FDA Announces Re-Labeling of 20 Anti-Seizure Medications
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The FDA announced that 20 anti-seizure drugs are to have its warning lables revised due to the potential risk of an increase in suicidal tendencies. Anti-seizure drugs are commonly used to treat patients diagnosed with epilepsy, and to treat nerve-pain.
The official announcement on the FDA’s website stated that:
Manufacturers of anti-epileptic drugs (AEDs) or anti-convulsant drugs will update product labeling to include a warning about an increased risk of suicidal thoughts or actions and will develop a Medication Guide to help patients understand this risk. These changes affect all approved AEDs except those indicated only for short-term use.
The AP reported, "among the 20 anti-seizure medications to amend its labels are GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax and Pfizer's Lyrica."
The FDA sent letters to physicians indicating the specific language to be placed on the labels. It was further noted by the AP that the New York-based Pfizer said it "worked closely with the FDA to update the labeling for its antiepileptic medicines."
In January of 2008, the FDA announced its first alert of the health concerns associated with these anti-convulsants. In the 2008 report, the FDA reported its findings on an analysis conducted to determine the corrolation between aniti-seizure medications and the increase in suicidal tendencies.
An FDA analysis of suicidality reports from placebo-controlled studies of 11 antiepileptic drugs shows that patients taking these drugs have about twice the risk of suicidal thoughts and behaviors (0.43 percent), compared with patients receiving placebo (0.22 percent). This risk corresponds to an estimated 2.1 per 1,000 more patients in the drug treatment groups who experienced suicidality than in the placebo groups.
With this in mind, the risk of an increase in suicidal tendencies is relatively low. Per the FDA's report, 2 people per every 1,000 taking anti-convulsants may experience this side effect.
The FDA advises that:
Patients who are currently taking antiepileptic medicines should not make any changes without first talking to their health care provider. Health care providers should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed for notable changes in behavior.