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Michele B. Kaufman, PharmD, BSc, RPh

New Generic

  • Perindopril erbumine tablets (generic Aceon)1

New Drugs, Indications, Dosage Forms, and Approval Recommendations

  • Collagenase clostridium histolytica injection (Xiaflex) has been approved by the FDA for treating the hand disease Dupuytren’s contracture. The agent breaks down excessive collagen in the hand, allowing patients to straighten the arm and have proper use of their fingers. The agent is also being studied to treat Peyronie’s disease.2

  • Dalfampridine tablets (Ampyra) have been approved by the FDA to improve walking in patients with multiple sclerosis (MS).3 Seizures might occur in patients who exceed the recommended daily dose of 10 mg twice daily, or in patients with moderate to severe kidney disease. Therefore, caution is advised in these patients.

  • Iloperidone tablets (Fanapt) have been approved by the FDA for the acute treatment of schizophrenia in adults.4 An atypical antipsychotic, it is a mixed dopamine D2/serotonin 5HT2A receptor antagonist.

  • Lamotrigine extended-release tablets (Lamictal XR) have received a new FDA-approved indication for once-daily, add-on therapy for epilepsy in patients 13 years and older, with primary, generalized tonic-clonic seizures.5

  • Liraglutide (Victoza) has been approved by the FDA as a once-daily injection for the treatment of Type 2 diabetes mellitus.6 Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is similar to exenatide. There is a label warning related to thyroid tumors that occurred in rats and mice. It is unclear whether medullary thyroid cancer will occur in adults; therefore, the agent should not be used in patients who already have this cancer or those with a family history of thyroid cancer.

  • Trazodone extended-release tablets (Oleptro) have been approved by the FDA for treating major depressive disorder in adults.7 This product is formulated using Labopharm’s proprietary Contramid long-acting drug delivery system. The product will be available later this year.

Safety Information

  • Didanosine (Videx/Videx EC) has undergone a label change in the warning and precautions sections related to the rare but serious complication of noncirrhotic portal hypertension. The label change was added because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices. A number of well-documented, postmarketing reports of this reaction were made following exclusion of other portal hypertension causes.8

  • Long-acting beta-agonists (LABAs), formoterol (Foradil), and salmeterol (Sereven) are required to have a risk management strategy (REMS) and a revised medication guide written specifically for patients. The goal is to educate patients about the appropriate use of LABAs. There also is a plan to educate healthcare professionals about the appropriate use of LABAs.9,10 This update is due to continued analysis of studies that show increased risk of severe asthma exacerbations, which lead to hospitalizations in adult and pediatric patients, including deaths in some LABA-utilizing patients. To safely use LABAs, the following need to be considered:

  • Single-ingredient LABAs should not be used as monotherapy; they should only be used in combination with an asthma controller;

  • LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controllers;

  • Use an LABA for the shortest duration required to achieve asthma control and discontinue it, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller; and

  • Use a combination product containing both an inhaled corticosteroid and an LABA to enhance adherence in pediatric and adolescent patients who require both of these classes to manage their asthma.

  • Olanzapine (Zyprexa) has undergone a label change related to its indications for use in adolescents ages 13-17 for treating schizophrenia and bipolar I disorder (manic or mixed episodes).11 The new label asks providers to consider alternative treatments in this patient population due to the increased potential for weight gain and hyperlipidemia. Additionally, the effectiveness and safety of this agent have not been determined in patients under 13.

