An attack on my liver: FDA's MedWatch adverse drug reports on Xenical

Dr. Sidney Wolfe of Public Citizen warned against the use of Xenical and Alli (weight-loss drugs in the orlistat class), after reviewing the reports of adverse reactions to them according to the U.S. government's FDA MedWatch reports. Here's the experience of one customer:

Monique Paulwell of Bowie, Maryland said she only took Alli four times before she began feeling fatigue, loss of appetite, a nagging headache and jaundice. "After a battery of tests, [doctors] said there had been an attack on my liver. By the time I was admitted to the hospital, I had 48 hours to live. It was that serious."

She said she thought taking Alli would help her lose a few pounds and maybe boost her acting career. Instead, she had a near-fatal experience her doctors told her was caused by the drug. She said she needed a liver transplant to save her life.

Public Citizen found that severe side effects affected dozens of patients who'd taken the drug, and that the drug's benefits, in any event, were minor, amounting to 4 - 5 pounds of weight loss. That has to be weighed against the 20% chance of side effects, some of which are severe, e.g., liver disease, pancreatitis, and kidney stones. The FDA received 47 reports of acute pancreatitis and 73 cases of kidney stones attributed to orlistats.

As with any drug, one should weigh the likely benefits in light of the possible harm. The advice of a pharmacist can be helpful in this context. A drug like Xenical works by blocking absorption of about a third of the fat enzymes that enter the body. Instead, the fat passes through the body to the gastrointestinal tract until it is excreted. These medications also block fat-soluble vitamins including vitamins A, B, and K.

Advice: For me, it's much easier to give advice like "maintain a healthy weight" than it is to follow my own advice. Yet it is important, especially because the surgical alternative for weight loss has some serious trade-offs, as discussed in my book, Getting Your Best Health Care: Real-World Stories for Patient Empowerment.

Thanks to Lara Salahi of ABC News for some of the background information here from their story on April 14.