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drug_recall neurontinNeurontin was introduced in 1994 by Warner-Lambert to help maintain the company’s epilepsy franchise. The popularity of the drug far exceeded predictions that within five years annual sales would reach $100 million, instead passing $900 million in 1999. The FDA approved Neurontin only as a supplemental drug to help combat epileptic seizures, as a treatment for Lou Gehrig’s Disease, attention deficit disorder and drug and alcohol seizures.
Despite the surge in sales, Neurontin’s popularity had nothing to do with a growing epilepsy target, but doctors began prescribing Neurontin for indications besides what was FDA approved to treat. Although Neurontin was being prescribed for ailments it was not approved to treat, including pain caused by nerve damage due to conditions like shingles and diabetes, companies are not allowed to promote drugs for unapproved uses. In May 2004, Pfizer agreed to pay more than $430 million to settle charges that a Warner-Lambert unit promoted Neurontin, since Pfizer acquired Warner-Lambert in 2000.
According to the drug’s labeling, Neurontin abuse and dependence potential “has not been evaluated in human studies.” Under federal law, the FDA and DEA work together to prevent abuse of prescription drugs. The difficulties with any pain drug is the testing it must go through for abuse and addition, for which other classes of drugs do not need to be tested. Since Neurontin was FDA approved mainly as an epilepsy drug, Neurontin abuse and addiction was not studied like it has been for Pfizer’s successor to Neurontin, Lyrica, which gained approval to treat nerve pain associated with diabetes and shingles in December 2004.
More than 70 percent of Neurontin sales come from uses besides epilepsy, mostly for pain management, which increases the likelihood of Neurontin abuse without the drug having to go through the stringent testing other pain drugs must go through for approval. Although worldwide sales for Neurontin totaled $481 million in the fourth quarter of 2004, the figure reflected a decline of 39 percent compared to the same period in 2003 because of the availability of generic versions of Neurontin.
Pfizer hoped Lyrica’s approval would pick up lagging Neurontin sales, but since the drug was approved for pain management, it had a lengthier and costlier development process than expected due to its potential for abuse and addiction. Unlike the absence of Neurontin abuse warnings, Lyrica was classified as a controlled substance under rules intended to limit prescription drug abuse by the DEA, which could limit its market.
Despite the hopes for Lyrica, its controlled substance classification is expected to eventually reach $1 billion in annual sales, which is far less than the $2.4 billion Neurontin reached in 2004. Even though Pfizer paid to settle charges of illegal promotion of Neurontin, a high number of patients taking the drug for off-label uses may have been at risk for Neurontin abuse and addiction as a result. It is important to understand the potential benefits and risks of a drug to determine if it is a good treatment option.
The FDA has requested 14 drugmakers to check their study data to see if use of epilepsy drugs results in suicidal behavior or thoughts, giving the drugmakers six months to respond.
Sales of anti-seizure drugs in the U.S. during 2004 were th...
Just weeks after Pfizer and its Warner-Lambert Co. unit were penalized $430 million in federal and state courts for selling Neurontin for purposes that have not yet been FDA approved, the company is again under fire for fraudulent marketing practices. ...
The world''s largest drug manufacturer, Pfizer, Inc., agreed to pay at least $400 million in order to settle civil charges regarding kickbacks to encourage doctors to prescribe the anti-epileptic drug Neurontin for other purposes.
The se...