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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 The application was withdrawn.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.
CORRECTION, Aug. 31, 1 p.m.: This fact-check has been corrected to reflect that the FDA approved thalidomide in the late 1990s, under strict conditions, as a treatment for people with multiple myeloma and lesions from leprosy, and required an extensive warning that it not be used by pregnant women. We’ve clarified the ruling statement to capture the context of the claim more precisely. The rating is not changed. The original fact-check has been archived here.
Since 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 first used more than six decades ago to treat morning sickness. The post includes a black-and-white picture of four children at a pool who have missing or malformed limbs, leaving the impression that these children were harmed by an FDA-approved drug.
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 didn’t approve thalidomide for pregnant women.
In 1960, FDA medical officer Dr. Frances Oldham 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 in 2004 after a study showed it raised the risk of heart attacks and strokes.
Thalidomide did get FDA approval in 1998, under tight restrictions, as a medicine to treat people newly diagnosed with multiple myeloma or leprosy flare ups. The FDA approval required the drug to carry new warning labels, including an extensive warning that it should not be used by women who are pregnant or planning to become pregnant, because of the risk of "severe and life-threatening human birth defects (deformed babies) or death of an unborn baby."
A post implicitly questioning the FDA’s approval of Pfizer’s COVID-19 vaccine showed a picture of disabled children and said, "Thalidomide was also FDA approved." The post gave the impression that the children in the image were harmed by an FDA-approved drug.
The FDA reviewed an application for a thalidomide drug in the 1960s to treat morning sickness, but withheld approval amid concerns about the evidence of effectiveness and reports that it caused children of the mothers who took it to be born with disabilities. The application was withdrawn in 1962.
The FDA approved thalidomide in 1998 for other conditions, but not for use by pregnant women.
We rate the claim False.
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
National Library of Medicine, Rofecoxib (Vioxx) voluntarily withdrawn from market, Oct. 26, 2004
U.S. Food and Drug Administration, Thalidomide (marketed as Thalidomid) Information, updated July 24, 2015
U.S. Food and Drug Administration, Medication Guide THALIDOMID, accessed Aug. 31, 2021
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