Last week Vidyya informed its readers that the FDA was considering pulling products with phenylpropanolamine from store shelves. Yesterday, the FDA stopped considering the move and decided to make it a reality.
The FDA 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 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
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.