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Pregnant Women to Benefit From Better Information on Drug Labels

Posted Oct 22 2008 4:37pm
The Food and Drug Administration (FDA) has taken action to give women and their health care professionals better information about the effects of medicines when used by a woman who is pregnant or breastfeeding.

The action is a proposed rule, published May 29, 2008, that would require major changes to the sections of prescription drug labeling (the prescribing information) concerning pregnancy and lactation (secretion of breast milk).

Why FDA is Taking Action
FDA wants women and their health care professionals to have the most useful and up-to-date information about the benefits and risks of medications when used during pregnancy and while breastfeeding.

"With this proposal, FDA's goal is to help women, their physicians, and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breastfeeding infants will benefit," says Rear Adm. Sandra Kweder, M.D., Deputy Director of FDA's Office of New Drugs.

Women and health care professionals need to be armed with available information on the effects of drugs when used in pregnancy because:

* women take an average of three to five drugs during pregnancy
* many pregnant women have medical conditions, such as asthma, high blood pressure, depression, or diabetes, that require them to continue taking drugs they were on before pregnancy
* new medical problems may begin or old ones may get worse during pregnancy, requiring drug treatment.
* a woman's body changes throughout the term of her pregnancy, which can affect the dose she needs of a particular drug.
* a woman will often need and take medications while she is breastfeeding, potentially exposing her child to the effects of these medications
* about half of the six million pregnancies in the United States each year are unplanned, exposing women to drugs before they know they are pregnant; improved labeling will help with assessing the risks of unintended drug exposure to the developing baby.

Labeling Background
The current standard for information on pregnancy and lactation in drug labeling dates back to 1979. It categorizes the risks of taking a drug during pregnancy under a five-letter system. Over the decades, medical experts have criticized the category system as confusing, overly simplistic, and not reflective of newer studies and medical knowledge.

Look of the New Labeling
Under the proposed rule, the current drug labeling format and category system would be replaced with a new format that gives more detailed information in the pregnancy and lactation sections. The new labeling will provide better information about a drug's risks to the expectant mother, the developing baby, and the breastfed infant. The labeling will also discuss the data about these risks, including information from pregnancy exposure registries.

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.


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