Women, Drugs, and Devices

5 cases that shook the FDA.


In 1972, an Associated Press reporter broke the story of a decades-long government-backed study that deliberately deprived its poor, African American male subjects of treatment for syphilis. Some had entered the study with the illness, others became infected after entering the study, but the effects on their lives were devastating. Public outrage over the Tuskegee Syphilis Study led to the National Research Act of 1974, which created a commission to draft recommendations for the ethical treatment of human research subjects, including pregnant women. Even before the commission was formed, the story of the morning sickness drug thalidomide, which was mostly centered in Europe, had heightened sensitivity about pregnant women and drugs.

In 1975 the commission released its recommendations for prenatal research, which included two ideas that continue to complicate research with pregnant subjects to this day. First, they said that the fetus must not be subjected to more than “minimal risk”—a less than precise requirement—if a study offers no therapeutic benefit to the woman. Second, they determined that for some kinds of research the father’s consent must be sought. The recommendations were then incorporated into the rules governing what research the government can fund and conduct. Sometimes, that meant that drugs that were prescribed for pregnant women, were actually developed for different conditions and prescribed “off-label.”

Here are several cases that show the complexities and problems of drugs for pregnancy (and in one case, a birth control device).

Name: Thalidomide

How it was used: As a sedative and sleeping pill, off-label for morning sickness

What happened: Developed in West Germany in the 1950s, the drug was soon linked to miscarriages and devastating birth defects, including limb deformities. At least 10,000 “thalidomide babies” were born around the world before the drug was banned in the early 1960s. The US escaped largely unscathed thanks to FDA medical officer Dr. Frances Oldham Kelsey, who refused to approve the drug without sufficient safety information.

The aftermath: Spurred by the crisis, the US government passed amendments in 1962 that require drug manufacturers to prove their products not only safe but effective, too. Thalidomide later re-emerged as a treatment for leprosy.

Name: Diethylstilbestrol (DES)

How it was used: Introduced in 1938 as the first synthetic form of estrogen, it was prescribed to prevent miscarriage, premature labor and related pregnancy complications—even though clinical trials in the 1950s showed it was ineffective.

What happened: In 1971, medical studies found that women exposed to DES in utero (“DES daughters”) were at heightened risk for developing clear cell ardenocarcinoma, a rare vaginal cancer. The FDA warned against its use, but by then, up to 10 million women and children had been exposed.

The aftermath: Women who took the drug have a heightened risk of breast cancer, as do their daughters (who also have higher rates of infertility, pregnancy complications and reproductive abnormalities). DES sons are at higher risk for non-cancerous testicular growths. Thousands of lawsuits have been filed, totaling billions of dollars.

Name: Bendectin

How it was used: A combination of the antihistamine doxylamine and vitamin B6, it was approved to treat morning sickness in 1956

What happened: Close to 33 million women worldwide took Bendectin over nearly three decades. But after families started suing for alleged birth defects in the 1970s, the manufacturer’s insurance premiums soared, and Merrell Dow voluntarily withdrew the drug in 1983.

The aftermath: In the wake of the lawsuits, Bendectin became one of the most-studied drugs in pregnancy. The combination of doxylamine/vitamin B6 was found to be safe, and in 2013, the same basic formula, renamed Diclegis, won FDA approval once more. Bendectin’s most important impact, though, may be in the courtroom: In 1993, in a case called Daubert v. Merrell Dow, the U.S. Supreme Court issued sweeping limits on expert witnesses and “junk science” that affected many areas of the law.

Name: Dalkon Shield

How it was used: Long-acting, reversible birth control that was supposed to be safer than the Pill

What happened: Introduced in 1971, the intrauterine device was used by more than 2 million women in the US and 4.5 million worldwide. But design flaws made its users susceptible to acute pelvic infections and spontaneous abortions, leading to hysterectomies and at least 18 reported deaths. 

The aftermath: Manufacturer A.H. Robins suspended sales in 1974 under pressure from the FDA, but didn’t recall the device, leaving thousands of women at risk. Robins eventually declared bankruptcy, 300,000 women filed claims, and lawyers hammered out a $3 billion settlement. The disaster fueled efforts to better regulate the medical device industry. It also discouraged a generation of women from using IUDs.

Name: Terbutaline

How it was used: Approved by the FDA to treat asthma, bronchitis and other lung diseases, it was used off-label to stop premature labor, even though studies eventually concluded it was ineffective.

What happened: In 2011, the FDA warned there was a risk of heart problems and even death for pregnant patients who were administered certain forms of terbutaline over an extended period (longer than two to three days). The agency said it had received reports of 16 deaths and 12 serious heart issues associated with prolonged use of the drug.

The aftermath: It’s still being used for to prevent preterm birth, but in much more controlled settings (i.e., not at home).

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