Health News

Female Viagra Banned by US FDA

Earlier we already mentioned that Viagra for females might enter the American market in case the Food and Drug Administration approves it.

The meeting of the US FDA advisory panel resulted in a unanimous prohibition of pink Viagra.

In the opinion of the Reproductive Health Drugs Advisory Committee, the maker of the pill, German Boehringer Ingelhein, did not provide enough evidence on the safety or effectiveness of the drug.

Therefore, the German drug known under the commercial name of Girosa has not yet been allowed onto the American pharmaceutical market.

Let us remind that the drug's active ingredient, flibanserin, works by influencing women's brain chemicals. A large number of studies suggest that approximately 40% of women have problems with sexual desire (known as Hypoactive Sexual Desire Disorder - HSDD).

However, the analysis of flibanserin clinical trials, which was published on the official website of the FDA, demonstrated that the ingredient did not lead to any "statistically significant improvement" in women suffering from sexual hypoactivity.

Moreover, the analysis proved that flibanserin can result in such side effects as depression and dizziness since it belongs to the category of anti-depressants that influence the level of serotonin.

Women, suffering from sexual dysfunction, can turn to the only approved medication for treatment of HSDD. Being produced by Proctor & Gamble, Intrinsa is a prescription drug that is proven to be safe and efficient.

SOURCE: www.wbahealth.com

Viagra’s Maker Receives FDA Warning

The 12-page letter received by Pfizer's Jeffrey Kindler and published on Wednesday, June 9th, actually represents a warning of the US Food and Drug Administration to the pharmaceutical giant.

The FDA claims Pfizer failed to report serious side effects that some the company's already marketed drugs might have. These drugs include erectile dysfunction pills Viagra, cholesterol control pills Lipitor, and seizure drug Lyrica.

Mr. Pace of the FDA said that the organization conducted a 1.5 month investigation of Pfizer headquarters last year and discovered that not only the pharmaceutical giant failed to report serious problems in patients, but also to investigate them.

As such, Pfizer did not submit the cases associated with visual problems in patients on Viagra by classifying them as "non-serious."

Reacting to the FDA warning, Pfizer said it would willingly cooperate with the body to "assure optimal surveillance and reporting of post-marketing adverse events."

It should be noted, however, that Pfizer has already promised to work on the problem. As such, the company said it will organize additional training for the staff to enhance their computerized reporting skills. In fact, the reporting behavior of Pfizer only worsened since then. For instance, the amount of late reports filed by Pfizer amounted to 4% in 2006-2008, whereas it reached 9% in 2008-2009.

SOURCE: www.wbahealth.com

South Korea Reveals the Dangers of Fake ED Drugs

According to an announcement made by Korean Food and Drug Administration on June 1st, the police of South Korea has discovered and seized thousands of fake Cialis pills.

Let us remind that one week earlier Dubai police discovered as much as 7 million fake Viagra pills.

These events suggest fake erectile dysfunction drugs are becoming more widespread, which means that men suffering from ED need to be as careful as possible when making purchase decisions.

A study, which was recently performed by Korean scientists, yielded several interesting results. The study examined 19 counterfeit ED pills and revealed that 30% of them differ in size from the original drug, 58% - in the content of active ingredient, and 42% - in color. The worst difference is, evidently, the content of active ingredient as it directly influences the health of patients. As the study showed, sometimes the content of active ingredient is twice as much as in the original pill, raising the risk of overdose. It was also discovered that some fake erectile dysfunction drugs contain unrelated ingredients, which might be ineffective or, what is worse, harmful.

The study performed by South Korean scientists examined 2 types of ED drugs – Pfizer’s Viagra (sildenafil) and Eli Lilly’s Cialis (tadalafil) – which were purchased at adult shops or in online stores.

The results of the study were presented at the American Urological Association annual conference in San Francisco, USA in the first week of June 2010.

SOURCE: www.wbahealth.com