Drug Safety Developments

Propecia Problems: Baldness Drug Linked with Long-Lasting Sexual Side Effects

Quoted from http://healthland.time.com/2012/07/12/propecia-problems-baldness-drug-linked-with-long-lasting-sexual-side-effects/

Propecia Problems: Baldness Drug Linked with Long-Lasting Sexual Side Effects

The adverse side effects of the anti-baldness drug could last for months or even years for some men

By Alexandra Sifferlin | @acsifferlin | July 12, 2012

In April, the Food and Drug Administration (FDA) updated the warning to finasteride, Merck & Co.’s drug marketed to treat both male pattern baldness (Propecia) and enlarged prostate (Proscar). The new warnings noted that the sexual side effects associated with the medication, including problems with libido, ejaculations and orgasm, could last even after patients stop taking the drug.

Now a new study published in the Journal of Sexual Medicine finds that side effects may not only continue after stopping finasteride, but they may last for months or even years.

[Article continues at original source]

Sexual side effects added to Merck drug labels

Quoted from http://www.reuters.com/article/2012/04/12/merck-warnings-idUSL2E8FCD4P20120412

Sexual side effects added to Merck drug labels

Thu Apr 12, 2012 12:56pm EDT

 

April 12 (Reuters) - Prescribing labels for Merck & Co's drugs for baldness and enlarged prostate will add reports of sexual side effects that continued after use of the medicines was stopped, U.S. health regulators said.

Labels will be revised for Proscar, which treats symptoms of enlarged prostate, and hair-loss treatment Propecia, the Food and Drug Administration said. The active ingredient in both drugs is finasteride.

The Propecia label will now include notification of problems with libido, ejaculation and orgasms that continued after use of the drug was ended. Proscar's label will include notification of decreased libido.

The labels of both drugs will also include a description of reports of male infertility and poor semen quality that normalized or improved after use of the drugs was stopped.

[Article continues at original source]

Lawsuit Blames Hair Loss Drug For Sexual Dysfunction And Mental Problems

Quoted from http://articles.courant.com/2011-03-03/health/hc-buck-propecia-lawsuit-0304-20110303_1_side-effects-propecia-hair-loss

Lawsuit Blames Hair Loss Drug For Sexual Dysfunction And Mental Problems

March 03, 2011|By RINKER BUCK, The Hartford Courant

A Connecticut law firm has filed a lawsuit against pharmaceutical manufacturer Merck & Co. on behalf of men who have taken Propecia, a prescription drug that combats hair loss but, its critics say, can also cause severe side effects such as sexual dysfunction and mental impairment.

Attorney Edward Jazlowiecki of Bristol has joined two other firms, in New Jersey and New York, in filing the suit, which alleges that Merck has failed to fully disclose the serious side effects of Propecia and failed to adjust its warnings in the American market even after European regulators forced the company to carry a stronger warning label.

Propecia, which is also marketed under the brand name Proscar, was originally introduced to treat men with enlarged prostates, but it won FDA approval in 1997 for the treatment of male pattern hair loss after patients noticed its restorative powers with hair. The drug's active ingredient is finasteride, which can help reduce the levels of the substance on the scalp that leads to hair loss.

FDA probes risks of HIV, prostate, other drugs

Quoted from http://www.reuters.com/article/idUSTRE6424DA20100503

FDA probes risks of HIV, prostate, other drugs

Mon May 3, 2010 2:50pm EDT

WASHINGTON (Reuters) - Regulators are investigating potential risks from Abbott Laboratories Inc's HIV drug Kaletra, GlaxoSmithKline Plc's prostate drug Avodart and other medicines.

The Food and Drug Administration said on Monday it was probing reports of liver toxicity with patients who used Kaletra to prevent HIV infection after exposure to the AIDS virus.

The agency also said it was investigating cases of male breast cancer in patients treated with Avodart as well as Merck & Co's prostate drug Proscar and baldness treatment Propecia.

The FDA releases a quarterly list of safety probes to inform the public about early investigations of potential side effects that have been reported. The list released on Monday covered issues identified between October and December 2009.

Being on the list does not mean the FDA has concluded the drug causes the specific risk, the agency said.

The FDA posted the list here