HIV drug linked to serious birth defects

An antiretroviral drug that is used to treat HIV has been linked to serious birth defects in children born to women who were taking the drug when they became pregnant and in the beginning of their first trimester. The drug, dolutegravir, is believed to increase a baby's chances of neural tube defects. These are defects of the spine, spinal cord or brain. Spina bifida is one of the most common of these defects.

The study that made this link involved over 11,500 babies in Botswana born to women who have HIV. About 9 percent of the women whose HIV was being treated with dolutegravir when they became pregnant gave birth to babies with a neural tube defect. Just 1 percent of those on other types of HIV drugs had babies with this type of birth defect.

So far, there has been no indication that beginning a drug regimen that includes dolutegravir later in pregnancy causes birth defects. However, the study hasn't yet been finalized.

Both the U.S. Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA) have issued safety alerts regarding the potential dangers of the drug, which the FDA approved five years ago.

Both agencies are advising childbearing-age women to talk with their doctors about alternative HIV drugs. Women who could become pregnant who choose to take dolutegravir are cautioned to use effective contraceptive measures.

The agencies also caution women who are already using the drug not to stop taking it without consulting their physicians about other HIV treatments. If HIV isn't controlled in pregnant women, babies can contract the virus.

Of course, this isn't the only drug that can be dangerous to a baby conceived while the mother is using it. Unfortunately, the dangers of some of these drugs aren't discovered until enough babies are born with birth defects that a link is suspected. Once the medical community is made aware of these dangers, they can advise women of childbearing age accordingly. The acne treatment Accutane, which is no longer prescribed, was one of those drugs. .

Women who believe their babies were harmed due to medications that they weren't warned about should seek legal guidance to determine what their options are to seek justice and help prevent other babies from suffering similar harm.

Source: Pharmacy Times, "FDA Issues Safety Alert for Drug Linked to Potential Birth Defects," Kristen Coppock, May 19, 2018

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