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A majority of panel members said that cautionary language should be strengthened and placed in a so-called «black box» to warn doctors and patients of some of the risks associated with the drug

The nonbinding recommendations raise the prospect the Food and Drug Administration could modify its approval of the Sanofi-Aventis SA drug, called Ketek, to exclude the treatment of the two lesser infections, which often clear up without drug treatment.

The FDA convened a two-day meeting of outside experts to discuss Ketek in light of concerns about its safety. An agency review found 13 reports of liver failure in patients treated with the drug through September. Reports of blurry vision also have been a concern. Doctors have prescribed the antibiotic more than 5.6 million times in the United States since the FDA approved it in 2004.

As CBS News Investigates reported on Dec. 13, there have been questions about the FDA’s handling of Ketek.

In an exclusive interview with CBS News, Dr. David Ross, who reviewed Ketek’s safety for the FDA, said he warned his superiors that the drug was, in his words, a «time bomb,» and was shocked last summer when the acting head of the agency, Dr. Andrew Von Eschenbach, told employees to keep concerns about the drug in-house — and out of the press.

Dr. John Jenkins, director of the FDA’s office of new drugs, declined to say what action the agency would take. The FDA isn’t bound to follow the advice of its outside experts, but usually does.

«We will be assessing the advice we received from the committee and discussing that very shortly,» Jenkins said.

The panel also recommended Sanofi-Aventis develop a medication guide to be given to patients, a move backed by the company.

Dr. John Edwards, of Harbor-UCLA Medical Center in Torrance, Calif., and the panel’s acting chairman, 의왕출장안마 called the two-day meeting particularly challenging, since it came amid concern that companies have diminishing interest in developing new antibiotics and increased interest in safety issues linked to the drugs.

Many experts fear overuse of antibiotics is hastening the increasing resistance of many bacteria to older drugs, making the development of novel treatments critical. Some panelists suggested reserving Ketek for second-line use in treating pneumonia.

The label of the drug was changed in June to add a bold-type warning about the rare reports of liver failure and severe injury, some of them fatal. A majority of panel members said that cautionary language should be strengthened and placed in a so-called «black box» to warn doctors and patients of some of the risks associated with the drug.

The FDA’s handling of Ketek remains under investigation by a Senate committee. Sen. Charles Grassley, R-Iowa, said this week the FDA intentionally withheld information from FDA advisers when they met in 2003 to consider recommending approval of the drug. FDA officials said they would comment after reviewing his allegations, contained in a 20-page letter sent to the agency.

Sanofi-Aventis said the risks associated with the drug, also known as telithromycin, appear to be comparable to those of other similar drugs and that it represents an important option in treating respiratory tract infections.

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The WHO plans an international meeting early next year to discuss the studies’ results and how to translate them into policies that promote safe male circumcision — done by trained health workers with sterile equipment — while teaching men that it will not make them invulnerable

The National Institutes of Health said Wednesday it closed the studies in Kenya and Uganda early, when safety monitors took a look at initial results this week and spotted the protection. The studies’ uncircumcised men are being offered the chance to undergo the procedure.

The link between male circumcision and HIV prevention was noted as long ago as the late 1980s. The first major clinical trial, of 3,000 men in South Africa, found last year that circumcision cut the HIV risk by 60 percent.

Still, many AIDS specialists had been awaiting the NIH’s results as a final confirmation.

«Male circumcision can lower both an individual’s risk of infection, and hopefully the rate of HIV spread through the community,» said AIDS expert Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases.

But it is not perfect protection, Fauci stressed. Men who become circumcised must not quit using condoms nor take other risks — and circumcision offers no protection from HIV acquired through anal sex or injection drug use, he noted.

«It’s not a magic bullet, but a potentially important intervention,» agreed Dr. Kevin De Cock of the World Health Organization.

Male circumcision is common at birth in the United States. But in sub-Saharan Africa, home to more than half of the world’s almost 40 million HIV-infected people, there are large swaths of populations where male circumcision is rare.

The WHO plans an international meeting early next year to discuss the studies’ results and how to translate them into policies that promote safe male circumcision — done by trained health workers with sterile equipment — while teaching men that it will not make them invulnerable.

If male circumcision were widely adopted, officials predicted that could help to avert tens of thousands of HIV infections in coming years; Fauci cited one model from South Africa that suggested possibly up to 2 million infections could be averted over a decade.

«This is tremendous news, and it could help millions of men while in turn reducing the risk faced by millions of women,» said Paul Zeitz of the Global AIDS Alliance.

Why would male circumcision play a role? Cells in the foreskin of the penis are particularly susceptible to the HIV virus, 영광출장안마 Fauci explained. Also, the foreskin is more fragile than the tougher skin surrounding it, providing a surface that the virus could penetrate more easily.

Researchers enrolled 2,784 HIV-negative men in Kisumu, Kenya, and 4,996 HIV-negative men in Rakai, Uganda, into the studies. Some were circumcised; others were just monitored.

Over two years, 22 of the circumcised Kenyans became infected with HIV compared with 47 uncircumcised men, a 53 percent reduction. In Uganda, 22 circumcised men became infected vs. 43 of the uncircumcised, a 48 percent reduction.

The researchers are offering all of the studies’ uncircumcised men the chance to undergo the procedure, and 80 percent of the uncircumcised Ugandans already have agreed, said lead researcher Ronald Gray of Johns Hopkins University.

Side effects were rare, including some mostly mild infections that were easily treated. The rate of side effects was comparable to those seen in circumcised U.S. infants, said Robert Bailey of the University of Illinois at Chicago, who led the Kenyan trial.

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