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way drug companies explain health risks is confusing and outdated.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.
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.