FACT CHECK: Did The FDA Approve The Drug Thalidomide In The 1960s?

Brad Sylvester | Fact Check Reporter

A post shared on Facebook claims thalidomide, a medication given to pregnant women to treat nausea in the 1950s and 1960s, was approved for use by the U.S. Food and Drug Administration (FDA) in the 1960s.

Verdict: False

The FDA did not approve the use of thalidomide until 1998, and it has never been approved for use by pregnant women, according to FDA records.

Fact Check:

Thalidomide is a sedative that was developed in the late 1950s and eventually marketed and prescribed in several countries to pregnant women to alleviate nausea in the late 1950s and early 1960s, according to the Science Museum in London’s website. The drug, however, caused severe birth defects in more than 10,000 children worldwide, the Dana-Farber Cancer Institute’s website states.

One post shared on Facebook claims the FDA approved the drug in the 1960s. It features a black-and-white image of two children, seemingly affected by thalidomide, sitting in a sandbox together. “Just a friendly reminder that the FDA approved thalidomide for use in the 60’s,” reads the image’s caption. “They’ve also approved over 20,000 drugs for consumption today! The FDA is rocking it!”

The post may be in response to the recent FDA approval of the Pfizer-BioNTech COVID-19 vaccine for people aged 16 and older. (RELATED: Did A Man Die ‘After Taking Malaria Medication Touted By Trump As Possible Cure For Coronavirus’?)

The FDA did not, however, approve thalidomide in the 1960s, The New York Times reported. Rather, FDA pharmacologist Frances Oldham Kelsey was instrumental in preventing the drug’s widespread use in the U.S., according to UChicago Medicine’s website.

Kelsey’s biography on the National Library of Medicine’s website describes how she was working as a pharmacologist for the FDA in 1960 when an application for the drug reached her for review. Kelsey determined the application lacked sufficient evidence of safety and rejected it, according to Smithsonian Magazine. By the early 1960s, evidence of the dangerous effects the drug had on children was mounting and it was withdrawn by its manufacturers in Europe, BBC News reported.

Kelsey was awarded the President’s Award for Distinguished Federal Civilian Service by President John F. Kennedy in 1962 for her efforts to prevent the dangerous drug from reaching the U.S. market, the FDA’s website states. The effects of thalidomide prompted Congress to pass the 1962 Kefauver-Harris Amendments which further tightened regulations around pharmaceutical drugs, according to a journal published in the National Library of Medicine.

Thalidomide was eventually approved by the FDA in 1998 as a treatment for leprosy, and later as a treatment for multiple myeloma, an article published in the Encyclopedia of Toxicology reports. The FDA imposes restrictions on which doctors are allowed to prescribe the medication and who is able to take the treatment, with multiple warnings that it is not to be taken by women who are or may become pregnant.

“It’s certainly true that FDA has approved thalidomide–not to treat pregnant women back in the 1950s, but more recently to treat leprosy and cancer (multiple myeloma),” Dr. Susan Ellenberg, professor of biostatistics, medical ethics and health policy at the University of Pennsylvania’s Perelman School of Medicine, said in an email to Check Your Fact. “Of course it’s contraindicated in women who are pregnant or who might become pregnant.”

Brad Sylvester

Fact Check Reporter
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