Intended for healthcare professionals


FDA advisory panel calls for suicide warnings over new antidepressantss

BMJ 2004; 328 doi: (Published 05 February 2004) Cite this as: BMJ 2004;328:303
  1. Ray Moynihan
  1. Washington

In a surprise move on 2 February, a panel of scientific advisers of the US Food and Drug Administration urged the agency to warn that new anti-depressants may increase the risk of suicidal thinking or behaviour among children and teenagers.

During a 10 hour hearing, experts weighed the official presentations of uncertain scientific data against powerful emotional testimony from dozens of families whose children have killed themselves or others after taking a selective serotonin reuptake inhibitor—a class including fluoxetine (Prozac), sertraline (Zoloft), and paroxetine (Paxil, Seroxat).

Sara Bostock told how her daughter Cecily stabbed herself to death with a large kitchen knife after taking paroxetine for two weeks. Cecily had recently graduated from Stanford, just received a large pay increase, and was close to a boyfriend and other loved ones.

Asking the Food and Drug Administration to continue studying the issue, the panel also decided to recommend “stronger warnings” about the suicide risks. The move lags behind earlier and stricter recommendations against paediatric use in the United Kingdom for most of these drugs, but it was nevertheless unexpected in the United States, where drug advertising is pervasive and prescriptions have risen sharply in recent years.

In 2002 almost 11 million prescriptions of selective serotonin reuptake inhibitors were written for people under 18, including more than five million for sertraline and paroxetine—neither of which are approved for children in the United States.

Mark Hudak, a panel member and a University of Florida professor, speaking towards the close of Monday's meeting, said: “If they are clearly very ill, anything that can be done should be done. [For a] lot of the people who spoke this morning, the picture they presented of their child was not someone who was very, very ill. It was someone with [milder illness] who was put on these drugs with terrible consequences. Something needs to be done to educate practitioners.”

FDA officials expressed great frustration that drug companies had been slow in supplying data from their unpublished antidepressant trials. GlaxoSmithKline was singled out for mislabelling suicide related events that were possibly associated with paroxetine under the heading “emotional lability.”

View Abstract