Neurontin News
January 31, 2008: FDA Warns of Suicidality Link to Antiepileptic Meds
The U.S. Food and Drug Administration (FDA) has issued a warning about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions. The drugs that are subject to the warning include Neurontin. FDA analysis of recent studies showed patients taking antiepileptics had about twice the risk of suicidal thoughts and behaviors, compared with patients receiving placebo. Read the FDA Press Release.
August 2006: An Estimated 300 Lawsuits Filed Over Neurontin
According to a recent USA Today report, an estimated 300 lawsuits have been filed to date, alleging that Neurontin causes suicide or suicide attempt. A first trial may take place in fall 2006. Plaintiffs allege that Neurontin-maker Pfizer Pharmaceuticals failed to disclose the risk of suicide, and are advocating that the FDA require a black-box warning. Pfizer has responded to the allegations, stating that there is no scientific evidence linking Neurontin to suicide. In December 2005, Pfizer changed the Neurontin prescribing information to include "suicide" and "suicide attempt" as infrequent adverse events.
April 22, 2005: Neurontin Recall for Empty Bottles and Partially-Filled Capsules
Pfizer Pharmaceuticals and the FDA notified healthcare professionals of the voluntary recall of 40,000 bottles (1 lot) of 100 mg capsules of Neurontin. A mechanical error in manufacturing resulted in some bottles containing empty or partially filled capsules. 100 mg strength capsules from lot #15224V - distributed in October and November, 2004 - are included in the recall. The production lot was distributed only in the United States, and no other Neurontin lots were affected. Click here to read more from the FDA.
July/August 2004: Drug Maker to Pay $430 Million in Fines, Civil Damages
Pharmaceutical manufacturer Warner-Lambert, a subsidiary of Pfizer Pharmaceuticals, agreed to plead guilty and to pay more than $430 million to resolve criminal charges and civil liability in connection with the illegal and fraudulent promotion of unapproved uses for Neurontin. Click here to read more from the FDA.