Baldness drug may have sexual side effects

Two Merck & Co. drugs - one to treat hair loss in men, the other to treat an enlarged prostate gland - will get revised labels warning of potential sexual side effects that can last even after patients stop taking the drugs, the U.S. Food and Drug Administration said Thursday.

The two drugs - Propecia to combat male pattern baldness, and Proscar, to treat enlarged prostates - share the same chemical compound, called finasteride. One dose of Propecia contains 1 milligram of finasteride; one dose of Proscar contains 5 milligrams.

The new Propecia label will include a warning of "libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug," the FDA said.

The Proscar label will include a warning about "decreased libido that continued after discontinuation of the drug," the agency said. The labels of both drugs will also carry about a description of reports of male infertility and/or poor semen quality that clears up or improves after the drugs are stopped.

Although a cause-and-effect relationship between the drugs and these side effects hasn't been established, case reports suggest there's a potential problem, the FDA said.

The agency added, however, that only a small percentage of men using these drugs have experienced an adverse sexual event.

Issues with fertility

The FDA said it believes the drugs are safe to take for their approved uses. It recommends that patients and their doctors consider the new information on the revised labels when weighing a best treatment option.

In 2011, both drugs' labels were changed to warn of the possibility of erectile dysfunction even after discontinuing the drug, according to the FDA.

Dr Anthony D'Amico, chief of genitourinary radiation oncology at Brigham and Women's Hospital in Boston, said that the revised labels contain "an important message that people need to hear".

"Particularly because Propecia is used by 20- and 30-year-olds for hair loss and these are people of childbearing age, so if they are getting issues with fertility that a big issue," he said.

Merck said: "Merck believes that Propecia and Proscar are generally well tolerated and effective for their respective intended uses in accordance with their approved product labeling. In addition, please note that a causal relationship between the use of Propecia or Proscar and continued sexual dysfunction after discontinuation of treatment has not been established."

D'Amico said Thursday's announcement from the FDA "points up the usefulness of post-marketing studies on drugs that have been studied, but not for long enough periods to know what can happen when large numbers of people use them and what happens when they are discontinued."

Read more:
Enlarged prostate: When to see a doctor

More information

For more on the label changes, visit the U.S. Food and Drug Administration.


(Copyright © 2012 HealthDay. All rights reserved.)

 

We live in a world where facts and fiction get blurred
In times of uncertainty you need journalism you can trust. For 14 free days, you can have access to a world of in-depth analyses, investigative journalism, top opinions and a range of features. Journalism strengthens democracy. Invest in the future today. Thereafter you will be billed R75 per month. You can cancel anytime and if you cancel within 14 days you won't be billed. 
Subscribe to News24
Voting Booth
The ANC's leadership race is heating up. Who do you think will be elected party president at Nasrec in December?
Please select an option Oops! Something went wrong, please try again later.
Results
Nkosazana Dlamini-Zuma has got it in the bag
6% - 207 votes
I foresee a second term for Cyril Ramaphosa
81% - 2698 votes
Don’t discount a Zweli Mkhize win
12% - 411 votes
Vote
Rand - Dollar
18.02
-1.0%
Rand - Pound
19.94
-2.6%
Rand - Euro
17.63
-1.5%
Rand - Aus dollar
11.66
-0.3%
Rand - Yen
0.12
-0.8%
Gold
1,658.43
-0.1%
Silver
18.71
-1.0%
Palladium
2,195.50
+2.1%
Platinum
863.50
-0.3%
Brent Crude
89.32
+3.4%
Top 40
56,921
-0.9%
All Share
63,264
-0.9%
Resource 10
59,793
+3.3%
Industrial 25
76,769
-2.2%
Financial 15
13,707
-2.8%
All JSE data delayed by at least 15 minutes Iress logo
Editorial feedback and complaints

Contact the public editor with feedback for our journalists, complaints, queries or suggestions about articles on News24.

LEARN MORE