Just as it is facing an increasing number of lawsuits over Propecia, its prescription drug to treat male pattern baldness, Merck & Co. recently pulled down its website for the drug. The development is fueling speculation in some quarters that new safety warnings will soon be added to the Propecia label. But so far, Merck hasn’t offered any explanation as to why it pulled www.propecia.com.
As we’ve reported in the past, Propecia (finasteride 1mg) is part of a class of drugs known as 5-alpha reductase inhibitors, or 5-ARIs. 5-ARIs like Propecia work by preventing the conversion of androgen testosterone to DHT, a hormone critical to male sexual performance. Merck markets another 5-ARI called Proscar (finasteride 5 mg) that is used to treat enlarged prostate.
Recently, a growing number of lawsuits have been filed around the country alleging Merck failed to warn users about the serious side effects, including erectile dysfunction, low libido, problems with orgasm, infertility, depression and suicide, associated with Propecia and Proscar. At least two claims – one of which involves 46 plaintiffs – are seeking mass tort status in New Jersey state court. Another plaintiff in New York has sought centralization of federal Propecia lawsuits in a multidistrict litigation. A class action lawsuit has also been filed on behalf of Proscar users in Canada. In all of the lawsuits, plaintiffs claim their sexual problems persisted even after they stopped taking the drugs.
Last Spring, a study published in the Journal of Sexual Medicine found that at men who take finasteride may develop an ongoing loss of libido and orgasm, even after they go off the medication. The study looked at 71 men who reported such side effects. The average duration of persistent sexual side effects was 40 months after they stopped taking finasteride. About 20 percent of the men still had side effects more than six years after stopping finasteride.
In 2008, Merck changed the Propecia label in Sweden to warn that the drug could lead to permanent erectile dysfunction. Similar changes were made to the labels in the U.K. and Italy in 2009 and 2010. But Merck didn’t make changes to the U.S. label until last year, and even then it didn’t warn that sexual side effects could persist after men stopped taking Propecia.
Now, the legal community is buzzing about the Propecia website. As of February 8, visitors to the site see a message that the propecia.com “website is not currently available.” For now, at least, the site only offers links to the drug’s current prescribing information, patient product information, the Propecia Persistence Program and a link encouraging visitors to report any negative side effects of Propecia to the FDA’s MedWatch program.
Some legal experts think the controversy surrounding Propecia is behind the missing website.
“One reason for Merck’s abrupt action might have something to do with the fact that a growing number of lawsuits are being filed against the company,” one plaintiffs’ attorney told the Baltimore edition of the Examiner.
If, as some think, Merck is preparing to issue new warnings for Propecia, that litigation could gain momentum. News of additional warnings might prompt more men to make a connection between their ongoing sexual problems and their use of Propecia, resulting in more – maybe thousands more – lawsuit filings.