Letter to Commissioner Mark McClellan, Food and Drug Administration

June 13, 2003
The Honorable Mark McClellan
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Commissioner McClellan:

I am writing to respectfully request that the Food and Drug Administration expedite its study of the effects of the antidepressant Paxil on children and teens. I also respectfully request that your agency place a hold on the GlaxoSmithKline's request to sell Paxil for children's use pending the outcome of this study.

As you know, the British Medicines and Healthcare Products Regulatory Agency banned use of the British version of Paxil among children this week. This agency also declared that it is clear that the benefits of using Paxil to treat depression in children do not outweigh the risks. The agency cited nine British studies that lasted as long as eight years and involved more than 1,000 patients between age of 7 and 18. These studies concluded that patients taking Paxil were 1.5 to 3.2 times more likely to have suicidal thoughts or episodes of self-harm than those taking a placebo.

Even though Paxil has not been approved in the United States for treating children, many doctors here prescribe the drug to them anyway. Despite the British findings, GlaxoSmithKline refuses to warn American doctors against using the drug for depressed children.

As you know, GlaxoSmithKline is itself a British company. The fact that Paxil has been banned for children in its home country underscores the importance of the United States completing its own study as quickly as possible to ensure that our kids aren't made more suicidal by a drug that's supposed to do exactly the opposite.

Thank you for your attention to this matter.

Sincerely,
Charles E. Schumer
United States Senator