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In 2001, the FDA claimed Pfizer used a marketing brochure for Neurontin that was misleading and wrote the company a letter to discontinue its use. Neurontin was FDA approved only to treat partial seizures along with other drugs when other drugs do not work first. Neurontin side effects are most commonly dizziness and drowsiness. Considered a relatively small market, Neurontin drug had little upward sales mobility until Pfizer began to promote it for off-label use despite the lack of studies showing the level of Neurontin side effects risks.

In March 2002, the New York Times ran an article revealing Neurontin was being illegally promoted for at least 11 off-label medical conditions and endangering patients with unknown Neurontin side effects as a result. According to court papers, a senior marketing executive appeared to have only sales in mind with no concern with Neurontin side effects when during a teleconference he told medical liaisons, “…I don’t want to hear that safety crap either, have you tried Neurontin, every one of you should take on just to see there is nothing (that the drug is safe), it’s a great drug.”

Consumer advocates criticize the FDA’s now slower action to sanction aggressive drug promotion, thus allowing a higher number of potential Neurontin side effects to occur. Due to the court evidence showing Pfizer’s business practices, especially regarding Neurontin, Public Citizen consumer group believes market forces or doctor expertise can not be counted on to protect the public from Neurontin side effects for indications that have not been shown to have low risk of Neurontin side effects with a suitable efficiency.

The loophole in the FDA’s off-label marketing rules that was used to boost Neurontin sales is not a practice applied only to Neurontin, according to Public Citizen consumer group, but an “integral part of the pharmaceutical industry’s marketing practices” that threaten the safety of consumers unknowingly risking Neurontin side effects when treating indications not FDA approved. Neurontin side effects were believed to be minimal when used for the proper indications. Since Neurontin was only approved as an add-on treatment for epilepsy after other drugs failed to have an adequate effect, prescribing Neurontin for other conditions puts a high number of patients at risk for suffering Neurontin side effects.

Neurontin has been able to grow into a $1.3 billion blockbuster hit, with up to 90% of Neurontin’s sales being attributed to off-label sales that endangers patients for Neurontin side effects.

"FDA requests Neurontin study data"

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...

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"Pfizer Sued Again Over Improper Marketing of Neurontin"

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. ...

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"Pfizer to Settle Neurontin Marketing Suit"

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...

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