Navigation Links
Baldness Drug May Cause Sexual Side Effects: FDA
Date:4/13/2012

By Steven Reinberg
HealthDay Reporter

THURSDAY, April 12 (HealthDay News) -- 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 in a news release.

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.

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.

Last year, 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 Thursday 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.

In a statement released Thursday afternoon, 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."

More information

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

SOURCES: Anthony D'Amico, M.D., chief of genitourinary radiation oncology, Brigham and Women's Hospital, Boston; April 12, 2012, news release, U.S. Food and Drug Administration; April 12, 2012, news release, Merck & Co., Whitehouse Station, N.J.


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Study Offers Insights Into Male Pattern Baldness
2. Hair Loss Research Study Reveals Important Breakthrough in the Treatment of Male Pattern Baldness
3. Stem Cell Defect Might Help Spur Common Baldness
4. Mouse Study Could Give New Clues to Fighting Baldness
5. Research Spots Potential New Target in Fight Against Baldness
6. Obstructive Sleep Apnea in Kids May Have Genetic Cause
7. UCLA study reveals how genes interact with their environment to cause disease
8. Virus Unlikely to Cause Chronic Fatigue Syndrome
9. RSA Innovator NetClarity Solves Networking Problems Caused by HP and Cisco Divorce
10. Popular nanoparticle causes toxicity in fish, study shows
11. Genetic cause discovered for rare bleeding disorder
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:6/25/2016)... City, Oklahoma (PRWEB) , ... June 25, 2016 ... ... helping both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic ... the Oklahoma City area —Johnson is one of the first doctors to perform ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from PsychTests.com reveals that behind ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... ... , ... Marcy was in a crisis. Her son James, eight, was out of control. Prone ... physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If ... at my other children and say he was going to kill them. If we ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... a startling report released today, National Safety Council research ... proven plan to eliminate prescription opioid overdoses. Prescription Nation ... tackling the worst drug crisis in recorded U.S. history, assigned a ... , New Mexico , Tennessee ... failing states, three – Michigan , ...
(Date:6/23/2016)... , June 23, 2016 Bracket , a ... its next generation clinical outcomes platform, Bracket eCOA (SM) ... on June 26 – 30, 2016 in Philadelphia ... electronic Clinical Outcome Assessment product of its kind to fully ... Bracket eCOA 6.0 is a flexible platform for ...
(Date:6/23/2016)... PRINCETON, N.J. , June 23, 2016  Guerbet ... of Premier Inc.,s Supplier Horizon Award . ... this year, Guerbet was recognized for its support of ... value creation through clinical excellence, and commitment to lower ... delighted to receive this recognition of our outstanding customer ...
Breaking Medicine Technology: