The manufacturer of controversial antidepressant Paxil found in its own trials that children on the drug went though hellish ordeals of “out of control” behavior, suicide threats, hallucinations and hospitalization, records show.
Those reports, obtained by The Post, are among 400 case studies of “adverse events” that led a scientist for the Food and Drug Administration to conclude that most antidepressants raise the risk of suicide in children.
At least 110 American kids have killed themselves while taking antidepressants during the past decade, new FDA data says.
With U.S. doctors continuing to prescribe Paxil and other antidepressants to millions of kids, the FDA is now considering whether to issue stronger warnings or advise against their use, as Great Britain has done.
The Post reviewed a sampling of reports of children who suffered horrific events during Paxil clinical trials from 1994 to 2001. One internal document lists 23 children and teens as making suicide attempts.
The kids swallowed handfuls of pills such as Tylenol, “self-mutilated,” or did other “self-damaging acts,” it states.
Other examples of alarming behavior outlined in the documents include:
A 10-year-old boy taking Paxil for two weeks “became violent and out of control with aggressive and agitated behavior toward himself.” He ran away from home and was put on suicide and escape watch in a children’s psychiatric ward;
An 11-year-old girl on Paxil for two weeks was hospitalized after telling her mom “she wanted to hang herself from the ceiling fan.”
An 11-year-old boy “held a knife to his wrist and threatened to harm himself” two days after stopping Paxil.
A 14-year-boy on Paxil for two weeks became enraged, punched pictures, broke glass and suffered deep cuts. After his anger eased, “He expressed hopelessness and possible suicide thoughts.”
In some cases, investigators working for Paxil manufacturer GlaxoSmithKline said the behavior was “possibly related” to taking Paxil; in others, they blamed the children’s depression, mental disorder or family problems.
In recent weeks, GSK has begun posting on its Web site some previously unpublished studies after state Attorney General Eliot Spitzer accused the company of fraud for withholding reports of kids who became violent or suicidal. But many documents remain privy only to GSK or under seal in lawsuits, sources said.
The FDA has now asked a group of Columbia University doctors to review the reports to determine whether antidepressants may have triggered the suicide attempts and other dangerous behavior in children.
Earlier this year, a scientist in the FDA’s own Office of Drug Safety, Dr. Andrew Mosholder, found that kids on antidepressants became suicidal twice as often as kids on sugar pills.
But FDA brass reacted coolly to his bombshell opinion. The agency forbade Dr. Mosholder to present his findings at a hearing in February or to discuss them, officials acknowledged.
Mosholder told Senate investigators he was pressured to change his recommendation, but refused.
“We feel that further research is needed before we come to a conclusion,” FDA spokeswoman Susan Cruzan told The Post. She called Mosholder’s suicide-link “premature.”
The FDA has warned doctors to beware of suicidal behavior when prescribing antidepressants to kids.
In defending its pediatric trials, a spokesman for GSK said that “not a single person” of more than 1,000 patients committed suicide.
“Any adverse event is taken seriously by the company,” spokesman Rick Koenig said Friday.