Obesity drug fears investigated 美国调查某减肥药副作用

US authorities are investigating concerns an anti-obesity drug widely available over the counter at chemists may cause liver damage.

美国当局正在调查一种柜台上可轻易得到减肥药，据说这种药可能造成肝脏损伤。

Trials suggests orlistat can help people lose 50% more weight

Orlistat went on sale under the brand name Alli without the need for a prescription¹（药方） in the UK in April.

The US Food and Drug Administration has received more than 30 reports linking the drug to serious liver injury.

However, manufacturer GlaxoSmithKline said there was no evidence the drug caused liver damage.

In six of the cases reported to the FDA patients went on to develop organ failure.

The pill, which works by blocking the absorption（吸收） of fat in the body, is aimed at adults with a Body Mass Index (BMI) of 28 or more. It is also available on prescription as Xenical.

Clinical trials suggest adding orlistat to a reduced-calorie, lower-fat diet, can help people lose 50% more weight than dieting alone.

Big sales

Since going on sale at UK pharmacies² around 200,000 people have bought the drug.

Diarrhoea and gas problems are to be expected if users persist in eating fat while taking the drug.

However, concerns have been raised over the medication's other possible side-effects.

The FDA said the most commonly reported adverse³ reactions（有害反应，逆反应） included the yellowing of skin or whites of the eyes, weakness and stomach pain.

Between 1999 and 2008, the agency received 32 reports of liver damage, 30 of which occurred outside the US. Of these 27 resulted in hospitalisation.

The agency said it was now conducting a review of the safety of the drug, but stressed no definite association with liver damage had been established at this stage.

It advised people who used orlistat to seek medical advice if they experience possible symptoms of liver injury, in particular weakness or fatigue⁴（疲乏，疲劳）, fever, jaundice（黄疸，偏见）, or brown urine.

Other symptoms may include abdominal⁵ pain（腹痛）, nausea⁶（反胃）, vomiting⁷, light-colored stools, itching⁸, or loss of appetite.

However, the number of reports of liver damage is very small when compared with the many thousands of people who have used the drug.

Experts also stressed that it is possible that many obese⁹ people have underlying¹⁰ physical problems which could increase their risk of liver damage.

Safety a priority

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) said it had received a total of 1,295 suspected adverse（不利的） drug reaction reports associated with orlistat, including 137 involving suspected liver damage, since it was licensed¹¹ in 1998.

The European Medicines Agency said there was no plan to change the product information at present - but the situation was under review.

In a statement, GlaxoSmithKline (GSK) said patient safety was its top priority, and reports of side effects were constantly monitored.

The statement went on to say the drug had been extensively tested in clinical trials involving 30,000 patients.

"Alli is a 'non-systemically' acting¹² medicine - it is minimally¹³ absorbed in the blood and works locally in the gastro-intestinal tract¹⁴.

"There is therefore no obvious biological mechanism¹⁵ to suggest liver damage can occur with Alli."