Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started
My Medicine

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Women's Health

Font Size

Deaths Prompt Abortion Pill Warning

Risk of Rare Infection From RU-486 Similar to Rate From Surgical Abortion
WebMD Health News

July 20, 2005 -- Following five deaths linked to the abortion pill RU-486, the FDA is alerting doctors and patients about the possible risk of rare but potentially serious infections from the drug.

The deaths occurred from 2001 to June 2005.

"We believe it is important to share with health care providers and patients the latest serious reports of infection associated with this drug that we have received," says Steven Galson, MD, acting director of the FDA's Center for Drug Evaluation and Research.

Same Risk as Surgical Abortion

The FDA says it is altering patient guides and "black box" warnings in the drug's label to warn of a risk of rare but serious bacterial bloodstream infection.

Approximately 460,000 American women have used RU-486, -- sold in the U.S. under the brand Mifeprex -- putting the risk of fatal infection at about one in 100,000, according to manufacturer Danco Laboratories. That's roughly the same rate of fatal infections seen with surgical abortions.

RU-486 is usually given in conjunction with the hormone misoprostol to cause an abortion.

"Childbirth, menstruation, and abortion, whether spontaneous, surgical, or medical, all create conditions that can result in serious and sometimes fatal infection, and there is no evidence that Mifeprex and misoprostol present a special risk of infection," the company notes in a statement.

Four women who died were in California while another died during a clinical trial in Canada in 2001. Regulators say they do not know why all reported U.S. cases were in California.

No Evidence Abortion Pill Caused Infections

In a statement, the FDA says it has no information showing that RU-486 directly caused the deaths. The bacterium Clostridium sordelli, which can also cause severe infection following childbirth or surgical abortions, was identified in three of the cases.

"The FDA will continue to evaluate all case reports and other information to determine if there is any causal relationship," the agency says.

Soon, Danco will mail a letter to doctors who prescribe RU-486 warning them of the possibility of severe infection in women who take the drug. The FDA warned that patients who experience nausea, vomiting, malaise, or other signs of infection after taking the drug should receive antibiotics to stave off possible serious bloodstream infection.

Today on WebMD

hands on abdomen
Test your knowledge.
womans hand on abdomen
Are you ready for baby?
birth control pills
Learn about your options.
Is it menopause or something else?
woman in bathtub
bp app on smartwatch and phone
estrogen gene

Send yourself a link to download the app.

Loading ...

Please wait...

This feature is temporarily unavailable. Please try again later.


Now check your email account on your mobile phone to download your new app.

Blood pressure check
hot water bottle on stomach
Attractive young woman standing in front of mirror