W.V. Sues Pfizer for Illegal Promotion of Anti-Psychotic Drug Geodon
Drug maker Pfizer illegally promotes its anti-psychotic drug Geodon for “off-label” treatments that have not been approved by the Food and Drug Administration, a new lawsuit filed by the West Virginia State Attorney General says.
The suit filed last month in Kanawha Circuit Court on behalf of the state by Attorney General Darrel V. McGraw alleges Pfizer has promoted so-called off-label uses of Geodon for most of the last decade, according to a report in the West Virginia Record.
Geodon was FDA-approved in 2001 for the treatment of schizophrenia, but since then, Pfizer has engaged in illegal promotion of the use of the drug for treatments that have not been given the FDA stamp of approval, the suit states.
While doctors are permitted to prescribe drugs to patients for unapproved “off label” treatments as they deem appropriate, drug companies like Pfizer are barred from promoting such uses of their drugs. Still, off-label promotion of drugs is a major controversy in the pharmaceutical industry, frequently cited by critics as an abuse of drug company authority that puts millions of patients at risk.
Promotion of Geodon Called Illegal
Geodon, which was touted as a safer alternative to older, first-generation anti-psychotic drugs, has been linked to serious side effects including weight gain, hyperglycemia, diabetes, and cardiovascular complications, according to the West Virginia lawsuit.
McGraw’s suit alleges Pfizer “illegally promoted Geodon for a variety of off-label purposes including, but not limited to, for use in pediatric patients and for higher than FDA-approved dosages.”
The company manufactured several formulations of Geodon for “the treatment of acute agitation in schizophrenic patients requiring rapid treatment acute manic or mixed episodes of Bipolar I Disorder and/or both schizophrenia and bipolar disorder,” the suit states.
The lawsuit accuses Pfizer of violating West Virginia laws “in the course of advertising, soliciting, selling, promoting and distributing” Pfizer “misrepresent[ed] Geodon’s safety and efficacy.”
Suit Seeks Injunction, Fines
The lawsuit filed by McGraw seeks a permanent injunction to prevent Pfizer from engaging in “unfair or deceptive conduct” in promoting Geodon. The suit also seeks $5,000 in civil penalties against Pfizer for each violation of the state Consumer Credit and Protection Act, and reimbursement of all costs the office incurs for bringing the suit, the Report states.
The case has been assigned to Judge Charles E. King Jr., according to the newspaper.
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