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FDA Issues Warning to Pfizer Regarding Zoloft Ad

May 23, 2005 |

In a strongly worded letter, the FDA advised pharmaceutical giant Pfizer Inc., that one of its direct-to-consumer (DTC) print advertisements for the powerful anti-depressant psychotropic drug Zoloft "is false or misleading because it omits important information relating to the risk of suicidality in patients taking Zoloft, in violation of the Federal Food, Drug, and Cosmetic Act…and implementing regulations…This ad is concerning from a public health perspective because it fails to include a serious risk associated with the drug."

The letter as well as a warning to health care professionals was also posted on the FDA’s website. The FDA has also issued an alert concerning Zoloft and the risk of pediatric suicide.

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