NEWARK (CN) – Bayer has been pushing over-the-counter drugs to women without FDA approval, and the FDA this week warned Bayer not do it, a class action claims in Federal Court. The drugs at issue are “Bayer Aspirin With Heart Advantage” and “Bayer Women’s Low-Dose Aspirin Plus Calcium.”
“On Oct. 27, 2008, the Food and Drug Administration (FDA) sent warning letters to Bayer HealthCare, LLC regarding two over-the-counter (OTC) products that combine aspiring with a dietary supplement into a single pill,” the complaint states. “Neither product has been approved by the FDA.”
The complaint adds, “because these products combine aspiring with a dietary supplement into one pill, the FDA considers them to be new drugs that must undergo FDA review before they can be marketed. The safety and effectiveness of these drugs has not been reviewed, nor approved, by the FDA.
“FDA further charged Bayer with misbranding the drugs because they did not bear adequate directions for intended uses, pursuant to 21 C.F.R. §201.5. Indeed, the FDA accused Bayer of labeling both products with directions and warnings that are inconsistent and contradictory.”
Bayer has been pushing Aspirin Heart Advantage since early this year, and Bayer Women’s Aspiring since 2002, the complaint states. The class demands refunds and treble damages. It is represented by John Ward with Ward & Olivo of Summit, N.J.