Wyeth Cautions On Giving Antidepressant To ChildrenSep 4, 2003 | The Star-Ledger
Wyeth has become the second drug maker to warn doctors about prescribing antidepressants to children under 18, because the medications may increase the risk of suicide.
The Aug. 22 letter about Effexor, which is one of Wyeth's best-selling products, comes two months after regulators in the United States and Great Britain issued a similar warning about Paxil, an antidepressant sold by GlaxoSmithKline.
"In pediatric clinical trials, there were increased reports of hostility and, especially in major depressive disorder, suicide-related adverse events, such as suicidal ideation and self-harm," wrote Victoria Kusak, Wyeth's vice president of global medical affairs.
The Wyeth letter was unusual because "Dear Doctor" notices are generally sent to warn about risks associated with uses approved by regulators. Effexor was never approved for use in children. And unlike Wyeth, Glaxo hasn't sent a warning to doctors in this country.
The move comes as the Food and Drug Administration is considering additional restrictions on the use of antidepressants. As part of that effort, an agency spokeswoman yesterday said additional clinical-trial data is being sought from drug makers.
In studies of children ages 6 to 17, Wyeth found that 2 percent of those who were given Effexor considered suicide, compared with none given a placebo, or dummy pill. There were no cases of suicide reported.
A spokesman for the Madison-based drug maker, Doug Petkus, said the letter was issued strictly as a precaution. He declined to say how many studies involved children who were given Effexor or when those unpublished studies began. He did say they are ongoing.
One expert suggested Wyeth issued the letter to blunt criticism, especially after the safety questions raised last year about its hormone-replacement therapy and, earlier, its diet pills, which were withdrawn from the market.
"Wyeth had problems with other drugs and it's better to be open about it than to be forced by the FDA," said Arif Khan, medical director at the Northwest Clinical Research Center in Bellevue, Wash., which conducted studies of Effexor. "It's a good strategy."