|
An advisory committee to the US Food and Drug Administration is
recommending that phenylpropanolamine (PPA), an ingredient found
in many common over-the-counter cough and cold medications and appetite
suppressants, be reclassified as unsafe, due to the fat that it
may increase the risk of hemorrhagic stroke.
Some of the products that would be affected if the FDA opts to
follow the panel's advice include drugs sold under the names:
- Alka-Seltzer Plus
- Acutrim
- Contac
- Comtrex
- Dexatrim
- Dimetapp
- Triaminic
- Robittussin CF
"Case reports have linked exposure to PPA to the occurrence
of hemorrhagic stroke," writes Dr. Ralph I. Horwitz from Yale
University's School of Medicine, and colleagues in the Hemorrhagic
Stoke Project report.
In Western countries, stroke is the third most common cause of
death and the second most common cause of neurologic disability
after Alzheimer's disease.
Hemorrhagic strokes are characterized by bleeding in the brain.
Symptoms typically begin abruptly with a headache, followed by steadily
increasing neurological symptoms, the type of which are dependent
upon the location of the brain where the bleeding occurs.
-
Rsearchers studied over 2000 adults aged 18 to 49, over a 5-year
period, including 702 individuals who were hospitalized due
to a stroke.
-
Stroke patients were 50% more likely than the control subjects
to have been exposed to a PPA-containing substance within three
days of their stroke.
- According to Dr. Horwitz, the results are not merely coincidental
and are statistically significant.
Of course, drug manufacturers are disputing the study's findings.
The Consumer Healthcare Products Association (CHPA) is a national
trade association that represents US manufacturers and distributors
of nonprescription, over-the-counter medicines and dietary supplements.
In a released statement, CHPA says " ... the hemorrhagic stroke
project did not establish a causal relationship between PPA and
hemorrhagic stroke."
They also maintain that possible errors in memory recall by the
patients may have skewed the study results. "For example, a
participant could incorrectly recall that they took product A-which
contains PPA-when in fact, they took product B-which contains no
PPA," according to the CHPA.
CHPA asserts the safety and effectiveness of PPA, but allows that
it "may consider, if warranted, recommending additional research
to confirm the safety of cough/cold medications and appetite suppressants
containing PPA."
| 