The U.S. Food and Drug Administration is calling for new warning labels on a class of drugs used primarily to treat enlarged prostates, because the medications may raise the risk of developing an aggressive form of prostate cancer.

In a statement released Thursday, the agency said the drugs involved include popular medications sold under the brand names Proscar and Propecia (sold by Merck & Co.) and Avodart and Jalyn (sold by GlaxoSmithKline).

According to the FDA, almost 5 million men were prescribed one of these medications between 2002 and 2009. Of these, nearly 3 million men were between the ages of 50 and 79.

The agency is advising doctors not to start patients on these drugs until prostate cancer — which can mimic the symptoms of an enlarged prostate — and other urological conditions have been ruled out.

According to the agency, this new warning is based on the results of two large prostate cancer trials.

Although these trials did not include Propecia, which is prescribed to treat hair loss in men, its label is also being updated. However, the FDA said “the applicability of the Avodart and Proscar studies to Propecia, is currently unknown.”

All of these drugs are part of a class of medications called 5-alpha reductase inhibitors (5-ARI). According to the FDA, Proscar, Avodart and Jalyn are approved to treat symptoms of enlarged prostate, while Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is a lower-dose version of Proscar.

Merck issued a statement Thursday on the FDA ruling.

“Merck stands behind the demonstrated safety and efficacy of Proscar [finasteride, 5mg] and Propecia [finasteride, 1mg]. Both products have been prescribed to millions of men, with Proscar prescribed to those suffering from benign prostatic hyperplasia (BPH or enlarged prostate) since 1992, and Propecia prescribed to men with male pattern hair loss since 1997,” the company statement said. “Merck’s goal is to ensure the product labeling includes all relevant trial information to help health-care professionals and their patients make informed treatment decisions.”

Less than a year ago, GlaxoSmithKline asked the FDA to approve the use of Avodart to prevent prostate cancer, although the FDA declined that request in January. The company based its reasoning on the results of one of the trials on which the agency is now basing its new warning.

In addition to this new side effect, recent research has shown that Proscar, Propecia and Avodart are all associated with increasing the risk of erectile dysfunction in men who take the medications.

Commenting on the FDA warning, prostate cancer expert Dr. Anthony D’Amico, chief of genitourinary radiation oncology at Brigham and Women’s Hospital in Boston, said, “I think that the warning is appropriate. The risk is very small, but not zero.”

“What both studies show conclusively is there is about a 1 percent increase in being diagnosed with high-grade prostate cancer if you got these drugs — even though you are less likely to get a low-grade cancer.”

Why that is is not clear, D’Amico said. “But I think the warning is fair,” he added.

The drugs really do work in preventing prostate cancer, D’Amico said. “You have to weigh the 24 percent reduction against the 1 percent increased incidence of high-grade disease,” he said.

“These drugs should only be used in men who have an additional indication to take them beyond prostate cancer prevention,” D’Amico said.

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Men who regularly get moderate exercise may have a lower risk of developing prostate cancer — including aggressive, fast-growing tumors, a new study finds.

Researchers found that among 190 men who underwent biopsies for possible prostate cancer, those who exercised moderately — the equivalent of three to six hours of walking per week — were less likely to be diagnosed with the disease.

Compared with their sedentary counterparts, these men were two-thirds less likely to have a biopsy positive for prostate cancer. In addition, men who got the equivalent of one to three hours of walking each week had an 86 percent lower chance of having an aggressive form of the cancer.

The findings, which appear in the current issue of the Journal of Urology, do not prove that exercise helps prevent prostate cancer. But they could offer men yet more incentive to get active.

“If you need one more reason to exercise, this could be one,” said senior researcher Dr. Stephen J. Freedland, of the Duke University Prostate Center and the VA Medical Center in Durham, North Carolina.

A number of studies have looked at the relationship between exercise and prostate cancer, and while most have pointed to a protective effect, about one-third have found no association, Freedland told Reuters Health.