  • Sibutramine (Meridia), marketed for weight loss, continues to be evaluated for safety.12 A recent review found it poses an increased risk of heart attack and stroke in patients with a history of cardiovascular disease. Although the product label already had a warning related to use in patients with cardiovascular disease, the manufacturer has added a new contraindication to the sibutramine label for patients with cardiovascular disease and a history of: 1) coronary artery disease; 2) stroke or transient ischemic attack; 3) arrhythmias; 4) congestive heart failure; 5) peripheral arterial disease; and/or 6) uncontrolled hypertension (e.g., >145/90 mmHg). Providers should monitor blood pressure and heart rate regularly. If there is an unremitting increase in blood pressure and/or heart rate, sibutramine should be discontinued. Sibutramine should also be stopped in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment.13TH

 

 

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

  1. Lupin receives US FDA approval for Perindopril erbumine tablets. Lupin Web site. Available at: http://www.lupinworld.com/28jan10.htm. Accessed Feb. 22, 2010.

  2. US FDA approves Auxilium drug for hand disease. Reuters Web site. Available at: http://www.reuters.com/article/idUSN0211921420100203. Accessed Feb. 22, 2010.

  3. Petrochko C. MS walking drug gets FDA nod. MedPage Today Web site. Available at: http://www.medpagetoday.com/Neurology/MultipleSclerosis/18112. Accessed Feb. 22, 2010.

  4. Fanapt available for acute schizophrenia. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fanapt-available-for-acute-schizophrenia/article/160985/. Accessed Feb. 22, 2010.

  5. FDA approves once-a-day Lamictal XR as add-on epilepsy therapy for primary generalized tonic-clonic seizures. Available at: http://www.medicalnewstoday.com/articles/177796.php. Accessed Feb. 22, 2010.

  6. FDA approves new treatment for Type 2 diabetes. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198638.htm. Accessed Feb. 22, 2010.

  7. Labopharm receives FDA approval for Oleptro. PR Newswire Web site. Available at: http://www.prnewswire.com/news-releases/labopharm-receives-fda-approval-for-oleptrotm-83429037.html. Accessed Feb. 22, 2010.

  8. Videx/Videx EC (didanosine): Labeling revision—risk of non-cirrhotic portal hypertension. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm. Accessed Feb. 22, 2010.

  9. Long-acting beta-agonists (LABAs): new safe use requirements. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201003.htm. Accessed Feb. 22, 2010.

  10. Gever J. FDA says LABA asthma drugs not safe for solo use. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18552. Accessed Feb. 22, 2010.

  11. Zyprexa (olanzapine): use in adolescents. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198402.htm. Accessed Feb. 22, 2010.

  12. Follow-up to the November 2009 early communication about an ongoing safety review of sibutramine, marketed as Meridia. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm198206.htm. Accessed Feb. 21, 2010.

  13. Petrochko C. FDA adds cardio warnings to weight-loss drug. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18088?. Accessed Feb. 22, 2010.

Issue
The Hospitalist - 2010(05)
Publications
The Hospitalist
Sections
Patient Care
Guidelines
Career
Clinical
All Content
Author(s)
Michele B. Kaufman, PharmD, BSc, RPh
Author(s)
Michele B. Kaufman, PharmD, BSc, RPh

New Generic

  • Perindopril erbumine tablets (generic Aceon)1

New Drugs, Indications, Dosage Forms, and Approval Recommendations

  • Collagenase clostridium histolytica injection (Xiaflex) has been approved by the FDA for treating the hand disease Dupuytren’s contracture. The agent breaks down excessive collagen in the hand, allowing patients to straighten the arm and have proper use of their fingers. The agent is also being studied to treat Peyronie’s disease.2

  • Dalfampridine tablets (Ampyra) have been approved by the FDA to improve walking in patients with multiple sclerosis (MS).3 Seizures might occur in patients who exceed the recommended daily dose of 10 mg twice daily, or in patients with moderate to severe kidney disease. Therefore, caution is advised in these patients.

  • Iloperidone tablets (Fanapt) have been approved by the FDA for the acute treatment of schizophrenia in adults.4 An atypical antipsychotic, it is a mixed dopamine D2/serotonin 5HT2A receptor antagonist.

