E-DRUG: Chlormezanone
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Dear Colleagues,
After chlormezanone's withdrawal from European and North American
markets by Sanofi Winthrop, the drug is still available in the
market in Pakistan.
We, as a Pakistani consumer and professional group, are running a
campaign against the availability of this drug. The Pakistani
Ministry of Health (MoH) says that it has banned chlormezanone and
manufacturers wrote in November 1996 to MoH that they have directed
thier field force to withdraw it from the market, but even today the
drug is available all over the country and is being used. Apart from
Sanofi Winthrop's Beserol, there are at least five local
manufacturers.
Getting exhausted with our efforts with manufacturers and MoH we are
now seriously exploring the possibility of public interest litigation
in this case. In order to prepare ourselves on this I have following
queries with a request to all those who have any answers to these to
please respond asap:
1. To date, in how many countries and which countries the drug has
been banned and which are the countries where it was actually
withdrawn from the market.
2. Can any body provide example(s) of any case, where public
interest litigation was tried for availability of a drug in a country
which was banned by the regulatory authority of the same country and
where MoH and manufacturers of that drug failed to withdraw it
(obviously manufacturers in our case, even if they are not
manufacturing it further, are waiting for the last pill to be sold).
Examples would be more pertinent for us if they are from third world
countries.
3. Can any body provide any further evidence about the toxicity of
chlormezanone after the publication of "Medication use and the risk
of SJ syndrome or toxic epidermal necrolysis" in NEMJ 1995; 333 (24):
1600-1607 and "Market withdrawl of Chlormezanone" in Prescrire
International, Feb 1997, vol.6, No 27, p17.
I look forward to hear from many of you soon.
Dr Zafar Mirza
Coordinator
Association for the Rational Use
of Medication in Pakistan
60-A, St.39, F-10/4
PO Box 2563, Islamabad, Pakistan
Phone: 92-51-281755
Fax: 92-51-291552
Email: zafar@arump.sdnpk.undp.org
Note from the moderator:
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Chlormezanone has been/is used as a muscle relaxant and for the
treatment of anxiety disorders.
In developing countries, sale of drugs "withdrawn" from the market
by the manufacturer or "banned" by the regulatory agency often
continues until the supplies are exhausted. One way to tackle such
situation would be to identify cases whose exposure to such drugs
have been associated with injury or deaths. The next step should be
to launch a media campaign to inform all concerned including
consumers, health professionals, regulatory agency and the
manufacturers about these cases. Most ethical drug companies are very
concerned about their image in the public and its possible any bad
publicity will lead them to remove their products from the market.
A case in point is the loperamide example in Pakistan. In 1990, all
pediatric formulations of the antidiarrheal loperamide (Imodium and
others) were banned in Pakistan. Janssen, the manufacturer announced
"voluntary withdrawal" of the liquid preparation of loperamide from
most developing countries but the sale continued. The media got
interested in the issue following a documentary by the Yorkshire
television, England, which showed deaths of Pakistani babies in
association with loperamide use. This had such an impact that the
manufacturers in association with the government pulled all remaining
products from the market. Within weeks several million bottles of
these products were withdrawn from the market and destroyed in major
cities of Pakistan.
I hope this is helpful.
Syed Rizwanuddin Ahmad
Email: srahmad@essential.org
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