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FDA
ISSUES PUBLIC HEALTH WARNING ON PHENYLPROPANOLAMINE
FDA,
today, is taking steps to remove phenylpropanolamine
from all drug products and has requested that all drug
companies discontinue marketing products containing
phenylpropanolamine.
FDA
today issued a public health advisory concerning the
risk of hemorrhagic stroke, or bleeding into the brain,
associated with phenylpropanolamine hydrochloride.
Phenylpropanolamine
is an ingredient used in many over-the-counter (OTC)
and prescription cough and cold medications as a decongestant
and in OTC weight loss products.
Adverse
events reported with these products led to concerns
that this ingredient might increase the risk of hemorrhagic
strokes. Manufacturers of products containing phenylpropanolamine
worked with FDA to plan a research program to clarify
whether any increase in risk exists.
Scientists
at Yale University School of Medicine conducted the
study in which the researchers found an association
between phenylpropanolamine use and stroke in women.
The increased risk of hemorrhagic stroke was detected
among women using the drug for weight control, and for
nasal decongestion, in the 3 days after starting use
of the medication. Men may also be at risk.
The
Nonprescription Drugs Advisory Committee met on October
19 to discuss safety issues related to phenylpropanolamine
use. The committee reviewed Yale’s Hemorrhagic Stroke
Project results and concluded that phenylpropanolamine
cannot be considered to be safe for continued use.
FDA
believes that although the risk of hemorrhagic stroke
is very low, even with phenylpropanolamine use, the
conditions for which these products are used do not
appear to warrant an increased risk of this serious
event from using this drug. We advise consumers to discuss
alternative over-the-counter and prescription products
with their health care providers or pharmacists.
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