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2010-09-24 Breaking News [Central News Agency]
The U.S. Food and Drug Administration (FDA) announced today that it will impose strict restrictions on the controversial diabetes drug Avandia but will not impose a complete ban. Meanwhile, European drug authorities have decided to ban it entirely.
The FDA stated in a release that the decision was made because "data show that patients taking Avandia face an increased risk of cardiovascular events such as heart attack and stroke."
Under the new U.S. restrictions, only newly diagnosed Type 2 diabetes patients who cannot control their blood sugar levels with other medications will be allowed to use Avandia.
The statement also noted that current Avandia users may choose to continue taking the drug.
FDA Commissioner Margaret Hamburg said, "After carefully weighing the benefits and risks, the FDA has taken this action today to protect patients."
In Europe, the European Medicines Agency (EMA) stated that diabetic patients in Europe will no longer be treated with Avandia. The agency had previously recommended that the drug be withdrawn from the market due to health concerns.
The EMA said in a statement that Avandia "will no longer be available in Europe in the coming months."
The drug is manufactured by British pharmaceutical company GlaxoSmithKline.
Avandia has long been linked to an increased risk of heart attack and stroke. In 2007, the FDA determined that the drug posed serious health concerns, prompting authorities to require warning labels. (Translator: Lin Zhiping, Central News Agency) 990924
Source: http:/ / iservice. libertytimes……=412891& type=Breaking% 20News
US Restricts, EU Bans Diabetes Drug Avandia
The U.S. Food and Drug Administration (FDA) announced today that it will impose strict restrictions on the controversial diabetes drug Avandia but will not impose a complete ban. Meanwhile, European drug authorities have decided to ban it entirely.
The FDA stated in a release that the decision was made because "data show that patients taking Avandia face an increased risk of cardiovascular events such as heart attack and stroke."
Under the new U.S. restrictions, only newly diagnosed Type 2 diabetes patients who cannot control their blood sugar levels with other medications will be allowed to use Avandia.
The statement also noted that current Avandia users may choose to continue taking the drug.
FDA Commissioner Margaret Hamburg said, "After carefully weighing the benefits and risks, the FDA has taken this action today to protect patients."
In Europe, the European Medicines Agency (EMA) stated that diabetic patients in Europe will no longer be treated with Avandia. The agency had previously recommended that the drug be withdrawn from the market due to health concerns.
The EMA said in a statement that Avandia "will no longer be available in Europe in the coming months."
The drug is manufactured by British pharmaceutical company GlaxoSmithKline.
Avandia has long been linked to an increased risk of heart attack and stroke. In 2007, the FDA determined that the drug posed serious health concerns, prompting authorities to require warning labels. (Translator: Lin Zhiping, Central News Agency) 990924
Source: http:/ / iservice. libertytimes……=412891& type=Breaking% 20News