With over 400 lawsuits pending against Merck & Co. in state and federal courts, attention is focusing on possibly permanent sexual side effects of Merck’s hair-loss drug Propecia.
The lawsuits allege that the drug causes sexual side effects that can persist even after the patient stops using the drug, Lawyers USA reports. These side effects include loss of libido, erectile dysfunction and infertility.
Propecia (finasteride) was approved by the U.S. Food and Drug Administration (FDA) in 1997 to treat male-pattern baldness. Proscar, the same medication in a higher dose, was approved in 1992 to treat benign prostate enlargement, according to the FDA. The warning labels on these drugs mentioned sexual side effects but indicated that these cleared up when the drug was discontinued, Lawyers USA wrote.
In April 2012, Merck agreed to change Propecia and Proscar labels in the U.S. to warn that sexual side effects may continue even after a patient stops taking the drug. But plaintiffs have alleged that the company knew about the risks far earlier because Merck had changed labels in other countries as early as 2008, Lawyers USA said.
Over 140 lawsuits have been consolidated in multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of New York and more than 150 New Jersey state court cases have been consolidated, Lawyers USA said. An MDL centralizes a number of lawsuits containing common questions in one court before one judge, making pre-trial proceedings more efficient and avoiding duplicate findings.
In 2012 the FDA notified doctors about the label changes. The agency advises doctors and patients to carefully consider the new label information when deciding treatment options. Adverse events can be reported to the FDA at MedWatchOnline.