Safety Alerts & Recalls

What does this mean?

Most of the orlistat safety information provided in this MHRA Safety Update has been available to healthcare professionals in the product information for the brand name prescription product Xenical. This alert is simply a reminder that changes in your diet and activity level and decisions to use medicine or dietary supplements to increase weight loss are best made under the guidance of a doctor or other healthcare professionals.

If you are taking Alli or Xenical, be sure to regularly review the risks and benefits of taking this medicine with your doctor or healthcare professional, especially if you have a history of pancreatitis, kidney or liver problems, or if you are taking other prescription medications including levothyroxine (medications for the thyroid) or antiepileptic medications (medications to control seizures).

MHRA Issues Orlistat (Alli, Xenical) Safety Update

The February 2010 Safety Update from the Medicines and Healthcare products Regulatory Agency (MHRA) describes several safety updates for orlistat, the active ingredient in the brand name products Alli and Xenical. Alli and Xenical are used for weight loss in combination with a reduced-calorie, lower-fat diet. Xenical has been licensed since 1998 and is available in 120 mg capsules as a prescription-only medicine. Alli was licensed in January 2009 and is available in 60 mg capsules without a prescription under the supervision of a pharmacist.

1) Updated Safety Information for Alli

A recent Europe-wide review of the safety information for Alli has led to a number of updates, which bring the product information in line with that for Xenical. The updated information for Alli alerts pharmacists and consumers to the risk of a rare kidney problem called oxalate nephropathy, drug-drug interactions with levothyroxine, drug-drug interactions with antiepileptic drugs, and reports of pancreatitis that have been reported in an unknown number of patients taking Alli. Patients with kidney disease, patients taking thyroid medications (including levothyroxine) or antiepileptic drugs and patients with a history of pancreatitis should consult a doctor before starting Alli.

2) Reports of Counterfeit Alli Capsules in the USA

Some consumers may be at risk after reports in the USA of counterfeit Alli that contained sibutramine rather than orlistat. Although the counterfeit product has not been found in the UK, it is still potentially available to UK customers via the Internet. Consumers should not buy medicines from unregulated websites.

3) Review of Liver Toxicity with Orlistat

In July 2009, there was a Europe-wide review of a possible association between orlistat and serious liver problems. The review included non-clinical, clinical trial, and post-marketing safety data provided by the license holders and a review of suspected adverse reaction reports submitted to the MHRA. The European review concluded that there is there is not enough evidence to show that Xenical or Alli are associated with more serious liver disorders than those already listed in the product information, and that no further action was recommended at this time.

For more information, please visit: more information here

Source: MHRA
Publication Date: 2010-03-17
Last Updated: 2010-11-08

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