One of the country’s most popular weight-loss drugs, Alli, is being recalled because of wide-spread tampering. The drug’s manufacturer, GlaxoSmithKline (GSK), confirms at least a dozen consumer complaints from seven states. Drug recall lawyers at Pintas & Mullins Law Firm are here to help anyone who was injured by a dangerous or defective medication.
GSK recently released a statement on the recall, detailing reports by consumer who found a range of different types of tablets and capsules inside Alli bottles. Some bottles were also missing labels or had protective seals that were clearly not made by GSK.
Fortunately, the company stated that it had not yet received any reports of serious consumer illnesses. Authentic Alli pills should be turquoise blue capsules with dark blue bands, imprinted with “60 Orlistat,” which is the active ingredient.
The seven states from which the defective reports came are: Alabama, Florida, Louisiana, Mississippi, New York, North Carolina, and Texas. The FDA has joined GSK in its investigation into the tampering. In 2010, the FDA issued a public warning regarding another case of Alli tampering. A fraudulent company had started manufacturing fake Alli pills and selling them online under the label.
Alli was introduced in 2007 to a highly-anticipatory consumer base. It is the first FDA-approved over-the-counter diet pill, meant for overweight adults who struggle to lose excess pounds. It is a reduced strength version (60 mg) of Xenical (120 mg), which is a prescription drug to treat obesity.
Links to Permanent Liver and Kidney Damage
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Two years after its approval, the FDA launched an investigation over concerns that Alli was causing severe liver injury, however, the agency found no causative relationship. The labels to both Alli and Xenical were changed to alert consumers of the symptoms of liver problems, such as yellowing of the eyes or skin, brown urine, and itching.
Several studies released in past years have linked Alli to kidney, liver, and other organ damage. The University of Rhode Island conducted a study in 2012, funded by the National Institutes of Health, on Alli and its potential to cause major organ damage. Researchers also found that Alli interfered with many different types of medication, including cancer treatments and blood thinners. They found that Alli in fact accelerated cancer cell growth.
The drug works by slightly inhibiting the absorption of fat in the intestines, which therefore decreases the number of calories the body takes in. Specifically, the drug disables lipase, which is an enzyme that helps break down dietary fat. When this enzyme is inhibited, fat goes undigested and continues through the intestines, into the colon and is eventually eliminated through waste.
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The drug does have some gross side effects, which is (thankfully) beyond the scope of this article, but those considering starting on the pill should definitely be aware of them. The Mayo Clinic’s page on Alli can be found here. Patients who should not take Alli include: those with problems absorbing food, anyone who has had an organ transplant, and those taking cyclosporine (brand name Neoral, Sandimmune, etc).
The digestive system is very complex, however, so manipulating certain enzymes like lipase may have consequences beyond initial weight loss. Alli also unintentionally limits the function of another key enzyme that plays an important role in detoxing the kidney, liver, and gastrointestinal system, which can result in severe toxicity if taken for long enough, or in vulnerable patients.
Our team of dangerous drug lawyers has been advocating on behalf of patients injured by dangerous or recalled drugs for nearly three decades. If you or someone you love was prescribed a medication and suffered a severe or life-threatening side effect, contact our firm immediately. Our case reviews are always free, confidential, and available to injured patients nationwide.