Avandia, a diabetes drug used to control blood sugar levels, faces severe new limitations. The U.S. and Europe both announced new policies for the drug in late September. The sale of Avandia will be completely stopped in Europe and restricted in the United States. According to the New York Times, U.S. patients will only be allowed to take the drug if their doctor “attests” that every other diabetes drug has been tried, and the patient is informed of Avandia’s “substantial” heart risks.
The Food and Drug Administration (FDA) has taken action despite scientific uncertainty. Although not all scientists agree, there have been studies that show that use of Avandia is related to heart attacks. “One study estimated that from 1999 to 2009, more than 47,000 people taking Avandia needlessly suffered a heart attack, stroke or heart failure, or died.”
Further, for the use of future medications, more information will be required than just the drug’s ability to control blood sugar levels. The latter has been the standard for over 80 years. Now, research will have to include the drug’s affect on the heart and whether the drug creates dangers. Another change regarding scientific information regarding medicines is the availability. It will continue to become more and more common for research to be required to be posted online. This changes drug makers’ ability to control scientific information regarding their product.
The changes in the availability of Avandia will certainly decrease the sales of the drug. However, the tough new restrictions will protect patients against the dangers of Avandia while still allowing it to be available for those who most need it.