Alli Liver Damage Risk Refuted by GlaxoSmithKline
Published: August 26th, 2009 • Comments: 5
GlaxoSmithKline PLC has released a statement in support of their orlistat-based weight-loss drug Alli, following the FDA’s announcement Monday that they are investigating reports of liver damage that may be linked to Alli and Xenical.
Alli (orlistat 60mg) is an over-the-counter product that was approved by the FDA in 2007 to help promote weight loss when used together with a low-calorie, low-fat diet. During its first full year on the market in the United States, Alli generated $131 million in sales for GlaxoSmithKline and has been viewed as a very important product for phamaceutical company.
On August 24, the FDA issued an Early Communication to notify the public that they are reviewing a potential liver damage risk with Alli and Xenical, a prescription version of the weight loss drug that contains 120 mg of orlistat. The FDA has received 32 reports of liver injury among users of orlistat weight loss drugs, including 27 cases that resulted in hospitalization and six that involved liver failure. The most common symptoms reported were jaundice, weakness or fatigue and stomach pain.
In a press release issued on August 25, GlaxoSmithKline refuted the potential Alli liver damage risk, pointing out that orlistat has been well-studied and no evidence has been found to indicate that it causes liver damage. The drug maker also pointed out that there can be many causes of liver damage, and people who are overweight and obese are predisposed to such disorders.
“alli is a ‘non-systemically’ acting medicine – it is minimally absorbed in the blood and works locally in the gastro-intestinal tract,” said GlaxoSmithKline in the statement responding to the FDA’s Early Communication. “There is therefore no obvious biological mechanism to suggest liver damage can occur with alli.”
An Early Communication by the FDA does not mean that any conclusions have been made that there is a causal relationship between Alli and liver damage. The communication is designed to keep the public informed of ongoing safety reviews involving drugs, and the agency indicated that they will communicate their findings as soon as the review of orlistat liver side effects is complete.
At this time, the FDA has urged consumers to report any Xenical or Alli side effects to their MedWatch Adverse Event Reporting program and to contact their doctors if they are experiencing symptoms possibly associated with the development of liver damage.
The FDA indicates that consumers currently taking Alli should continue to use the product as directed, and users of Xenical have been advised keep taking the drug as prescribed, pending any final conclusions.
Comment by Carol on 27 August 2009:
I took this medication for weight loss and I was one of the ppl who had the “bad” side effects of oil in my stools. This was not convenient and I had no control over the side effect. Now I’m worried about what it may have done to my liver. How can I find out?
Comment by other on 29 August 2009:
I’ve taken it for 2 years and lost over 100 lbs. I have no issues with my liver and I believe those 32 people already had liver issues.
Comment by April on 9 October 2009:
I have been taking Alli for less than a year. The best way to avoid the side effects is to watch what you eat. I’ve always wondered what it was doing to my body that I didnt know of. I read another site showing the best way to reverse liver damage… eating fruits and vegetables and purifying the liver.
Comment by Penny on 16 October 2009:
Hmmm, I’ve taken Alli for 6 months and went from 87kg to 76kg with exercise and pretty healthy eating plan. I’ve had the oily stools but so what?That’s what it does, and I’ve never had these side effects with “no control”, other people have told me that and it’s usually coz they eat junk, or more than 2000 cal/day – do what the manufacturers say and there’s no problems, just oily discharge when you go naturally. I will finish using Alli in 3 weeks, and my liver function tests ( as of August anyway) have all been outstanding, so I’m not bothered.
Comment by lisa on 8 January 2010:
I just started taking it and the only treatment effect I had was the first day (because of what I ate the day before). Watch your fat/cal intake, hydrate, eat fruits and veggies, you should be fine. I agree the bad side affects are people not watching what they eat and the 32 probably had liver isses before starting the program.