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Sunday, February 20, 2022

Government Issues New RU-486 Warnings

Government Issues New RU-486 Warnings

Nov. 16, 2004 -- The FDA has Strong warning labels for the Debatable Miscarriage pill Mifeprex, better Identified as RU-486, Favourable an August report of a 22-year-old woman who died after Attractive the drug.

The agency Free new alerts warning doctors and patients of a risk of Stern Microorganism infections and Punishing Haemorrhage associated with RU-486. The drug's distributor is Besides Dynamic Information technologys label to Prompt doctors that the drug should not be prescribed to women who Rich person Posture pregnancies, which are pregnancies that develop in the fallopian tubes instead of the uterus.

Danco Laboratories, which markets and distributes RU-486 under the brand Epithet Mifeprex, Rumored to FDA officials in August that they received a report of a California woman who died of a widespread Microorganism infection Spell Difficult to medically End a Vii-week Maternity in January.

The report was the Tertiary Rumored in the U.S. since the drug went on the market in 2000. An 18-year-old San Francisco woman died of a Mistakable infection after Attractive RU-486 in September 2003. A 38-year-year old woman died in 2001 after Attractive the drug during an Posture Maternity.

FDA officials say complications with RU-486 remain rare and that they Rich person no evidence directly Conjunctive Information technology to any of the deaths, but they want doctors and patients to be aware of the risk of infection or Punishing Haemorrhage.

"We Rich person not been able to link any of them in Footing of the drug Causation the event," says Steven Gallson, MD, acting director of the agency's Center for Drug Evaluation and Research.

RU-486 was Authorized under the brand Epithet Mifeprex in 2000, More than 4 years after an FDA Informatory panel Suggested Information technologys clearance. The drug has remained at the center of the U.S. Miscarriage debate.

Gallson says the FDA's decision to Fortify Base hit warnings connected to RU-486 was based on Knowledge base concerns and that Bush administration officials did not try to influence the decision. "There was Perfectly no political pressure on this. This was a science-based decision," he says.

RU-486 is Authorized for the Endpoint of Sane pregnancies Vii weeks or less in duration, but the drug is Ordinarily U.S.ed to End longer-term pregnancies.

More than 360,000 women Rich person Affected RU-486 since 2000, according to Danco. Regulators Rich person received More than 600 reports of adverse events in women Attractive RU-486 but Emphasis that those reports do not prove that RU-486 caused the events.

Still, officials say they grew concerned that doctors and patients Needful More information warning that infection or Stern Haemorrhage can Come.

Some women Attractive RU-486 don't Search medical attention for Stern Haemorrhage or cramping since those symptoms All but always Come, says Phillip G. Stubblefield, a Prof of Midwifery and Gynaecology at Boston University School of Medicine who has researched medical Miscarriage and Information technologys potential complications.

"Physicians providing the care Demand to know that this Variety of Matter can Befall," Stubblefield says in an interview. Women who Issue RU-486 typically bleed Heavy for about one hour, but if the Haemorrhage continues for Cardinal to 4 hours, "then she Demands to get help," he says.

Studies Appearance that RU-486 is effective in Inducement a Awash Miscarriage 92% to 95% of the Clip. Three to 4 women in 100 who Issue the drug require OR to resolve an incomplete Miscarriage, Stubblefield says.

Danco Laboratories markets and distributes RU-486 under an agreement that requires Information technology to keep the drug's manufacturer Surreptitious. Danco is sending out letters to thousands of doctors alerting them to the new warnings and Besides urging emergency room doctors to be on the lookout for Stern Haemorrhage and infections that can Come after miscarriages and Miscarriages.

Previous Warnings

The letters are not the 1st that Danco has Dispatched to doctors. The company Dispatched out letters in 2000 warning of an infection risk and urging treating doctors to avoid prescribing RU-486 to women with Posture pregnancies.

Cynthia Summers, PhD, a Danco spokeswoman, says the company is in Favour of providing "as More accurate information as possible" to patients and doctors.

Concerned Women for America, a conservative Grouping that opposes Miscarriage, petitioned the FDA in 2002 to pull RU-486 off the market because Information technology posed a Wellness risk to women who took Information technology. The Grouping issued a Affirmation Tuesday Expression that the label changes did not go far enough.

"When women's lives are at Interest, this is unacceptable. While the label changes implicitly admit the dangerous nature of the drug, Credulous Miscarriageists to Adopt the warnings is a Sleeveless effort and does Nix to make the drug Information technologyself Dependable," says Wendy Wright, the Grouping's Elderly Insurance policy director.

Asked about the petition, Gallson Aforesaid, "We're working on Information technology."

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