  • Lamotrigine extended-release tablets (Lamictal XR) have received a new FDA-approved indication for once-daily, add-on therapy for epilepsy in patients 13 years and older, with primary, generalized tonic-clonic seizures.5

  • Liraglutide (Victoza) has been approved by the FDA as a once-daily injection for the treatment of Type 2 diabetes mellitus.6 Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is similar to exenatide. There is a label warning related to thyroid tumors that occurred in rats and mice. It is unclear whether medullary thyroid cancer will occur in adults; therefore, the agent should not be used in patients who already have this cancer or those with a family history of thyroid cancer.

  • Trazodone extended-release tablets (Oleptro) have been approved by the FDA for treating major depressive disorder in adults.7 This product is formulated using Labopharm’s proprietary Contramid long-acting drug delivery system. The product will be available later this year.

Safety Information

  • Didanosine (Videx/Videx EC) has undergone a label change in the warning and precautions sections related to the rare but serious complication of noncirrhotic portal hypertension. The label change was added because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices. A number of well-documented, postmarketing reports of this reaction were made following exclusion of other portal hypertension causes.8

  • Long-acting beta-agonists (LABAs), formoterol (Foradil), and salmeterol (Sereven) are required to have a risk management strategy (REMS) and a revised medication guide written specifically for patients. The goal is to educate patients about the appropriate use of LABAs. There also is a plan to educate healthcare professionals about the appropriate use of LABAs.9,10 This update is due to continued analysis of studies that show increased risk of severe asthma exacerbations, which lead to hospitalizations in adult and pediatric patients, including deaths in some LABA-utilizing patients. To safely use LABAs, the following need to be considered:

  • Single-ingredient LABAs should not be used as monotherapy; they should only be used in combination with an asthma controller;

  • LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controllers;

  • Use an LABA for the shortest duration required to achieve asthma control and discontinue it, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller; and

  • Use a combination product containing both an inhaled corticosteroid and an LABA to enhance adherence in pediatric and adolescent patients who require both of these classes to manage their asthma.

  • Olanzapine (Zyprexa) has undergone a label change related to its indications for use in adolescents ages 13-17 for treating schizophrenia and bipolar I disorder (manic or mixed episodes).11 The new label asks providers to consider alternative treatments in this patient population due to the increased potential for weight gain and hyperlipidemia. Additionally, the effectiveness and safety of this agent have not been determined in patients under 13.

  • Sibutramine (Meridia), marketed for weight loss, continues to be evaluated for safety.12 A recent review found it poses an increased risk of heart attack and stroke in patients with a history of cardiovascular disease. Although the product label already had a warning related to use in patients with cardiovascular disease, the manufacturer has added a new contraindication to the sibutramine label for patients with cardiovascular disease and a history of: 1) coronary artery disease; 2) stroke or transient ischemic attack; 3) arrhythmias; 4) congestive heart failure; 5) peripheral arterial disease; and/or 6) uncontrolled hypertension (e.g., >145/90 mmHg). Providers should monitor blood pressure and heart rate regularly. If there is an unremitting increase in blood pressure and/or heart rate, sibutramine should be discontinued. Sibutramine should also be stopped in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment.13TH

 

 

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

  1. Lupin receives US FDA approval for Perindopril erbumine tablets. Lupin Web site. Available at: http://www.lupinworld.com/28jan10.htm. Accessed Feb. 22, 2010.

  2. US FDA approves Auxilium drug for hand disease. Reuters Web site. Available at: http://www.reuters.com/article/idUSN0211921420100203. Accessed Feb. 22, 2010.

  3. Petrochko C. MS walking drug gets FDA nod. MedPage Today Web site. Available at: http://www.medpagetoday.com/Neurology/MultipleSclerosis/18112. Accessed Feb. 22, 2010.

  4. Fanapt available for acute schizophrenia. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fanapt-available-for-acute-schizophrenia/article/160985/. Accessed Feb. 22, 2010.

