Expectant Mothers and the Safety of Prescription Drugs

The information about drug safety for pregnant women is quite lacking, which can have disastrous consequences.

Pregnant women often find themselves in harm’s way after taking certain prescription drugs or they discover harm has been done to their unborn child, sometimes after childbirth and maybe much later. The Food and Drug Association (FDA) is finally taking steps to ensure that pregnant women are provided with the much needed information about drug safety so that they can make the right decision regarding their health care. This information will also be helpful for breast-feeding mothers.

How Pharmaceutical Companies Classify Drugs

Updated regulations of the FDA have changed the way pharmaceutical companies’ present information about medical risks associated with a drug. The old system, which was established in 1970, was quite vague and gave the leeway to pharmaceutical companies to classify many drugs in the category “animal studies have shown potential risks to the fetus, but no adequate studies exist for humans.” In effect, the pharmaceutical company could wash its hands of the risk and leave the tough decision to the expectant mother.

A New Ruling by the FDA

The new rule formulated by the FDA requires the pharmaceutical companies to provide information under three sub-sections: ‘Pregnancy’, ‘Lactation’, and ‘Females and Males with Reproductive Potential’. The information must be detailed with respect to the risks involved and how it affects a specific population, for example, pregnant women and breast-feeding mothers. The information must include the data supporting the study. The pharmaceutical companies also have to provide information whether they have a registry where data is collected and maintained about how pregnant women and breast-feeding mothers are affected by the drug.

A person may think that expectant mothers do not take prescription drugs. Studies have shown that this is not true. A report by the New York Times indicates that over six million pregnancies occur annually in the United States and during the course of pregnancy, pregnant women are administered on average three to five prescription drugs.

An Imperfect System

The new rule does not plug all the holes in the system and will not be a complete solution. The new rule is a “paper action” and will not be enforcing the pharmaceutical companies to undertake actual tests to study the effects of prescription drugs on expectant and breast-feeding mothers. Pharmaceutical companies will still be able to push the tough decision of administering a particular drug to the pregnant woman and her doctor. The effected women and their doctors will again be required to take uninformed guesses about the pros and cons of a prescription drug.

Our St. Louis medical malpractice attorney is of the opinion that this failure could have similar consequences as that of failure to mandate the testing of drugs on other sections of the population. However, mandating the pharmaceutical companies to provide available information is a good starting point as long as it does not lead to a further reduction in the number of safety tests that are performed.

If you or your child are a victim of an unsafe prescription drugs, then you may be able to claim compensation for your losses and pain and suffering. Consult with Zevan and Davidson Law Firm LLC at (314) 588-7200. We are committed to protecting innocent mothers and their unborn children from drug company negligence and lax government oversight.