Merck reveals that one of its heart drugs could cause birth defects. Here’s what it’s doing.

WASHINGTON — Merck has disclosed that one of its drugs, known as vernakalant, contains a metabolite that can cause birth defects. The U.S. Food and Drug Administration has required the company to conduct a…

Merck reveals that one of its heart drugs could cause birth defects. Here’s what it’s doing.

WASHINGTON — Merck has disclosed that one of its drugs, known as vernakalant, contains a metabolite that can cause birth defects.

The U.S. Food and Drug Administration has required the company to conduct a post-marketing safety trial, which the FDA will allow for the drug for use in pregnant women who are unable to have their own children.

The drug is used to lower blood pressure in people who are having a heart attack, stroke or stroke.

The incidence of birth defects associated with the drug was not known until now, said Dr. Dale Hahn, a cardiologist and vice chairman for research and clinical affairs for Merck. He said that after reviewing the safety results, Merck was able to determine that the incidence of birth defects was “minimal.”

The “probable” indication for women who are pregnant is for cardiovascular monitoring, including obtaining a pregnancy test during a heart attack or other cardiovascular event.

Still, it is a huge step forward for the medical community, said Dr. John Rhome, chief of division of diabetes, nutrition and nutrigenetics at the Washington University School of Medicine. “If no women had taken it, it would be a moot point,” he said.

First-world countries frequently ask, “Why is this a question?” he said. “Who cares about this?” But in developing countries, women are concerned with the consequences of poor nutrition and can receive these pills at a fraction of the cost, he said.

Because Merck had not reported on the safety of its drug, Rhome said he had doubted it had been used in the United States, where the trend has been away from pharmaceuticals. But because the safety data are now available, he said, “that opens it up for more use by doctors.”

Hahn said that there was no data to show that the pregnant woman could be affected differently from other women.

In a report that was filed with the FDA last October, Merck reported one case of birth defects associated with the drug that could be traced to its use.

According to the report, the post-marketing information showed that while there were 22 births with “impacted” babies associated with use of the drug during fetal development, the pattern of the difference was not established. That, and the small number of cases overall, were reasons why the drug should be allowed for use in pregnant women, Hahn said.

According to the Food and Drug Administration, the drug’s warning was amended in late 2018 to reflect that post-marketing data had revealed a “mild to moderate” incidence of birth defects associated with the drug. The updated label includes a “considered-at-risk” indication for use in women who are pregnant.

Rhome said he was aware of studies that showed that vernakalant, based on its DNA, should not be contaminated with other substances. But pregnant women who want to be monitored for something like heart attacks, which can cause problems for the fetus, might want to consider this drug as well, he said.

“I definitely think that the current model works and in people who are borderline heart patients,” he said. But that did not exclude the possibility that some women would opt for the drug. “This is the first recognition of it, and I think there’s always a potential there,” he said.

In all, 24 patients in the United States and 64 in Europe were known to have been on the drug and taken it during pregnancy, according to the FDA.

The FDA has ordered a post-marketing safety study for the drug that will be finished in 2020, for use in pregnant women who are unable to conceive their own children. Merck will also conduct a randomized clinical trial of pregnant women who will no longer have the drug after they give birth and report results in 2022.

The American Heart Association says that no heart attack is preventable. It recommends that people who have a known risk for a heart attack discuss it with their doctor before taking new drugs or undergoing surgery.

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