Four years ago, Michelle Van Syckel was losing weight and having trouble adjusting to her new school.
Doctors diagnosed the then- 14-year-old with depression and prescribed different drugs over the next few months, her mother said. One was Paxil, a widely used antidepressant.
Later that year, though, she said her daughter became violent and attempted suicide. She blames the drug and its manufacturer, GlaxoSmithKline, arguing that such serious side effects can be caused by a group of medicines used by millions of Americans each year.
“She used knives, scissors, razor blades. Her personality changed,” said her mother, Lisa Van Syckel of Flemington, N.J., who filed a lawsuit against Glaxo. “You don’t go from being an honor roll student who gives you hugs to someone who’s violent and thinks you’re the devil within a few weeks.”
Numerous other lawsuits have been filed against several drug makers that sell antidepressants. Also known as SSRIs selective serotonin reuptake inhibitors these pills include Pfizer’s Zoloft, Eli Lilly’s Prozac and Wyeth’s Effexor. Last year, the retail market for the drugs was $11.3 billion, according to Verispan, a market research firm.
Concerns have lingered ever since a 1990 study in the American Journal of Psychiatry reported that some patients became suicidal after taking Prozac. But the companies deny a link exists between their drugs and a risk of suicidal thoughts among youngsters.
“There’s really no established cause and effect at this point,” said Philip Perera, a Glaxo medical director. “What we have, po tentially, is a signal that needs to be looked at more carefully. It’s a terribly difficult and muddled area to be conclusive about.”
The controversy erupted again recently when United Kingdom regulators warned doctors not to prescribe the pills, except Prozac, to children under 18.
They also pointed to newly disclosed data about Paxil that showed the drug wasn’t effective, but could increase the risk of suicide.
On Monday, the issue will undergo further scrutiny when the U.S. Food and Drug Administration holds a meeting to review years of data about antidepressants and any link to suicide. The session won’t yield a recommendation; a second meeting is scheduled for the summer.
There’s little debate that antidepressants are prescribed regularly for children. Between 1987 and 1996, such usage tripled, according to a recent study in the Archives of Pediatric and Adolescent Medicine.
This occurred though the FDA has approved only Prozac for anyone younger than 18, and this occurred only two years ago. But doctors are free to prescribe medicines if they believe patients will benefit, a practice known as off-label usage.
Glaxo and other companies, though, never published all of the available clinical-trial data involving depressed children, including studies showing negative results. This means doctors who prescribed the pills to children did so with incomplete knowledge.
Glaxo’s Perera acknowledged that not every study was published in a medical journal, because the results might be inconclusive. But he also maintained that results were not suppressed because summary findings were circulated at scientific conferences.