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PHARMA - ABORTION PILL MIFEPREX INFECTION WARNING

Abortion pill to carry 'black box' warning

 

BY OUR PHARMA  CORRESPONDENT

20 July, 2005: Following the death of two more California women after taking abortion pills, the Food and Drug Administration has asked Mifeprex makers to change label to warn women and doctors on signs of unusual infection.

The total death count after taking the abortion pills have now reached five and federal drug regulators suspect bacterial infections as the cause. As a result, the drug's label will warn women and doctors to watch out for signs of an unusual infection that is not always accompanied by fever, the Food and Drug Administration announced.

The latest warnings about Mifeprex (also known as RU-486) which contains misoprostol will be included in a "black box" warning that is already on the drug's label. Such warnings are the highest level of alert by the drug agency four of them most likely suffered lethal bacterial infections.

Meanwhile, Mifeprex's maker Danco Laboratories said the company did not think the medicine caused bacterial infections as the same infection has been reported after childbirth and other gynecological situations. Still, the company thought it was important to warn doctors and patients to watch for the signs of such an infection so that this did not happen again.

Samples from the women who died have proved that the bacterium involved was Clostridium sordellii. Infection with this bacteria can cause nausea, vomiting, diarrhea and weakness but does not necessarily lead to abdominal pain and infection.

Doctors who suspect an infection in one of their patients should start them on antibiotics 
immediately.

However, there is no cause to be panicky as of yet because according to estimates, the risks of death from infection for users of the pill is roughly one in 100,000 uses, FDA announcement said.

 

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