to prescribe. Category B was significantly affected in a mixed linear model, and both categories B and C were significantly affected in a multivariate model.
“The new system of revised labeling may be more ambiguous and present new challenges for clinical decision making that could result in decreased access to medications for pregnant women,” Dr. Robinson said.
Dr. Robinson and her coauthors reported no relevant disclosures.
SOURCE: Robinson A et al. ACOG 2018. Abstract OP5.
REPORTING FROM ACOG 2018
VIDEO: Few transgender patients desire care in a transgender-only clinic
AUSTIN, TEX. – Transgender patients face many barriers to care, including a lack of necessary expertise among providers, but a large majority of those surveyed in a study in which they were asked whether they would want to go to a transgender-only clinic said they would not.
Lauren Abern, MD, of Atrius Health, Cambridge, Mass., discussed the aims and results of her survey at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
The anonymous online survey consisted of 120 individuals, aged 18-64 years: 100 transgender men and 20 transgender women. Of these, 83 reported experiencing barriers to care. The most common problem cited was cost (68, 82%), and other barriers were access to care (47, 57%), stigma (33, 40%), and discrimination (23, 26%). Cost was a factor even though a large majority of the respondents had health insurance; a majority of respondents had an income of less than $24,000 per year.
The most common way respondents found transgender-competent health care was through word of mouth (79, 77%).
When asked whether they would want to go to a transgender-only clinic, a majority of both transgender women and transgender men respondents either answered, “no,” or that they were unsure (86, 77%). Some respondents cited a desire not to out themselves as transgender, and others considered the separate clinic medically unnecessary. One wrote: “You wouldn’t need a broken foot–only clinic.”
“Basic preventative services can be provided without specific expertise in transgender health. If providers are uncomfortable, they should refer [transgender patients] elsewhere.” said Dr. Abern.
The survey project was conducted in collaboration with the University of Miami and the YES Institute in Miami.
Dr. Abern also spoke about wider transgender health considerations for the ob.gyn. in a separate presentation at the meeting and in a video interview.
For example, transgender men on testosterone may have persistent bleeding and may be uncomfortable with pelvic exams.
Making more inclusive intake forms and fostering a respectful office environment (for example, having a nondiscrimination policy displayed in the waiting area) are measures beneficial to all patients, she said.
“My dream or goal would be that transgender people can be seen and accepted at any office and feel comfortable and not avoid seeking health care.”
AUSTIN, TEX. – Transgender patients face many barriers to care, including a lack of necessary expertise among providers, but a large majority of those surveyed in a study in which they were asked whether they would want to go to a transgender-only clinic said they would not.
Lauren Abern, MD, of Atrius Health, Cambridge, Mass., discussed the aims and results of her survey at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
The anonymous online survey consisted of 120 individuals, aged 18-64 years: 100 transgender men and 20 transgender women. Of these, 83 reported experiencing barriers to care. The most common problem cited was cost (68, 82%), and other barriers were access to care (47, 57%), stigma (33, 40%), and discrimination (23, 26%). Cost was a factor even though a large majority of the respondents had health insurance; a majority of respondents had an income of less than $24,000 per year.
The most common way respondents found transgender-competent health care was through word of mouth (79, 77%).
When asked whether they would want to go to a transgender-only clinic, a majority of both transgender women and transgender men respondents either answered, “no,” or that they were unsure (86, 77%). Some respondents cited a desire not to out themselves as transgender, and others considered the separate clinic medically unnecessary. One wrote: “You wouldn’t need a broken foot–only clinic.”
“Basic preventative services can be provided without specific expertise in transgender health. If providers are uncomfortable, they should refer [transgender patients] elsewhere.” said Dr. Abern.
The survey project was conducted in collaboration with the University of Miami and the YES Institute in Miami.
Dr. Abern also spoke about wider transgender health considerations for the ob.gyn. in a separate presentation at the meeting and in a video interview.
For example, transgender men on testosterone may have persistent bleeding and may be uncomfortable with pelvic exams.
Making more inclusive intake forms and fostering a respectful office environment (for example, having a nondiscrimination policy displayed in the waiting area) are measures beneficial to all patients, she said.
“My dream or goal would be that transgender people can be seen and accepted at any office and feel comfortable and not avoid seeking health care.”
AUSTIN, TEX. – Transgender patients face many barriers to care, including a lack of necessary expertise among providers, but a large majority of those surveyed in a study in which they were asked whether they would want to go to a transgender-only clinic said they would not.
Lauren Abern, MD, of Atrius Health, Cambridge, Mass., discussed the aims and results of her survey at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
The anonymous online survey consisted of 120 individuals, aged 18-64 years: 100 transgender men and 20 transgender women. Of these, 83 reported experiencing barriers to care. The most common problem cited was cost (68, 82%), and other barriers were access to care (47, 57%), stigma (33, 40%), and discrimination (23, 26%). Cost was a factor even though a large majority of the respondents had health insurance; a majority of respondents had an income of less than $24,000 per year.
