DOCTOR'S VIEW ARCHIVEMedical Authors and Editors: Barbara K. Hecht, Ph.D. and Frederick Hecht, M.D.
Sept 14, 2004 -- The FDA is holding a public hearing on the occurrence of suicidal thinking and attempts in regard to antidepressant drugs in children and teens. The stories on this hearing began as follows in the Washington Post and New York Times today:
The Washington Post: "Two to 3 percent of children treated with antidepressants had suicidal thoughts or behavior as a result of the drugs, officials said yesterday (at the FDA hearing).... In a sharp departure from a decade-old position, agency officials said the increase in suicidal tendencies was not a result of the children's underlying depression but was caused by the medications themselves."
The New York Times: "Top officials of the FDA acknowledged for the first time on Monday that antidepressants appeared to lead some children and teenagers to become suicidal. Dr. Robert Temple, director of the FDA's office of medical policy, said ...that analyses of 15 clinical trials, some of which were hidden for years from the public by the drug companies that sponsored them, showed a consistent link with suicidal behavior."
Sept 15, 2004 -- Antidepressants prescribed to children should carry a clearly stated warning that they can sometimes trigger suicidal thoughts or actions. That was the unanimous recommendation yesterday by two FDA advisory panels convened to examine the risks of giving medications known as SSRIs (selective serotonin reuptake inhibitors) to children.
Our Comments: The FDA advisory panels opted for the strongest possible warning instead of recommending a ban on the use of most SSRI antidepressants by children and teenagers, as the British did in December, 2003.
The dilemma the FDA and the British regulators face lies in the benefit-to-risk analysis. Risks have to be weighed against benefits in using any drug as compared to withholding it. The use of the drug can only be justified if the possible benefits outweigh the risks.
The benefit-to-risk ratio here is of concern. There is good evidence that SSRIs can induce suicidal thinking in children and teenagers while there is very little evidence that SSRIs help youngsters with depression.
The only SSRI that the British permit children and teens to have is fluoxetine (Prozac) since a large study found that it was effective in youngsters but not by much. The other SSRIs have shown no benefit at all for children and teens.
The FDA will decide what to do within a few months. It can accept or reject the advisory panels' recommendation to require the strongest possible warning about the risk of suicide with SSRIs in youngsters. Or the FDA can do something else and , for example, issue a ban similar to that in Britain.
We and most other observers expect the FDA to accept the advisory panels' recommendation to require the strongest possible warning about the risk of suicide with SSRIs in youngsters.
The FDA seems to be extremely reluctant to follow the British action and ban any of the SSRIs for children or teens. There was a similar hearing back in February at which senior FDA officials were skeptical that SSRIs may lead youngsters to become suicidal.
Soon after the February meeting, it was leaked that the testimony of a top FDA safety reviewer, Dr. Andrew Mosholder, had been canceled because of his views. Dr. Mosholder had concluded that the drugs caused some youngsters to become suicidal and the drugs' risks outweighed their benefits for children and teens. The FDA has admitted that this was the case.
Given this background, what is at stake in the decision the FDA has to make regarding these drugs for youngsters also involves the reputation of the FDA itself for transparency and integrity.