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More Information on cisapride (Propulsid)

Letter Requesting Ban on Cisapride (Propulsid)

April 11, 2000

Jane Henney, M.D.
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Henney:

We have obtained new FDA reports concerning 23 additional U.S. deaths since the beginning of this year from cardiac arrhythmias or sudden cardiac arrest/death associated with the use of the heartburn drug, Propulsid. These are in addition to the 80 previous FDA-announced heart rhythm-associated deaths (based on reports received through December 31, 1999) which formed the basis of the announcement on March 23rd to eventually stop the marketing of Propulsid. The continued occurrence of arrhythmia-associated fatalities, for a current total of 103 such deaths, further emphasizes the serious public health dangers of the FDA's going along with Johnson and Johnson's reckless decision to allow this deadly drug to remain in pharmacies for more than four more months, until mid-August. We insist that you order the removal of all stocks of Propulsid from retail or wholesale channels of commerce within the next two weeks in order to prevent additional people from being killed by this drug. There are numerous safer alternatives to Propulsid.[1]

The 23 newly-reported deaths (reported between January 1, 2000 and March 28th) occurred in people using Propulsid. All involved ventricular arrhythmias, non-specified arrhythmias, cardiac arrest or sudden death. The death reports included people of all ages ranging from a 9-month-old male infant to a 77- year-old man. Thirteen of the 23 people, more than one-half, were under 60 years of age.

When the announcement was made on March 23rd that Johnson and Johnson would stop the marketing and distribution of Propulsid by July 14th and allow it in pharmacies until mid-August, it was stated that there would be a "limited access" program set up in order to make the drug available for people with certain disorders such as diabetic gastroparesis, in which there is an impairment of emptying the stomach of food, and for other "off-label" conditions. None of these conditions are FDA-approved uses of the drug since there is not adequate data on the effectiveness of Propulsid for treatment of these medical problems. The argument for the limited access program was that there are no other drugs to which these patients will respond. This program will take the form of an Investigational New Drug Exemption (IND). There would have to be a certification that the patient had an EKG, had been tried on other alternatives first, and was not taking any of the 41 drugs which are contraindicated for use with Propulsid because of life-threatening interactions. There is no excuse, however, for taking so long to set up such a program and allowing four more months of, in essence, unlimited access to this dangerous drug while the limited access program is being set up.

In 1978, after a petition and a lawsuit from Public Citizen's Health Research Group to immediately ban the diabetes drug phenformin because it was causing a large number of deaths and there were safer alternatives, the drug was immediately taken off the market. In a matter of weeks, not months, it was made available under an IND to those patients whose physicians thought there were no other alternatives. Although there had been hundreds of thousands of patients using the drug before it was banned, similar to the number estimated to be using Propulsid, only three or four thousand used it under the provisions of the IND after it was removed from the market and that number dwindled to very few within several years. FDA officials have said that there are a similarly small number of patients who would qualify for Propulsid under the conditions of the new program.

Unless the FDA forces Johnson and Johnson to promptly clear this drug off drug store shelves, a large number of further preventable deaths are certain to occur in the United States, mainly in people for whom there are numerous alternatives for the treatment of gastroesophageal reflux disease (GERD), also referred to as "heartburn", the principle medical condition for which the drug is prescribed. We look forward to a prompt reply to this urgent request.

Sincerely,

Sidney M. Wolfe, M.D.
Director

Elizabeth Barbehenn, Ph.D.
Staff Pharmacologist

Larry Sasich, Pharm. D, M.P.H.
Staff Researcher

Peter Lurie, M.D., M.P.H.
Deputy Director
Health Research Group

Michele Leslie, M.D.
Resident in Family Medicine
Ottawa General Hospital
Ottawa, Canada


ENDNOTE

[1] First, not eating or drinking alcohol within three hours of bedtime should be tried. Second, elevating the head of the bed. Third, a trial of antacids or H2 receptor antagonists such as Tagamet, Pepcid or Zantac. Fourth, only if none of these are effective, a trial with a proton pump inhibitor such as Prilosec can be attempted.

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