Women who are pregnant sometimes face a difficult decision between treating their ailment and protecting the health of their baby. According to the CDC, less than 10% of FDA-approved medications have adequate information regarding the potential risk for birth defects. This is because most pharmaceutical companies do not include pregnant women in clinical research trials for therapies. As a result, physicians must often use their discretion when prescribing medications during pregnancy, without the benefit of randomized, controlled clinical trials that test safety and effectiveness of drugs in pregnant women and the effects on fetuses.
Controlling Medication Distribution to Prevent Fetal Harm
One of the most famous cases that illustrates the serious risks pregnant women face when taking untested medications involves isotretinoin or Accutane. First approved by the FDA in 1982, Accutane is a prescription retinoid that treats severe nodular acne that is unresponsive to other acne treatments such as antibiotics. However, since this medication was untested in pregnant women when it was first approved, it is estimated that between 1982 and 2003, 2,000 women have become pregnant while taking isotretinoin and have experienced devastating results. Research has linked isotretinoin to both internal and external abnormalities like a cleft palate, missing ears, serious central nervous system malformations, and death in unborn babies. As a result, the FDA gave isotretinoin an X rating that indicates that risk involved with the use of the drug outweighs the benefits in pregnant women.
The FDA has taken some steps to help women access only safe medications during pregnancy. Since the risk of birth defects while on isotretinoin is significant, the FDA implemented S.M.A.R.T, or the System to Manage Accutane Related Teratogenicity. Under this program, women must take a monthly pregnancy test and be declared negative before being prescribed isotretinoin. This stringent program also ensures that doctors only prescribe a one-month supply of isotretinoin at a time, and strictly dictates that patients fill the prescription within seven days of their doctor’s appointment. Patient education about isotretinoin and a series of consent forms are required to prevent women from taking the medication during pregnancy.
The FDA and the CDC work to warn women that their medication could be harmful during pregnancy.
Source: fda.gov
Making Informed Decisions
One of the most crucial steps to take to minimize your risk for birth complications when taking medications during pregnancy is by disclosing your full medical history. Women who are pregnant or plan to become pregnant are advised by drug manufacturers to disclose that information to doctors to avoid drugs that are harmful to unborn babies. Disclosing your medical history is especially important if you are sexually active and are not using birth control.
You can also help protect yourself and your unborn child against serious health effects by reporting side effects right away to your doctor, even if they do not seem serious. Your doctor will be able to make recommendations based on your current health status and help you make the most informed decision about safe medications to take during your pregnancy that pose the least risk to your baby. Taking medications exactly as they are prescribed is another key component that will help you get the most out of the therapies during your pregnancy.
