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Posted On 05.22.12 by in Product Liability
After reading the Examiner’s coverage on the devastating side effects of Merck & Co.’s hair-growth drug Propecia, more men are now coming forward to say they are also unsuspecting victims.
One victim who says the drug ruined his life is 30 year-old Las Vegas resident Kevin Malley (702-219-5632) who is currently conducting a multi-day hunger strike outside of Merck’s corporate headquarters in Whitehouse, N.J.
While Malley is battling colossal Merck at the drug-giant’s front door, other Propecia victims are also speaking out across the country.
“Thank you for your Propecia pieces. I’m 50 and started the med when I was 37. It’s destroyed my life,” D.W. from Los Angeles emailed the Examiner.
Apparently, there are many more men suffering from Propecia’s ravages. In a document obtained by the Examiner, an official at the FDA wrote: “The FDA wants to know about all adverse reactions potentially caused by finasteride. This includes cases of patients who developed Peyronie’s [disease], anxiety, panic attacks, cognitive dysfunction, chronic insomnia, muscle wasting and the other persistent side effects.”
Among those other persistent side effects that have gone unlisted in Merck’s Propecia labeling, an American doctor wrote in a related correspondence, are “reduced exercise tolerance, weight gain with increased fat deposition and muscle and joint aches.”
Most doctors who know about Propecia’s hair growth properties still have no idea about the drug’s persistant sexual side effects. “Many of my friends take Propecia and I had no idea it had these side effects … and I stay on top of the latest medical news,” says Dr. Bashir A. Zakria, Assistant Professor, Division of Sports Medicine at Baltimore’s Johns Hopkins Medical Institutes.
Last year, researchers from the George Washington University and Boston University medical schools published separate studies in the Journal of Sexual Medicine that reported Propecia’s persistent 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.
GWU School of Medicine Professor Michael S. Irwig, M.D., had 71 research participants in his study and reported that 94 percent developed low libido, 92 percent developed erectile dysfunction and decreased arousal, and 69 percent developed problems with orgasm.
“It turns out that almost all had multiple sexual functionproblems,” said Dr. Irwig. “It’s been very frustrating for a lot of these men because they’ve sought care from medical professionals who are unaware of the risk of persistent sexual dysfunction since it was not originally suggested in the literature.”
GW’s Irwig says it is not known exactly what causes these side effects. What is known is that unlike the vast majority of drugs, whose side effects cease when the drug is discontinued, “finasteride is different because it 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.”
Amid growing revelations that its hair growth drug causes permanent side effects, Merck initially took down the drug’s official website (www.Propecia.com) and replaced it with directions for reporting negative side effects to the FDA. Last month, Merck quietly relaunched the site.
In part, information on the site now reads:
“In general use, the following have been reported: breast tenderness and enlargement; depression; allergic reactions including rash, itching, hives, and swelling of the lips and face; problems with ejaculation; testicular pain; difficulty in achieving an erection that continued after stopping the medication; and, in rare cases, male breast cancer.”
The warning of ongoing impotence — “difficulty in achieving an erection that continued after stopping the medication”— marks the first time Merck has digitally acknowledged a growing problem among men the world over who have taken Propecia.
However, Merck does not cite any sources of the reported side effects introduced by the phrase “In general use,” so it is not known how the company arrived at the conclusion that its drug is causing in some patients what appears to be permanent impotence.
Known clinically as “Post-Finasteride Syndrome” (for Propecia’s generic name, Finasteride), the condition is marked by a host of sexual, mental and physical side effects — including impotence, Peyronie’s disease and depression — that do not resolve themselves after quitting Propecia, and may be irreversible. With annual sales of more than $400 million, Propecia was approved by the FDA in 1997 for the treatment of male pattern baldness.
“The fact that the FDA has now revised the labeling of Propecia and Proscar to include much more serious side effects has huge implications from a legal standpoint,” says attorney Alan Horwitz, co-founder of Ingerman & Horwitz LLP, (www.ihlaw.com) whose firm took the initiative to produce a free educational brochure on Propecia’s persistent and severe side effects while no information was forthcoming from Merck.
“Now that the FDA has expanded the list of sexual adverse events linked to Propecia and Proscar, there are probably thousands of former and current finasteride users that are suddenly realizing they may be at risk,” Horwitz said.
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