US warns drugs may have sexual side effects

[lls8]

US warns drugs may have sexual side effects


WASHINGTON (April 14, 2012): Two Merck drugs for treating male baldness and enlarged prostate will now carry extended labels to add more possible sexual side effects, US regulators said.

The changes involve Propecia and Proscar, both of which contain the active ingredient finasteride, after patients reported additional adverse effects that were not apparent at the time of the drugs' approval, the US Food and Drug Administration said Friday.

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

Proscar, which treats symptoms of enlarged prostate, will now have a label that adds "decreased libido that continued after discontinuation of the drug."

In addition, both labels are being revised to "include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation," the FDA said.

FDA spokeswoman Stephanie Yao said the drugs were previously known to cause adverse sexual events in a small number of patients, and that information was included on labels at the time of approval.

The latest labeling change "expands the list of sexual adverse events reported to the FDA postmarketing," she told AFP, adding that "no new clinical studies were reviewed to evaluate these adverse events."

Proscar was approved for the US market in 1992 and Propecia in 1997. In 2011, both drugs' labels were "revised to include erectile dysfunction that continued after drug discontinuation," the FDA said.

Last year, labels for Proscar and Propecia were also changed to advise of the possibility of an increased risk of high-grade prostate cancer.

The agency noted that even though "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."

Since these side effects may be important to some patients, doctors were urged to discuss them with patients when deciding on treatment options.

In the case of Propecia, clinical trials showed 3.8 percent of men had reported one or more adverse sexual experiences, compared to 2.1 percent who were taking a placebo.

"Propecia and Proscar are generally well tolerated and effective for their respective intended uses in accordance with their approved product labeling," Merck said in a statement.

The company added that "a causal relationship between the use of Propecia or Proscar and continued sexual dysfunction after discontinuation of treatment has not been established," and expressed support for ongoing monitoring of adverse event reports. -- AFP

http://www.thesundaily.my/news/349696

[lls8]

US WARNS TWO DRUGS MAY HAVE SEXUAL SIDE EFFECTS
AFP

April 14, 2012, 3:41 pm

Another report from Australian TV "Channel 7 News":

http://au.news.yahoo.com/world/a/-/w...-side-effects/

[lls8]

US WARNS OF CANCER-AGENT IN JAPAN WEIGHT LOSS PILLS

AFP; April 4, 2012, 7:49 am

WASHINGTON (AFP) - The US Food and Drug Administration on Tuesday warned consumers not to take a product called "Japan Rapid Weight Loss Diet Pills" because they contain a suspected cancer-causing agent.

The pills, advertised as promoting weight loss, are distributed by a company called Xiushentang and sold on popular web sites including Amazon.com, said the FDA.

Consumers are advised to stop using the pills -- which are packaged in three colors: green, yellow and blue -- and discard them. They should also see a doctor if they have experienced any side effects, the agency said.

An FDA lab analysis has confirmed that the pills, "Japan Rapid Weight Loss Diet Pills Green" contain "undeclared phenolphthalein," the agency said in a statement.

"Phenolphthalein is a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States."

The FDA has classified the agent as "not generally recognized as safe and effective," and it has been found to potentially damage or even cause mutations in a person's DNA, the warning said.

A similar notice was issued for "Japan Rapid Weight Loss Diet Pills Yellow" because they contain both phenolphthalein and sibutramine, a weight loss agent found in the drug Meridia that was removed from the market in 2010 because it boosted the risk of heart attack and stroke.

"The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke," the FDA said.

A third product, "Japan Weight Loss Blue" contains sibutramine and ephedrine alkaloids. Products containing ephedra have been banned because they can boost blood pressure to risky levels.

The agency said the dangerous weight loss pills are part of an emerging trend in which companies sell products purporting to be dietary supplements but which contain hidden ingredients that can be harmful.

http://au.news.yahoo.com/world/a/-/w...ht-loss-pills/

[Joea]

For bizarre side effects, it would be hard to beat Clomipramine, also known as Anafranil. In 1 of 20 persons taking it, you will cum when you yawn, how weirdly awesome is that ?

In about 5% of patients (both male and female), it can cause inadvertent orgasms when yawning.

Search for Clomipramine on wiki to find out more. This is something for me to file under strange but true ? Imagine if they made a drug that made 19 in 20 person cum when they yawn, going to outsell viagra I think