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Subscribe To Our Syndicated NewsFDA Orders Amgen to Update Labels
-July 31, 2008
Recent reports claim that the Food and Drug Administration has ordered the labels for anemia drugs manufactured by Amgen to be updated.
The FDA believes the wording on the labels needs to be stronger to further restrict the use of the medications for patients with cancer.
FDA Takes Action for Patient Safety
The FDA announced their decision to have Amgen change their labels earlier this week and the request marks the first time that the agency has ordered a drug company to change prescribing information.
The FDA is enabled to do so in accordance with a 2007 law that gives them permission to take action if a drug’s label isn’t warranted as being sufficient.
Amgen Sales Drop
According to reports, sales of Amgen drugs such as Aranesp and Procrit have dropped in light of studies that their use by patients with anemia thought to be caused by chemotherapy could make cancer worse or shorten lives.
Sales of Aranesp, which is considered Amgen’s flagship product, have fallen 13 percent and in the U.S. alone, sales have decreased by 26 percent.
New Labels to be Implemented
The new labels will explain that the use of the medications shouldn’t begin until a patient’s hemoglobin drops to 10 grams per deciliter of blood.
Wording on the current labels says the drug is safe for patients until their hemoglobin rises to 12 grams per deciliter will also be edited.
(Source: New York Times)
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