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drug_recall neurontinNeurontin was FDA approved as an ad-on treatment of epilepsy. The off label use of Neurontin has been controversial as evidence uncovered in court documents show strategic planning by Pfizer, Inc., who acquired Parke-Davis the original Neurontin producer, in order to allow the drug to become a “blockbuster hit. A drug is considered a blockbuster when it sells $1 billion per year, which Neurontin was able to do despite what is considered to be a small market with little upward sales mobility for epilepsy treatment.
The FDA sent letters warning the Neurontin maker of some marketing materials that violated agency rules. Still, Neurontin was able to grow into an over $1.3 billion per year blockbuster hit, with estimates up to 90% of Neurontin’s sales attributed to off-label sales. A former Parke-Davis employee turned whistle-blower claims Neurontin experienced boosted sales after the drug company gave doctors thousands of dollars to promote off-label uses of Neurontin at medical meetings.
According to Public Citizen consumer advocacy group, the Neurontin circumstantial and direct evidence gathered over the years “is the most complete and well documented case of off-label promotion to ever come into public view.” Neurontin’s maker Pfizer, Inc. is the world’s largest drug company and is now the major target of lawsuits.
A Neurontin lawsuit, as well as another Pfizer drug has caused a consumer coalition group to sue the company claiming Neurontin was improperly promoted. The Neurontin lawsuit has prompted government prosecutors to look into the whistle blower’s charges and could possibly seek payback for the millions of dollars public insurance plans have spent on Neurontin. The consumer advocated under the California Unfair Competition Law only need to show Neurontin promotion amounted to an unfair business practice in order to seek court penalties.
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...
Public Citizen - The Illegal Corporate Creation of a Blockbuster Drug
DrugInfo Net - Concerns about Neurontin