By ANDREW BRIDGES, Associated Press WriterFri Dec 15, 8:34 PM ET
Benefits of an antibiotic linked to rare reports of severe liver problems, including several deaths, outweigh its risks in treating pneumonia but not less serious bacterial infections like bronchitis and sinusitis, federal health advisers said Friday.
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.
On Friday, the FDA panelists voted 16-3 to say Ketek's benefits outweigh its risks in treating pneumonia. In 17-2 votes, the outside advisers said that wasn't the case for bronchitis and sinusitis, which are less serious infections and often spontaneously resolve on their own.
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, 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 (news, bio, voting record), 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.
-------------------- There is no wealth but life. -John Ruskin
All truth goes through 3 stages: first it is ridiculed: then it is violently opposed: finally it is accepted as self evident. - Schopenhauer Posts: 5639 | From Aptos CA USA | Registered: Apr 2005
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Americans place their trust in government. As Iowa's senior U.S. Senator, I work to make sure the federal government earns the public's trust.
As a U.S. Senator, part of my job includes making laws that govern the country.
Of equal or arguably greater importance, part of my Constitutional responsibility includes oversight authority to help ensure the laws are faithfully executed.
For more than 25 years, I have served as a sentinel on Capitol Hill to keep all branches of the federal government accessible and accountable to the American people.
That includes my legislative victory to make Congress live under the same workplace laws it applies to Main Street. Enacted in 1995, the Congressional Accountability Act forces members of Congress to understand how the laws we pass impact employers and workers across the country.
As a senior member of the Judiciary Committee, I also work to make the federal judiciary more accessible, accountable and understandable to the taxpaying public. That includes my long-standing efforts to allow cameras into federal courts and to put a permanent watchdog in place with an inspector general for the judicial branch of government.
As for my oversight work of the executive branch, I've ruffled more than a few feathers along the way. Once I sink my teeth into an issue, the object of my inquiry discovers my bite is as fierce as my bark. Just ask the FBI, IRS, HHS, FDA, USDA, and the Departments of Energy, Justice, Homeland Security and Defense to name a few.
As a freshman senator in the early 1980s, I got the run-around from Pentagon officials when I started connecting the dots that would reveal scandalous financial mismanagement at the U.S. Defense Department.
When higher-ups refused to allow me to question a budget analyst about his report exposing flagrant disregard for the defense budget and tax dollars, I hopped in my orange Chevette and drove to the Pentagon to track him down myself.
Although I used unconventional means to exercise my oversight authority, it helped save tax dollars in the end. That's because the same budget analyst who was not allowed to brief me one-on-one was later forced to testify at a congressional hearing about the budget-busting defense program. That gave me the arsenal necessary to freeze spending on unaccountable defense spending in the mid-1980s.
For the last two years, botched safety processes at the Food and Drug Administration have led me to set my sights on patient safety. I want to make sure consumers can trust what's in their medicine cabinets. I am not trying to tie up the important system that regulates and approves life-saving drugs and innovative medical devices for the marketplace. Rather, I am insisting on accountability.
My concerns began when the drug safety agency tried to suppress information about the dangers of antidepressants when used by children and teenagers. Since then, I have introduced legislation to improve independent post-market surveillance by the FDA and to require information about clinical trials be publicly available.
Sunshine is the best disinfectant to pull questionable activities out of the shadows of obscurity. Nothing gets the ball rolling in Washington faster than front-page news and roiled public opinion.
Two years ago I called a congressional hearing to probe the FDA's handling of the withdrawn painkiller Vioxx. It might be time to round up another oversight hearing after the runaround I got recently at the FDA.
The FDA refused to allow me to question an internal investigator who is leading an inquiry into alleged fraud involved with clinical trials for the antibiotic Ketek. The FDA approved Ketek for the marketplace using falsified clinical data. Now the drug is linked to adverse effects, including abnormal liver function.
So for only the second time in 23 years, I resurrected in June my unconventional means to fulfill my Constitutional oversight responsibilities. I appeared at the FDA's doorstep.
But agency officials refused to let the FDA investigator talk to me.
Bureaucratic stonewalling won't deter this U.S. Senator. I won't rest until the light of day exposes what ought to be available for public consumption. It all boils down to keeping the government accountable to the people and strengthening the public trust in government."
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