Doctors raise questions, concerns about FDA suicide warning

Dec 09, 2008

Medical specialists at the nation's largest professional meeting on epilepsy discussed multiple questions and concerns they have about data presented by the FDA in support of its recent suicide alert on anticonvulsant drugs (AEDs) and the potential effect of the federal agency's analyses on clinical practice and the way AED drug trials are to be conducted in the future.

It is well known that non-adherence to antiepileptic drug therapy can lead to a dramatic increase in accidents and deaths. For these reasons, epileptic experts believe it is imperative that patients continue their antiepileptic therapy to prevent the occurrence of serious accidents and death.

During the American Epilepsy Society's annual meeting, epidemiologists, epileptologists and psychiatrists offered a critical review of the FDA's methodology and analyses, describe the suicide alert's potential impact on patient compliance and seizure management, and its likely effect on the selection of patients for AED regulatory studies.

Among the doctors' concerns is that news reports of the FDA's analyses have confused patients and, perhaps, some physicians on the risks associated with epilepsy drugs. They cite data showing that the risk of suicide possibly associated with AEDs is extremely small compared to the potential danger of leaving patients untreated. Also of concern is that epilepsy patients prone to suicidal ideation or behavior will be excluded from clinical trials of new AEDs.

Source: American Epilepsy Society

Explore further: Anthrax shipments came from military site in Utah desert

Related Stories

Experimental diet pill shows promise, little risk

Jul 14, 2010

(AP) -- An experimental diet pill helped about half the people who tried it lose some weight and keep it off a year later, without the heart problems that some earlier drugs caused, a study found.

Review: Reports on Pfizer drug studies misleading

Nov 11, 2009

(AP) -- Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug found that reporting of the results was often fudged, indicating the medicine worked better than internal company documents ...

Study raises caution on new painkillers

Mar 12, 2008

A new class of painkillers that block a receptor called TRPV1 may interfere with brain functions such as learning and memory, a new study suggests. The experiments with rat brain found that the TRPV1 receptor regulates a ...

Recommended for you

Pentagon: Anthrax shipments broader than first thought

17 hours ago

The Pentagon said Friday that the Army's mistaken shipments of live anthrax to research laboratories were more widespread than it initially reported, prompting the Defense Department's second-ranking official ...

Anthrax shipments came from military site in Utah desert

May 29, 2015

The U.S. Army's mistaken shipment of live anthrax samples to government and commercial laboratories occurred at a military post in a desolate stretch of the Utah desert that has been testing chemical weapons ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.