Is Alli Causing Liver Failure?
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So, what is Alli (interestingly pronounced (pronounced al-eye)? It started its life as the weight loss drug Xenical. The FDA approved Xenical as a prescription drug in 1999, and the FDA recently approved Alli for over-the-counter (OTC) marketing and sale. In January 2009, the European Union approved a nonprescription version of orlistat, and currently, over 100 countries have approved orlistat for marketing. However, between 1999 and the latter part of 2008, 32 reports of serious liver injury due to orlistat consumption have arisen, including six cases of liver failure.
Nevertheless in Canada, Hoffman-LaRoche has reportedly funded a series of ads, called “Julie’s Story,” not naming any particular weight loss drug. The Roche Campaign consisted of a series of ads portraying already slim women as needing a boost to look even more sexy and desirable. In making that statement, Roche may be promoting an obesity drug meant for a much smaller population of obese women. From the ads, it seems that Roche may be trying to expand their customer base and encourage young, healthy women to take an unnecessary risk in order to trim off an extra 5-10 pounds or so, just to fit Roche’s vision of the chic woman.
Xenical (Roche) is the 120 milligram per pill prescription predecessor of Alli (Glaxo Smithkline), which is the 60 milligram over the counter version of the generic compound, orlistat.
Orlistat is also known as tetrahydrolipstatin (which was featured as molecule of the month by 3Dchem.com, and that drug is a derivative of lipstatin, which comes from the bacterium, Streptomyces toxitricini, and which works by inhibiting pancreatic lipase, an enzyme that breaks down triglycerides in the intestine.
Without pancreatic lipase, food derived triglycerides have a difficult time hydrolyzing into absorbable free fatty acids. Instead, the body eliminates the unaffected and undigested triglycerides. This phenomenon results in the body retaining fewer calories from fat.
Physicians usually prescribe Xenical to patients who have an initial body mass index (BMI) of greater than or equal to 30 (kilograms per meter square) or in patients with an initial BMI greater than or equal to 27, with additional risk factors such as diabetes or hypertension. In other words, Xenical is prescribed for patients needing assistance with weight loss management and most doctors will advise patients to take Xenical in conjunction with a reduced caloric diet.
So, do we have a prescription drug that the FDA just recently approved for over the counter (OTC) drug sales that is causing liver failure? Is the manufacturer trying too hard to broaden their potential customer pool now that it is OTC?
Go read about Suzanne’s story and what Dr. Warren Bell says about Alli:
"For a hundred bucks a month you lose a pound or two and get oily farts and uncontrollable slimy stools," said family physician Dr. Warren Bell, a board member of PharmaWatch, an organization that encourages citizen reporting of adverse drugs effects. "Only the desperate or foolish - or the people who make Xenical - would call this a captivating arrangement."
Dr. Bell isn't exaggerating, either. According to the US Federal Drug Administration (FDA), Xenical's side effects include, "Oily spotting, gas with discharge, urgent need to have a bowel movement, oily or fatty stools, oily discharge, an increased number of bowel movements" and an "inability to control bowel movements." Here's the kicker, The FDA considers this only a partial list of side effects.”
Despite the side effects and the FDA's concern, Glaxo argues that since Alli is only 60 mg, it is safe if taken as directed, and The UK News has reported the following Glaxo statement:
“GlaxoSmithKline said there was no evidence the drug causes liver injury, noting that it primarily acts on the intestinal tract. A spokeswoman said Alli’s safety had been established by 100 clinical studies involving more than 30,000 patients.”
With some simple addition, it’s easy to determine that taking two Alli pills equals taking one Xenical. And since Alli is OTC, there are no physicians in the loop to ensure that the consumer is not abusing orlistat, or using it despite suffering from Anorexia, Bulimia nervosa or compulsive over eating.
Besides, any drug that upsets the body's system in the manner described above, might also be contributing to more serious, but less acute, disorders such as liver disorders, or gallbladder distention.
It seems safe to say that there is still no miracle weight loss drug that will replace good nutrition and healthy exercise. And although obese individuals, who are under physician supervision, might benefit from taking an orlistat preparation, that segment of the population would not account for the high consumer sales numbers that the manufacturers of Alli and Xenical currently enjoy.