What every mother should know
Women of child-bearing years often wonder if the drugs they consider taking could have a negative impact on their baby’s development should they become pregnant. Such women would do well to understand the FDA’s designation of Pregnancy Categories X, D, C, B and A, and to understand that these categories are not as clearly delineated as one might think. In fact, the pregnancy category can even change depending on the problem which the drug is prescribed to treat.
To further show the difficulties in assessing the safety of the categories, a Pregnancy Category B drug might seem, intuitively, to be safer than a Pregnancy Category C drug for a woman wishing to become pregnant. However, this is not necessarily the case, as the former has not been studied as extensively in regard to fetal development as the latter.
All women of child-bearing years should be apprised that popular Selective Serotonin Reuptake Inhibitors (SSRI’s) such as Celexa, Effexor, Lexapro, Paxil, Prozac and Zoloft are all either Pregnancy Category C or D drugs, while popular anti-seizure medications Depakote and Topamax are in Pregnancy Category D or X, depending on what problem they are prescribed to treat. Depakote and Topamax are in Category D when used for the treatment of epilepsy or manic episodes associated with bipolar disorder; however, Depakote and Topamax move to Pregnancy Category X when prescribed for the prevention of migraine headaches.
Pregnancy Category X is the most dangerous drug designation for a developing fetus. Category X means that studies in pregnant animals or humans have demonstrated that the drug can cause fetal abnormalities. Pregnancy Category X drug indicates that the drug’s risks of use for a woman trying to become pregnant clearly outweighs any possible benefits of the drug.
Pregnancy Category D means that positive evidence of fetal risk exists for humans based on adverse reaction data from investigations, studies or marketing experiences. Nevertheless, according to the category D rating which the FDA has determined to be “appropriate,” potential benefits of the drug may be worth the risks for pregnant women, depending, of course, on the individual situation.
Pregnancy Category C means that animal studies have shown adverse effects on the unborn, but that there are no adequate, well-controlled studies in humans. Does that mean the drug is safe for the potential fetus of a woman trying to become pregnant, or safer than a Pregnancy Category D drug? The dearth of research is hardly assuring. Again, the FDA says of drugs in this category that the possible benefits may make the drug worth the risk for pregnant women.
Pregnancy Category B indicates that minimal reproduction studies have not demonstrated a risk to the fetus, and that there are no adequate, well-controlled studies in pregnant women. Does that mean a drug in this category is safer than a drug in Category C? We will not bet our future on it.
Pregnancy Category A means that adequate, well-controlled studies have failed to demonstrate a fetal risk in the first trimester of pregnancy, and that there is no evidence of risk in later trimesters.
The lesson seems clear. Read the fine print before taking any drug, and carefully weigh the benefits with the potential risks.
Matthews & Associates is handling cases all across the country involving the SSRI’s Celexa, Effexor, Lexapro, Paxil, Prozac and Zoloft, as well as anti-seizure medications Depakote and Topamax. Contact us for a free consultation if you or someone you love has been injured by one of these drugs.