(CNSNews.com) - Sen. Jim DeMint (R-S.C.) is urging Congress to pass a bill that would suspend the abortion-inducing drug RU-486 from the market until the Government Accountability Office conducts an independent review of the FDA's approval process.
The FDA approved the drug in September 2000, declaring it "safe and effective," but the drug manufacturer now says at least five American women have died after taking the drug combination.
"RU-486 is a deadly poison that is killing pregnant women," said DeMint. "This drug should never have been approved, and it must be suspended immediately."
Earlier this year, Senator DeMint introduced S.511, The RU-486 Suspension and Review Act, also known as "Holly's Law." The bill currently has 9 cosponsors in the Senate. Rep. Roscoe Bartlett (R-Md.) reintroduced Holly's Law in the House, where it currently has 69 cosponsors. "I introduced Holly's Law to suspend FDA approval of the dangerous and deadly abortion drug RU-486 because I think medicine should help people and not kill them," Bartlett said.
The law was prompted by the 2003 death of 18-year-old Holly Patterson who died within a week of taking RU-486.
The drug's manufacturer Danco Laboratories issued a statement on Monday saying that in the almost five years the drug has been available, it has received reports of five deaths from serious bacterial infection and sepsis.
One woman died in Canada during a clinical trial in 2001, and four others died in California between late 2003 and mid-2005.
Some 600 other women have experienced adverse events from RU-486, including 200 that were either life-threatening or extremely serious.
The FDA this week said the drug's label will be changed to warn women and doctors to watch out for signs of an unusual infection that is not always accompanied by fever.
"If there were any doubts about the deadly effects of this drug before, there should not be any now," said Senator DeMint. "The FDA's acknowledgment of these new deaths clearly indicates a serious problem with the drug's safety. Congress must act quickly to suspend this drug before more women die."
DeMint says a change in labeling is not enough to protect the health and safety of women.
"Congress needs to act to take this deadly drug off the market and force a serious review of its safety - something that should have been done before it was ever approved. The FDA skipped important steps in its approval and, as a result, women have died."
See Earlier Story:
FDA Issues Health Warning After Reports of Abortion Pill Deaths (July 20, 2005)
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