The European Medicines Agency has said that four suspects had been “serious toxicity,” related to medicine in recent years, one of which was fatal.
Although the small number of cases considered 38million across Europe have received the diet pills for weight loss doctors, the regulator said it was now looking at what evidence is to combine the drug liver damage.
Next, decide whether or not licenses for medicines containing orlistat need to be modified or canceled.
Orlistat, available since 1998, taking the intestines to absorb fat so it is excreted instead.
It comes in a form over-the-counter 60mg, known as Alli, and an order only 120 mg, marketed as Xenical.
Official figures show that orlistat accounted for 74 per cent of the 1.45million weight-loss drugs prescribed in England in 2009,
Two other pills for obesity, known as rimonabant (Acomplia) and sibutramine (Meridia), has worked to change the way patients think about food, but is excluded from the sale of the last few years, when the main alternative to GPS Xenical.
A Europe-wide review was made in 2009, a possible link between orlistat and “severe liver damage,” or damage to the liver, but found “sufficient evidence”.
But the EMA, the drug across the continent, announced on Thursday was still investigating prevalence.
“The European Medicines Agency has initiated a review of orlistat containing anti-obesity drugs, to determine if the rare cases of liver injury have an impact on risk-benefit profile and operating conditions,” he said in a statement .
“The review includes prescription drugs approved in the center of Xenical (orlistat 120 mg) and the center approved over-the-counter drug Alli (orlistat 60 mg), and a number of drugs containing orlistat, or have already been or are being to be approved at national level. ”
He said the “vast majority” of reports of liver injury is not serious, and serious injuries were reported as “very rarely”.
Between August 2009 and January this year, the EMA, said he had heard about 21 suspected liver damage associated with the prescription dose of orlistat.
Four of them were serious, fatal and one test for a liver transplant.
Between 1997 and 2011 were 21 cases in which the connection may have been presented, out of the 38m people using this medicine.
Between May 2007 and January this year, there were nine reports of “severe liver damage suspected” is linked to low doses of medication, but all are not convincing, and be seen “in the context of total 11 million patients. ”
EMA said: “The Committee is reviewing all the information relevant to the risk of hepatotoxicity containing the drug orlistat, and give an opinion on the marketing authorization of these drugs should be revoked, suspended or modified.”
Roche, the pharmaceutical giant that manufactures Xenical, said it was the most tested food substance that is was 100 different clinical trials. But a spokesman said it would investigate the concerns of patients.