New Data Shows 45 Percent of Patients with Stage 1 Hypertension Reached Normotension with BENICAR(R) and BENI...(f olmesartanmedoxomil in patients with u...),Health

The prescribing information for BENICAR HCT also includes the following warnings regarding its hydrochlorothiazide component:

BENICAR HCT is not recommended in patients with severe renal impairment and is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs

Fetal/Neonatal Morbidity and Mortality

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Hepatic Impairment

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hypersensitivity Reaction

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.

Systemic Lupus Erythematosus

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Lithium Interaction

Lithium generally should not be given with thiazides.

Adverse Events

In clinical trials, the withdrawal rates due to adverse events (AEs) were similar with BENICAR and BENICAR HCT to placebo: BENICAR (2.4 percent vs 2.7 percent); BENICAR HCT (2.0 percent vs 2.0 percent). The incidence of AEs with BENICAR and BENICAR HCT were similar to placebo. The only AE that occurred in > 1 percent of patients treated with BENICAR and more frequently than placebo was dizziness (3 percent vs 1 percent). AEs reported in > 2 percent of patients taking BENICAR HCT and more frequently than placebo included nausea (3 percent vs 0 percent), hyperuricemia (4 percent vs
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