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FDA’s panel rejects ‘Female Viagra’

Flibanserin – the ‘pink pill’ purported to be a remedy for the low sexual desire of millions of women fails to convince the Food and Drug Administration. The panel of reproductive advisers felt that the two studies conducted by the promoter Boehringer Ingelheim did not outweigh side effects, including fatigue, depression and fainting.

Drug treatment to boost women's sex drive remains elusive after a decade of searching by some of the world's biggest drugmakers.

The proposed drug Flibanserin is originally studied for curbing depression antidepressant , but the resaercher’s interest towards its libido-boosting properties after some women reporting unusually high levels of sexual satisfaction, following the use of the pink pill.

Flibanserin works on serotonin and other brain chemicals, but the exact mechanism by which it boosts libido remains to be understood.

A panelist Paula Hillard, a gynecologist from Stanford University School of Medicine, says: "… women's sexual health is important and … many women suffer from sexual dysfunction, but I'm not convinced of a clinically meaningful benefit for this drug".

 The FDA will make its own decision on the drug in coming months, though it usually follows the advice of its panelists.

The attempt to trigger sexual interest through brain chemistry is the drug industry's latest approach to find a female equivalent to the blockbuster success of Pfizer's erectile dysfunction drug, Viagra.

Since Viagra’s 1998 launch, more than two dozen experimental therapies have been studied for so-called "female sexual dysfunction," a market worth an estimated $2 billion.

Initially, Pfizer tested Viagra on women, hoping that the drug's ability to increase blood flow to the genitals would increase libido. When that didn't work, drugmakers turned to hormones, including testosterone.

In 2004, an FDA panel rejected Procter & Gamble's testosterone patch, Intrinsa, due to unknown risks from long-term use. Two years earlier a massive government study found that hormone replacement therapy in postmenopausal women increased heart disease and breast cancer, raising concerns about the safety of all hormones.

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Stay away from Internet-based erectile dysfunction (ED) drugs

Stay away from non-prescription erectile dysfunction (ED) drugs sold on the Internet, the experts say. Internet-based companies market them, men continue to buy them and experts continue to warn of the dangers of counterfeit drugs for erectile dysfunction.

A study conducted in South Korea and presented at the American Urological Association annual meeting in San Francisco, finds that not only can these knock-off drugs be contaminated, they may contain too much of the active ingredient or none at all.

The drugs could especially be dangerous for men with hypertension or heart disease, the study found.

Since the advent of Viagra (sildenafil citrarte) in 1998, the market for these and similar products — legitimate or not — has mushroomed.

“Given the personal nature of the problem and many men’s reluctance to discuss it, even with a doctor… men who have sexual dysfunction are prepared to try anything and they do try a large number of bizarre things,” says Dr. John Morley, director of geriatrics at St. Louis University. “They try all the Viagra look-alikes, so people are going to buy them.”

“Buying off the Internet without going through a regular pharmacy might appear cheaper or better but they’re usually not and they usually don’t work,” he adds.

In the Korean study, the medical team compared 19 counterfeit erectile dysfunction (ED) drugs against prescription Viagra, obtained directly from Pfizer Pharmaceuticals, and Cialis (tadalafil citrate), provided by Lilly.

Fifty-eight percent had too much active ingredient, sometimes as much as 2.4 times more, while 3 percent had no active ingredient at all. Some contained unapproved compounds intended to promote an erection and even potential toxins, including mercury and lead.

Only one of the counterfeit drugs contained “proper active ingredients,” the researchers stated. Some contained.

 “All these drugs have side effects and that’s probably the big reason why patients should be getting them through a physician,” Morley said. “While these things may be cheaper, they potentially have much greater side effects.”


More Than 40% of U.S. Teens Have Had Sex

 June 2, 2010: More than 40 percent of unmarried U.S. teenagers — or 4.3 million teen males and females — have had sex at least once, according to the report by the U.S. National Center for Health Statistics.

.These figures reflect a flattening trend of teen pregnancies seen since 2002 and capping of downward trend witnessed between 1995 and 2002.

“One of the great success stories of the past two decades has been the extraordinary declines in teen pregnancy and childbearing,” said Bill Albert, chief program officer at the National Campaign to Prevent Teen and Unplanned Pregnancy. “This progress has recently stalled out.”

What is quite alarming is that 1 in 5 teen girls and 1 in 4 teen boys who had had sex said they would be pleased if they or their partner got pregnant.

The study, which analyzed data from the 2006-2008 National Survey of Family Growth, also found that

·         about one-quarter of female teens and 29 percent of males reported two or more sexual partners, the same as 2002. Females who started having sex when they were younger were more likely to accumulate more partners.

·         While most teens had not had intercourse in the month before being asked about this (76 percent of females and 79 percent of males, the same as 2002), 12 percent of females and 10 percent of males reported having sex in the prior month.

·         The majority of teens had used some form of contraception during their first intercourse: 79 percent of females and 87 percent of males. And condom use is on the rise. As in 2002, it ranked as the most common form of birth control and was used at least once by 95 percent of teens.

·         The next favored form of birth control was withdrawal (58 percent), then the pill (55 percent).

·         Seventeen percent of teens said they had used the rhythm method, as compared to 11 percent in 2002.

·         Seventy-one percent of female teens in 2006-2008 “agreed” or “strongly agreed” that “it is OK for an unmarried female to have a child,” about the same proportion as 2002. But now 64 percent of males agreed with the statement, up from 50 percent in 2002.

·         Fourteen percent of females and 18 percent of males interviewed said they would be “a little pleased” or “very pleased” if they or their partner got pregnant. On the flip side, 58 percent of never-married female teens and 47 percent of males said they would be “very upset” if this happened, pointing to the importance of motivation in not getting pregnant.

 “With nearly half of all teenagers stating that they are sexually active, we cannot afford to keep our heads in the sand about ensuring that our young people have access to comprehensive sex education,” said Cecile Richards, president of Planned Parenthood Federation of America. “While it’s encouraging to hear that a majority of them are using some form of birth control, many of the attitudes revealed in this report tell us that there is plenty of room for more comprehensive sex education that includes information about abstinence, contraception, healthy relationships, and responsible decision-making.”

The full report is available at  National Center for Health Statistics, part of the U.S. Centers for Disease Control and Prevention.



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