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Some panelists suggested reserving Ketek for second-line use in treating pneumonia

영광출장마사지OIO_2367_5459 영광출장안마 영광출장안마 영광출장마사지 검증된업체 영광오피걸 영광여관바리レ영광출장맛사지レ영광출장만남レ영광출장맛사지レ영광오피걸The 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., 영덕출장안마 and the panel’s acting chairman, 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.


Gunman Kills 7, Wounds 15 in Slovakia

홍천출장안마Five of the people killed Monday were members of a Roma family who lived in an apartment where the man began his attack with a machine gun and two pistols, said Interior Minister Daniel Lipsic. Roma, also known as Gypsies, often face discrimination in eastern Europe, but Lipsic and police chief Jaroslav Spisiak said the unidentified gunman’s motive was not known.

Another man shot and killed outside the building was «probably» also a member of the same family, Lipsic said.

«So far we don’t know the motive … so I will not speculate whether it did or did not have (a) racial motive,» he told reporters. «I doubt it, but of course the investigation is ongoing.»

The shooting took place at midmorning in the rundown Devinska Nova Ves neighborhood on the outskirts of the Slovak capital, surrounded by fields and industrial areas.

The five Roma who died in the apartment — four women and a man — lived in a brown high-rise building, Spisiak said.

Police rushed to the scene as the attacker, 양구출장안마 about 50 years old, was leaving the building, and he fired indiscriminately at people in the area, wounding 15, including a policeman and a 3-year-old boy who was shot in the ear, Lipsic said.

The seventh fatality was a woman who was shot in the area as she walked to the balcony of her apartment when she heard the gunfire, Lipsic said.

Afterward, SME, a daily newspaper in Slovakia, released a photograph of a person it identified as the gunman. It shows a middle-aged man standing on a sidewalk and pointing a machine gun at an unidentified target overhead. The man appears to have planned the shootout because he is wearing device over his ears to protect his hearing.

The Slovak news agency TASR, referencing a police statement, identified the gunman late Monday as a 48-year-old local who was in legal possession of the weapons he used for the killing spree. Without citing a source, TASR also reported that the man died from a gunshot to his head.

Daniel Zitnan of Bratislava’s Children’s Hospital said the 3-year-old boy who was shot while riding in a car was only slightly hurt and released after treatment.

Renata Vandriakova — who heads the emergency room at one of Bratislava’s hospitals and oversees the city’s response to health emergencies — said one of the 15 wounded had to be operated on and was in critical condition.

Emergency crews blocked off the scene of the attack, which is close to a kindergarten and a supermarket.

Hours after the attack, stunned residents milled about in disbelief.

«I’m shocked,» said 20-year-old Andre Smahovski, a student whose friend was injured in the shooting. «Normally this doesn’t happen here.»

Christian Padour, 40, described how his sister-in-law was at a doctor’s office when a woman who had been shot by the gunman entered — to the horror of those present.

«I feel safe here, but now it looks like the Wild West,» Padour said.

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