  5. FDA approves once-a-day Lamictal XR as add-on epilepsy therapy for primary generalized tonic-clonic seizures. Available at: http://www.medicalnewstoday.com/articles/177796.php. Accessed Feb. 22, 2010.

  6. FDA approves new treatment for Type 2 diabetes. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198638.htm. Accessed Feb. 22, 2010.

  7. Labopharm receives FDA approval for Oleptro. PR Newswire Web site. Available at: http://www.prnewswire.com/news-releases/labopharm-receives-fda-approval-for-oleptrotm-83429037.html. Accessed Feb. 22, 2010.

  8. Videx/Videx EC (didanosine): Labeling revision—risk of non-cirrhotic portal hypertension. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm. Accessed Feb. 22, 2010.

  9. Long-acting beta-agonists (LABAs): new safe use requirements. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201003.htm. Accessed Feb. 22, 2010.

  10. Gever J. FDA says LABA asthma drugs not safe for solo use. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18552. Accessed Feb. 22, 2010.

  11. Zyprexa (olanzapine): use in adolescents. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198402.htm. Accessed Feb. 22, 2010.

  12. Follow-up to the November 2009 early communication about an ongoing safety review of sibutramine, marketed as Meridia. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm198206.htm. Accessed Feb. 21, 2010.

  13. Petrochko C. FDA adds cardio warnings to weight-loss drug. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18088?. Accessed Feb. 22, 2010.

New Generic

  • Perindopril erbumine tablets (generic Aceon)1

New Drugs, Indications, Dosage Forms, and Approval Recommendations

  • Collagenase clostridium histolytica injection (Xiaflex) has been approved by the FDA for treating the hand disease Dupuytren’s contracture. The agent breaks down excessive collagen in the hand, allowing patients to straighten the arm and have proper use of their fingers. The agent is also being studied to treat Peyronie’s disease.2

  • Dalfampridine tablets (Ampyra) have been approved by the FDA to improve walking in patients with multiple sclerosis (MS).3 Seizures might occur in patients who exceed the recommended daily dose of 10 mg twice daily, or in patients with moderate to severe kidney disease. Therefore, caution is advised in these patients.

  • Iloperidone tablets (Fanapt) have been approved by the FDA for the acute treatment of schizophrenia in adults.4 An atypical antipsychotic, it is a mixed dopamine D2/serotonin 5HT2A receptor antagonist.

  • Lamotrigine extended-release tablets (Lamictal XR) have received a new FDA-approved indication for once-daily, add-on therapy for epilepsy in patients 13 years and older, with primary, generalized tonic-clonic seizures.5

  • Liraglutide (Victoza) has been approved by the FDA as a once-daily injection for the treatment of Type 2 diabetes mellitus.6 Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is similar to exenatide. There is a label warning related to thyroid tumors that occurred in rats and mice. It is unclear whether medullary thyroid cancer will occur in adults; therefore, the agent should not be used in patients who already have this cancer or those with a family history of thyroid cancer.

  • Trazodone extended-release tablets (Oleptro) have been approved by the FDA for treating major depressive disorder in adults.7 This product is formulated using Labopharm’s proprietary Contramid long-acting drug delivery system. The product will be available later this year.

Safety Information

  • Didanosine (Videx/Videx EC) has undergone a label change in the warning and precautions sections related to the rare but serious complication of noncirrhotic portal hypertension. The label change was added because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices. A number of well-documented, postmarketing reports of this reaction were made following exclusion of other portal hypertension causes.8

  • Long-acting beta-agonists (LABAs), formoterol (Foradil), and salmeterol (Sereven) are required to have a risk management strategy (REMS) and a revised medication guide written specifically for patients. The goal is to educate patients about the appropriate use of LABAs. There also is a plan to educate healthcare professionals about the appropriate use of LABAs.9,10 This update is due to continued analysis of studies that show increased risk of severe asthma exacerbations, which lead to hospitalizations in adult and pediatric patients, including deaths in some LABA-utilizing patients. To safely use LABAs, the following need to be considered:

  • Single-ingredient LABAs should not be used as monotherapy; they should only be used in combination with an asthma controller;

  • LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controllers;

  • Use an LABA for the shortest duration required to achieve asthma control and discontinue it, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller; and

  • Use a combination product containing both an inhaled corticosteroid and an LABA to enhance adherence in pediatric and adolescent patients who require both of these classes to manage their asthma.

