Quite confusing is this latest announcement from the FDA.
They [FDA] have now added warning labels to GlaxoSmithKline's Alli, the over the counter weight loss pill that was expected to earn the company billions of dollars when it was launched in 2007.
The warnings, writes Katherine Hobson of the Wall Street Journal Health Blog, will advise people taking orlistat — the active ingredient in both drugs to be on the lookout for itching, yellow eyes or skin, dark urine and loss of appetite, all of which are symptoms of liver problems.
Sales of Alli have been less than remarkable which could possibly be down to the number of adverse reports submitted the the regulator of which anal leakage is one of the more popular of the many reported.
The FDA have also added a warning label to what is basically a prescription version of Alli, namely Xenical.
Xenical is manufactured by Roche and sold by GSK.
Orlistat (marketed as a prescription under the trade name Xenical by Roche in most countries, or over-the-counter as Alli.
GSK said in a statement it is "committed to ensuring that consumers and physicians understand the safety profile" of alli.
“GSK is committed to ensuring that consumers and physicians understand the safety profile of orlistat and alli," said Howard Marsh, chief medical officer for GSK Consumer Healthcare.
"Although reports of serious liver injury in people taking orlistat are rare, GSK takes all adverse events reports seriously. Reaching and maintaining a healthier weight is one of the most important things people can do for their health. GSK wants people to have the information they need to choose the right weight loss aid for their situation,” he added.
Alli has been the butt [pun intended] of many jokes since its launch in 2007. One such jibe was a video uploaded to youtube. It was created by the makers of Leptopril, AG Waterhouse IP Holdings LLC. Leptopril, also known as Leptoprin, is a dietary supplement.
This latest announcement comes hot on the heels of the MHRA's announcement yesterday where it appeared that they had been instrumental in the prosecution of a 44 year old man who had been selling unlicensed slimming pills.
MHRA Head of Operations, Danny Lee-Frost, said:
"The products being sold by Mr Green have undergone no quality control and he continued selling these products even after he was made aware of the dangers of what he was doing.
"This is yet another example of the danger of buying any type of drug from an unregulated source. You simply don't know what you are taking, the dosage, the conditions it was made in or most importantly, the effect it might have on your health."
Put Danny Lee-Frost comments with this from the FDA:
The FDA has cautioned that there is a potential, rare occurrence of liver failure in people who take the weight-loss medications Xenical or Alli, both of which contain the active ingredient orlistat. At least 12 cases of severe liver injury have been reported in people taking Xenical and one case has been reported with the use of Alli.
Though the cause-and-effect relationship of severe liver injury with orlistat use has not been established, the FDA has revised the drug labels for Xenical and Alli to include new safety information about the rare occurrence of severe liver injury.
In the words of Danny Lee-Frost, the MHRA's Head of Operations:
"...You simply don't know what you are taking, the dosage, the conditions it was made in or most importantly, the effect it might have on your health."
One has to laugh at the irony.
Full story at the WSJ
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