When a pregnant woman comes down with a cold or minor infection, the information about what options are safe for treating her symptoms often are nonexistent. Similarly, if a woman is being treated for a chronic illness, pregnancy can throw her treatment regimen into disarray with uncertainty about the impact of her medicines. Too often, physicians struggle to find reliable information on how a particular medication can potentially affect an expectant mother or what doses are appropriate during her pregnancy. Yet, an estimated 75 percent of all mothers-to-be use four to six prescriptions or over-the-counter drugs at some time during their pregnancy.
I am not a mother. I am not a doctor. But my job requires me to step in and fix things that are clearly broken. Drug makers are required to label their drugs so that doctors can decide whether to prescribe a drug to a pregnant woman or new mother, but the current system is confusing and often inaccurate as the risks and information is not clearly spelled out. Maybe that’s because it was designed in 1975.
That’s right, the current drug labeling system is 36 years old. Here’s how it works right now: drugs must be classified under one of five letter categories – A,B,C,D, and X – based on that drug’s ability to cause birth defects and other effects on reproduction and pregnancy. The letters imply a graduation of risk that does not exist. For example, consumers falsely assume that drugs labeled under category ‘X’ pose the most risk in pregnancy and drugs labeled as ‘A’ pose the least.
Here’s how category “A” is described -- “Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.” Now here’s category “X” – “Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities.”
These labels are far too vague to be useful. In reality, drugs in the ‘X’ category may be no more dangerous than the drugs in the other categories. Just about everyone agrees this system has got to change, but it is taking a lifetime to change it.
The Food and Drug Administration, the agency that is charged with keeping prescription drugs regulated and safe, started working on revamping the drug labeling system in 1997. It took 10 years just to develop a proposal to improve the system, which was released in 2008. By August of 2008, everyone that had an opinion on how this new system should work submitted their suggestions. The FDA received 73 comments on their proposal – a very small number considering most rule changes are met with hundreds, if not thousands of comments. As of March 2011, the final review of the pregnancy labeling rule is incomplete.
Yesterday, I personally asked FDA Commissioner Margaret Hamburg to expedite her agency’s work implementing this long overdue overhaul. There needs to be a sense of urgency at the FDA to get this guidance out and implemented, otherwise mothers, pregnant women and their doctors have no choice but to rely on a flawed relic of the past to help them make critical health care decisions.
If you have a few minutes, tell the FDA what you think: http://www.fda.gov/AboutFDA/ContactFDA/default.htm