One question has been whether the positive findings reflect a greater tendency of health-conscious exercisers to get screened for prostate cancer. This study avoided that issue, Freedland said, by focusing on men who were sent for biopsies after concerning findings from prostate specific antigen (PSA) testing or a digital rectal exam.

He and his colleagues found that among the 111 sedentary men in the study, half were diagnosed with cancer after biopsy. That compared with 27 percent of those men who got the equivalent of three to six hours of walking each week.

And among men diagnosed with prostate cancer, 51 percent of sedentary patients had more-aggressive cancer, versus 22 percent of those who had been mildly active — getting the equivalent of one to three hours of moderate walking per week.

Exercise itself remained linked to a lower risk of prostate cancer after the researchers accounted for a number of other factors, like age, weight and race.

Along with studies finding a relationship between exercise habits and lower prostate cancer risk, there is also research showing that the connection is biologically plausible, Freedland said.

For one, he noted, exercise has been shown to lower blood levels of testosterone and other hormones that may stimulate prostate tumor growth. Exercise is also believed to stimulate the immune system and the body’s natural antioxidant mechanisms, both of which may help prevent the development of prostate cancer.

SOURCE: Journal of Urology, November 2009.

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The US food and drug safety watchdog warned Thursday that an over-the-counter men’s sex aid, labeled as all-natural, contains a chemical similar to the active ingredient in Viagra and could be dangerous.

“‘Stiff Nights’, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal,” the Food and Drug Administration (FDA) said in a statement.

The FDA began probing Stiff Nights after receiving a customer complaint about the product. The agency did not reveal the nature of the complaint.

The investigation found that rather than being all-natural, Stiff Nights contains sulfoaildenafil, a chemical similar to the ingredient in Viagra.

“Because this product is labeled as an all-natural dietary supplement, consumers may assume it is harmless and poses no health risk,” said Deborah Autor, director of the FDA?s Center for Drug Evaluation and Research Office of Compliance.

“In fact, this product is illegally marketed and can cause serious complications,” she said.

Sulfoaildenafil could interact with prescription drugs known as nitrates and cause dangerously low blood pressure.

Stiff Nights is sold online and at retail stores in bottles or blister packs containing red capsules.

A bottle of 12 Stiff Nights capsules was being offered Thursday on Amazon for around 27 dollars.

Another website — mystiffnights.com — said the product is made with “only the finest herbs and greens.”

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LONDON (AFP) – Men will be able to buy Viagra on the High Street for the first time instead of going to a doctor after Boots launched a nationwide scheme on Friday.

Stores across the country will sell the erectile dysfunction drugs to men after they undergo a private half-hour consultation with a pharmacist.

Pharmacists will conduct a pre-screening questionnaire, take a medical history and conduct a series of blood tests, including checking glucose, blood pressure and cholesterol levels to rule out a more serious health problem.

The scheme follows a trial at Boots stores in Manchester.

Pharmacist James Longden, who led the trial, said men had travelled from around the country to buy the small blue pills.

“We had men coming not just from the North West but from all over.

“They were really positive about it. Sometimes it can be a bit of an embarrassing subject to talk about and many didn’t know where to turn to for help,” Longden said.

Costing 55 pounds for the initial screening and four tablets, the price will drop to 26.59 pounds for further supplies of four tablets.

Erectile dysfunction affects one in 10 men in Britain and it is estimated that only 10 percent of the estimated 2.3 million men who suffer are being treated.

But research by Boots has indicated that 47 percent of men would prefer to suffer in silence rather than discuss erection problems with anyone.

Patricia Lohr, medical director of the sexual healthcare charity BPAS, said women should also have the convenience of buying drugs from their chemist rather than seeing a doctor.

“It’s fine that men will be able to pick up Viagra alongside their shaving foam at their local pharmacist.

“But why can’t women access effective contraception by the same easy means? The contraceptive pill is safe, effective and used by millions of women worldwide – many more than men who use Viagra.

“A pharmacist can’t even provide a woman with a repeat prescription for the pill – she has to return to the doctor’s surgery time and again.”

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