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Health & medicine fact checks

Explore claims publishers have checked about health & medicine. Read their original ratings and follow the evidence.

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PolitiFactHealth & medicine

Thalidomide was FDA-approved for pregnant women in the 1960s.

Publisher’s rating: False

Research from related reporting supports the distinction central to the claim: thalidomide was not FDA-approved for general use, although some U.S. doctors gave it to pregnant women. The reporting says William S. Merrell applied for FDA approval in late 1960, but “The drug, thalidomide, was not approved that year or the next.” It adds that an FDA medical reviewer kept it from being approved for general use. This evidence contradicts the claim that the FDA approved it for pregnant women in the 1960s. The fact that pregnant patients received the drug does not establish FDA approval. The reporting says doctors were already giving thalidomide to U.S. patients, including pregnant women, and describes one woman’s experience in the early 1960s: her doctor gave her a sedative for nausea, and she was “unwittingly part of an unregulated U.S. clinical trial for thalidomide.” It reports that Merrell distributed unlabeled doses to doctors. Thus, the evidence describes use outside FDA approval, not an FDA authorization for pregnant women. The excerpts establish the relevant contrast but do not provide the FDA application file, a complete approval history, or a count of U.S. patients. The conclusion here is limited to what the related reporting states: no approval for general use in the period described, alongside unauthorized or unregulated use that reached some pregnant patients.