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Propulsid is a prescription drug
The drug was prescribed to treat nocturnal heartburn
The drug is based around Cisapride
Cisapride as a treatment was never officially
Complaints, addressed directly to Jansse
The
response from Janssen
Propulsid is a prescription drug developed by Janssen Pharmaceutica
and marketed by its parent company Johnson and Johnson. The drug has been
generally available since July 1993 when it was first approved by the Food
and Drug Administration, and since then has been used by over thirty million
US residents, including former President Clinton.
The drug was prescribed to treat nocturnal heartburn, caused by Gastro
Intestinal Reflux Disease. This disease is caused by the retention of stomach
acid in such a way that it causes heartburn. It works by increasing the
movement of food through the gastrointestinal system. Common antacids can
temporarily relieve this condition, but a more long-term solution that was
offered by Janssen was Propulsid.
The drug is based around Cisapride, a chemical compound that was
previously utilized to perform a similar function. Cisapride alone, however,
was widely seen as more harmful than helpful. There were six cases in the
1980s whereby Cisapride was prescribed either below or equal to the
recommended dosage and heart rhythm disturbances were recorded for up to
fifteen days following treatment. When treatment with Cisapride halted, the
abnormalities in heart rhythm ceased and the general pattern of heart rhythm
returned to normal. From 1988 to 1991 a variety of different articles were
published in medical journals linking Cisapride with abnormalities in heart
rate, resulting in heart beats of up to 130 beats per minute. This level was
reached purely through the use of the drug. No physical activity or
alternative method of increasing heart rate was necessary. Such a rate is at
best unhealthy, and at worst may result in a heavy strain on the heart and
possible premature death.
Cisapride as a treatment was never officially withdrawn from sale,
instead surviving to be ‘updated’. This ‘updated’ version was Propulsid, a
new form of treatment for similar conditions, with Cisapride functioning as
the main component. Although there had been a history of difficulties with
Cisapride the new drug was welcomed into the practices of doctors and
physiotherapists around the USA. However, within months of FDA approval,
Propulsid began to receive complaints from doctors that seemed to show it up
as just as dangerous as its predecessor.
Complaints, addressed directly to Janssen, were being made by doctors
around the country. They were aware of the existence of Cisapride within the
new drug and so knew of the possible difficulties. Patients began to show
similar symptoms to the old drug, including fainting following consumption of
Propulsid and a rapidly increasing heart rate.
The response from Janssen was to address correspondence to all
physicians across the US advising them of categories of people who should not
be prescribed Propulsid. Patients already on a course of antibiotic or
antifungal drugs were not to use Propulsid. Similarly, patients with a
personal or family history of heart difficulties were advised only to use the
drug with strong caution. A combination of antibiotics and Propulsid would be
even more dangerous, increasing the risk of developing a heart rhythm
abnormality, or even causing a sudden heart-related death.
Do I have a Propulsid Case?
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