The most common way respondents found transgender-competent health care was through word of mouth (79, 77%).
When asked whether they would want to go to a transgender-only clinic, a majority of both transgender women and transgender men respondents either answered, “no,” or that they were unsure (86, 77%). Some respondents cited a desire not to out themselves as transgender, and others considered the separate clinic medically unnecessary. One wrote: “You wouldn’t need a broken foot–only clinic.”
“Basic preventative services can be provided without specific expertise in transgender health. If providers are uncomfortable, they should refer [transgender patients] elsewhere.” said Dr. Abern.
The survey project was conducted in collaboration with the University of Miami and the YES Institute in Miami.
Dr. Abern also spoke about wider transgender health considerations for the ob.gyn. in a separate presentation at the meeting and in a video interview.
For example, transgender men on testosterone may have persistent bleeding and may be uncomfortable with pelvic exams.
Making more inclusive intake forms and fostering a respectful office environment (for example, having a nondiscrimination policy displayed in the waiting area) are measures beneficial to all patients, she said.
“My dream or goal would be that transgender people can be seen and accepted at any office and feel comfortable and not avoid seeking health care.”
REPORTING FROM ACOG 2018
Report: Abortion in U.S. is safe and effective
, according to a consensus study report by the National Academies of Science, Engineering, and Medicine.
Six private foundations commissioned a comprehensive report from the National Academies, which focused on eight questions related to the safety and quality of U.S. abortion care. The resulting Committee on Reproductive Health Services limited itself to these questions and did not make specific policy or clinical recommendations, though they did note that “state regulations have created barriers to optimizing each dimension of quality care.” The report was released on March 16.
The committee focused on the four legal abortion methods in the United States – medication, aspiration, dilation and evacuation (D&E), and induction – and concluded that all four are safe, but that induction is so rare that there is a lack of quality research on the procedure’s risks in women with prior cesarean deliveries. D&E, though less painful, costly, and time consuming than induction, is banned in Mississippi and West Virginia (with exceptions for emergencies) and limited elsewhere in the country by a lack of physicians trained to perform the procedure.
In attempting to assess the physical and mental health risks of abortion procedures, the committee found that “much of the published literature on these topics does not meet scientific standards for rigorous, unbiased research.” Surveying research that they considered high quality, the committee concluded that there is no increased risk of secondary infertility, pregnancy-related hypertensive disorders, abnormal placentation, preterm birth, breast cancer, or mental health disorders such as depression, anxiety, or posttraumatic stress disorder associated with a woman having an abortion.
The committee was not able to find high-quality research to evaluate the risk of ectopic pregnancy, miscarriage or stillbirth, or long-term mortality associated with abortion. However, it did find an increased risk of preterm birth before 28 weeks’ gestation in a nulliparous women who had had two or more aspiration abortions, compared with women with no abortion history. The risk of preterm birth is greater in women if the interval between their abortion and their next conception is less than 6 months. The same risk exists for short intervals between pregnancy in general, the committee noted.
Overall, they wrote, “serious complications are rare and occur much less frequently than during childbirth.”
The committee identified several kinds of state-level regulations that are obstacles to effective abortion care in the United States. Such regulations “may limit the number of available providers, misinform women of the risks of the procedures they are considering, overrule women’s and clinicians’ medical decision making, or require medically unnecessary services and delays in care.” Some laws “prohibit the abortion method that is most effective for a particular clinical circumstance” (for example, D&E).
Access to care varies widely geographically, and 17% of women must travel more than 50 miles to obtain an abortion. Regulations that required counseling, whether the woman desires counseling or not, are cited as an example of inferior patient-centered care.
The committee delineated safeguards that are necessary to manage emergencies that might arise from an abortion procedure, such as resuscitation and monitoring equipment to be located in a facility for procedures involving moderate and deep sedation. However, they did not find any evidence that it is necessary for clinicians performing abortions to have hospital admitting privileges. In the Whole Woman’s Health v. Hellerstedt decision in 2016, the U.S. Supreme Court ruled that the admitting privileges requirement in Texas was an undue burden on access to care. The committee wrote that it is sufficient for the facility to have an emergency transfer plan in place.
The committee also identified areas for further evaluation. First, whether the Food and Drug Administration should expand the distribution of mifepristone, the only drug currently approved for medication abortions, but which can only be dispensed to patients in clinics, hospitals, or medical offices under the supervision of a certified prescriber. The committee also called for examining more effective methods of pain management, whether advanced practice clinicians can be trained to perform D&Es, and ways to provide more social and psychological supports for lower-income women or who are at risk of intimate partner or other forms of violence.
On March 16, the National Academies of Science, Engineering, and Medicine released a comprehensive report finding that abortion is safe and effective but inaccessible to many women.
