ID :
16552
Thu, 08/21/2008 - 10:04
Auther :
Shortlink :
https://oananews.org//node/16552
The shortlink copeid
Thousands of diabetics 'must see doctor'
(AAP) Australian diabetics taking the controversial drugs Avandia and Avandamet have been told to have their treatment reviewed after the medications were linked with heart failure and death.
More than 30,000 people are taking the two drugs, which were found to double the risk of cardiac failure and mortality in some people in two major studies releasedlast year.
Pharmaceutical company GlaxoSmithKline (GSK) has announced changes to the drugs' guidelines for use, and has urged all patients to see a doctor as soon as possibleto discuss their treatment.
Under the new guidelines, no patients with any degree of cardiac failure should takethe drugs, and they must not be taken with insulin.
No new patients should be started on so-called triple therapy, a common course ofthree drugs in combination to treat diabetes.
Dr Michael Elliott, medical director of GSK Australia, said the Therapeutic Goods Administration (TGA) had assessed the available data and decided this was the bestcourse of action for Australian patients.
"Our primary focus is on informing doctors of the changes so they can review the treatment of patients currently on Avandia or Avandamet, in accordance with thechanges to the product information," Dr Elliott said.
"Patients using Avandia or Avandamet should continue taking their medication but make an appointment with their doctor to review their treatment as soon as possible." Avandia, known generically as rosiglitazone, first came under the spotlight in May when a New England Journal of Medicine study found it could increase the risk ofheart failure and death by 43 per cent.
This also implicates Avandamet, which is Avandia combined with another diabetestreatment, metformin.
Another report published in Diabetes Care last July showed that Avandia and a related drug, Actos, doubled the risk of heart failure in some patients. No changeshave been announced for Actos.
Professor Don Chisholm, an endocrinologist at the Garvan Institute in Sydney, said the insulin and cardiac risk were already known and supported by diabetesspecialists.
But the move to stop new patients starting triple therapy was more controversial andwould face criticism, Prof Chisholm said.
"I don't agree with it because we know that Avandia in combination therapy is highly effective and the evidence that there's any adverse outcome of using it in tripletherapy is very, very minimal," he said.
"Not being able to use it will put people at a disadvantage." GSK says the changes are not warranted because no adverse data has been seen since2007 and two new studies released this year support the drugs' safety.
A TGA spokeswoman said the agency was completing a final safety investigation of themedications.
More than 30,000 people are taking the two drugs, which were found to double the risk of cardiac failure and mortality in some people in two major studies releasedlast year.
Pharmaceutical company GlaxoSmithKline (GSK) has announced changes to the drugs' guidelines for use, and has urged all patients to see a doctor as soon as possibleto discuss their treatment.
Under the new guidelines, no patients with any degree of cardiac failure should takethe drugs, and they must not be taken with insulin.
No new patients should be started on so-called triple therapy, a common course ofthree drugs in combination to treat diabetes.
Dr Michael Elliott, medical director of GSK Australia, said the Therapeutic Goods Administration (TGA) had assessed the available data and decided this was the bestcourse of action for Australian patients.
"Our primary focus is on informing doctors of the changes so they can review the treatment of patients currently on Avandia or Avandamet, in accordance with thechanges to the product information," Dr Elliott said.
"Patients using Avandia or Avandamet should continue taking their medication but make an appointment with their doctor to review their treatment as soon as possible." Avandia, known generically as rosiglitazone, first came under the spotlight in May when a New England Journal of Medicine study found it could increase the risk ofheart failure and death by 43 per cent.
This also implicates Avandamet, which is Avandia combined with another diabetestreatment, metformin.
Another report published in Diabetes Care last July showed that Avandia and a related drug, Actos, doubled the risk of heart failure in some patients. No changeshave been announced for Actos.
Professor Don Chisholm, an endocrinologist at the Garvan Institute in Sydney, said the insulin and cardiac risk were already known and supported by diabetesspecialists.
But the move to stop new patients starting triple therapy was more controversial andwould face criticism, Prof Chisholm said.
"I don't agree with it because we know that Avandia in combination therapy is highly effective and the evidence that there's any adverse outcome of using it in tripletherapy is very, very minimal," he said.
"Not being able to use it will put people at a disadvantage." GSK says the changes are not warranted because no adverse data has been seen since2007 and two new studies released this year support the drugs' safety.
A TGA spokeswoman said the agency was completing a final safety investigation of themedications.
