The Food and Drug Administration's approval of a new over-the-counter weight-loss product sent dieters' hopes - and Phoenix physician Art Mollen's worries - soaring.
The drug orlistat, sold under the brand name Alli in 60-milligram capsules, was approved in February. It's also is available by prescription as 120-mg Xenical capsules.
The FDA says Alli should be used only by people 18 and older and in conjunction with a reduced-calorie, low-fat diet and an exercise program, but Mollen says he sees potential for abuse of the medicine.
Question: Who is likely to reach for these products?
Answer: There are literally millions of people in this country who want to lose weight. When someone tells them they're going to lose a lot of weight by taking a particular medicine, they're going to try it.
I think the most serious potential for abuse is among teenagers, including body-builders who want to get down to the leanest body weight possible and females who want to be thinner, and among people who have eating disorders like anorexia or bulimia.
Q: What controls are there for weight-loss products like these that are sold without a prescription?
A: Alli is designed to be taken up to three times a day with meals, and at 60 mg per capsule, it's supposed to be safer than Xenical. But if people take more, no one will know. The makers of Alli say that most people in their studies lost five to 10 pounds over six months. Even over-the-counter drugs supposedly can't make false claims, but questions have been raised about the accuracy of the studies.
Q: How does Alli work?
A: By blocking the absorption of some of the fat in your meals. In Xenical, the prescription version, orlistat blocks about 30 percent of the fat from being absorbed. There's a caveat stating that it won't work if you don't cut calories and start exercising. Well, we all know that.
Q: What are the side effects?
A: The most serious is loose stools. If you take Alli, you won't fully absorb fat-soluble vitamins like vitamins A, D and E, so you'll need to take a multivitamin. It shouldn't be used if you have diabetes or thyroid disease or take blood thinners.
Q: Have the safety and effectiveness of prescription weight-loss products been better?
A: Over the years they have included amphetamines, which are central-nervous system stimulators that speed up your metabolism and suppress your appetite. But as we've learned, there are numerous side effects, including elevated blood pressure, insomnia, increased pulse rate and heart palpitations.
The most famous of these was the fen-phen diet, which included the drugs fenfluramine and phentermine. That caused serious heart problems affecting the mitral (heart) valves. When it was banned, everyone who'd been taking the drug was advised to get an echocardiogram.
Q: How do the non-prescription drugs stack up?
A: TrimSpa is a popular one that has been in the news lately because Anna Nicole Smith was the spokesperson. It's basically a common blend of appetite suppressants, with nothing unique in it. Others contain ingredients like caffeine, the herb ma juang (a species of ephedra), guarana (a tropical berry extract) and green tea that pump you up.
These types of products can cause insomnia, hypertension, irritability and emotional highs and lows, and even increase the risk of stroke. Phenylpropanolamine (PPA), which was used in over-the-counter weight-control drugs and decongestants, was found to increase the risk of stroke sixfold. The FDA has removed it from the market.
Q: Do any of these products get at the root of the problem?
A: If there's a lesson to be learned, it's that exercise and diet are what help people lose weight and maintain the loss. I've had patients over the years who have lost 10 or 20 pounds with products like these and felt great, but inevitably, if they haven't changed their lifestyle, they regain the weight.