ORIGINAL REPORT — In a report today, the Associated Press covers a Food and Drug Administration announcement that “drugs used by millions of patients to control epileptic seizures must carry warnings about heightened risks of suicide.”
Only about 1 in 500 patients face an increased risk of suicidal thoughts and behavior while taking the drugs. The new warning emphasizes that the risks are about the same among all antiseizure drugs. The FDA advised patients to consult their doctor before making any changes to their treatment.
The FDA announcement lists the medications required to be accompanied by the warning, which include, according to the AP, “blockbuster products like GlaxoSmithKline’s Lamictal, Johnson & Johnson’s Topamax and Pfizer’s Lyrica.”
Seizure drugs were the fifth best-selling class of drugs in the U.S. last year, with sales over $10 billion, according to pharmaceutical research firm IMS Health. GlaxoSmithKline’s Lamictal posted sales of $2.2 billion for 2007, while Pfizer’s Lyrica had sales of $1.8 billion.
The AP report also states that “physician groups … pressured FDA in recent months to take a measured approach on the warnings, arguing they could cause more harm than good if patients stop taking the drugs.” A similar backlash occurred several years ago, over concerns that a warning about antidepressant medications might unduly prohibit potentially suicidal patients from getting the benefits of those medications.
Doctors have succeeded in curbing other FDA safety warnings in recent years. In 2004, regulators added a black box warning about suicide to antidepressant drugs. However, FDA scaled back the language last year after psychiatrists said it was causing patients to stop taking their medicines, putting them at even greater risk of suicide.
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