A high-quality foundation of evidence, contributed to by many U.S. family planning researchers, provided the studies on which the conclusions of the National Academies are based. We are fortunate that the Society of Family Planning provides research funding and a forum for family planning researchers to continue to produce the high-quality evidence used by policy makers to improve access to and quality of abortion care.
Eve Espey, MD, MPH, is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. She reported having no relevant financial disclosures.
On March 16, the National Academies of Science, Engineering, and Medicine released a comprehensive report finding that abortion is safe and effective but inaccessible to many women.
A high-quality foundation of evidence, contributed to by many U.S. family planning researchers, provided the studies on which the conclusions of the National Academies are based. We are fortunate that the Society of Family Planning provides research funding and a forum for family planning researchers to continue to produce the high-quality evidence used by policy makers to improve access to and quality of abortion care.
Eve Espey, MD, MPH, is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. She reported having no relevant financial disclosures.
On March 16, the National Academies of Science, Engineering, and Medicine released a comprehensive report finding that abortion is safe and effective but inaccessible to many women.
A high-quality foundation of evidence, contributed to by many U.S. family planning researchers, provided the studies on which the conclusions of the National Academies are based. We are fortunate that the Society of Family Planning provides research funding and a forum for family planning researchers to continue to produce the high-quality evidence used by policy makers to improve access to and quality of abortion care.
Eve Espey, MD, MPH, is professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. She reported having no relevant financial disclosures.
, according to a consensus study report by the National Academies of Science, Engineering, and Medicine.
Six private foundations commissioned a comprehensive report from the National Academies, which focused on eight questions related to the safety and quality of U.S. abortion care. The resulting Committee on Reproductive Health Services limited itself to these questions and did not make specific policy or clinical recommendations, though they did note that “state regulations have created barriers to optimizing each dimension of quality care.” The report was released on March 16.
The committee focused on the four legal abortion methods in the United States – medication, aspiration, dilation and evacuation (D&E), and induction – and concluded that all four are safe, but that induction is so rare that there is a lack of quality research on the procedure’s risks in women with prior cesarean deliveries. D&E, though less painful, costly, and time consuming than induction, is banned in Mississippi and West Virginia (with exceptions for emergencies) and limited elsewhere in the country by a lack of physicians trained to perform the procedure.
In attempting to assess the physical and mental health risks of abortion procedures, the committee found that “much of the published literature on these topics does not meet scientific standards for rigorous, unbiased research.” Surveying research that they considered high quality, the committee concluded that there is no increased risk of secondary infertility, pregnancy-related hypertensive disorders, abnormal placentation, preterm birth, breast cancer, or mental health disorders such as depression, anxiety, or posttraumatic stress disorder associated with a woman having an abortion.
The committee was not able to find high-quality research to evaluate the risk of ectopic pregnancy, miscarriage or stillbirth, or long-term mortality associated with abortion. However, it did find an increased risk of preterm birth before 28 weeks’ gestation in a nulliparous women who had had two or more aspiration abortions, compared with women with no abortion history. The risk of preterm birth is greater in women if the interval between their abortion and their next conception is less than 6 months. The same risk exists for short intervals between pregnancy in general, the committee noted.
Overall, they wrote, “serious complications are rare and occur much less frequently than during childbirth.”
The committee identified several kinds of state-level regulations that are obstacles to effective abortion care in the United States. Such regulations “may limit the number of available providers, misinform women of the risks of the procedures they are considering, overrule women’s and clinicians’ medical decision making, or require medically unnecessary services and delays in care.” Some laws “prohibit the abortion method that is most effective for a particular clinical circumstance” (for example, D&E).
Access to care varies widely geographically, and 17% of women must travel more than 50 miles to obtain an abortion. Regulations that required counseling, whether the woman desires counseling or not, are cited as an example of inferior patient-centered care.
The committee delineated safeguards that are necessary to manage emergencies that might arise from an abortion procedure, such as resuscitation and monitoring equipment to be located in a facility for procedures involving moderate and deep sedation. However, they did not find any evidence that it is necessary for clinicians performing abortions to have hospital admitting privileges. In the Whole Woman’s Health v. Hellerstedt decision in 2016, the U.S. Supreme Court ruled that the admitting privileges requirement in Texas was an undue burden on access to care. The committee wrote that it is sufficient for the facility to have an emergency transfer plan in place.
The committee also identified areas for further evaluation. First, whether the Food and Drug Administration should expand the distribution of mifepristone, the only drug currently approved for medication abortions, but which can only be dispensed to patients in clinics, hospitals, or medical offices under the supervision of a certified prescriber. The committee also called for examining more effective methods of pain management, whether advanced practice clinicians can be trained to perform D&Es, and ways to provide more social and psychological supports for lower-income women or who are at risk of intimate partner or other forms of violence.
, according to a consensus study report by the National Academies of Science, Engineering, and Medicine.
