FDA Advisory Committee Recommendations re CCBs

January 25, 1996

A Food and Drug Administration advisory committee recommended January 25th, that the FDA take steps to discourage doctors from prescribing short acting nifedipine. Recently published studies reviewed here by Furberg and Psaty have suggested that the drug may increase the risk of death from heart disease. Dr. Robert Temple, a top official of the FDA reported that the agency was already working on changing the drug's labeling. The FDA emphasized that the recommendation is relevant only for the short acting version of nifedipine (Procardia and Adalat) and does not include the extended release version of the medication (Procardia XL or Adalat CC) or any other calcium channel blockers, which appear safe. Patients are discouraged from discontinuing their medication without consulting their physicians. The panel recommendations are covered in more detail in JAMA, vol. 275, no.6.

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