Precautions :

Pulmonary Hypertension

Certain centrally-acting weight loss agents that cause release of serotonin from nerve terminals have been associated with pulmonary hypertension (PPH), a rare but lethal disease. In pre-marketing clinical studies, no cases of PPH have been reported with sibutramine capsules. Because of the low incidence of this disease in the underlying population, however, it is not known whether or not MERIDIA may cause this disease.

 

Seizures

During premarketing testing, seizures were reported in < 0.1% of sibutramine treated patients. MERIDIA should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops seizures.

 

Bleeding

There have been reports of bleeding in patients taking sibutramine. While a causal relationship is unclear, caution is advised in patients predisposed to bleeding events and those taking concomitant medications known to affect hemostasis or platelet function.

 

Gallstones

Weight loss can precipitate or exacerbate gallstone formation.

 

Renal Impairment

MERIDIA should be used with caution in patients with mild to moderate renal impairment. MERIDIA should not be used in patients with severe renal impairment, including those with end stage renal disease on dialysis (see Pharmacokinetics-Special Populations-Renal Insufficiency).

 

Hepatic Dysfunction

Patients with severe hepatic dysfunction have not been systematically studied; MERIDIA should therefore not be used in such patients.

 

Interference With Cognitive and Motor Performance

Although sibutramine did not affect psychomotor or cognitive performance in healthy volunteers, any >CNS active drug has the potential to impair judgment, thinking or motor skills.