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FDA Guide on Antidepressants Offers Challenges : Complying with schedule in agency's medication guide 'almost impossible' for first 12 weeks.


 

MONTREAL – Prescribing antidepressants to children comes with its own set of challenges, Dr. Neil S. Kaye said at the annual meeting of the American Academy of Psychiatry and the Law.

For one thing, it's difficult to comply with the visit schedule suggested by the Food and Drug Administration, said Dr. Kaye, a psychiatrist in private practice in Wilmington, Del.

The agency's “Medication Guide: About Using Antidepressants in Children and Teenagers” recommends: “After starting an antidepressant, your child should generally see his or her health care provider:

▸ Once a week for the first 4 weeks.

▸ Every 2 weeks for the next 4 weeks.

▸ After taking the antidepressant for 12 weeks.

▸ More often if problems or questions arise.”

After 12 weeks, “we get to become providers again,” Dr. Kaye said, noting that the visit schedule goes back to whatever the physician thinks is appropriate.

“You'll see it's almost impossible to comply” with that schedule for the first 12 weeks, Dr. Kaye said. “Nobody has enough time slots; there aren't enough doctors available; and managed care does not really want to pay for that.”

Dr. Kaye wrote to one senator complaining about the recommendations. “He said … his office's view after contacting the FDA was that the FDA didn't really intend for that to be what is said and done, even though it's what they've written,” Dr. Kaye said.

Doctors need to make themselves available to parents whose children are taking these drugs, Dr. Kaye continued. “When you look at cases that have been litigated, one of the major issues is doctors and their staffs not returning phone calls in a timely manner,” he said.

“That breeds anger, that breeds malpractice, that breeds bad outcomes. We need to return patients' [and parents'] calls. It sounds simple, but it needs to be said.”

Physicians also need to alert parents that their children may get worse initially, “either because of the drug or because the drug has not yet started and the disorder is still going on,” he said.

“And we need to let everyone know what [side effects] to watch for,” including akathisias, restlessness, and induction of hypomania.

Dr. Kaye noted that the media have really jumped on the story of problems with prescribing antidepressants. “As of Sept. 8, there were more than 3.6 million Internet articles on this topic,” he said. “This is hot.”

Unfortunately, the media have done an effective job of scaring people away from antidepressants, according to Dr. Kaye, who has consulting arrangements with many pharmaceutical companies.

“Twenty-five percent of people surveyed say that antidepressants are harmful to someone who's depressed and suicidal,” Dr. Kaye said. “That's a big number of people who will be driven away from what could be life-saving treatment because of the hype and what the media has done.”

How have physicians responded to the hype? “We're scared,” he said, noting that there has been a big drop in the number of antidepressants being prescribed.

And the number of doctors willing to prescribe them seems to be decreasing as well.

“Pediatricians and primary care doctors are saying, 'This is too litigious; we're not going near this–you have to see a specialist,' Dr. Kaye said. “And of course there aren't enough psychiatrists to take on those patients in a timely manner, so a crisis is being developed, without a doubt.”

A study released last year by Medco Health Systems Inc., the pharmacy benefit manager, showed a 10% dropoff in prescribing antidepressants for patients younger than 18 years in 2004.

Medco reported that no difference was seen in the dropoff rate between primary care physicians and psychiatrists.

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