  • Olanzapine (Zyprexa) has undergone a label change related to its indications for use in adolescents ages 13-17 for treating schizophrenia and bipolar I disorder (manic or mixed episodes).11 The new label asks providers to consider alternative treatments in this patient population due to the increased potential for weight gain and hyperlipidemia. Additionally, the effectiveness and safety of this agent have not been determined in patients under 13.

  • Sibutramine (Meridia), marketed for weight loss, continues to be evaluated for safety.12 A recent review found it poses an increased risk of heart attack and stroke in patients with a history of cardiovascular disease. Although the product label already had a warning related to use in patients with cardiovascular disease, the manufacturer has added a new contraindication to the sibutramine label for patients with cardiovascular disease and a history of: 1) coronary artery disease; 2) stroke or transient ischemic attack; 3) arrhythmias; 4) congestive heart failure; 5) peripheral arterial disease; and/or 6) uncontrolled hypertension (e.g., >145/90 mmHg). Providers should monitor blood pressure and heart rate regularly. If there is an unremitting increase in blood pressure and/or heart rate, sibutramine should be discontinued. Sibutramine should also be stopped in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment.13TH

 

 

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

  1. Lupin receives US FDA approval for Perindopril erbumine tablets. Lupin Web site. Available at: http://www.lupinworld.com/28jan10.htm. Accessed Feb. 22, 2010.

  2. US FDA approves Auxilium drug for hand disease. Reuters Web site. Available at: http://www.reuters.com/article/idUSN0211921420100203. Accessed Feb. 22, 2010.

  3. Petrochko C. MS walking drug gets FDA nod. MedPage Today Web site. Available at: http://www.medpagetoday.com/Neurology/MultipleSclerosis/18112. Accessed Feb. 22, 2010.

  4. Fanapt available for acute schizophrenia. Monthly Prescribing Reference Web site. Available at: http://www.empr.com/fanapt-available-for-acute-schizophrenia/article/160985/. Accessed Feb. 22, 2010.

  5. FDA approves once-a-day Lamictal XR as add-on epilepsy therapy for primary generalized tonic-clonic seizures. Available at: http://www.medicalnewstoday.com/articles/177796.php. Accessed Feb. 22, 2010.

  6. FDA approves new treatment for Type 2 diabetes. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198638.htm. Accessed Feb. 22, 2010.

  7. Labopharm receives FDA approval for Oleptro. PR Newswire Web site. Available at: http://www.prnewswire.com/news-releases/labopharm-receives-fda-approval-for-oleptrotm-83429037.html. Accessed Feb. 22, 2010.

  8. Videx/Videx EC (didanosine): Labeling revision—risk of non-cirrhotic portal hypertension. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm. Accessed Feb. 22, 2010.

  9. Long-acting beta-agonists (LABAs): new safe use requirements. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201003.htm. Accessed Feb. 22, 2010.

  10. Gever J. FDA says LABA asthma drugs not safe for solo use. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18552. Accessed Feb. 22, 2010.

  11. Zyprexa (olanzapine): use in adolescents. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198402.htm. Accessed Feb. 22, 2010.

  12. Follow-up to the November 2009 early communication about an ongoing safety review of sibutramine, marketed as Meridia. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm198206.htm. Accessed Feb. 21, 2010.

  13. Petrochko C. FDA adds cardio warnings to weight-loss drug. MedPage Today Web site. Available at: http://www.medpagetoday.com/tbprint.cfm?tbid=18088?. Accessed Feb. 22, 2010.

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