Six private foundations commissioned a comprehensive report from the National Academies, which focused on eight questions related to the safety and quality of U.S. abortion care. The resulting Committee on Reproductive Health Services limited itself to these questions and did not make specific policy or clinical recommendations, though they did note that “state regulations have created barriers to optimizing each dimension of quality care.” The report was released on March 16.
The committee focused on the four legal abortion methods in the United States – medication, aspiration, dilation and evacuation (D&E), and induction – and concluded that all four are safe, but that induction is so rare that there is a lack of quality research on the procedure’s risks in women with prior cesarean deliveries. D&E, though less painful, costly, and time consuming than induction, is banned in Mississippi and West Virginia (with exceptions for emergencies) and limited elsewhere in the country by a lack of physicians trained to perform the procedure.
In attempting to assess the physical and mental health risks of abortion procedures, the committee found that “much of the published literature on these topics does not meet scientific standards for rigorous, unbiased research.” Surveying research that they considered high quality, the committee concluded that there is no increased risk of secondary infertility, pregnancy-related hypertensive disorders, abnormal placentation, preterm birth, breast cancer, or mental health disorders such as depression, anxiety, or posttraumatic stress disorder associated with a woman having an abortion.
The committee was not able to find high-quality research to evaluate the risk of ectopic pregnancy, miscarriage or stillbirth, or long-term mortality associated with abortion. However, it did find an increased risk of preterm birth before 28 weeks’ gestation in a nulliparous women who had had two or more aspiration abortions, compared with women with no abortion history. The risk of preterm birth is greater in women if the interval between their abortion and their next conception is less than 6 months. The same risk exists for short intervals between pregnancy in general, the committee noted.
Overall, they wrote, “serious complications are rare and occur much less frequently than during childbirth.”
The committee identified several kinds of state-level regulations that are obstacles to effective abortion care in the United States. Such regulations “may limit the number of available providers, misinform women of the risks of the procedures they are considering, overrule women’s and clinicians’ medical decision making, or require medically unnecessary services and delays in care.” Some laws “prohibit the abortion method that is most effective for a particular clinical circumstance” (for example, D&E).
Access to care varies widely geographically, and 17% of women must travel more than 50 miles to obtain an abortion. Regulations that required counseling, whether the woman desires counseling or not, are cited as an example of inferior patient-centered care.
The committee delineated safeguards that are necessary to manage emergencies that might arise from an abortion procedure, such as resuscitation and monitoring equipment to be located in a facility for procedures involving moderate and deep sedation. However, they did not find any evidence that it is necessary for clinicians performing abortions to have hospital admitting privileges. In the Whole Woman’s Health v. Hellerstedt decision in 2016, the U.S. Supreme Court ruled that the admitting privileges requirement in Texas was an undue burden on access to care. The committee wrote that it is sufficient for the facility to have an emergency transfer plan in place.
The committee also identified areas for further evaluation. First, whether the Food and Drug Administration should expand the distribution of mifepristone, the only drug currently approved for medication abortions, but which can only be dispensed to patients in clinics, hospitals, or medical offices under the supervision of a certified prescriber. The committee also called for examining more effective methods of pain management, whether advanced practice clinicians can be trained to perform D&Es, and ways to provide more social and psychological supports for lower-income women or who are at risk of intimate partner or other forms of violence.
FDA approves new injection product to reduce preterm birth risk
Makena, a progestin injection for the prevention of preterm birth that has been approved for use since 2011, has received U.S. Food and Drug Administration approval for a subcutaneous auto-injection product to supplant its intramuscular injection formulation, announced its manufacturer, AMAG Pharmaceuticals, on Feb. 14.
The intramuscular injection’s 7-year orphan drug exclusivity expired earlier in February. AMAG plans to offer both products priced at parity, according to the company’s press release. The newer product has a smaller, thinner needle. Both products are intended for use in a woman who has a singleton pregnancy of less than 37 weeks’ gestation and who has had a prior spontaneous preterm singleton delivery. The intramuscular injection is available in both single-dose and multidose vials.
Makena revenues in 2017 were nearly $400 million. The drug was the subject of a price controversy in 2011 under its maker at the time, KV Pharmaceutical, which subsequently cut the price by more than half.
The injection has several contraindications, including blood clots and hormone-sensitive cancers. Its efficacy is based on an improved number of women who used it and were delivered at more than 37 weeks’ gestation rather than on a directly demonstrated clinical benefit in neonatal morbidity or mortality.
Read more in AMAG’s press release.
Makena, a progestin injection for the prevention of preterm birth that has been approved for use since 2011, has received U.S. Food and Drug Administration approval for a subcutaneous auto-injection product to supplant its intramuscular injection formulation, announced its manufacturer, AMAG Pharmaceuticals, on Feb. 14.
The intramuscular injection’s 7-year orphan drug exclusivity expired earlier in February. AMAG plans to offer both products priced at parity, according to the company’s press release. The newer product has a smaller, thinner needle. Both products are intended for use in a woman who has a singleton pregnancy of less than 37 weeks’ gestation and who has had a prior spontaneous preterm singleton delivery. The intramuscular injection is available in both single-dose and multidose vials.
