Senior citizens skeptical about signing up for a new Medicare prescription drug benefit program, are being urged by President George Bush to enroll in the scheme which is promising a choice of plans with monthly premiums as low as $20.Bush was
Older people with insomnia slept better and longer after taking an experimental sleep medication, according to research at Wake Forest University Baptist Medical Center. W. Vaughn McCall, M.D., a sleep expert, presen
A new flu vaccine has been approved by U.S. health officials in an attempt to bolster up supplies after last season's shortage.It is hoped that the new vaccine, by GlaxoSmithKline will fill the vo
Results from a new study presented today at the 75th Annual Scientific Meeting of the Aerospace Medical Association (AsMA) in Anchorage, USA, suggest that MalaroneTM (atovaquone and proguanil hydrochloride) would not be expected to affect th
The Food and Drug Administration approved Vitrase (hyaluronidase for injection). Vitrase is an injectable drug approved as an adjunct to (in combination with) other injected drugs to increase their absorption and disper
Scientists in the U.S. have developed a lotion which repairs sun damaged skin. The lotion which contains a protein which mends DNA damaged by the sun is presently undergoing clinical trials.Manufacturers
Citing a concern that young teenagers may not safely use the morning after pill without a doctor's guidance, the Food and Drug Administration (FDA) late today officially rejected a plan to make the pill available over-the-counter in America's pharmacies
Results of a new double-blind, placebo-controlled, randomized clinical study show that daily nutritional supplementation with a combination of chromium picolinate and biotin (marketed as Diachrome?significantly improved coronary risk factors in people with
GlaxoSmithKline has announced that it is expanding its ability to increase vaccines supplies for Americans by acquiring a vaccine research and production facility in Marietta, Pennsylvania. This acquisiti
The current rate of growth in the generics market puts it on pace to outgrow branded pharmaceuticals, which should only grow by single digits in 2004, according to business intelligence firm Cutting Edge Information
Date: Monday, 12-Feb-2007
The Food and Drug Administration (FDA) in the United States has issued a warning about an antibiotic used to treat sinusitis and bronchitis.The FDA say the controversial drug Ketek was too risky to treat those diseases and although it will remain on the market to treat pneumonia, stronger warnings about possible side effects such as blurred vision and loss of consciousness, will be placed on the drug's labels.
The FDA also says the drug in future will carry a "black box" warning, the strongest possible, against its use by patients with a disease known as myasthenia gravis that causes muscle weakness.
The latest warnings follow a year-long FDA investigation into reports of severe liver damage and death in some Ketek patients that sparked debate over the drug's safety and also over the agency's handling of its approval.
Ketek, known generically as telithromycin, already carried a bold warning for possible liver damage and has been linked to 14 cases of severe liver problems, including five deaths.
The FDA announcement pre-empts a House Energy and Commerce subcommittee hearing on drug safety issues, including Ketek.
The subcommittee will examine irregularities in the approval of Ketek and the FDA's handling of the antibiotic also remains under investigation by the Senate.
Ketek, known generically as telithromycin, already carried a bold warning for possible liver damage.
The FDA has repeatedly been criticized by some for withholding information about Ketek's approval.
The agency cleared the drug in 2004 even though an investigation found a key safety study was tainted by fraud.
FDA officials said other data provided adequate reassurance.
Until late last year, doctors had prescribed the antibiotic more than 5.6 million times in the United States since it won FDA approval.
Ketek is produced by Paris-based drug company Sanofi Aventis.