FDA Proposes Major Revision Of Breastfeeding And Pregnancy Drug Labels

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Main Category: Pregnancy / Obstetrics
Also Included In: Regulatory Affairs / Drug Approvals;  Women's Health / Gynecology;  Pediatrics / Children's Health
Article Date: 29 May 2008 - 2:00 PDT

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The US Food and Drug Administration (FDA) announced yesterday Wednesday 28th May, that it was putting forward major revisions to the physician labelling of prescription, including biological, drugs to better inform how these products affect mothers and babies during pregnancy and breastfeeding, so that for example, doctors can make better prescribing decisions and be in a better position to give advice to women who are or could fall pregnant.

This could also have a knock on effect for patients because as the FDA explained, the content of physician labelling information is often adapted for patient medication guides when the labelling is approved for a prescribed drug.

The FDA said physicians and pharmacists would have much better information about the effects of prescription drugs, and the proposed revision could have a huge impact on the the wellbeing of women and public health in general.

Drugs during pregnancy is a big thing in the US which sees around six million pregnancies a year, and where women on average take up to five prescription drugs during pregnancy. This is in addition to women with ongoing medical conditions such as asthma and high blood pressure who need to continue with their medication during and after pregnancy.

Following a series of public meetings and focus groups with various stakeholders to get comments on the current labelling system, the new revisions proposed by the FDA include a requirement to explain, based on available information, the potential benefits and risks for mothers and their unborn children, as well as how these might change during the pregnancy.

The currrent labels use a category system based on letters to show the risk of a drug during pregnancy. Comments from stakeholders suggest this is misleading and leads health professionals and patients to form an inaccurate and over-simplified view of the risks, plus it makes it difficult to update the labels in the light of new information.

The new rule proposes to replace the letter categories from the pregnancy section of the drug labels, and replace them with a new format based on written sub-sections, as follow:

Fetal Risk Summary

• Describes what is known about the effects of the drug on the unborn child, and if any risks have been assessed from animal or human testing.
• Includes a "risk conclusion" based on available evidence, together with examples (depending on quality and quantity of evidence).
• An example of a risk conclusion might be: "Human data indicate that [name of drug] increases the risk of cardiac abnormalities," followed by a summary of the main effects of the drug.

Clinical Considerations

• Describes the effects of the drug if taken before a woman knows she is pregnant.
• Discusses the risks of the condition the drug is being taken for to the mother and the baby, dosing information, and how to deal with complications.

Data

• Gives more detail from human and animal studies on the evidence described in the Fetal Summary.

The pregnancy section of the prescription drug label would also reveal if there was a pregnancy exposure registry for the drug. Such registries keep records of reported side effects.

The breastfeeding section of the label would be formatted in the same way as the pregnancy section and inform about drug use during breastfeeding, for example stating how much gets into the breastmilk and how it might affect the breastfed baby.

The FDA proposes to phase out the old system with for example all newly approved drugs using the new system and older drugs moving to the new system as their labels are updated.

You can make comments on the FDA's proposed new ruling by going to the Federal Documents Management System/eRulemaking portal at www.regulations.gov

Click here for more information on the proposed new label rules (FDA).

Sources: FDA.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
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