fighting-baldness
Member
- Reaction score
- 1
Merck & Co. (MRK) (MRK)’s baldness drug Propecia and enlarged prostate therapy Proscar will carry labels linking them to sexual dysfunction after the treatments are no longer used, U.S. regulators said.
Propecia’s packaging will include warnings about libido, orgasm and ejaculation disorders that occur after patients stop using the medicines, the Food and Drug Administration said yesterday in a statement. Proscar’s similar warning is limited to decreased libido, and both drugs will include on their labels reports of infertility and poor semen quality that normalized when people stopped using the drugs, the agency said.
“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,†the FDA said in its statement.
Pamela Eisele, a spokeswoman for Merck, didn’t respond to telephone calls and an e-mail seeking comment on the label revision.
The FDA reviewed 421 reports of sexual dysfunction from 1998 to 2011 related to Propecia. Of these, 59 cases reported the condition lasted longer than three months after drug discontinuation. The agency reviewed 131 cases of erectile dysfunction and 68 cases of decreased libido with Proscar from 1992 to 2010
http://www.businessweek.com/news/2012-0 ... -after-use
Propecia’s packaging will include warnings about libido, orgasm and ejaculation disorders that occur after patients stop using the medicines, the Food and Drug Administration said yesterday in a statement. Proscar’s similar warning is limited to decreased libido, and both drugs will include on their labels reports of infertility and poor semen quality that normalized when people stopped using the drugs, the agency said.
“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,†the FDA said in its statement.
Pamela Eisele, a spokeswoman for Merck, didn’t respond to telephone calls and an e-mail seeking comment on the label revision.
The FDA reviewed 421 reports of sexual dysfunction from 1998 to 2011 related to Propecia. Of these, 59 cases reported the condition lasted longer than three months after drug discontinuation. The agency reviewed 131 cases of erectile dysfunction and 68 cases of decreased libido with Proscar from 1992 to 2010
http://www.businessweek.com/news/2012-0 ... -after-use