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Drug Maker: No Mortality Hike When Anemia Drug Was Used in Clinical Trial
April 23rd, 2007

Drug Maker: No Mortality Hike When Anemia Drug Was Used in Clinical Trial

 

The pharmaceutical company Amgen says it has good news for patients and investors alike.

 

The New York Times reports that Amgen issued an overview Friday of a closely-watched clinical trial of its anemia drug Aranesp, saying that the medicine did not increase the death rate of lung cancer patients who were using it.

 

Earlier studies had indicated that Aranesp and other drugs in the same class might cause blood clots, worsen cancer or increase the risk of death if overused. In fact, the U.S. Congress had already entered into the discussion about the safety of these anemia drugs.

 

Last month, the House Committee on Energy and Commerce sent letters to drug makers Amgen (Epogen and Aranesp) and Johnson & Johnson (Procrit), asking them to clarify when they knew about the possible risks associated with the drugs and how they have promoted the drugs, the Times reported. The drugs are used by nearly a million Americans a year, mainly to treat anemia from kidney disease or cancer chemotherapy.

 

On March 9, the U.S. Food and Drug Administration and the drug makers agreed to put a "black box" warning (the most serious kind) on the labels of the anemia drugs to warn about the newly identified risks. An FDA advisory panel is scheduled to meet May 10 to discuss the safety of the drugs.

 

While the results from the lung cancer trial are encouraging, the Times reports that a number medical experts say more research is needed to ensure that these drugs are safe to use with other diseases as well.

HealthDay.com