FDA Increases Warning on Mifepristone; Drug Still Considered Extremely Safe

The US Food and Drug Administration (FDA) announced on Monday that Mifepristone’s label will be changed to acknowledge that there are risks associated with any abortion, and that physicians prescribing the drug should instruct their patients to contact them if they experience excessive bleeding or bacterial infection. The FDA maintains that these adverse affects could occur “following any termination of pregnancy,” including miscarriage, surgical abortion, or medical abortion, the San Francisco Gate reports. Though no causal relationship between the drug, also known as RU-486, and these risks has been established, the push to reconsider labeling came after the death of a woman in California after a bacterial infection in her uterus caused blood poisoning, according to the New York Times. There is still question from Danco Laboratories, the American maker of the drug, over whether the death was caused by Mifepristone or by another medication for cancer the woman was taking at the time. Mifepristone has been taken by roughly 360,000 women in the United States since it was approved by the FDA in 2000. According to the Association of Reproductive Health Professionals, Mifepristone is safer than taking a pregnancy to full term. The drug is also safer than both Tylenol, which is the cause of 150 deaths a year, and Viagra, which is five times more likely than Mifepristone to cause death. DONATE to protect the right to a safe, legal abortion


New York Times 11/16/04; San Francisco Gate 11/16/04; Association of Reproductive Health Professionals

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