The FDA Never Approved Thalidomide For Pregnant Women

Maxim Sorokopud

Health

30th August 2021

The FDA Never Approved Thalidomide For Pregnant Women

The FDA prevented widespread distribution in the U.S. (Getty Images).

The Claim

The Food and Drug Administration approved thalidomide, which resulted in infant deaths and severe birth defects

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In a now-deleted tweet that has been reposted as a screenshot, politician Billy Prempeh shared an image of children who had been affected by the drug thalidomide which was accompanied by the text, “Thalidomide was also FDA approved.”

The screenshot and/or claim have since been shared across social media, with posts gaining dozens or even hundreds of interactions. The implication is that because the FDA has approved dangerous drugs before, its approval of a COVID vaccine holds less import.

A supporting image within the article body

Misbar’s Analysis

Misbar’s investigation found that thalidomide never gained FDA approval for pregnant women. In fact, a medical reviewer from the FDA was responsible for rejecting Thalidomide applications, thus preventing it from widespread distribution in the U.S. Thalidomide was first developed as a morning sickness drug in Germany and was distributed throughout Europe in the ‘50s and ‘60s. It is estimated to be responsible for the deaths or birth defects of around 10,000 infants.

Arizona State University’s analysis shows that thalidomide was given to patients in the U.S. in an unregulated clinical trial. In 1962, the results of this trial led the government to pass stronger regulations and guidelines for overall drug approval processes.

In 1975, the FDA approved thalidomide for treating leprosy, and there is no indication that it was given to a pregnant woman. In 1998, the FDA also approved thalidomide to treat certain other conditions. However, any woman who was prescribed the drug had to provide substantive evidence that she was not pregnant, including proof that she was using two forms of contraceptives and monthly pregnancy tests. According to the FDA website, this approval still stands in the present day.