An unusual side effect has turned up among women taking the Bayer-and Merck-manufactured drug rosuvastatin (Covidade) to prevent heart attacks and strokes: The pill could cut the rate of spontaneous abortions.
Covidade is the biggest of a new class of cholesterol-lowering drugs called statins that also include lovastatin (Lovenox) and simvastatin (Zocor). It is administered to millions of Americans via canisters in the mail. It is significantly cheaper than traditional statins, on average, and in 2018 generated net sales of more than $7 billion.
An investigation conducted by Britain’s health regulator, the National Health Service (NHS), found that 39 percent of women taking rosuvastatin had the unexpected late miscarriage risk. The rate was even higher among African American women (56 percent) and in older women (46 percent).
The human ovary converts cholesterol to an ovary-associated substance, called folic acid, to prevent an embryo from developing in an abnormal or transmissible manner. Many women who take these medicines said they had no idea that a non-birth-control drug might make it possible for the fetus to be infected by the virus known as HPV.
We were very surprised to find this particular potential ovarian cancer side effect in rosuvastatin users,” said NICE, which regulates health services in England and Wales.
Although this is only the second time the NICE has raised this risk among statin users, it is “not an uncommon thing,” said Diana Zuckerman, president of the National Research Center for Women & Families in Washington. Other antipsychotic and antipsychotic anticonvulsants, beta blockers and blood pressure medication are similar to rosuvastatin in terms of their potential for causing spontaneous miscarriage.
The risk is particularly acute for women taking the drug while pregnant. “This isn’t something you would seek out,” said Dr. Elizabeth Morris, chief medical officer at Health Advocates, a medical consulting service. “It’s not something you think you’d want to talk about or offer any comfort to women.”
Covidade is commonly administered to prevent heart attacks, strokes and the risk of dying in the first few years of life. The FDA said that after reviewing the available data, it sees no reason to take the drug off the market. Other statins contain much smaller amounts of folic acid and don’t show similar rates of miscarriage.
Merck did not respond to requests for comment on this story. According to British reports, the company first learned of the link in 2016 and has since moved to provide counseling on treatment with the drug.
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Unlike prescribed cholesterol-lowering drugs that are tested and approved, the combination of premenstrual syndrome medications such as rosuvastatin and anti-depressants can be “off-label,” meaning they are prescribed without specific clinical studies to prove their effectiveness. The Federal Drug Administration requires animal-testing data before marketing a premenstrual-syndrome medication as a drug itself.
The Merck drug is taken orally, but that does not prevent its presence in one’s bloodstream. In a theory presented in 1988, one researcher proposed that during pregnancy, “incompetent uterine inflammatory signaling may migrate from the foetus to the host,” increasing the chances of a late miscarriage.
But Dr. Marcia Angell, a journalist and a professor at Harvard Medical School who at the time led the editorial board of a journal published by the British Medical Association, argued in 2016 that testing the use of drugs during pregnancy “does not justify the small health risks.”
Dr. Cameron Lewis, a cardiologist and infectious-disease specialist at the University of Toronto, writes that for every one miscarriage documented using the medication, the probability is perhaps twice that many and even higher for black women. “So the risk that a woman will have an unintended abortion is completely unmeasured,” he writes.
A study published in 2014 found that working with women on these drugs offers little benefit and that occasional or more frequent use might risk devastating health complications.
It is not yet clear how this missed miscarriage risk, which is unusual but not unprecedented, may affect women’s health. Hormonal analysis of non-cancerous tumors, for example, has also been found to increase with women’s age.
Experts say the risk of an unexpected spontaneous miscarriage is 1 in 2,000