Propulsid and FDA warning

[Mary__0__0]

  Recently I read that the Food and Drug Administration strengthened the warning label for Propulsid after reports of 38 drug-related deaths in a five-year period.  There have been reports of severe adverse reactions, including heart rhythm disorders and deaths associated with the use of the drug in combination with certain other medications or with people who had particular underlying medical conditions.
  I have been taking Propulsid since August, 1997, for what my doctor thinks might be a stomach motility problem. (My tests included upper and lower GI series as well as an abdominal scan.  My symptoms, which recurred periodically for over two years, included nausea, fatigue, and loss of appetite with resultant weight loss.)  I have not had any problems since taking Propulsid.  As a matter of fact, I have cut down to two  tablets per day.
  Now I am concerned about the new FDA warning.  How many deaths occurred in the first, second, etc. years?  What were the underlying conditions?  Can Tagamet be taken along with Propulsid?  (I used Tagamet as a common wart treatment for about a month.)  Is the risk less when taking a lower dose?  Are there any other drugs/medicines with fewer side effects  for slow gastric emptying?
  Thank you,
  Mary
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Dear Mary,
The recent FDA warning has caused much anxiety and confusion for patients and physicians.  The Propulsid insert has always contained a warning that the drug may cause an EKG abnormality (prolongation of the QT interval).  The recent FDA warning reports that 38 people taking Propulsid have had fatal cardiac arrhythmias, although the FDA can not directly link the deaths to the use of the drug.  People at risk are for a Propulsid-induced cardiac problem have one or more of the following features: history of cardiac arrythmia, ischemic cardiac disease, electrolyte abnormalities ( specifically potassium and magnesium), end stage lung or liver disease, and kidney failure.  Some medications increase the risk of Propulsid induced cardiac arrythmias.  Certain antibiotics (erythromycin, clarithromycin) , antifungal agents, medications to treat AIDs and antidepressants are associated with the cardiac arrythmias. I have not found any reference that Tagamet increases the risk of cardiac irregularities.
You are already following one of the FDA recommendations-take the lowest dosage that controls your symptoms and do not take Propulsid if it is not improving the reflux.  If you are anxious about a possible cardiac event, you should ask your physician to perform an EKG.  This test will indicate whether the Propulsid dosage that you take is affecting your heart.
This information is presented for educational purposes only.  Always consult your personal physician for specific medical questions.
HFHSM.D.-rf
*keywords: Propulsid, adverse effects
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