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cilostazol (PLETAL)


A comprehensive review of the safety and effectiveness of this drug. If the drug is not a Do Not Use product, information on adverse effects, drug interactions and how to use the medication are included.
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cilostazol (PLETAL)
  • We list this drug as a Do Not Use drug because it has limited effectiveness and may lead to an increased risk of death.


Search results below include Additional Information from Public Citizen where your selected drug is a primary subject of discussion.

Letter to the Food and Drug Administration concerning a study in the New England Journal of Medicine amplifying our concerns about the safety of cilostazol (HRG Publication #1468)
Three members of the FDA's Cardiovascular and Renal Advisory committee voted against approving the drug due to these safety problems which were evident in the studies presented to that committee on July 9, 1998. These included abnormal electrocardiograms, increased heart rate, increased ventricular arrhythmias (premature ventricular contractions) and a suggestion, though not statistically significant, of increased mortality, even though the longest time studied on the drug was just six months.
Letter to the FDA urging that they reject the application for approval of cilostazol (Pletal) as there are other remedies for a non-threatening condition (HRG Publication #1458)
We strongly urge you to reject the application for approval of cilostazol (Pletal), a drug to treat intermittent claudication, a chronic, non-life-threatening condition for which there are alternative solutions, including exercise, that do not involve the multitude of known and potentially life-threatening risks that exist with cilostazol.