On the heels of consumer watchdog group, Public Citizen, calling for a ban of diet drug Alli, we see that GlaxoSmithKline (GSK)—makers of well-known type 2 and last-resort diabetes drug, Avandia—has chosen to offload the once golden weight loss wonder.
Apparently, Alli is not so golden anymore. GSK just reported on their first quarter earnings for 2011, and Alli sales were not exactly stellar. Case in point, Alli sales in Europe were down £14 million in first quarter 2011 vs prior year. And in the US? That’s a bit more ambiguous, though GSK does report “The USA grew 1% to £241 million, with strong performances from Sensodyne, Tums, Poligrip, Biotene, and Breathe offsetting lower sales of alli and Aquafresh.” Translation: Alli pooped in the US (no pun intended, see below).
Ok, financials are one thing—but there’s more to the Alli story than declining sales. And it begs the question, why would Sanofi-Aventis—if rumors are true—be considering buying Alli from GSK?
Let’s recall that Alli was only approved for sale in 2007. That’s not all that long ago. Then by April, 2009 Alli was the subject of conversation with the CDER Drug Safety Oversight Board—over concerns of an Alli link to possible severe liver injury.
In August, 2009 the FDA sent out its Early Communication to alert consumers that Alli was indeed under review for severe liver injury risk.
By May, 2010 the FDA announced a revised label for Alli (and Xenical) that would include a warning about “rare reports of sever liver injury”.
Fast forward to Public Citizen’s call for a ban on Alli this month—which draws attention to some digging consumer watchdog group did over at the FDA’s AERS database that found Alli to “have been associated with 47 cases of acute pancreatitis and 73 cases of kidney stones”.
In addition to being linked to serious liver injury, Alli is not exactly a dieter’s dream. We covered Alli’s rather gross side effects in an earlier story—and since then it’s not hard to find Alli users online who apparently have no shame in sharing stories of “oily orange stuff” dripping down their legs. GSK themselves recommended wearing dark clothes or carry additional clothes in case of an accident.
Seriously—possible Alli side effects reportedly include fatty or oily stools, oily spotting, intestinal gas with discharge, an increased number of bowel movements, or poor bowel control.
So given Alli’s recent sales decline, the potential for more serious adverse events to occur while taking Alli, the outcry for a ban on Alli—and the fact that it’s really not a pleasant way to lose weight—why would anyone want to buy the Alli brand?
Well, regardless of whether it’s Sanofi-Aventis or someone else, I hope their business plans include cross-promotion with Depends and Subtle Butt…
After recently posting about the FDA’s early communication on its safety review of Alli (aka orlistat) things seemed kind of quiet. The communication indicated that there had been reports of liver-related serious adverse events.
The Alli adverse event reports were low in numbers—especially when you consider that it was over a 9 year period. Regardless, there have been serious reports of liver injury. And once word came out about them via the FDA, Alli manufacturer GSK needed to respond.
So, GSK has begun its damage-control campaign—starting with yesterday’s press release that was carried on reuters.com with the following headline: “FDA states consumers should continue to use Alli”. That is a true statement—but it’s also standard operating procedure as far as FDA Read the rest of this entry »
Whoo-boy! There’s a successful date night waiting to happen. Slim down with Alli, fit into that outfit and oh, by the way, can we stop at Rite Aid for some Gas-X?
Back in 2007 when Alli was approved for OTC use for weight loss, anyone and everyone who was looking to lose a few pounds was all over it. What wasn’t to latch onto and love? Pop a pill, and let the pill block about 25% of the fat your body would absorb during a given meal.
Ah, but as with all weight loss plans, there were a few catches. Yes, exercise is advised. And yes, diet modification is not only advised, but necessary. See, that excess fat (the 25% mentioned above) that isn’t absorbed needs to go somewhere—somewhere out of your body. And that can mean gas, “oily spotting” (that’s how Glaxo’s site describes it), or loose or more frequent stools that may be hard to control.
I love this line from Glaxo—while truthful and transparent, which you have to give them credit for, I challenge anyone to read it and not go “ewww!“: Read the rest of this entry »