Makena revenues in 2017 were nearly $400 million. The drug was the subject of a price controversy in 2011 under its maker at the time, KV Pharmaceutical, which subsequently cut the price by more than half.
The injection has several contraindications, including blood clots and hormone-sensitive cancers. Its efficacy is based on an improved number of women who used it and were delivered at more than 37 weeks’ gestation rather than on a directly demonstrated clinical benefit in neonatal morbidity or mortality.
Read more in AMAG’s press release.
Makena, a progestin injection for the prevention of preterm birth that has been approved for use since 2011, has received U.S. Food and Drug Administration approval for a subcutaneous auto-injection product to supplant its intramuscular injection formulation, announced its manufacturer, AMAG Pharmaceuticals, on Feb. 14.
The intramuscular injection’s 7-year orphan drug exclusivity expired earlier in February. AMAG plans to offer both products priced at parity, according to the company’s press release. The newer product has a smaller, thinner needle. Both products are intended for use in a woman who has a singleton pregnancy of less than 37 weeks’ gestation and who has had a prior spontaneous preterm singleton delivery. The intramuscular injection is available in both single-dose and multidose vials.
Makena revenues in 2017 were nearly $400 million. The drug was the subject of a price controversy in 2011 under its maker at the time, KV Pharmaceutical, which subsequently cut the price by more than half.
The injection has several contraindications, including blood clots and hormone-sensitive cancers. Its efficacy is based on an improved number of women who used it and were delivered at more than 37 weeks’ gestation rather than on a directly demonstrated clinical benefit in neonatal morbidity or mortality.
Read more in AMAG’s press release.
FDA approves new HPV assay
Manufacturer Becton Dickinson announced on Feb. 13 that it had received premarket approval from the U.S. Food and Drug Administration for a human papillomavirus (HPV) assay.
The Onclarity assay detects 14 types of high-risk HPV from specimens collected from cervical cancer screening via a SurePath liquid-based Pap test. It has previously been approved in Europe, Canada, and Japan. The bench-top molecular testing platform used for the assay has received prior FDA approval for chlamydia and gonorrhea infection testing.
The assay in particular identifies the HPV genotypes 16, 18, and 45, which are associated with more than two-thirds of cervical cancers and precancerous cervical lesions and as many as 94% of glandular cervical cancer cases.
Manufacturer Becton Dickinson announced on Feb. 13 that it had received premarket approval from the U.S. Food and Drug Administration for a human papillomavirus (HPV) assay.
The Onclarity assay detects 14 types of high-risk HPV from specimens collected from cervical cancer screening via a SurePath liquid-based Pap test. It has previously been approved in Europe, Canada, and Japan. The bench-top molecular testing platform used for the assay has received prior FDA approval for chlamydia and gonorrhea infection testing.
The assay in particular identifies the HPV genotypes 16, 18, and 45, which are associated with more than two-thirds of cervical cancers and precancerous cervical lesions and as many as 94% of glandular cervical cancer cases.
Manufacturer Becton Dickinson announced on Feb. 13 that it had received premarket approval from the U.S. Food and Drug Administration for a human papillomavirus (HPV) assay.
The Onclarity assay detects 14 types of high-risk HPV from specimens collected from cervical cancer screening via a SurePath liquid-based Pap test. It has previously been approved in Europe, Canada, and Japan. The bench-top molecular testing platform used for the assay has received prior FDA approval for chlamydia and gonorrhea infection testing.
The assay in particular identifies the HPV genotypes 16, 18, and 45, which are associated with more than two-thirds of cervical cancers and precancerous cervical lesions and as many as 94% of glandular cervical cancer cases.
Study seeks optimal duration of second stage of labor
, according to researchers.
The researchers performed a retrospective analysis of more than 103,000 pregnancies from the Consortium on Safe Labor, a study of electronic medical records from 12 U.S. sites from 2002 to 2008, according to a study published in Obstetrics & Gynecology.
The duration of the second stage was calculated from the time of 10-cm cervical dilation to the time of birth. The researchers stratified the results into nulliparous women who did or did not receive an epidural, and multiparous women who did or did not receive an epidural.
For nulliparous women, rates of spontaneous vaginal birth (rather than operative vaginal birth or cesarean delivery) without morbidity increased slightly in the second half-hour over the first, then decreased. Rates decreased steadily for multiparous women. Both decreases occurred regardless of epidural status. Deliveries with morbidity varied, to as high as a 12.3% likelihood that a nulliparous woman with an epidural would deliver with maternal or neonatal morbidity or mortality between 3 hours’ and 6 hours’ second-stage duration.
The researchers noted the various society recommendations for when to diagnose second-stage arrest, but concluded: “In our study, we did not observe an inflection at a particular hour mark. ... Ultimately the willingness to accept a certain percentage risk of morbidity to achieve vaginal delivery is up to the woman and clinician.”
