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CooperSurgical Lands US FDA Warning Letter Over ParaGuard TV Spot

 
• By Brenda Sandburg

The agency's "Bad Ad" program issued a warning letter that claims the promotion for CooperSurgical's copper-containing intrauterine contraceptive lacked any safety information.

A TV screen is seen in the background, with a hand holding a remote in the foreground.
The TV spot lead to a rare warning letter from the FDA's Office of Prescription Drug Promotion. • Source: Shutterstock

A TV promotion CooperSurgical Inc. issued for its intrauterine copper contraceptive Paragard raised red flags for the US Food and Drug Administration, as it excluded any risk information, raised public health concerns, and was a repeat violation.

The video, titled “Paragard: Family Planning During the Pandemic,” aired on an NBC television station in Boston. In a warning letter to CooperSurgical president Holly Sheffield, the FDA’s Office...

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