Label Changes for:
Xenical (orlistat) Capsules
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Rare cases of leukocytoclastic vasculitis have been reported. Clinical signs include palpable purpura, maculopapular lesions, or bullous eruption.
- A pharmacokinetic study, where amiodarone was orally administered during orlistat treatment, demonstrated a reduction in exposure to amiodarone and its metabolite, desethylamiodarone [see Clinical Pharmocology (12.3)]. A reduced therapeutic effect of amiodarone is possible. The effect of commencing orlistat treatment in patients on stable amiodarone therapy has not been studied.
- Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs.
- Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs. Patients should be monitored for possible changes in the frequency and/or severity of convulsions
Before you take XENICAL, tell your doctor if you
- have a seizure disorder (epilepsy)
- take Medicines used to treat seizures may not work as well while you take Xenical. Talk to your doctor right away if your seizures happen more often or get worse while you take Xenical.
- Pregnancy .....added
5 WARNINGS AND PRECAUTIONS
5.3 Increases in Urinary Oxalate
- Some patients may develop increased levels of urinary oxalate.....
8 USE IN SPECIFIC POPULATIONS
Pregnancy Category X
- Xenical is contraindicated.....
- There have been rare postmarketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure in patients treated with orlistat with some of these cases resulting in liver transplant or death. Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light colored stools, or right upper quadrant pain) while taking orlistat. When these symptoms occur, orlistat and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained
Other Clinical Studies or Postmarketing Surveillance
- Rare cases of increase in transaminases and in alkaline phosphatase and hepatitis that may be serious have been reported. There have been reports of hepatic failure observed with the use of Xenical in postmarketing surveillance with some of these cases resulting in liver transplant or death. Rare cases of hypersensitivity have been reported with the use of Xenical. Signs and symptoms have included pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis. Very rare cases of bullous eruption have been reported. Reports of decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. Hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine. Pancreatitis has been reported with the use of Xenical in postmarketing surveillance. No causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively established.
PATIENT PACKAGE INSERT
What are the possible risks of XENICAL?
- Xenical has been shown to reduce the absorption of certain vitamins. You should take a multivitamin containing vitamins D, E, K, and beta-carotene once a day at least 2 hours before or after the administration of Xenical, such as at bedtime.
- Some patients taking Xenical may develop an increased risk for the development of kidney stones. Promptly report any symptoms of back pain or blood in the urine.
- Some patients prescribed Xenical may already be at increased risk for the formation of gall stones. Weight loss with Xenical can increase the risk of gall stones. Promptly report any symptoms of pain in the upper right portion of the abdomen. The pain may be accompanied by nausea and vomiting.
- There have been rare reports of severe liver injury in patients taking Xenical. Promptly discontinue Xenical and contact your healthcare provider if you develop symptoms suggestive of liver impairment, such as loss of appetite, itching, yellowing of the skin, dark urine, light colored stools, or right upper quadrant pain.