Los Angeles Federal Judge Repeals Order To Block Television Advertisements for Paxil

A Los Angeles federal judge yesterday repealed a temporary injunction barring national television advertisements that promote the anti-depressant Paxil as non-habit-forming, the Los Angeles Times reports. The decision marks a victory for Paxil manufacturer GlaxoSmithKline and the FDA, which approved the ads (White, Los Angeles Times, 10/11). U.S. District Judge Mariana Pfaelzer issued the order in August in a lawsuit filed last year by 35 patients who alleged that they experienced "severe withdrawal symptoms," such as nausea, fever, dizziness and "electric zaps," after they ended treatment with Paxil (California Healthline, 8/21). GSK voluntarily withdrew the ads, although the injunction never took effect because Pfaelzer issued a stay of her order to consider additional arguments from the FDA about whether Paxil is habit-forming (Los Angeles Times, 10/11). In August, the FDA filed a brief that said patients often experience side effects when they end treatment with certain medications, but the agency considers treatments habit-forming only when they prompt "drug-seeking behavior" (AP/Nando Times, 8/21). Pfaelzer agreed and yesterday repealed the injunction order against the Paxil ads (Wilborn, AP/Contra Costa Times, 10/11). The order had "challenged the FDA's authority as the sole arbiter of accuracy and truth in direct-to-consumer marketing," the Los Angeles Times reports.

FDA and GSK officials praised the decision to repeal the injunction order. FDA spokesperson Brad Stone said, "We are very gratified by the judge's decision." David Stout, president of U.S. pharmaceuticals for GSK, added, "Experts including the FDA and leading physician and mental health organizations agree that antidepressant medications like Paxil are non-habit-forming" (Los Angeles Times, 10/11). However, Karen Barth, an attorney for the plaintiffs in the lawsuit, said that the FDA, which she said has 14 staff members to review 32,000 pieces of promotional material from pharmaceutical companies, "does not have the ability, or the authority, to decide these issues." Pfaelzer will decide on Nov. 18 whether the lawsuit qualifies for class-action status (AP/Contra Costa Times, 10/11).