Archived fact-check: Thalidomide, the morning-sickness drug that caused disabilities, wasn’t FDA-approved

Editor's note, Aug. 31, 2021: When this fact-check first published on Aug. 30, 2021, our reporting did not account for the FDA's approval of thalidomide in the late 1990s, under strict conditions, as a treatment for people with multiple myeloma and lesions from leprosy. There were still explicit warnings for pregnant women not to use the drug. We updated our original fact-check to narrow the claim we were fact-checking. The new version can be found here. This webpage contains the story in its original format.

Facebook posts
stated on Aug. 23, 2021 in a Facebook post

Like Pfizer vaccine, “Thalidomide was also FDA approved.”

By Gabrielle Settles
Aug. 30, 2021

IF YOUR TIME IS SHORT<
•Thalidomide was prescribed around the world as a drug to treat nausea during pregnancy. It was directly linked to thousands of children being born with severe physical disabilities.
• The FDA reviewed an application for thalidomide in the early 1960s, but withheld approval amid concerns about the evidence of its effectiveness and reports of side effects. The application was withdrawn.
• The case led to a tightening of regulations for FDA drug reviews.

After the Food and Drug Administration granted full approval to Pfizer’s COVID-19 vaccine for adults Aug. 23, many skeptics of the vaccine have gone on social media to challenge the agency’s safety record and credibility. 

"Thalidomide was also FDA approved," says one Facebook post, referring to a drug used more than six decades ago to treat morning sickness. The post includes a picture of four children at a pool who have missing or malformed limbs.  

This Aug. 23 post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.) 

Thalidomide was widely prescribed to pregnant mothers around the world before it was shown to cause thousands of cases of babies born with disabilities, such as missing and malformed limbs. 

But the post gets a key fact wrong: The FDA never approved thalidomide.

In 1960, FDA medical officer Dr. Frances Oldahm Kelsey, reviewing an approval application for thalidomide from drug maker Richardson-Merrell, found problems with the company’s claims about its effectiveness.

"The claims were just not supported by the type of clinical studies that had been submitted in the application," Kelsey said in an autobiographical interview. A transcript of her interviews was provided by the FDA.

Many of the doctors’ reports submitted with the application were "more testimonials than scientific studies," Kelsey said.

She also looked into reports that thalidomide’s side effects for adults included painful tingling in the hands and feet. Thousands of babies whose mothers took the drug while pregnant were born with severe defects to their limbs, internal organs, eyesight and hearing. 

Richardson-Merrell withdrew the application in 1962. By then, the company and another drug maker, Smith, Kline & French, had already given about 20,000 Americans thalidomide as part of clinical trials — and at least 17 babies were born with disabilities from the drug. 

The thalidomide case is often held up as a turning point in the FDA's evaluation of drugs and medical devices. FDA standards are today considered among the world's strictest, said Dr. Henry Miller, senior fellow at the Pacific Research Institute, former FDA medical reviewer and founding director of the agency’s Office of Biotechnology.

It was the thalidomide case that led the Kennedy administration in 1962 to enact the Kefauver-Harris Amendments, which tightened regulations for drug reviews, including a requirement that evidence of a drug’s effectiveness be "based on adequate and well-controlled clinical studies conducted by qualified experts." A 1997 law simplified the process for drug reviews but the FDA still generally requires results from two well-controlled clinical studies for a drug approval.

The approved Pfizer vaccine and the other vaccines authorized for emergency use were evaluated based on the FDA's evidence standards.

Even with the stricter standards, the FDA has approved products that were later shown to cause harm, such as breast implants, which were linked to anaplastic large-cell lymphoma, and Vioxx, an anti-inflammatory pain medicine that was pulled from the market after a study showed it raised the risk of heart attacks and strokes. 

But thalidomide was not one of those products.

A post implicitly questioning the FDA’s approval of Pfizer BioNTech’s COVID-19 vaccine said, "Thalidomide was also FDA approved." 

The FDA reviewed an application for a thalidomide drug in the 1960s, but withheld approval amid concerns about the evidence of effectiveness and reports of its side effects. The application was withdrawn in 1962.

We rate the claim False.

Sources

FDA, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine, Aug. 26, 2021

Facebook post, Aug. 23, 2021

U.S. Food and Drug Administration, Frances Oldham Kelsey: Medical reviewer famous for averting a public health tragedy, accessed Aug. 25, 2021

U.S. Food and Drug Administration, Autobiographical Reflections of Frances Oldham Kelsey, Ph.D., M.D., accessed Aug. 26, 2021

National Library of Medicine, Thalidomide‐induced teratogenesis: History and mechanisms, June 4, 2015

Smithsonian Magazine, The Woman Who Stood Between America and a Generation of ‘Thalidomide Babies’, May 8, 2017

U.S. Food and Drug Administration, Kefauver-Harris Amendments Revolutionized Drug Department, updated Sept. 10, 2012

U.S. Food and Drug Administration, What to Know About Breast Implants, updated Jan 13, 2021