The authors reported having no disclosures.
SOURCE: Grantz KL et al. Obstet Gynecol. 2018 Feb;131(2):345-53.
, according to researchers.
The researchers performed a retrospective analysis of more than 103,000 pregnancies from the Consortium on Safe Labor, a study of electronic medical records from 12 U.S. sites from 2002 to 2008, according to a study published in Obstetrics & Gynecology.
The duration of the second stage was calculated from the time of 10-cm cervical dilation to the time of birth. The researchers stratified the results into nulliparous women who did or did not receive an epidural, and multiparous women who did or did not receive an epidural.
For nulliparous women, rates of spontaneous vaginal birth (rather than operative vaginal birth or cesarean delivery) without morbidity increased slightly in the second half-hour over the first, then decreased. Rates decreased steadily for multiparous women. Both decreases occurred regardless of epidural status. Deliveries with morbidity varied, to as high as a 12.3% likelihood that a nulliparous woman with an epidural would deliver with maternal or neonatal morbidity or mortality between 3 hours’ and 6 hours’ second-stage duration.
The researchers noted the various society recommendations for when to diagnose second-stage arrest, but concluded: “In our study, we did not observe an inflection at a particular hour mark. ... Ultimately the willingness to accept a certain percentage risk of morbidity to achieve vaginal delivery is up to the woman and clinician.”
The authors reported having no disclosures.
SOURCE: Grantz KL et al. Obstet Gynecol. 2018 Feb;131(2):345-53.
, according to researchers.
The researchers performed a retrospective analysis of more than 103,000 pregnancies from the Consortium on Safe Labor, a study of electronic medical records from 12 U.S. sites from 2002 to 2008, according to a study published in Obstetrics & Gynecology.
The duration of the second stage was calculated from the time of 10-cm cervical dilation to the time of birth. The researchers stratified the results into nulliparous women who did or did not receive an epidural, and multiparous women who did or did not receive an epidural.
For nulliparous women, rates of spontaneous vaginal birth (rather than operative vaginal birth or cesarean delivery) without morbidity increased slightly in the second half-hour over the first, then decreased. Rates decreased steadily for multiparous women. Both decreases occurred regardless of epidural status. Deliveries with morbidity varied, to as high as a 12.3% likelihood that a nulliparous woman with an epidural would deliver with maternal or neonatal morbidity or mortality between 3 hours’ and 6 hours’ second-stage duration.
The researchers noted the various society recommendations for when to diagnose second-stage arrest, but concluded: “In our study, we did not observe an inflection at a particular hour mark. ... Ultimately the willingness to accept a certain percentage risk of morbidity to achieve vaginal delivery is up to the woman and clinician.”
The authors reported having no disclosures.
SOURCE: Grantz KL et al. Obstet Gynecol. 2018 Feb;131(2):345-53.
FROM OBSTETRICS & GYNECOLOGY
Ambulatory BP monitoring shows hypertension prevalence 1 year after preeclampsia
as it misses forms of hypertension commonly experienced in that population, according to a study published Feb. 5 in Hypertension.
Researchers at Erasmus University, Rotterdam, the Netherlands, conducted a retrospective cohort study of 200 women who underwent 24-hour ambulatory BP monitoring and office BP measurement at a 1-year follow-up for delivery with severe preeclampsia. Measurements were taken between 9 months and 15 months after delivery.
“Current clinical guidelines on the prevention of [cardiovascular disease] and stroke after a hypertensive pregnancy disorder lack advice on [ambulatory BP monitoring] after delivery. We think that [ambulatory BP monitoring] should be offered to all women who experienced severe preeclampsia for more accurate BP assessment,” wrote Laura Benschop, MD, and her coauthors.
SOURCE: Benschop L et al. Hypertension. 2018 Feb;71:491-8.
as it misses forms of hypertension commonly experienced in that population, according to a study published Feb. 5 in Hypertension.
Researchers at Erasmus University, Rotterdam, the Netherlands, conducted a retrospective cohort study of 200 women who underwent 24-hour ambulatory BP monitoring and office BP measurement at a 1-year follow-up for delivery with severe preeclampsia. Measurements were taken between 9 months and 15 months after delivery.
“Current clinical guidelines on the prevention of [cardiovascular disease] and stroke after a hypertensive pregnancy disorder lack advice on [ambulatory BP monitoring] after delivery. We think that [ambulatory BP monitoring] should be offered to all women who experienced severe preeclampsia for more accurate BP assessment,” wrote Laura Benschop, MD, and her coauthors.
SOURCE: Benschop L et al. Hypertension. 2018 Feb;71:491-8.
as it misses forms of hypertension commonly experienced in that population, according to a study published Feb. 5 in Hypertension.
Researchers at Erasmus University, Rotterdam, the Netherlands, conducted a retrospective cohort study of 200 women who underwent 24-hour ambulatory BP monitoring and office BP measurement at a 1-year follow-up for delivery with severe preeclampsia. Measurements were taken between 9 months and 15 months after delivery.
