Gilead Sciences is voluntarily recalling one lot of its AIDS drug Vistide after it discovered some vials of the injectable medicine had particles in them.
Gilead ($GILD) said it is unaware of any complaints related to the recalled drug but cautioned that patients injected with particulates face the chance of severe reactions, even death, depending on the size of the particles and the patient's underlying medical condition. Vistide, the brand name for cidofovir, is for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS and is actually the company's first approved product.
The company said in a notice that some particles were found in vials during packaging and it is trying to figure out the underlying cause. Dr. Hans Reiser, Gilead's senior vice president for medical affairs, said in a letter to providers that the company doesn't know of any complaints about Vistide in the last 12 months but is doing a "targeted analysis of its global safety database to specifically identify any potential signals that may be related to particles and/or contamination in Vistide." The recalled lot began shipping Oct. 12.
While it's at it, Gilead is reviewing the supply situation for the drug. The company said there is nothing in the supply chain to replace the recalled lot. Gilead suggested that doctors and hospitals check with other manufacturers about replacement stocks. The FDA last summer approved both Mylan ($MYL) and Indian drugmaker Emcure Pharmaceuticals to make generic cidofovir.
Gilead's manufacturing has had few reported problems. It received a warning letter in 2010 for its plant in San Dimas, CA, which logged a variety of GMP problems, including issues with aseptic processing.