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The Food and Drug Administration warned yesterday that anyone taking 10 popular antidepressants should be closely monitored for signs of suicidal thoughts or behavior.
The move comes after an unusual hearing last month in which parents pleaded with an FDA panel to recommend the medicines not be prescribed for teenagers and children. Some recounted how family members committed suicide after taking one of these drugs.
In issuing its warning, however, the FDA decided to include adults, explaining that older clinical data is now being reviewed in addition to pediatric data. But agency officials continue to say that no scientific link appears to exist between these medicines and suicide.
“We do not know whether or not the treatment causes these changes,” said Russell Katz, who heads the FDA’s neuropharmacological division, in a conference call with reporters. “It may just be the natural course of the disease,” in which depression may lead to suicide.
The warning affects some of the best-known depression treatments, including Prozac, Effexor, Zoloft and Paxil. Millions of Americans take these drugs annually and last year, the retail market exceeded $11 billion, according to Verispan, a market-research firm.
The product labels on most of these medications already carry some wording about suicide, usually that it may be inherent with depression. But the FDA wants drug makers to use explicit language in bold print about worrisome behavioral changes, such as agitation.
“Today’s warnings on antidepressants potentially making patients suicidal is a major advance,” said Joseph Glenmullen, a psychiatry instructor at Harvard Medical School, who testified at the FDA hearing. “Antidepressants can make children and adults suicidal.”
At the same time, many other families and their doctors over the past decade have said antidepressants saved lives. This argument is also cited by drug manufacturers, which have repeatedly denied their pills cause suicidal thoughts.
Concerns have lingered since a 1990 study in the American Journal of Psychiatry reported some patients became suicidal after taking Prozac.
The findings prompted an emotional debate at an FDA hearing, but did little to sway usage.
The controversy erupted anew last year, after British medical authorities warned doctors not to prescribe these drugs, except Prozac, to children under 18. They also pointed to newly disclosed data showing Paxil wasn’t effective and could increase the risk of suicide.
The warnings prompted the FDA to begin its own review. The agency scoured 25 studies involving 4,000 children and teens. There were no reported suicides, but 109 patients experienced one or more suicide-related behaviors or attempts. However, definitions varied.
A growing chorus of consumer advocates, scientists and parents, however, began lobbying the agency to move faster. They argued antidepressants should not be prescribed for youngsters at all, although Prozac is already approved for such use.
Lisa Van Syckel, a Flemington resident, sued GlaxoSmithKline, the maker of Paxil, after her then- 14-year-old daughter was diagnosed with depression and prescribed a series of antidepressants.
“She used knives, scissors, razor blades. Her personality changed,” Van Syckel said earlier this year. “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.”
Jennifer Tierney of Kernersville, N.C., yesterday described her daughter as turning from a sweet, popular honor student into a raging loner after taking Effexor for migraines at age 14.
“I’m just very sorry that it took so long for them to act on this issue, because there’s been so much tragedy that occurred,” Jennifer Tierney said.
One consumer advocate expressed satisfaction at the FDA decision, but called for drug makers to release all unpublished clinical trial data. Drug makers are not required to release this data, which critics say allows negative findings to remain suppressed.
“The FDA finally caved in to public pressure,” said Vera Sharav of the Alliance for Human Research Protection. “But they’re still shielding these companies by failing to explicitly connect the use of these drugs and the side effects.
“I will say that having cautionary wording in a prominent place in product labels is good, because it will alert doctors. That’s important. But we need a law that requires clinical data to be available for inspection by consumers and the medical community.”
There is little debate antidepressants are prescribed regularly for children and adolescents. Between 1987 and 1996, usage tripled, according to a recent study in the Archives of Pediatric and Adolescent Medicine.
This occurred even though the FDA approved only Prozac for anyone younger than 18, and that occurred only two years ago. But doctors are free to prescribe medicine if they believe patients will benefit, a practice known as off-label usage.
Several companies, however, 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, critics say.