“Current clinical guidelines on the prevention of [cardiovascular disease] and stroke after a hypertensive pregnancy disorder lack advice on [ambulatory BP monitoring] after delivery. We think that [ambulatory BP monitoring] should be offered to all women who experienced severe preeclampsia for more accurate BP assessment,” wrote Laura Benschop, MD, and her coauthors.
SOURCE: Benschop L et al. Hypertension. 2018 Feb;71:491-8.
FROM HYPERTENSION
USPSTF: Screen all pregnant women for syphilis
The U.S. Preventive Services Task Force issued a draft recommendation that all pregnant women be screened for syphilis infection.
The recommendation, released Feb. 6, follows an evidence review of studies conducted since the task force’s most recent recommendation in 2009, which also called for universal screening of pregnant women.
“Despite consistent recommendations and legal mandates, screening for syphilis in pregnancy continues to be suboptimal in certain populations,” the evidence review noted. The rate of congenital syphilis in the United States nearly doubled from 2012 to 2016.
“Because the early stages of syphilis often don’t cause any symptoms, screening helps identify the infection in pregnant women who may not realize they have the disease,” task force member Chien-Wen Tseng, MD, of the University of Hawaii, said in a statement.
Treatment is most effective early in pregnancy, and can reduce the chances of congenital syphilis. The draft recommendation calls for pregnant women to be tested at the first prenatal visit or at delivery, if the woman has not received prenatal care.
Comments can be submitted until March 5 at www.uspreventiveservicestaskforce.org/tfcomment.htm.
dwatson@frontlinemedcom.com
The U.S. Preventive Services Task Force issued a draft recommendation that all pregnant women be screened for syphilis infection.
The recommendation, released Feb. 6, follows an evidence review of studies conducted since the task force’s most recent recommendation in 2009, which also called for universal screening of pregnant women.
“Despite consistent recommendations and legal mandates, screening for syphilis in pregnancy continues to be suboptimal in certain populations,” the evidence review noted. The rate of congenital syphilis in the United States nearly doubled from 2012 to 2016.
“Because the early stages of syphilis often don’t cause any symptoms, screening helps identify the infection in pregnant women who may not realize they have the disease,” task force member Chien-Wen Tseng, MD, of the University of Hawaii, said in a statement.
Treatment is most effective early in pregnancy, and can reduce the chances of congenital syphilis. The draft recommendation calls for pregnant women to be tested at the first prenatal visit or at delivery, if the woman has not received prenatal care.
Comments can be submitted until March 5 at www.uspreventiveservicestaskforce.org/tfcomment.htm.
dwatson@frontlinemedcom.com
The U.S. Preventive Services Task Force issued a draft recommendation that all pregnant women be screened for syphilis infection.
The recommendation, released Feb. 6, follows an evidence review of studies conducted since the task force’s most recent recommendation in 2009, which also called for universal screening of pregnant women.
“Despite consistent recommendations and legal mandates, screening for syphilis in pregnancy continues to be suboptimal in certain populations,” the evidence review noted. The rate of congenital syphilis in the United States nearly doubled from 2012 to 2016.
“Because the early stages of syphilis often don’t cause any symptoms, screening helps identify the infection in pregnant women who may not realize they have the disease,” task force member Chien-Wen Tseng, MD, of the University of Hawaii, said in a statement.
Treatment is most effective early in pregnancy, and can reduce the chances of congenital syphilis. The draft recommendation calls for pregnant women to be tested at the first prenatal visit or at delivery, if the woman has not received prenatal care.
Comments can be submitted until March 5 at www.uspreventiveservicestaskforce.org/tfcomment.htm.
dwatson@frontlinemedcom.com
FDA recommends voluntary recall of Limbrel
The Food and Drug Administration announced on Dec. 4 that it recommends the voluntary recall of Limbrel, a medical food product in capsule form that is currently marketed to “manage the metabolic processes associated with osteoarthritis.”
The FDA’s ongoing investigation at this point considers the product to be an unapproved new drug rather than a medical food product. However, the agency does not have mandatory recall authority. It has recommended the recall to the product’s manufacturer, Primus Pharmaceuticals, on the basis of the risk of liver injury and hypersensitivity pneumonitis associated with continued use of the product.
The agency had received 194 adverse event reports as of Nov. 21, of which it found a likely association of the events with Limbrel in at least 30 cases, and continues to evaluate reports, which consumers can submit through MedWatch. The FDA is currently testing samples of the product and has advised consumers to cease taking it, though the manufacturer has declined thus far to recall it.
The safety alert advises that “health care providers who are aware that their patients are taking Limbrel should advise them to immediately stop taking the product.”
The Food and Drug Administration announced on Dec. 4 that it recommends the voluntary recall of Limbrel, a medical food product in capsule form that is currently marketed to “manage the metabolic processes associated with osteoarthritis.”
