The U.S. Food and Drug Administration announced that the controversial diabetes Avandia drug will be is most sold starting in November, due to cardiovascular risks that it poses to patients of retail pharmacies.
Under the new rules, which will come into force on 18 November, the drug will be available for patients who have been safely using drugs, those who have had no success in the control of their blood sugar with other drugs for diabetes or patients who was informed of the risks or still choose to take Avandia (rosiglitazone).
These patients must be registered in a special program to be eligible to receive the drug, according to the FDA.
"The program access to drugs Avandia-Rosiglitazone rosiglitazone drugs shall be available to patients registered mail-order pharmacies certified program," the Agency said in a statement released Wednesday. "The drug manufacturer, GlaxoSmithKline, will withdraw rosiglitazone current supply chain drug and pharmacies will provide instructions on return drugs."
Rosiglitazone is also sold under the names Avandamet (where the drug is combined with metformin) and Avandaryl (rosiglitazone and glimeperide). The new rules apply to these drugs combination thus.
According to Bloomberg News, GlaxoSmithKline said it intends to inform pharmacists and physicians on the new program access over the next two months, company spokeswoman Mary Anne Rhyne said. In the meantime, patients should discuss their options with their physician before making changes to their treatment of diabetes.
The withdrawal of Avandia and products related to pharmacy shelves comes eight months after the use of rosiglitazone FDA severely limited for the diabetes type 2 patients for whom other drugs do not work.
"It is like a nightmare decade draws to a close," said Dr. Steven Nissen, Chief of cardiovascular medicine at the Cleveland Clinic, USA Today. "Eleven years after the drug was introduced, it is therefore limited that virtually anyone can get access."
Nissen has long measures taken by the FDA this week. He led a study published in 2007, which found that people with type 2 diabetes who took the drug had an increase of 40% of the risk of heart attack. This increased risk has been supported in subsequent tests.
It is believed that more than 23 million Americans suffer from diabetes type 2, and in accordance with the FDA, almost half a million Americans filled an order for rosiglitazone in the first 10 months of 2010. This number has been on the decline, however, the Agency added.
In fact, the new decision "reflects the decline in the number of doctors and patients who are ready to use the drug in clinical practice," said Dr. Ronald Tamler, Professor of medicine and leader of the clinical trials at Mount Sinai Diabetes Center in New York. "Patients who are still taking the drug can be re-evaluated by a certified prescriber or can be passed to a safe and effective alternative", he said.
As part of restrictions put in place by the FDA in September, doctors had to expose and document the eligibility of a patient to use Avandia. They also have to tell patients about cardiovascular risk with Avandia safety, and patients must acknowledge that they understand these risks.
In Europe, the European Agency of drugs last year suspended marketing of the drug, forcing patients to find other drugs to control their rate of sugar in the blood.
Rosiglitazone belongs to a class of drugs called thiazolidinediones. It is intended to be used with diet and exercise to control blood glucose in patients with diabetes type 2.
The most recent FDA action does not affect other major thiazolidinediones, Actos (pioglitazone), made by Takeda Pharmaceuticals. This medication has not shown, seen in the trials of Avandia heart risks.
Speaking at the action of the FDA in September, Dr. Ronald Goldberg, Professor at the University of Miami Miller School of medicine Diabetes Research Institute, has seen little use for Avandia. A solution of similar and more secure alternative - Actos - exists, "one would think there is very little room for Avandia," he said at the time.
Goldberg also said that he is more prescribe Avandia, except for patients who have been using it for many years.
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