As more news reports link the baldness drug Propecia to persistent male sexual dysfunction, some are questioning the validity of the connection.
Writing for The Atlantic, Lindsay Abrams blames “anti-finasteride fanatics” for raising undue alarm among the millions of men who have been prescribed the popular hair-growth drug. The criticism comes despite Propecia’s growing list of serious side effects being well-documented on both sides of the Atlantic.
In fact, the Food and Drug Administration’s counterparts in Europe were the first to require Propecia’s maker, drug giant Merck & Co., to include stronger warnings in the drug’s packaging there.
In 2006, the Swedish Medical Products Agency began investigating reports of persistent sexual dysfunction side effects which continue in men despite discontinuing finasteride, Propecia’s active ingredient.
In 2008, Merck changed the label in Sweden to include the following warning: “In addition, the following have been reported in post-marketing use: persistence of erectile dysfunction after discontinuation of treatment.”
In 2009, the Swedish Medical Products Agency concluded that Propecia could lead to permanent erectile dysfunction. Merck then changed the product label in other European countries to include a warning of permanent erectile dysfunction as an adverse reaction.
In the United Kingdom, Merck included the following warning: “In addition, the following have been reported in post-marketing use; persistence of erectile dysfunction after discontinuation of treatment with Propecia; male breast cancer.”
In Italy, Merck revised the label in March 2010 to include a warning of persistent erectile dysfunction after discontinuation of treatment.
In this country, the FDA has been slow to react and relatively ineffective in its warnings to physicians and patients regarding the severity and persistence of Propecia’s side effects, even after use of the drug has been discontinued.
The agency’s sluggishness comes despite two studies published last year in The Journal of Sexual Medicine by researchers from the George Washington University and Boston University schools of medicine and a just published follow-up study by GWU lead researcher Dr. Michael Irwig, MD, that links Propecia to persistent male sexual dysfunction.
In addition, AdverseEvents, the leading resource for information on drug side effects, released a report earlier this year identifying FDA approved medications that are most associated with causing brain-related side effects. By a wide margin, the top drug linked to side effects involving loss of libido was Propecia.
In commenting on the report, Duke University Medical Center Professor P. Murali Doraiswamy, M.D., said, “While the warning signals in this report don’t necessarily prove a causal relationship, they are often the first sign of such a link.”
Professor Doraiswamy, who is Duke’s leading neuropsychiatric drug safety researcher said, “It is critical for consumers and prescribers to be aware of such potentially adverse effects. Some of these side effects, such as loss of libido or amnesia, can have a devastating impact on a person’s quality of life.”
There is no known cure for men who have had their sexual function harmed by Propecia. What is known is that unlike the vast majority of drugs whose side effects cease when you stop taking them, Propecia is different.
Explains GWU’s Dr. Irwig: “Finasteride can actually change the brain’s chemistry. The enzyme 5 alpha reductase is present in many areas of the brain. It is rare for a drug to have the capability to persistently change the brain’s chemistry.”
With the latest spate of new reports on Propecia’s debilitating side effects comes word that well over 100 lawsuits have already been filed on behalf of men who say Propecia has ruined their lives.
“Every day, I hear about more men who say Propecia has shattered their lives,” says lawyer Alan Horwitz, managing partner of the Ingerman & Horwitz LLP law firm (www.ihlaw.com). “In fact, we’ve received so many inquiries questioning Propecia’s safety, we‘ve produced an educational brochure that is downloadable from our website which highlights the drug’s horrific side effects.”
Those side effects include erectile dysfunction, impotence, greatly reduced libido, testicular pain, problems with orgasms and gynecomastia – an over-development of the male breast linked to cancer.
The FDA approved Propecia in 1997 as a hair-growth drug to treat male pattern baldness despite any in-depth study of the drug’s long-term side effects – which was troubling to at least one member on the drug’s approval committee.
At that time, FDA dermatologic drug chief Dr. Michael Weintraub said his main concern was whether it was safe for young men to take a pill for many years … especially one that affects hormones … merely to fight hair loss.
Doubts on the drug’s safety were also raised from outside the FDA.
In 2000, Dr. Sherman Frankel, Professor of Physics at the University of Pennsylvania, petitioned the FDA to reconsider Propecia’s approval. In an exclusive phone interview with the Examiner, Dr. Frankel asserted that he documented to the FDA that Propecia contains many times the amount of finasteride required to promote hair growth and warned of the potential for serious side effects at the higher dose.
“I questioned why Merck chose the 1mg dose when a dose of 0.20mg would have the same effect on hair-growth. The only reason I could find was a financial one – with the higher dose, Merck could realize a much greater profit,” Dr. Frankel said.
The FDA rejected Frankel‘s request.
According to the agency, Merck’s annual Propecia sales are now in excess of $400 million.
Says Propecia attorney Horwitz: “Over the last few days, the public’s awareness has been raised about Propecia’s safety, thanks to reports on ABC, NBC, CNN, Time and other widely-distributed national and global news outlets. Now’s the time for the FDA to step up and take immediate action that adequately warns the public and prescribers about Propecia’s real dangers.”
GW’s Irwig agrees, saying, “I am in favor of anything that helps spread the word on Propecia’s devastating side effects and will be glad to present my findings to doctors at any hospital or medical institution in the world.”
“In both Europe and the U.S., some of the world’s leading medical authorities and research institutions have warned that Propecia presents a clear and present danger to thousands, if not millions of otherwise healthy young men. Those research findings are backed up by lawsuits filed in every state of the union that contain the real life accounts of how Propecia has already destroyed the manhood of thousands of men,” says attorney Horwitz.
“In my opinion, spreading the word to an unsuspecting American public about Propecia is not the work of “anti-finasteride fanatics”, rather, it is exactly the role of a responsible press,” Horwitz concluded.