The FDA’s ongoing investigation at this point considers the product to be an unapproved new drug rather than a medical food product. However, the agency does not have mandatory recall authority. It has recommended the recall to the product’s manufacturer, Primus Pharmaceuticals, on the basis of the risk of liver injury and hypersensitivity pneumonitis associated with continued use of the product.
The agency had received 194 adverse event reports as of Nov. 21, of which it found a likely association of the events with Limbrel in at least 30 cases, and continues to evaluate reports, which consumers can submit through MedWatch. The FDA is currently testing samples of the product and has advised consumers to cease taking it, though the manufacturer has declined thus far to recall it.
The safety alert advises that “health care providers who are aware that their patients are taking Limbrel should advise them to immediately stop taking the product.”
The Food and Drug Administration announced on Dec. 4 that it recommends the voluntary recall of Limbrel, a medical food product in capsule form that is currently marketed to “manage the metabolic processes associated with osteoarthritis.”
The FDA’s ongoing investigation at this point considers the product to be an unapproved new drug rather than a medical food product. However, the agency does not have mandatory recall authority. It has recommended the recall to the product’s manufacturer, Primus Pharmaceuticals, on the basis of the risk of liver injury and hypersensitivity pneumonitis associated with continued use of the product.
The agency had received 194 adverse event reports as of Nov. 21, of which it found a likely association of the events with Limbrel in at least 30 cases, and continues to evaluate reports, which consumers can submit through MedWatch. The FDA is currently testing samples of the product and has advised consumers to cease taking it, though the manufacturer has declined thus far to recall it.
The safety alert advises that “health care providers who are aware that their patients are taking Limbrel should advise them to immediately stop taking the product.”
Consider calcipotriol contact allergy when psoriasis doesn’t improve
Researchers at the University of Leuven (Belgium) conducted patch tests on six patients between 2004 and 2016 who presented with psoriasis that did not improve with use of topical calcipotriol.
Reports of contact allergy to calcipotriol are rare in the literature, considering its widespread use. However, the patch testing and successful alternative treatment confirmed the diagnosis of allergic contact dermatitis in all six cases.
“The lesions improved following replacement of calcipotriol therapy with topical corticosteroids and/or oral medication,” wrote An Goossens, MD, of the contact allergy unit in the department of dermatology at the university.
Five of the patients were adults ranging in age from 26 to 59 years (two men and three women), and the sixth was a 10-year-old girl. They all had lesions on their feet, scalp, or hands.
The successful patch test consisted of a 2 mcg/mL solution of calcipotriol in citrate-buffered isopropanol.
Patients who are diagnosed with this specific allergy may be able to tolerate treatment with a different topical vitamin D analog such as tacalcitol (Contact Derm. 2017 Nov. doi: 10.1111/cod.12910).
Researchers at the University of Leuven (Belgium) conducted patch tests on six patients between 2004 and 2016 who presented with psoriasis that did not improve with use of topical calcipotriol.
Reports of contact allergy to calcipotriol are rare in the literature, considering its widespread use. However, the patch testing and successful alternative treatment confirmed the diagnosis of allergic contact dermatitis in all six cases.
“The lesions improved following replacement of calcipotriol therapy with topical corticosteroids and/or oral medication,” wrote An Goossens, MD, of the contact allergy unit in the department of dermatology at the university.
Five of the patients were adults ranging in age from 26 to 59 years (two men and three women), and the sixth was a 10-year-old girl. They all had lesions on their feet, scalp, or hands.
The successful patch test consisted of a 2 mcg/mL solution of calcipotriol in citrate-buffered isopropanol.
Patients who are diagnosed with this specific allergy may be able to tolerate treatment with a different topical vitamin D analog such as tacalcitol (Contact Derm. 2017 Nov. doi: 10.1111/cod.12910).
Researchers at the University of Leuven (Belgium) conducted patch tests on six patients between 2004 and 2016 who presented with psoriasis that did not improve with use of topical calcipotriol.
Reports of contact allergy to calcipotriol are rare in the literature, considering its widespread use. However, the patch testing and successful alternative treatment confirmed the diagnosis of allergic contact dermatitis in all six cases.
“The lesions improved following replacement of calcipotriol therapy with topical corticosteroids and/or oral medication,” wrote An Goossens, MD, of the contact allergy unit in the department of dermatology at the university.
Five of the patients were adults ranging in age from 26 to 59 years (two men and three women), and the sixth was a 10-year-old girl. They all had lesions on their feet, scalp, or hands.
The successful patch test consisted of a 2 mcg/mL solution of calcipotriol in citrate-buffered isopropanol.
Patients who are diagnosed with this specific allergy may be able to tolerate treatment with a different topical vitamin D analog such as tacalcitol (Contact Derm. 2017 Nov. doi: 10.1111/cod.12910).
FROM CONTACT DERMATITIS