UPDATE: FDA To Boost Suicide Warnings On Epilepsy Drugs
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- The Food and Drug Administration Tuesday ordered new warnings about an increased risk of suicidal thoughts and behaviors associated with 11 drugs used to treat epilepsy and certain psychiatric disorders.
The agency also issued a public-health advisory aimed at alerting consumers about the issue. The FDA said a review of clinical studies showed there was one additional case of suicidal thoughts or behaviors for every 500 patients treated with an anti-epileptic drugs instead of placebo, or fake pill. The agency said patients, family members and caregivers should pay close attention to any unusual day-to-day changes in mood, behavior and actions like becoming depressed or becoming preoccupied with death and dying.
The drugs include Topamax by Johnson & Johnson (JNJ), Lamictal by GlaxoSmithKline PLC (GSK), Pfizer Inc.'s (PFE) Lyrica and Neurontin and Novartis AG's (NVS) Tegretol and Trileptal.
The agency will require the makers of the drugs to include the warnings in drug labels and in a medication guide given to patients who fill the prescriptions. The warnings will not be placed in a so-called "black box," which is considered the agency's toughest warning and appears at the top of a drugs' label. It also impacts drug advertising as the contents of the box need to be discussed in advertisements.
The issue first cropped up in January after the FDA said it had reviewed about 200 studies involving 44,000 patients drugs and found a doubling of the risk of suicidal thinking or behavior among patients taking the epilepsy medicines. The agency said it wasn't sure what caused the increased risk. In July, an FDA advisory panel recommended against a black-box warning because it felt the risk of suicidal thoughts and behaviors wasn't that strong.
The American Epilepsy Society said Tuesday that FDA's analysis was "flawed" and was concerned the warnings would cause patients to stop treatment.
"The risk of suicide possibly associated with [the epilepsy drugs] is extremely small compared to the potential danger of leaving patients untreated," the group said in a statement.
Epilepsy is a disorder affecting the electrical signals in the brain and is often marked by seizures.
Companies are required to add the suicidality warnings to the drug labels. Pfizer said it would comply with FDA's request. Johnson & Johnson has noted there's already a discussion about suicide attempts in the Topamax label. Topamax is also approved to treat migraines while Lyrica is approved to treat certain pain conditions from diabetes, shingles and fibromyalgia.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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Publié le 16 Décembre 2008 Copyright © 2008 Dowjones
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