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After several years of availability, it now seems that Propulsid has
inherited the same problems as its predecessor. The best illustration of the
problems with Propulsid can be made with statistics. Since its approval by
the FDA, there have been over 340 reports of heart rhythm abnormalities in
patients prescribed with Propulsid. Of these, at least 80 cases have resulted
in deaths.
It took two years from the approval of Propulsid for warning labels to
begin appearing on the containers. The World Health Organization had
identified problems with Cisapride as early as 1989. The research team had
identified a distraction in the electrical activity of the heart. However, it
was not until February 1995 when Janssen Pharmaceutica finally provided
warning labeling on its products. There was nothing to warn patients or
doctors that what they thought was simply a cure for heartburn could in fact
cause death.
The FDA recognized that there may be some minor adverse effects
associated with Propulsid when it was approved. These effects were thought to
be fairly standard and by no means dangerous or life threatening. From then
on, however, a number of new side-effects were discovered and subsequently
added to the Propulsid label. Such possibilities included: sudden cardiac
death, heart attack, irregular heartbeat and QT interval prolongation.
The problem with Propulsid does not end here. It would be safe to assume
that a drug that already had proven side-effects, plus a main constituent
that had already been the cause of major side-effects, would only be
available to adults. Indeed, the official FDA approval only covered adults,
and the official statement on such situations is that Propulsid was only ever
approved for use by adults. However, many children and premature babies were
administered Propulsid to treat colic. Considering that the product was not
even approved for use on children, the proportion of the deaths that were
children is somewhat astonishing. Of the 80 reported deaths on record at the
FDA, 11 were children. There were also another 20 children that survived
Propulsid-related heart irregularities.
A combination of drugs can cause Propulsid to become more dangerous.
However, this is not all. A certain number of other illnesses, when combined
with Gastro Intestinal Reflux Disease, can have a similar effect.
Do I have a Propulsid Case?
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