Movement Pushes for More Information Regarding Drug Interactions in Pregnant Women
From conception to childbirth, pregnant women are challenged with managing their own health while worrying about the welfare of their unborn child. Every year, approximately 500,000 pregnant women in the U.S. battle conditions that require medical treatment, such as cancer, psychiatric illness, autoimmune disease, and influenza. Numerous warnings exist about the use of any type of medication whether prescription or over the counter. These battles leave a pregnant mother and her doctor carefully considering the proper dosage necessary to maintain health without harming the child.
Pregnancy Presents Unique Prescription Rules
Determining what is appropriate for a pregnant mother has not been easy. Shifts in the metabolism of a pregnant woman are substantial compared to a woman who is not pregnant, and, therefore, require changes in treatment. To what extent change is necessary has become difficult to determine. Conducting scientific studies on a pregnant woman to make these determinations raises both ethical and legal issues.
Better Information About Pregnant Women About the Impact of Medications
The Second Wave, a movement begun this spring in Washington and composed of 30 doctors, ethicists, scientists, and government officials, aims at providing better information regarding how drugs affect pregnant women. Only in the 90’s did studies begin to include women, and, as recent as twenty years ago, members of the medical community were still using the male body as their research models and adapting those results to women. A recent 2003 law made it possible for not only women, but in some cases, children to be included in these scientific studies.
Second Wave encourages doctors and agencies to gather data on pregnant women and eases any fears by emphasizing that a lot can be done on a less dramatic level. Blood samples can be drawn and analyses conducted on pregnant women who are already taking medication out of necessity. Unfortunately, chronic illnesses that many women have do not disappear during pregnancy. It is inevitable that pregnant women will be taking medication, and studies show that two thirds of women take up to five drugs over the course of their pregnancy and labor. It is these women that can be used for the study.
While the Second Wave program looks for pregnant women willing to participate, the U.S. Food and Drug Administration is proposing to revamp its system for notifying pregnant women about adverse effects of drugs. Strikingly, only a dozen prescription drugs are approved for use by the FDA and most of these are all pregnancy related, leaving mothers with other common conditions in the dark as to effects of most medications on their unborn child.
Right now the FDA’s notification system consists of classifying drugs into one of five pregnancy-related categories, with A being the safest and X being the least necessary. Research on Category C drugs, which the FDA believes covers nearly 70% of all drugs, is much less conclusive in terms of safety for unborn children. Consequently, the FDA is moving towards eliminating these categories in favor of a system that more narrowly defines each individual drug and its effect on pregnant and nursing women. Below is a brief description of each of the five categories:
- Category A: Large number of human studies show no increased risk of birth defects when used by pregnant women. Examples include: Levothyroxine (thyroid hormone), B6, folic acid.
- Category B: Large number of animal studies show no increased risk of birth defects. No well done human studies have been conducted. Examples include: Zofran (antiemetic), amoxicillin (antibiotic).
- Category C: Animal studies suggest an increased risk and there are no large well-done human studies. Drug’s benefits may be worth the potential risk. Examples include: Zoloft, Paxil (antidepressants); Tamiflu (antiviral); Amitiza; any ACE inhibitors.
- Category D: Human studies show an increased risk of birth defects, but drug’s benefits may outweigh that risk. Examples include: tetracycline (antibiotic); Cytoxan (chemotherapy).
- Category X: Human studies show increased rates of birth defects and animal studies suggest an increased risk. The risk usually outweighs the benefits. Examples include: Accutane (acne treatment); Lipitor (cholesterol reducer).
If you or a loved one thinks you have been the victim of medical negligence because you have been wrongly prescribed medication during pregnancy or experienced adverse side effects as a result of being wrongly prescribed medication during pregnancy, you may be entitled to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Contact a medical malpractice lawyer today for a free and confidential case evaluation.
Tags: drug interactions, medical malpractice lawyer, medical negligence, pregnancy