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Pregnant Women to Benefit From Better Information on Drug Labels

Posted Oct 22 2008 4:37pm


Why FDA is Taking Action



* women take an average of three to five drugs during pregnancy
* new medical problems may begin or old ones may get worse during pregnancy, requiring drug treatment.

Labeling Background

Look of the New Labeling

Current labeling, which assigns different letters based on risk, is not well-understood.

For example, the letter A indicates human studies suggest there was no risk to pregnant women or to the fetus with this drug. Folic acid and levothyroxine have a letter A on their labels.

The letter B, which can be found on amoxicillin, ondansetron (Zofran), and some insulins, indicates that there are no good human studies but animal studies found no evidence of risk in pregnant women.

The letter C -- no good clinical studies, but some evidence of potential harm from animal studies -- is used on labels of some antidepressants (sertraline [Zoloft] and fluoxetine [Prozac]) and asthma medications such as albuterol.

The letter D indicates there are some data from clinical trials that indicate a risk to the fetus (paroxetine [Paxil], phenytoin [Dilantin]).

Finally, X is used for drugs such as isotretinoin (Accutane) that have been found to be teratrogenic in clinical trials.

When it does away with the letters, the FDA will replace the letters with text warnings.

Risks associated with use during pregnancy and lactation will be detailed in three parts:

The first section, called the fetal risk summary, would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: "Human data indicate that (name of drug) increases the risk of cardiac abnormalities." This would be followed by a summary of the most important data on the drug's effects.
Another section, called clinical considerations, would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.
The third section, under the heading of data, would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the fetal risk summary.


Did you miss this post about safety of prenatal vitamins?

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