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To the credit of the FDA, they have not allowed the incident to escape
unnoticed and have been taking measures to ensure that as soon as problems
have been reported they have been addressed. The FDA is responsible for the
safety of every American citizen to some extent as they control what can and
cannot be sold or prescribed with regard to food and drugs. Problems with
Propulsid were discovered within months of the general release of Propulsid
in 1993, and the FDA taken steps to protect the consumer since then. From
pressuring Janssen to begin placing warning labels on the product to publicly
declaring the health risks as they were discovered, the FDA was pivotal in
its withdrawal.
06/30/98 On the 30th of June 1998 CNN released details of the FDA
warning doctors of the possible problems with Propulsid. The FDA acknowledged
by this time that Propulsid could cause serious heart problems. They were not
in a position, however, to ban the drug completely, and there was no adequate
alternative to the treatment. The FDA therefore advised doctors to attempt to
find an alternative to each condition prior to the prescription of Propulsid.
The drug was still permitted if an alternative could not be found, but
remained strongly discouraged.
01/24/00 By January 2000 the FDA’s opinion of Propulsid was not just
that it was dangerous, but that in some cases it may be lethal. The drug was
still not banned completely from sale, instead being addressed as a ‘last
resort’. Prior to this warning the actual dangers had not been fully
recognized, and death from the drug was thought to be impossible. However, as
more and more cases of deaths or serious adverse reactions were reported, the
FDA began to take a more stern view.
23/03/00 After over five years of sales, and over 30 million patients,
the drug Propulsid was withdrawn from sale. No longer was it a last resort,
it was completely cancelled apart from major cases where there was no
possible alternative. Pressure from the FDA had meant that Janssen took the
easiest course of action and voluntarily withdrew the product. The drug was
to remain available until July 14, 2000 so that doctors and patients had
sufficient time to find an alternative.
04/13/00 Public Citizen, a citizen advocacy group, claimed that by
allowing Propulsid to remain on sale the FDA was endangering people’s lives.
According to the group, between this date and the date of withdrawal 23
deaths were discovered, and the group stated that this figure illustrates
that allowing the drug to remain on sale was a dangerous and perhaps unwise
decision.
Do I have a Propulsid Case?
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