
FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
Lawsuits against Pfizer Inc. regarding Zoloft and GlaxoSmithKline PLC over Paxil were revived by the U.S. Supreme Court in Wyeth v. Levine. The lawsuits claim that the two companies failed to warn that these drugs might cause suicidal tendencies in adult patients.
Bloomberg.com reported that the high court told federal appeals courts that in light of the recent ruling against Wyeth, they need to reconsider their dismissal of the two cases. In the Wyeth case the Supreme Court made it easier for injured patients to sue drugmakers.
The two suits involving Zoloft and Paxil, stem from suicides of a man and a woman after each took one of the drugs.
The Wyeth case involved an anti-nausea drug that caused a death of a Vermont woman. Pfizer and GlaxoSmithKline say that their case is different. They contend that because the Food and Drug Administration (FDA) had considered suicide warnings for adult patients but rejected the idea, makes it a different situation that is not applicable to the Wyeth ruling.
Pfizer stated in a court filing that, " FDA repeatedly determined that the scientific evidence did not support such an association." The U.S Court of Appeals, Third Circuit in Philadelphia agreed with that argument holding that the FDA studied the issue for over 20 years and found that suicide warnings for adult patients, "are without a scientific basis and would therefore be false and misleading."
In 2005 the FDA required antidepressant drugmakers to include in their packaging, inserts to warn Doctors as well as their patients, about the risk of suicide among children. In 2007 the FDA extended this requirement of a warning to patients aged from 18 to 24.
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Lebanon
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Phone: (615) 444-2900