National News Desk

Judge Bans Paxil Commercials; Justice Department Disagrees With Decision

Posted by Staff Writer
Wednesday, August 21, 2002 12:00 AM EST
Category: Major Medical
Tags: Defective Drugs, Antidepressants and Other Psychiatric Drugs, Paxil, Paroxetine Hydrochloride

A Federal judge ordered pharmaceutical maker GlaxoSmithKline to immediately pull all commercials for its psychiatric drug Paxil that claim the medication is "non-habit forming." The ruling was made after U.S. District Judge Mariana Pfaelzer determined the advertisements were misleading, saying they "created inaccurate expectations about the ease of withdrawal from the drug." Paxil has been linked to severe withdrawal complications when patients stop taking the medication.

The ruling comes one year after 35 former Paxil users filed a class-action lawsuit against Glaxo, alleging the medication led to "severe withdrawal reactions." Glaxo changed Paxil's labeling in December 2001 to warn of possible withdrawal problems in users but continued to run commercials claiming the drug is not habit-forming. On Tuesday, the Justice Department asked Judge Pfaelzer to reconsider her ruling, saying that it contradicted the U.S. Food and Drug Administration's (FDA) earlier decision that the commercials were appropriate. The FDA has stated that Paxil causes a discontinuation syndrome but is not habit-forming.


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