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October 23, 1996

The FDA's Decisions Regarding New Indications for Approved DrugsWhere's the Evidence?

JAMA. 1996;276(16):1342-1343. doi:10.1001/jama.1996.03540160064035

In this issue of The Journal, Dr Grossman and colleagues1 criticize the use of sublingual nifedipine capsules in the treatment of hypertensive emergencies and pseudoemergencies. Sublingual nifedipine gained proponents because it is easy to use and rapidly lowers blood pressure, alleviating the concerns of the physician and staff. Recommendations to use sublingual nifedipine capsules have permeated the literature,2,3 and such recommendations continue, even as recently as a letter4 last month proposing that ancillary staff in nursing homes could draw up 0.1 mL of nifedipine into a syringe to administer orally to patients with "urgent needs for reduced blood pressure." Grossman et al point out that, in addition to the lack of evidence that an asymptomatic elevation in blood pressure should be lowered urgently and the considerable potential dangers of administering an oral drug for a hypertensive emergency, no studies have supported the use of sublingual nifedipine capsules