http://www.nytimes.com/2014/12/04/health/medicines-taken-during-pregnancy-to-get-clearer-warnings-on-risk.html 2014-12-03 22:11:07 Medicines Taken During Pregnancy to Get Clearer Warnings on Risk The Food and Drug Administration on Wednesday replaced a system that officials described as confusing and outdated with a clearer, more consistent explanation of dangers. === WASHINGTON — The The current system, developed in the 1970s, used letters of the alphabet to denote risk, with X being the most dangerous, but doctors said it was too vague. For example, many drugs fell into a middle category and often got a letter grade of C that gave pregnant women a muddled message: that dangers were not ruled out because animal studies showed potential risks to the fetus, but that no adequate studies existed for humans. “The A B C system was useless,” said Jacques Moritz, director of gynecology at Mount Sinai St. Luke’s and Mount Sinai Roosevelt in New York. “Everything was C, and all it said was there was no known data during pregnancy, but that wasn’t necessarily the case.” Starting in June, when the The rule will affect many women. There are more than six million pregnancies in the United States every year, and studies have shown that women typically take three to five prescription drugs during the course of their pregnancies. “It requires that more information about drugs will be provided than ever before, and in a manner that speaks directly to the concerns” that doctors and their patients are likely to have, said Dr. Sandra Kweder, deputy director of the Office of New Drugs in the Center for Drug Evaluation and Research at the F.D.A. The rule, which comes about six years after a draft version was first proposed, stops short of requiring companies to do studies if none exist. But Dr. Kweder said requiring companies to include the available information is a good start. And sometimes having to address an issue can drive research, she said. “Oftentimes research is out there in the medical literature,” she said. “Oftentimes companies know about it,” but choose not to include it.