Lamisil is a prescription drug developed for the treatment of fungal infections (onychomycosis). Lamisil was approved by the FDA in tablet form May 13, 1996, and is manufactured by Novartis. Lamisil was developed specifically to combat onychomycosis, which is one of the hardest to treat forms of external infection. An estimated 10 million individuals in the U.S. suffer from onychomycosis.

Through clinical trials and post-marketing reports, Lamisil has been associated with serious liver problems resulting in liver transplant and death. As of April 2001, the FDA had received and reviewed 16 cases of liver failure involving Lamisil, including 11 deaths and two liver transplants.

On May 9, 2001, the FDA issued a health advisory regarding Lamisil’s association with liver failure and death. Also, Novartis sent out a “Dear Doctor” letter in May of 2001 to warn physicians about reports of liver problems, announce labeling changes, and warn about prescribing and dispensing errors with Lamisil.

Leave a Comment

Your email address will not be published. Required fields are marked *