Resources for Food and Drug Administration (FDA)

FDA Advisory Committees Oppose OTC Status For Statins

Medicalnewstoday

wo Food and Drug Administration advisory committees recommended that the agency not approve over-the-counter status for lovastatin 20 mg (Mevacor).

During the joint meeting of the Nonprescription Drug Advisory Committee and the Endocrinologic Drugs Advisory Committee ASHP voiced its opposition to the proposal, focusing its comments on the ongoing need to evaluate effectiveness and safety.

"Use of statins requires ongoing vigilance, said Cynthia Reilly, ASHP director of clinical standards and quality. "The existing model for OTC medications would place the entire burden for performing these functions on the patient and would likely result in increased adverse drug events."

View the Resource

Share or bookmarklet this web page at: