February 11, 2009 10:14 PM
New Diabetes Drug Approved
Diabetics frightened by reports that a popular treatment may destroy some patients' livers are getting a long-awaited new choice: The Food and Drug Administration has approved Avandia, a drug that promises to fight diabetes with fewer liver risks.
SmithKline Beecham Pharmaceuticals said Avandia will be commercially available within a few days, following FDA approval Tuesday.
No one can say for certain that Avandia never will damage some diabetics' livers like its competitor, Rezulin, has. But in studies of over 4,000 patients, Avandia has not shown signs of such damage, prompting some doctors to eagerly await the treatment as an alternative for their patients.
Still, if liver damage is a rare side effect, then it may appear only after hundreds of thousands of people try the drug. So the FDA stressed Wednesday that diabetics who try the new drug should have a liver test before beginning Avandia, and then have their livers checked every two months during the first year of therapy.
Anyone with symptoms suggesting liver problems should contact a doctor for a liver test, the FDA warned. Symptoms include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and dark urine or jaundice. If jaundice occurs, Avandia should be stopped.
Avandia is for Type 2, or adult-onset, diabetes, which afflicts about 14 million Americans whose bodies lose the ability to properly use insulin, the hormone that processes blood sugar.
Avandia, known chemically as rosiglitazone, works by somehow resensitizing the body to insulin.
Rezulin, which is chemically related to Avandia, works the same way, and was widely cheered when it hit the market in 1997 as the first drug to target that underlying cause of diabetes. Some 750,000 Americans use it, including many who have failed other therapies.
Shortly after Rezulin hit the market, however, reports it caused liver failure began surfacing. FDA officials list 43 Rezulin patients who suffered acute liver failure. Of those, 28 died and seven needed liver transplants to survive.
The FDA said those cases may represent only 10 percent of all Rezulin-related liver damage. Last month, the agency's scientific advisers called for new restrictions on Rezulin's sales, but the FDA has not yet decided whether to follow that advice.
Avandia also can cause side effects, including mild to moderate swelling, an increase in blood cholesterol and anemia, but the FDA said the problems usually were not severe enough to require stopping the drug.
Written By Lauran Neergaard
SmithKline Beecham Pharmaceuticals said Avandia will be commercially available within a few days, following FDA approval Tuesday.
No one can say for certain that Avandia never will damage some diabetics' livers like its competitor, Rezulin, has. But in studies of over 4,000 patients, Avandia has not shown signs of such damage, prompting some doctors to eagerly await the treatment as an alternative for their patients.
Still, if liver damage is a rare side effect, then it may appear only after hundreds of thousands of people try the drug. So the FDA stressed Wednesday that diabetics who try the new drug should have a liver test before beginning Avandia, and then have their livers checked every two months during the first year of therapy.
Anyone with symptoms suggesting liver problems should contact a doctor for a liver test, the FDA warned. Symptoms include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and dark urine or jaundice. If jaundice occurs, Avandia should be stopped.
Avandia is for Type 2, or adult-onset, diabetes, which afflicts about 14 million Americans whose bodies lose the ability to properly use insulin, the hormone that processes blood sugar.
Avandia, known chemically as rosiglitazone, works by somehow resensitizing the body to insulin.
Rezulin, which is chemically related to Avandia, works the same way, and was widely cheered when it hit the market in 1997 as the first drug to target that underlying cause of diabetes. Some 750,000 Americans use it, including many who have failed other therapies.
Shortly after Rezulin hit the market, however, reports it caused liver failure began surfacing. FDA officials list 43 Rezulin patients who suffered acute liver failure. Of those, 28 died and seven needed liver transplants to survive.
The FDA said those cases may represent only 10 percent of all Rezulin-related liver damage. Last month, the agency's scientific advisers called for new restrictions on Rezulin's sales, but the FDA has not yet decided whether to follow that advice.
Avandia also can cause side effects, including mild to moderate swelling, an increase in blood cholesterol and anemia, but the FDA said the problems usually were not severe enough to require stopping the drug.
Written By Lauran Neergaard
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