Pharma's Market

Published: Wednesday, 26 Aug 2009 | 9:52 AM ET

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British drugmaker GlaxoSmithKline

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[GSK  Loading...      ()   ] is trying to keep from having to tighten its belt over new safety concerns with its weightloss pill, alli (rhymes with ally and the company oddly uses a lower case "a")

As European sales of the diet drug kicked in GSK sold $171 million worth of alli in the second quarter.  That's not a lot of money for an industry that measures blockbuster drug sales by the billions, but it's big for an over-the-counter consumer product.  In other words, it's a drug you don't need to get a prescription for.  In the first quarter of this year the company posted alli sales of $42 million and in all of last year revenue came in at $139 million.  So, even though the sales are relatively small, it's an important, fast-growing product.

Perhaps that explains why GSK came out last night with a pretty strongly worded statement essentially refuting a so-called "early communication" the FDA issued about alli on Monday.  The agency says it has received 32 reports from people who took orlistat and who suffered "serious liver injury, including 6 cases of liver failure...."  Orlistate is the scientific name for alli and Xenical, which is a prescription-strength version of it sold by Roche. The FDA says no cause and effect has been established at this point, but it's looking into the situation.  In the meantime, it's telling people to simply take the drug as directed.

Glaxo says it "stands firmly behind the safety and efficacy of alli."  It also claims that there's "no obvious biological mechanism to suggest liver damage can occur with alli."  The company says it's monitoring and evaluating the liver damage reports but adds, "People who are overweight and obese are predisposed to liver-related disorders."  But if you do a Google search under "alli lawsuits" a whole bunch of plaintiffs' lawyer websites come up with the new FDA information already.

Alli has a well-known, but nonetheless embarrassing and uncomfortable potential side effect.  Let's just say the pamphlet that comes with the drug warns new patients to carry around a change of clothes.

Desperate dieters may have been willing to put up with that.  The question now is whether publicity over a much more serious issue, albeit only suspected and as yet unproven, could scare them off.

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