[Pharmwaste] Medicines need clearer information about possible fetal risk

DeBiasi,Deborah dldebiasi at deq.virginia.gov
Thu May 29 14:24:23 EDT 2008


FDA proposes new pregnancy labels for drugs 

Medicines need clearer information about possible fetal risk

The Associated Press
updated 12:36 p.m. ET, Thurs., May. 29, 2008

WASHINGTON - Doctors may soon get a new way to tell which medications
are safe for women to use during pregnancy and when they breastfeed.

Today, prescription drugs carry a code in the fine print of their labels
that rank their pregnancy safety: Category A means it's deemed safe;
Category X means it's known to harm human fetuses. A drug given the
remaining B, C or D codes have varying levels of evidence one way or the

That's too confusing, the Food and Drug Administration declared
Wednesday. So the agency proposed a change: Strip away the codes.
Replace them with clearly marked sections in the drug's label that
describe what research shows about fetal risk - and whether that
information comes from studies in people or only in animals - and other
information, such as whether pregnant women need different doses than
other patients.

"It's a population that has very, very special needs," FDA Commissioner
Andrew von Eschenbach said in announcing the proposal.

There are 6 million pregnancies a year in the United States, and
pregnant women take an average of three to five prescription drugs
during their pregnancy, the FDA said.

Specialists say there's far too little research done on medication risks
during pregnancy and breastfeeding.

But if the new rule takes effect - it's open for 90 days of public
comment before FDA makes a final decision - the hope is that labels
eventually would lay out the pros and cons that are known in ways that
help women and their doctors make more rationale decisions, said FDA's
Dr. Sandra Kweder, who led the 11-year effort for a change.

For example, a drug today might be labeled Category X when newer
research shows the risk for fetal harm is only during the first
trimester. Or animal studies might show a drug has the potential to
sedate a breastfed baby - when FDA now knows that so little gets into
human breast milk for that risk to be real.

The proposal also says drug labels should include the background risk of
birth defects to put warnings in context: If 10 cases of a particular
birth defect occur in every 1,000 pregnancies anyway, how many more
would occur with use of a certain drug?

(c) 2008 The Associated Press. All rights reserved. This material may
not be published, broadcast, rewritten or redistributed.
URL: http://www.msnbc.msn.com/id/24876623/

Deborah L. DeBiasi
Email:   dldebiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov
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