Abortion pill advisory issued
Danco Laboratories LLC of New York City, manufacturer of Mifeprex (mifepristone), has issued a letter to providers that alerts them that six women have developed serious illnesses and two have died after taking the abortion drug.1 No causal relationship has been established between the drug and the illnesses in any of the cases, the letter states.2
Officials with Danco, the Population Council (the New York City-based research organization that granted exclusive license to Danco to manufacture, market, and distribute Mifeprex) and the Food and Drug Administration (FDA) said it was important to provide prescribers of Mifeprex with updated safety information, remind them of their responsibility to provide patient counseling, and to report certain events to Danco, states Heather O’Neill, Danco spokeswoman.
The letter reminds providers that the FDA-approved regimen for administration of Mifeprex is:
- 600-mg Mifeprex taken orally in the office or clinic;
- 400 mcg of misoprostol taken orally in the office or clinic 48 hours after the Mifeprex.
In all of the reported cases, misoprostol was given vaginally, not orally, which is the approved regimen, the letter states. In information posted by the FDA, the agency states that it has not reviewed data on the safety and effectiveness of vaginal administration of misoprostol.3 (Read the provider letter, as well as answers to frequently asked questions, at the FDA Medwatch web site, www.fda.gov/medwatch. Click on "2002" under "Safety Alerts for Drugs," then click on "Drugs." Click on "Mifeprex" to read the two items.)
The move to issue the advisory letter came after Danco Laboratories received three reports of ruptured ectopic pregnancies, including one death from hemorrhage due to a ruptured ectopic pregnancy.1 In addition, the company has recorded two cases of serious systemic bacterial infection, one of them fatal, following treatment with Mifeprex and misoprostol, as well as a report of myocardial infarction occurring in a 21-year-old woman three days following the mifepristone/miso- prostol regimen.
Providers are reminded that confirmed or suspected ectopic pregnancy is a contraindication for the use of mifepristone and should be ruled out prior to initiating drug treatment. (Review "Gauging the Effectiveness of Mifepristone and Misoprostol," the February 2001 Contraceptive Technology Reports inserted in the February issue of Contraceptive Technology Update.)
"Because ectopic pregnancy may be present despite your best efforts to rule it out before starting Mifeprex treatment, you should be mindful of the possibility of an ectopic pregnancy throughout the treatment period and have a plan for its management," the letter states.
In the case of the infection reports, the company notes that while serious infection in medical abortion is rare, providers should be aware of such possibilities if patients report symptoms or have signs of infection. Women should be reminded to contact providers immediately if they have severe pain, heavy bleeding, bad-smelling discharge, or fever.
During the first office visit for medical abortion, women should be presented the Mifeprex medication guide, and they also should read and sign the patient agreement provided by the company. In addition, providers are reminded to report serious adverse events including death, hospitalization, blood transfusion, and other major events to the company, as well as cases of ongoing pregnancy following treatment with the Mifeprex regimen.
Affirm abortion safety
Clinicians should convey to women the safety of medical abortion through talking not only about their own personal experiences in providing medical abortion, but also pointing to the extensive literature surrounding medical abortion, says Vanessa Cullins, MD, vice president for medical affairs for the New York City-based Planned Parenthood Federation of America.
"There are over half a million women that have had safely had medical abortion performed worldwide, and in the United States, and we are gathering extensive data that indicate that medical abortion is provided very safely, whether using the FDA-approved protocol or the evidence-based alternative, which uses lower doses of mifepristone," she states. (See "Slow entry seen for mifepristone in 2001," in CTU, December 2001, p. 140.)
According to Cullins, Planned Parenthood affiliates have performed about 13,000 medical abortions using mifepristone since its U.S. introduction and have experienced very few adverse effects.
"Less than 1% of women have had adverse events, and no one has died from medical abortion in our experience," she reports. "And in fact, our complication rates are lower than those seen in the literature."
Planned Parenthood’s medical protocol for the administration of mifepristone is designed to confirm the presence of an intrauterine pregnancy, rule out the possibility of an ectopic pregnancy, and ensure continuing patient support, states Cullins in a letter to the editor following the issuance of the Danco Laboratories letter.4 Patients receive comprehensive counseling, including information about when and how to seek additional information and care, should the need arise, she notes.
When the manufacturer’s letter was issued, Cullins says Planned Parenthood forwarded information to its affiliate medical directors, and they in turn advised their staff to provide reassurance if they received any type of inquiries from women.
"Both providers and women should have confidence in medical abortion," says Cullins.
References
1. Okie S. Physicians sent abortion pill alert. Washington Post, April 18, 2002; A02.
2. Danco Laboratories LLC. Dear health care provider [letter]. New York City; April 19, 2002.
3. Food and Drug Administration. Mifepristone Questions and Answers. April 17, 2002. Accessed at www.fda.gov.
4. Cullins V. Dear Editor (letter). Washington Post, April 23, 2002; A16.
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