Experts Speak Out: FDA Approval of Orlistat

Feb. 8, 2007 — -- This summer, with the Food and Drug Administration's permission, pharmacies will begin selling alli, an over-the-counter version of the weight loss drug orlistat.

The decision marks the first time such a drug has been available without a prescription. And with the nation's obesity problem ballooning, some diet experts say the pill could be a boon for those looking to give their weight loss efforts a boost.

But some also say the side effects -- which include severe diarrhea -- may limit public acceptance of the drug. And one consumer group has already come forward to argue that the FDA overlooked the drug's potential to have even more serious health effects.

Here is more of what the experts had to say:

David L. Katz, M.D., MPH, FACPM, FACP

Director, Prevention Research Center

Yale University School of Medicine

New Haven, Conn.

"Obesity really is a desperate problem in this country, so it's hard to justify not doing everything possible to combat it. orlistat works -- a little -- so the FDA is obligated to weight the pros and cons of disapproval versus those of approval.

"While this drug is of limited utility for weight loss, it has clear potential for abuse by teens striving for thinness. I worry about use by those with eating disorders. Fortunately, the side effects will limit the extent of this hazard, as anal leakage is not likely to be too socially acceptable among image-conscious teens -- or anyone else, for that matter."

Keith-Thomas Ayoob, EdD, RD, FADA

Associate Professor

Department of Pediatrics

Albert Einstein College of Medicine

Bronx, N.Y.

"It's safe to use, but it blocks the absorption of about 30 percent of fat. That's both the good and the bad news. It's good, because it could represent a significant reduction in calories absorbed. It's bad because, face it, if those fats don't get absorbed, they also don't just go away. They go into your colon. Think mineral oil and do the math.

"It's also going to block the absorption of fat-soluble vitamins, hence the warning to take it in conjunction with a multivitamin, which should compensate for the lowered absorption of fat-soluble vitamins.

Carla Wolper, MS RD CDN

Obesity Research Center

St. Luke's Hospital

New York, N.Y.

"It's hard to imagine people abusing this drug, as it would cause violent cramps and horrible diarrhea. Abuse would consist of eating a lot of fat and taking more than the recommended dose. The unabsorbed fat is excreted in the feces.

"If there is too much fat in the digestive tract there are several possibilities, all unpleasant. One is a slow and subtle leakage of oil from rectum onto underwear and clothing -- and possibly Aunt Tillie's embroidered pillows.

"This side effect may be unnoticed until one undresses and finds the brown oily and very smelly stains on clothing."

Sidney Wolfe, M.D.

Director, Health Research Group

Public Citizen nonprofit consumer advocacy organization

Washington, D.C.

"At a time when colon cancer is a leading cause of death and disease in the United States, the FDA's decision to approve, for over-the-counter use, a diet drug that clearly causes precancerous lesions of the colon is the height of recklessness and shows a profound lack of concern for the public's health.

"In April 2006, after opposing the OTC switch, we petitioned the FDA to ban the prescription version of orlistat, Xenical, because of the two studies documenting its ability to cause [precancerous lesions]. There are no human studies of long enough duration or follow-up to make any acceptable statement allaying concerns about human cancer from orlistat.

"In opposing the over-the-counter approval a year ago, we stated that 'the switch of orlistat to OTC status would be a serious, dangerous mistake in light of its marginal benefits, frequent coexistence of other diseases, common, bothersome gastrointestinal adverse reactions, significant inhibition of absorption of fat soluble vitamins, and problematic use in the millions of people using the blood thinner warfarin (Coumadin).'"

Madelyn H. Fernstrom, Ph.D., CNS

Associate Professor and Director

UPMC Weight Management Center

University of Pittsburgh Medical Center

Pittsburgh, Pa.

"Until now, this category of OTC weight loss compounds has been filled with dietary supplements and compounds claiming safety and efficacy, but which can document neither. None are FDA approved. So while alli might not work for the majority of consumers, it will certainly not harm them.

"Those who do not change their lifestyles will not lose weight, so they will not continue with the compound. The multivitamin is important -- not only for this compound, but dieters often don't meet their requirements for vitamins, and people need to be reminded."

George Bray, M.D.

Pennington Center

Baton Rouge, La.

"Many patients use herbal preparations for weight loss. One feature of orlistat is that it is has been thoroughly tested in clinical trials, someone that cannot be said of any other formulation available without medical prescription. It thus provides a very good alternative to what is now being used by the public."

Robert Kushner, M.D.

Professor of Medicine

Northwestern University Feinberg School of Medicine

Chicago, Ill.

"Obesity continues to be a very serious health risk. Physician prescription for anti-obesity medications is quite minimal given the number of patients who may benefit. Furthermore, obesity continues to be an unspoken and unaddressed problem in the medical office. Therefore, I presume that the FDA wants to make medications that are safe directly available to the consumers so they can take personal action for their own health.

"Consumers will discover very quickly that they must modify the amount of dietary fat in order to minimize the treatment effects -- so there will be a steep behavioral learning curve."

Richard Fleming, M.D.

Cardiologist

VA Medical Center

Reno, Nev.

"This is a disaster waiting to happen. It makes no difference whether we are talking about orlistat, phen-fen, amphetamines (used in the 1960s), or the other medications used for the last 50 years, there are consequences to using these drugs.

"When the nonsteroidal medications (NSAIDs) were allowed on the market, I feared many people would experience problems with stomach ulcers and kidney damage. Now we are going to allow people to take another medicine OTC with side effects, which not only include diarrhea, but the loss of important vitamins necessary for human health.

"Having done research on the effects of some of these medications and published the results in peer-reviewed medical journals, let me be the first to say it's just a matter of time."