Watchdog Group Asks FDA to Add Warning on Label of Constipation Drug That May Cause Miscarriage

By May 19, 2009 Drug Safety

Consumer advocacy group Public Citizen has asked federal regulators to require a black box warning on the label of a drug it says may induce miscarriage or premature labor, the Associated Press reported May 6. Amitiza (lubiprostone) is prescribed to people who suffer from chronic constipation, but it is chemically similar to misoprostol, which can induce labor and miscarriage in pregnant women. Amitiza’s label currently warns that the drug has not been tested in pregnant women and that they should use it only if the benefits outweigh the risk to the fetus, but Public Citizen wants a stronger label. Neither the FDA nor the drug’s maker, Sucampo Pharmaceuticals, commented for the story.
Amitzia, which is considered less addictive and easier to tolerate than older laxatives, was prescribed more than a million times in 2008. Its chemical cousin, misoprostol, is approved for treatment of gastric ulcers in the United States. However, misoprostol also causes uterine contractions and thins the cervix, which is why it is widely used off-label, and approved in other countries, to induce labor and end pregnancies. In fact, it may be prescribed with the abortion drug RU-486. It is also used when a natural miscarriage or other obstetric problem leaves tissues in the uterus.
It is unclear whether Amitzia has similar effects. No studies have been done examining the drug’s effect on human pregnancies, but studies with Guinea pigs have shown a 4% miscarriage rate. For that reason, it is still available to pregnant women, although its label suggests that they weigh the risks of using Amitzia against its benefits. A spokesman for Public Citizen called that label “grossly inadequate” and lacking in useful information.
As a defective prescription drug attorney, I agree. While I am sure most patients will do what’s best for their unborn children, they must be armed with good information to do so. As things currently stand, they must rely on a doctor or their own self-directed research to find that information. History has shown over and over again that pharmaceutical companies cannot be trusted to disclose information that might hurt their drugs’ sales. Pregnant women taking Amitzia could run extremely serious risks — inducing a miscarriage or giving birth prematurely, which can cause death and serious birth defects in the baby and is also extremely expensive. Until quality studies in humans establish that Amitzia is safe, women should at least be clearly warned of the risks.
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