January 31, 2008: FDA Warns of Suicidality Link to Antiepileptic Meds
The US Food and Drug Administration issued a warning about the higher risks of suicidal thoughts and behaviors among patients who are taking drugs known as antiepileptics for epilepsy, bipolar disorder, migraine headaches, and other medical conditions. The affected drugs subject to warning include Neurontin. FDA examined the results of the studies conducted for those who are taking antiepileptics and it showed that it had twice the risks of suicidal thoughts and behaviors compared with patients who are taking placebo.
August 2006: An Approximate 300 Lawsuits Filed Over Neurontin
Result of the USA Today report stated that there was an approximated 300 lawsuits were filed, claiming that Neurontin can result suicide or suicide attempt. The initial trial may be held in the fall of 2006. The plaintiffs claim that Pfizer Pharmaceuticals, the manufacturer of Neurontin, was unable to reveal the risks suicide, and FDA stressed the inclusion of black box warning in its label. Pfizer answered the allegations and stating that there is no scientific proof to connect Neurontin to suicide. Then in December 2005, Pfizer altered the Neurontin prescribing information to include “suicide” and “suicide attempt” as rare adverse events.
April22, 2005: Neurontin Recall for Empty Bottles and Partially-Filled Capsules
Pfizer Pharmaceuticals and FDA informed the healthcare providers of the voluntary recall of about 40,000 bottles, equivalent to one lot, of 100mg capsules of Neurontin. There was a mechanical mistake in a production that resulted in some bottles with empty or partially-filled capsules. The 100mg capsules from the lot#15224V, which was distributed between October and November 2004, were included in the recall. The production lot was distributed only in USA and there was no other Neurontin lots were affected.
July/August 2004: Drug Maker to Pay $430 Million in Fines, Civil Damages
Warner-Lambert, a subsidiary of Pfizer Pharmaceuticals, agreed to plead guilty and settled to pay more than $430 million to resolve the criminal cases and civil liability in relation with the unlawful and fraudulent promotion of unapproved uses of Neurontin.