Liver risk from diet pills investigated

22nd September 2011 -- The European Medicines Agency has started a review of anti-obesity medicines which contain orlistat, because of concerns over rare cases of liver damage.

The agency, which licences drugs and monitors their safety across Europe, is acting after 21 suspected cases of liver damage thought to be linked to the treatments were recorded between 1997 and January this year. These included one death and one patient who needed a liver transplant. It points out that the number of cases is small for medicines used by 38 million patients.

Xenical and Alli

Orlistat belongs to a class of medications called lipase inhibitors. Such medications block the intestines from absorbing some of the fat in the foods that you eat. Specifically, orlistat blocks about 25% of the fat that you consume. Fats that are not absorbed exit your body through your stools, or bowel movements.

Review

The review includes the prescription-only Xenical (orlistat 120 mg) and the over-the-counter-medicine Alli (orlistat 60 mg).

Between May 2007 and January 2011 there were nine reports of suspected severe liver injury with orlistat 60 mg. This treatment has been used by 11 million patients.

The agency stresses there may be other reasons for liver injury in many cases and that most reports of liver injury are not serious.

The EMA says the risk of liver reactions with orlistat is already well known and it has been monitoring the medicine's safety since it was first licenced.

The liver risk is mentioned in the product information leaflets, which contain a warning that hepatitis, cholelithiasis, and increased transaminases and alkaline phosphatase are possible side effects, and that patients who experience symptoms such as yellowing of the skin and eyes, itching, stomach pain, and liver tenderness should stop taking the capsules and tell their doctor.

The UK regulator MHRA's website has the last safety update issued for these medicines in February 2010.

The alert said patients with kidney disease should consult a doctor before starting Alli.

It also advised patients who are taking the thyroid medicine levothyroxine and antiepileptic drugs to consult a doctor before starting alli.

The new review will focus on the strength of evidence relating to severe liver injury.

The Committee for Medicinal Products for Human Use (CHMP) is now reviewing all relevant data on liver risks and Orlistat and will issue an opinion on whether or not licences should be revoked, suspended or changed.