"Nov. 9, 2011 -- The FDA is again considering approval of an experimental weight loss drug it rejected a year ago over concerns about potential heart problems and birth defects in babies born to women who take the drug.
Single doses of 800 mg XENICAL and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
Should a significant overdose of XENICAL occur, it is recommended that the patient be observed for 24 hours. Based on human and animal studies, systemic effects attributable to the lipase-inhibiting properties of XENICAL should be rapidly reversible.
XENICAL is contraindicated in:
- Pregnancy [see Use In Specific Populations]
- Patients with chronic malabsorption syndrome
- Patients with cholestasis
- Patients with known hypersensitivity to XENICAL or to any component of this product
Prescribing Document Revised: October 2013This monograph has been modified to include the generic and brand name in many instances.
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