The maker of the dangerous RU 486 abortion drug Mifeprex says it is changing the labels that appear on bottles of the drugs to include updated safety information. Danco Laboratories also admitted that five women have died from using the drugs, including a woman who apparently died in the last month or two.
In a statement released Monday, Danco admitted it has received “reports of five deaths from serious bacterial infection and sepsis” since the FDA approved its application to sell the abortion pill in September 2000.
One of the women, Brenda Vise, died during the clinical trials in the U.S. and Canada in 2001 after taking the abortion drug during an ectopic pregnancy. The other four women who died after using the abortion pill lived in California.
Danco reports that two women died in 2003, one in early 2004, and “a recent one in mid 2005.” The company did not reveal any additional information about the recent death.
Admitting that abortion “can result in serious and sometimes fatal infection,” Danco announced Monday that it “is modifying the labeling for Mifeprex to include updated safety information.”
Though it did not say what kind of information will be included, Cynthia Summers, the company’s marketing director, indicated it will soon send letters to all doctors who are authorized to prescribe and dispense the abortion drug. The letter will also go to all emergency room directors across the nation.
Danco says it is working with the FDA to modify the drug’s label.
The drug already carried the Food and Drug Administration’s highest level black box warning — which warns consumers that it is especially dangerous. Last November, the agency required Danco to place new warnings on the packaging.
The new warning labels, coming eight months after the FDA required them, are intended to highlight how infections can bring about the death of a woman using the abortion drug.
Yet, Danco denies its drug is responsible for the women’s deaths.
“No causal relationship between these [women’s deaths] and the use of Mifeprex and misoprostol has been established,” Danco said Monday.
However, Frank Gentle, supervising coroner investigator who looked into the death of teenager Holly Patterson in 2003, said “septic shock, due to endomyometritis (inflammation) due to therapeutic, drug-induced abortion,” caused Patterson’s death. Endomyometritis is an inflammation of the mucous membrane lining of the uterus.
In other words, “the abortion caused inflammation, which caused the shock, which caused her death,” Gentle said.
According to Danco, more than 500,000 women have used the mifepristone abortion drug.