Drug Manufacturers Must Update Explanation of Risks to Expectant Mothers, Says FDA

Posted By Paulson Coletti Trial Attorneys PC || 5-Dec-2014

The Food and Drug Administration recently announced that pharmaceutical manufacturers have to change the way they explain the risks expectant mothers face when taking their drugs. According to the FDA, the current way drug companies explain health risks is confusing and outdated. The FDA is hoping to lower the amount of babies born with birth abnormalities caused by exposure to certain pharmaceutical drugs in utero.

Drug manufacturers have been using the same risk explanation system for more than 40 years, and regulators believe it is time for change. The system uses an A-B-C rating with drugs classified as "X" posing the most severe risks to mothers and their unborn children. Many medical experts have been expressing concern that this system is just too vague. For example, what about drugs with a "C" rating? It's not the safest for mother or baby, but it isn't the most dangerous either. So what does a mother decide?

The rule replacing this archaic grading system will dissect the risks by severity as well as by category: pregnancy, lactation, and fertility. The warning label will include information on how the drug could affect a woman and her fetus at all stages, from pre-conception to post-birth. The change is much needed, highlighted by the fact that most American women take between 3-5 prescription drugs over the course of their pregnancy.

Many medical experts are hailing the new regulations, but it didn't come easy. From the time the new rule was first proposed until its implementation was about six years. Even with these new rules, women should still closely communicate with their doctors to develop an accurate understanding of the effects their prescription drug use will have on their ability to conceive and on the health of their baby.

If your child was born unhealthy or with a defect because of a dangerous prescription drug, we invite you to contact a Portland injury lawyer at our firm to discuss your legal rights and options.