For the second time in the past two months, a pharmaceutical company is warning that an anti-depressant drug should not be prescribed to children because it may cause suicidal thoughts or self-harm.
Wyeth Pharmaceuticals Inc., based in New Jersey, has sent a letter to health care professionals across the country warning of possible problems with giving Effexor to children.
In a two-page letter dated Aug. 22, Dr. Victoria Kusiak, Wyeth’s vice president for global medical affairs, warned that in recent clinical trials Effexor was not effective in treating depression or anxiety and that there were increased “reports of hostility and especially in Major Depressive Disorder, suicide-related adverse events such as suicidal ideation and self-harm.”
In June, British drug manufacturer GlaxoSmithKline sent letters to doctors in Britain and Ireland warning of a similar concern with its well-known anti-depressant, Paxil. Officials at the U.S. Food and Drug Administration then advised American doctors not to prescribe Paxilfor children, citing unpublished studies done by Glaxo indicating that the drug increases suicidal thinking among adolescents.
Effexor is used to treat depression and bipolar disorder and is similar to Paxil, Prozac and Zoloft.
Wyeth spokesman Douglas Petkus said the company decided to notify health care professionals as a precaution.
“Companies typically don’t release data that is sent to the FDA, but in this case we felt it was important for physicians to be aware of the studies because we know it is being prescribed to children,” Petkus said.
Petkus said the company is still doing clinical trials on adolescents. He would not say if Wyeth is trying to obtain FDA approval to give Effexor to children. Even though the drugs aren’t approved for children, many doctors prescribe the anti-depressants to them because they have used them successfully with adult patients.
In the late 1990s, the FDA offered drug makers a six-month extension on the patents for certain drugs, including anti-depressants, if the companies were willing to do clinical trials of their effects on children, said FDA spokesman Brad Stone.
So far, the makers of Effexor and Paxil are the only two manufacturers of anti-depressants who have submitted data pointing to a potential link between their drugs and increased thought of suicide in teens, Stone said.
The FDA originally approved Effexor for use in adults in December of 1993. It is one of the company’s bestselling drugs.
In its letter, Wyeth points out that there were no suicides in the clinical trials. The studies were done on children and teenagers 6 to 17. Wyeth did not say how large the study group was.
But the studies did show that when it comes to having suicidal thoughts, 2 percent of those on Effexor had them, compared with none on the placebo. With hostility or aggressive behavior, the numbers were 2 percent on Effexor and 1 percent on a placebo.
Those numbers are similar to GlaxoSmithKline’s studies on Paxil, which doesn’t surprise some experts.
“There’s no reason why Paxil should be any different than other drugs in this class. If they analyzed them all the same way, they would likely get similar results,” said Dr. Irving Kirsch, a professor of psychology at the University of Connecticut. Kirsch has done several studies on the effects of anti-depressant drugs on adults.
Others said the company may be sending out a notice now because the FDA is taking a closer look at anti-depressants and their effects on children after the Paxil studies.
“I doubt the company would have sent this out without some pressure from the FDA,” said Dr. Leigh Thompson, a former top scientist who was involved at Eli Lilly with getting Prozac approved by the FDA.
Thompson runs his own consulting business assisting drug companies in winning FDA approval.
“This is now two drugs in this class that seem to have problems when it comes to children,” Thompson said. “I think you’ll see the FDA look closely at this whole field.”
Just as Glaxo did with Paxil, Wyeth officials cautioned that Effexor is not FDA-approved for children.
“You may need to reassess the benefit-risk balance when treating individual patients,” the letter states. “If a decision is made to discontinue a patient from Effexor, treatment should not be discontinued abruptly due to risk of discontinuation symptoms.”