[新聞] FDA Removes Restrictions on Avandia

[johnnyjaiu (人若犯我 加倍奉還)]

TIME http://goo.gl/kcDvtl

The Food and Drug Administration (FDA) is rolling back warnings and
restrictions on the diabetes drug rosiglitazone (Avandia), after an independent
analysis revealed the drug did not increase the risk of heart attacks.


In 2010, the FDA placed restrictions on the use of the drug, manufactured by
GlaxoSmithKline, limiting its prescription to physicians in a registry who were
educated about the medication's increased heart risks. Patients also had to
acknowledge the risk, and could only use the drug if they had exhausted all
other options to control their blood sugar. The decision was based on a review
of clinical trials involving the drug published in 2007.

However, this summer, an FDA panel met to discuss and reassess the decision
after a new study, called RECORD, found no greater risk for heart disease
associated with Avandia than with other diabetes drugs. In a close vote, an FDA
advisory panel voted on June 6 to modify the restrictions, and those changes
are now being implemented. Out of the 26 FDA panel members, 13 voted to modify
the Avandia restrictions, seven voted to remove the restrictions entirely, and
five voted to leave the restrictions in place. Only one person voted to remove
the drug from the market entirely.

(MORE: The Vote Is In: FDA Panel Says Modify the Avandia Restrictions)

With the new labeling, Avandia will once again be recommended for controlling
blood sugar along with a healthy diet and exercise. And patients will now be
able to get the drug from their pharmacists rather than special registries.

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版主偷偷更新版標都不說的吼~ :P

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