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Mifepristone: not a panacea

By Helen Ransom - posted Wednesday, 2 November 2005


In US trials of the drug, 99 percent of women reported at least one adverse effect - fourteen were hospitalised (eight of them with excessive bleeding and one suicidal) - yet amazingly it was accepted by the US Food and Drug Administration in 2000.

Five American women have since died from serious bacterial infection and sepsis after taking RU486, including 18-year old Californian, Holly Patterson.

In September 2003, four days after taking the drug, Holly returned to hospital, complaining of severe pain and bleeding. She returned again three days later, vomiting and in great pain, and died that afternoon.

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These deaths and numerous complications prompted the FDA to twice change RU486's packaging  to warn women of the potential side-effects, including nausea, abdominal pain, vomiting, excessive and prolonged bleeding, heart attack, haemorrhage, impaired future fertility, birth defects when an abortion doesn’t occur, harm to future children, and death.

It warns women not to take RU486 if “you cannot easily get emergency medical help [including blood transfusions and emergency resuscitation] in the two weeks after you take [RU486]”. The FDA has also published 676 “adverse event” reports documenting complications suffered by American women, 200 of which were life-threatening or extremely serious.

These reports can be viewed online, and even a cursory glance reveals a hoard of problems from the same “suspect medication”, including 72 cases requiring blood transfusions, 17 ectopic pregnancies and 7 serious infections.

Here’s what one 25-year old woman said in her report after being issued with the drug:

I followed [the] directions exactly, and after taking the RU486, I was in excruciating physical pain, for at least 12 hours straight and I was bleeding extremely excessively … The only thing I could do was lie on the floor and pull my hair to deal with the pain … I thought I was going to die. After about seven hours of this I really wanted to.

Holly Patterson never told her parents she had taken the drug, and when she started to get abdominal pains she told her dad they were simply menstrual cramps. It wasn’t until days later a doctor told Monty Patterson what had happened to his daughter.

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"The medical community treats this as a simple pill you take, as if you're getting rid of a headache,” Monty Patterson said.

"The procedure, the follow-ups, it's all too lackadaisical. The girl gets a pill. Then she's sent home to do the rest on her own. There are just too many things that can go wrong."

The serious health risks to women taking RU486 should never been downplayed, and the drug should never be marketed to women as a medical panacea as simple and harmless as taking a Panadol.

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Article edited by Virginia Tressider.
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About the Author

Helen Ransom is a political adviser and is currently studying a Grad Dip in Theology at Catholic Theological College, Melbourne.

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