Hair Loss Products

Study Confirms the Side Effects of Hair Loss Drug

Propecia, the popular baldness drug is in news again. FDA has now confirmed the hair loss treatment drug may cause sexual dysfunction in men. Following this, the agency has issued label changes to Finasteride drugs.

Over the past several months, there have been arguments in favor of and against Propecia, the brand name of Finasteride in 1mg dose, and another Finasteride drug under the brand name Proscar which is used to treat benign prostate hypertrophy (BPH). Finasteride reduces male hormone activity and is also associated with side effects.

Manufactured by Merck & Co., Propecia was approved by US food and drug administration (FDA) in 1997 to treat male pattern baldness. However, recent studies have shown that Propecia can have several implications in men, including sexual dysfunction and prostate cancer.

Recently, Michael S. Irwig, M.D., a professor at George Washington University, in his study, argued that drugs like Propecia could result in prolonged and possibly irreversible male sexual dysfunction, impotence, clinical depression, greatly reduced libido, testicular pain, problems with orgasms, gynecomastia, breast cancer and high-grade prostate cancer. In another study, Boston University School of Medicine found that Propecia has been linked to erectile dysfunction as well as loss of libido.

However, The International Society of Hair Restoration Surgery (ISHRS), the world's leading medical authority on hair loss and hair restoration, maintains the efficacy and safety of the drug in treating hair loss. The agency maintained that since FDA approved Proscar (finasteride 5mg) and Propecia (finasteride 1mg) for treating BPH and hair loss respectively in December 1997, they have been recorded with a low adverse event profile. According to ISHRS, Proscar has been used by over 20.5 million patients while Propecia has been used by over 6.7 million patients.

Now, FDA has found the drug caused reduced libido in some users and in other users it caused male infertility and poor semen quality. When they stopped taking the drug the symptoms improved, but in some cases the symptoms remained for more than three months after stopping the medicine.

FDA came to this conclusion after reviewing 421 reports of sexual dysfunction from 1998 to 2011 reported to Propecia. The agency has found that 59 people reported sexual problems after using Propecia while 131 cases of erectile dysfunction and 68 cases of decreased libido with Proscar from 1992 to 2010.

FDA has ordered for new label that warns people that Propecia may cause reduced libido and other sexual disorders that could be continued after discontinuation of the drug. The label will also include a new description of reported cases of male infertility that improved after patients stopped taking the drug.

"Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs," according to FDA. "Information about these adverse events may be important to individual patients. Therefore, prescribers and patients need to be aware of them, as part of a discussion of risk and benefits of finasteride when determining the best treatment options."

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