Acne Medications and Birth Defects: A Secret History
Here is a forgotten chapter of pharmaceutical history. The acne drug Accutane, made by Roche Pharmaceuticals, has been associated with hundreds of birth defects. Since 2005, the iPLEDGE program has required patients, physicians, and pharmacists to register and for patients to prove they are using birth control before they can be prescribed this potentially dangerous drug. But it was not always like this.
When Accutane hit the US market, after quickly going through the FDA approval process, it was listed as a category C drug for risk of birth defects, meaning it had only a moderate risk. The PDR said women ‘should not’ get pregnant while taking Accutane. Moderate risk means there are some animal studies showing birth defects, but it’s not clear if it’s really relevant to humans. Doctors were not required to perform pregnancy tests or for women to take birth control.
Accutane hit the media and was hailed as a wonder drug. Sales skyrocketed to the wildest expectations of Roche executives. Soon all the girls with pimples were demanding that pill that her schoolmate had given her and that had made her blemishes disappear.
But not everyone was so optimistic. Accutane did not impress the Europeans. It was banned in Sweden and Italy and heavily restricted in other countries, likely related to the results of those trials, which could have included birth defects associated with Accutane use.
If there were birth defects in the European trials, were they reported to the FDA?
Nobody seems to remember. Hmm…
In a series of articles over a decade ago in a newspaper called the Columbus (Ohio) Dispatch, Mark Somerson reported on this story in a series of investigative journalism articles. Surprisingly, this story about a drug that was as dangerous as thalidomide never made it beyond the banks of the Wabash River.
Not only Europeans were wary of Accutane, but also some American dermatologists. In fact, Frank W Yoder, MD, who along with Gary L. Peck MD first reported the use of isotretinoin for acne treatment in 1977, long before it was picked up by Roche, warned of the drug’s dangers in the January 1983 issue of the Journal of the American Medical Association, saying “the potential toxicity of this drug has been seriously underestimated.” Both American doctors and scientists working for Roche later proved that it was known before it hit the market that Accutane potentially had a very dangerous risk of birth defects, based on the fact that it was derived from compounds related to the vitamin A, well known for many years to cause birth defects in women. Yodell and another doctor involved in the US trials recalled discussing birth defects that occurred during the European trials, though the exact names of the people involved were never released.
In fact, Roche knew about Accutane for years before American dermatologists wrote about it, but did nothing with the drug. Somerson reported that Dr. Werner Bollage, a company scientist, wrote in 1971 that it was “inconceivable to develop an agent” that would cause birth defects for a “complaint as common as acne.”
For its US clinical trial in the early 1980s, Roche required all women to take a pregnancy test, and one woman who became pregnant was advised to have an abortion. However, once the drug hit the market, it was no longer needed, Somerson reports.
Dr. Henry H. Roenigk, another dermatologist who participated in the US Accutane trial, had birth defects with Accutane (presumably in Europe). Following this, Roche wrote a letter to all the doctors who had been involved in the US trial, telling them not to “disclose trade secrets.”
Nine months after Accutane hit the market in May 1982, babies with birth defects began to appear.
On September 8, 1983, after the first cases of birth defects were reported in the United States, the Health Research Group wrote to the FDA urging it to order pregnancy tests and not hide warnings about birth defects in the “letter small” at the end of the product label. .
In 1988, the FDA estimated that there could be as many as 1,300 babies born with birth defects due to Accutane. Some of the babies were so deformed that they died of pain after a few years of life in an institution. Probably many more babies had mild cognitive defects. And what’s worse, despite all efforts, birth defect rates never went down until iPLEDGE.
No one deserves that, for any reason.
