The U.S. Food and Drug Administration has announced that Avandia, a drug used to treat Type 2 diabetes, now will be only prescribed to individuals who can prove that they have no other alternative for effectively treating their condition …
The FDA cited heart risks as the reason behind the tougher restrictions on what was once the world’s most popular diabetes drug. One study estimated that from 1999 to 2009, more than 47,000 people taking Avandia suffered a heart attack, stroke or heart failure, or died.
Approved in 1999, Avandia helps control blood sugar levels in diabetics by making patients more sensitive to their own insulin. Because of Avandia, in 2008 the FDA announced it would not approve medicines just because they help diabetics control blood sugar levels—the industry standard for more than 80 years.
Patients now taking Avandia may stay on the medication, but only if they sign forms stating they are aware of the risks. About 600,000 diabetics currently take Avandia and that number is expected to plunge dramatically.
The drug has been completely restricted in Europe.
Read the FDA’s official press release, “FDA significantly restricts access to the diabetes drug Avandia.”
Read the New York Times article, “FDA to Restrict Avandia, Citing Heart Risk.”
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