Alli Side Effects Include Kidney Injuries and Kidney Stones: FDA Warns

Some have called for an Alli and Xenical recall due to kidney injuries and liver problems highlighted by research dating back to at least 2011.

Federal regulators announced that the over-the-counter weight loss drug Alli will carry new label warnings instructing doctors and patients to be aware of the risk of acute kidney injury (AKI) and kidney stones, and to stop using the drug immediately if detected.

Officially approved by the U.S. Food and Drug Administration (FDA) in 2007, Alli (orlistat) is a 60mg OTC weight loss medication that is a lower-dose version of Xenical, which is a 120mg dose of orlistat. The medications are meant to be combined with a reduced-calorie diet, and work by preventing the absorption of fats, thereby reducing caloric intake.

Alli and Xenical Safety Concerns

However, as early as May 2010, the FDA issued a drug safety communication about possible liver problems with Alli and Xenical, indicating that the agency had received at least 13 reports of severe liver injury among users. In two of the cases, the patient died, and three required liver transplants. However, only one of the reports involved the use of Alli, all of the others involved the much larger Xenical dose.

In 2011, a study warned that 2% of Xenical users were hospitalized for kidney problems after they began taking the drug. This led to the consumer watchdog group, Public Citizen, filing a petition that demanded a Xenical and Alli recall. The petition argued that the health risks were too high and the weight loss benefits were too low to justify putting the drugs on the market.

While Xenical already carries some kidney risk warnings, its over-the-counter version, Alli, had avoided the requirement until now.

Alli Kidney Risks Warning

On June 10, the agency issued an Alli drug safety communication, announcing the approval of new warnings on the drug facts label alerting doctors and consumers to the risk of acute kidney injuries and kidney stones.

The FDA determined that new warnings were needed after conducting periodic safety reviews over several years. Those reviews included searches of the FDA Adverse Event Monitoring System (AEMS) for reports involving acute kidney injury, oxalate nephropathy, hyperoxaluria and calcium oxalate kidney stones.

The agency identified 12 reports of kidney complications associated with Alli use, including nine submitted to the AEMS and three described in medical literature. The patients had a median age of 61. Among those with no prior history of kidney injury, complications developed anywhere from less than one month to 17 months after starting Alli, with an average exposure time of 2.5 months.

Eight of the reports involved acute kidney injury, two involved both an AKI with oxalate nephropathy, with two other cases involving hyperoxaluria with calcium oxalate kidney stones. The agency notes that the severity of the cases was “substantial,” with eight patients being hospitalized and two requiring dialysis.

Previously, FDA drug regulators believed that the risks of kidney injury were dose-specific, meaning Xenical carried a greater threat, but now they indicate that does not appear to be the case.

“Our data analysis also suggests that orlistat-associated oxalate nephropathy and kidney injury may not be dose-dependent, as the difference in dietary fat absorption inhibition between the 120 mg (Xenical) and 60 mg (alli) doses is 5%, indicating the risk exists at both prescription and nonprescription doses.”

— U.S. Food and Drug Administration Alli Drug Safety Communication

FDA Alli Use Recommendations

Since Alli is an OTC medication and not prescribed, the FDA urges consumers to read the label warnings carefully before beginning use, and to tell their healthcare professional if they have suffered any previous kidney problems when considering taking the drug.

The agency warns consumers to be aware of the symptoms of acute kidney injury or kidney stones, which can include:

• Back or groin pain
• Painful urination
• Blood in their urine
• Feet and leg swelling
• Less frequent urination

Consumers who experience these side effects should stop taking Alli immediately and consult a healthcare provider, the FDA warns.

The agency indicates that doctors should make sure patients they counsel about weight loss inform them of the kidney risks when discussing Alli, and should urge them to stop using the drug if any symptoms of kidney problems arise.

Both doctors and patients who experience side effects involving Alli use are urged to file a report with the FDA MedWatch adverse event reporting program.

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