Phenylpropanolamine in drugs could be a risk for stroke
BMJ 2000; 321 doi: https://doi.org/10.1136/bmj.321.7268.1037/a (Published 28 October 2000) Cite this as: BMJ 2000;321:1037
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Your statement that "an advisory 14 member panel of the US Food and
Drug Administration (FDA) voted overwhelmingly to ban phenylpropanolamine
in non-prescription decongestants and appetite suppressants" could lead
readers to believe that this drug had actually been banned.
The true situation is stated by respondant Hans Mohr who wrote (7
November 2000), "the FDA has recommended a voluntary withdrawal of
phenylpropanolamine products from the market." Recommending a voluntary
withdrawal is not the same thing as a ban.
In visits to 24 pharmacies in my area (suburban Philadelphia,
Pennsylvania) I found over-the-counter decongestant products containing
PPA in 8 of them. Most of the others had removed this product in response
to the FDA recommendation.
Competing interests: No competing interests
According to the brazilian newspaper "Folha de Sao Paulo"
(Nov 9, 2000, COTIDIANO, p. C-8), the Agencia Nacional de Vigilancia
Sanitaria (Anvisa, the brazilian federal
governament regulatory organ akin to the american FDA) has
ordered on Nov 8 all products containing phenylpropanolamine withdrawn
from the market since Nov 9. This has been done.
To me it seems an absurdly premature decision. I agree with
the opinions posted by H.Mohr and T.Trinh about this matter.
Competing interests: No competing interests
The withdrawal of phenylpropanolamine from the market is premature
and will likely lead to increased visits to physicians offices for upper
respiratory tract infections by patients worried about OTC remedies. While
further study
of the link between the drug and hemporrhagic stroke is worth studying,
and perhaps extending the study to other decongestants, the safety record
of phenylpropanolamine is superior to almost all other medications we
routinely prescribe in general practice and indeed to many OTC drugs.
I wonder if this knee jerk reaction will become the norm
for all adverse drug reports; in recent years we have had
similar scares over calcium channel blockers, claritin, oral
contraceptives etc but none of these were substantiated.
Competing interests: No competing interests
The minister of health of mexico sent a communication to the news:
in the next month all drug stores in mexico cannot sell medications containing
phenylpropanolamine.
Many physicians say that decision is not correct.
Competing interests: No competing interests
Once again, we see the media sensationalizing a seemingly innocent
article on page 1037 of a reputable journal concerning what may be a
flawed study as the article points out (I guess we'll know when it is
published and peer-reviewed). How does so little and unproven information
become so volatile and over-reported?
If we are to be concerned about this risk for hemorrhagic stroke with PPA
(one possible case in Canada in the last 20 years?) Then, might we also
pull all OTC NSAIDS - ibuprofen in Canada and ibuprofen and naproxen in
the U.S. because of the risk of G.I. bleeds causing death? Should we pull
ASA, iron preparations, acetaminophen because of their respective possible
toxicities? This list could be extended ad infinitum.
Furthermore, who
are the spineless bureaucrats in the FDA and Health Canada who succumb to
this kind of pressure from the media, who seek not to protect the public,
but only to fill their coffers by selling more copy and air-time relying
on the fear and ignorance of the people who would fall for their shoddy
and shameful tactics. O.J., move over.
Competing interests: No competing interests
Realizing that the FDA is to protect public safety, I believe that
now after 35 or more years of this product, being out and used widley here
and world wide, the choice to take this away from the consumer for cold
treatments is absurd. Indeed a good track record. The Yale study only?
What other weight and factors did the fda panel take in consideration?
Making PPa a prescription now would entail another line of beurocratic
cost. OTC products save people money and saves lost time in schools and
work . taking away another line of treatment away for the people.
Concluding from this study that women are at risk of PPA dosages is one
concern. But again we do not know the studies selection guidelines. One
sure thing will follow this withdrawl, lawsuits after lawsuits. Litigation
beyond sight. The lawyer will love this one. Any substance is dangerous,
its how we use it that makes it reasonably safe. Be aware and take care.
Competing interests: No competing interests
As I write these words, the FDA has recommended a voluntary
withdrawal of phenylpropanolamine products from the market. This appears
to be a classic knee-jerk reaction to a problem that may not exist.
Considering six billion doses of this product were sold in the U.S.
last year, and the FDA has received only 44 reports of hemorrhagic stroke
in 31 years, this seems like a classic case of heavy-handed bureaucracy
overriding common sense. Furthermore, the astonishing number of doses
compared to the number of adverse events, speaks volumes for the good
safety record of these products. There is no doubt that ASA, which no one
is considering banning, has a much worse safety record, but is considered
a useful drug that is freely available to the public.
This strange preoccupation with phenylpropanolamine is even more
bizarre when we consider that tobacco related illness is thought to kill
350,000 Americans per year and yet tobacco is legal and no voluntary
withdrawal from the market is being recommended.
This is not to say we should not worry about medication that may
cause strokes in healthy young adults. These allegations should be
investigated in a sensible manner and particular attention should be paid
to the doses that were used by the alleged victims of the drug.
I say this because, as pharmacist, I have lost track of the number of
persons who have complained of adverse reactions to products containing
pseudephedrine, phenylpropanolamine, phenylephrine, and ephedrine. In
almost all cases the adverse drug reactions, usually insomnia,
nervousness, tachycardia and heart palpitations, were the result of using
two to four times the recommended dose. ( I would be scared to know what
these patients blood pressure readings were)
My recommendation would be to increase the size and scope of the
warning labels on these products. That way the medicine’s apparently
acceptable safety record would be maintained and the public would have
clear warnings regarding the dangers of exceeding the recommended dose,
as well as clear warnings to those who should not take the medicine at
all.
Competing interests: No competing interests
This kind of global news without publication of the study is very
disturbing to practicing physicians.
We can not read the study to evaluate it. It appears to be just a
prelinary case-control study, which can only be suggestive.
Was in time-release forms or immediate release forms of the
medications? What were the exact numbers and the P value. How were the
patients selected? How well did the controls match the patients for blood
pressure, smoking, diabetes, headaches, sinusitis and other
characteristics.
None-the-less, I can't review the science only the publicity in the
papers that my patients are reading. I can't give them any further info.
Publicity withou publication should be labeled as unethical. In
today's world, any publicity should be followed immediately with internet
publication. Delays are unacceptable and should be considered unethical.
Competing interests: No competing interests
This article is, indeed, just preliminary information. It
should be seen as a call to action, resulting in appropriately managed
studies, including larger-based retrospective ones. Please don't drop the
area of study
just because the initial numbers were inadequate!
Competing interests: No competing interests
FDA goes overboard
In 1969 I reported a case of hypertensive crisis in a GI
who took an excess dose of PPA to get a "high"
(N Engl J Med 1969; 280:877-878). Could it be that in
the case control study the patients suffering a stroke
took more than the suggested dose?? In my
experience of 35 years of practise PPa has been a very
safe and effective decongestant with far less side
effects than sudafed which is now the only
recommended decongestant in the US.
I agree that this is another kneejerk response by the
FDA similar to the ban on cyclamate which is now
available all over the world except in the United States.
Competing interests: No competing interests