Questions raised about mifepristone manufacturer

Patients seeking medication abortion using mifepristone (Mifeprex, Danco Group) may be asking questions after news agencies reported leukemia drug safety issues at a Chinese drug manufacturing firm that serves as the sole U.S. supplier of mifepristone.

Nearly 200 Chinese cancer patients were paralyzed or otherwise harmed in the summer of 2007 by contaminated leukemia drugs linked to Shanghai Hualian, the Chinese manufacturer. Shanghai Hualian is a division of the Shanghai Pharmaceutical Group, one of China's largest pharmaceutical companies. Chinese drug regulators have closed the factory that produced the drugs and are conducting an investigation into the matter.1

Danco Group of New York City serves as the sole U.S. distributor of mifepristone, which is marketed as Mifeprex. According to Abby Long, MPH, Danco's director of marketing and public affairs, the plant in which mifepristone is manufactured most recently was inspected by the Food and Drug Administration (FDA) in May 2007. The plant passed inspection, says Long.

Mifepristone is manufactured in a mifepristone-only factory and is not subject to cross-contamination from other drugs, states Long. In addition, Danco submits samples of each lot to a third-party FDA-inspected laboratory before the product is released in the United States, she reports.

Rep. Henry Waxman (D-CA), chairman of the Committee on Oversight and Government Reform, has called for the FDA to share its plans for continuing to ensure the safety of drugs manufactured for the United States by Shanghai Pharmaceutical Group.2 Planned Parenthood Federation of America (PPFA) has joined Waxman in the request for FDA action.3

"We, along with the rest of the public health community, look to the FDA to ensure that all drugs entering the United States are safe and effective," said Vanessa Cullins, MD, PPFA vice president of medical affairs, in a statement on the request. "We expect the FDA to fulfill its mission and provide information on and assurances for continued monitoring in the upcoming briefing with Rep. Waxman."

In an open letter to Planned Parenthood clients, Cullins acknowledges that some patients may have questions about mifepristone medication abortion as a result of the news reports.4 "As a trusted reproductive health care provider, Planned Parenthood closely monitors patient experiences to ensure the highest standard of care," Cullins states in the letter. "Our monitoring shows that mifepristone medication abortion continues to be a safe abortion option."

Method gains ground

Mifepristone gained FDA approval in September 2000 as an alternative to surgical abortion. Use of the medication method has grown since its approval: In 2005, 57% of abortion providers, or 1,026 facilities, provided one or more medication abortions, a 70% increase from the first half of 2001.5 According to a Guttmacher Institute report, medication abortion in 2005 accounted for 13% of all abortions and 22% of abortions before nine weeks' gestation.5

Safety information for the Mifeprex label was revised in 2005 after reports of deaths from serious bacterial infection and sepsis following use of the mifepristone/misoprostol medication abortion regimen. Since mifepristone's U.S. approval, the FDA has been informed of six deaths in the United States due to serious infections following medical abortion with mifepristone and misoprostol. Five cases were found to involve infection with the bacteria, Clostridium sordellii, and one case involved infection with Clostridium perfringens. While sepsis is a known risk related to any type of abortion, the symptoms in all of the cases were not the usual symptoms associated with the disease state. In all but one case, misoprostol was used intravaginally.6

Reports of fatal sepsis in women undergoing medical abortion are very rare — about one in 100,000, according to the FDA.

References

  1. Hooker J, Bogdanich W. Tainted drugs tied to maker of abortion pill. The New York Times. Jan. 31, 2008. Accessed at www.nytimes.com.
  2. Waxman H. Letter to Dr. Andrew von Eschenbach. Accessed at oversight.house.gov.
  3. Planned Parenthood Federation of America. Planned Parenthood Calls on FDA to Ensure Continued Patient Safety. Press release. Accessed at www.plannedparenthood.org.
  4. Cullins V. Open Letter to Planned Parenthood Clients From PPFA Vice President of Medical Affairs Vanessa Cullins. Accessed at www.plannedparenthood.org.
  5. Jones RK, Zolna MRS, Henshaw SK, et al. Abortion in the United States: Incidence and access to services, 2005. Perspect Sex Reprod Health 2008; 40:6-16.
  6. Food and Drug Administration. Questions and Answers on Mifeprex (mifepristone). August 2007. Fact sheet. Accessed at www.fda.gov.