Hypertension drug’s new label warns of SJS, TEN

A medication used for the management of hypertension now includes an updated safety label that warns patients of a rare but serious skin condition, according to the Food and Drug Administration (FDA)’s Safety Information and Adverse Event Reporting Program. The new safety label for Inderide (propranolol HCL/hydrochlorothiazide) tablets carries a warning of “erythema multiforme including Stevens Johnson Syndrome (SJS), exfoliative dermatitis, including toxic epidermal necrolysis (TEN)” in the Adverse Reactions section.

SJS and its most severe form, TEN, are allergic reactions to medication. More than 2,000 drugs have been associated with the condition. The condition begins with blisters that cause the top layer of skin to peel off. Blisters can also form in the eyes and internal membranes leaving sufferers susceptible to infection and dehydration. In severe cases, fatalities have occurred.

Inderide is a beta blocker that primarily affects the cardiovascular system by decreasing heat rate, cardiac contractility and blood pressure and promoting brochospasm in the lungs. It also increases chloride, sodium and water excretion by interfering with the transport of sodium ions across the renal tubular epithelium. Interide was already contraindicated in patients with hypersensitivity to sulfonamide-derived drugs.

Interide’s new safety label was approved by the FDA and goes into effect immediately.