The FDA made headlines this week by approving not one but two new diet pills. Belviq (lorcaserin) and Qsymia (pronounced kyoo-sim-EE-uh and containing phentermine plus topiramate) are the first new weight loss drugs in 13 years.
The last diet drug cleared by the FDA was Xenical (orlistat), which is now sold over the counter as Alli. It initially received a lot of attention but lost some of its luster when people discovered some unpleasant side effects. Because this drug works by preventing the absorption of fat, adverse reactions may include flatulence, frequent bowel movements, wet farts [officially dubbed “flatus with discharge”] and here is the big one…”fecal incontinence.” Not surprising that orlistat was not a big best seller.
There is clearly a pent up demand for new and better tolerated weight loss medications. More than one third of Americans are officially obese according to the CDC. Just go to any mall and look around and you will see a lot of overweight people. And we want a quick fix.
For decades Americans have looked for an easy way to lose weight. Despite the popularity of vibrating gizmos and battery-powered gadgets, diet pills are the preferred method. No muss, no fuss, no will power, no exercise. Just swallow a pill and the pounds are supposed to melt away like butter. Diet pill popularity can rise and fall like the numbers on a dieter’s scale. During the 1950s and 1960s doctors often prescribed amphetamines to curb appetite.
Dexedrine (dextroamphetamine), one of the most popular products then, is still available by prescription. But because amphetamines have the potential for abuse, they are no longer doctors’ first choice for overweight patients.
During the 1970s and 1980s, over-the-counter weight loss products hit their heyday. Dexatrim (phenylpropanolamine or PPA for short) was one of the most popular brands.
As early as 1980 British researchers had raised a red flag. They gave PPA to healthy young medical students and noted side effects such as alarming elevations in blood pressure along with dizziness, heart palpitations, headache, insomnia, anxiety and restlessness.
By 1990, doctors in the U.S. had reported142 bad reactions to PPA, including strokes, seizures and even deaths. But it was ten years later before the FDA made a move. Yale investigators had found that women who took PPA for the first time tripled their risk of a stroke. Those using the drug as an appetite suppressant appeared to be at 16 times the risk.
FDA staffers estimated that PPA might have been responsible for 200 to 500 strokes in people under the age of 50 each year. Extrapolating over the years, PPA might have accounted for as many as 10,000 strokes in people not generally vulnerable to that problem. At that point, the agency announced that over-the-counter weight loss products would have to be removed or reformulated without PPA.
The phen-fen phenomenon of the 1990s was the next big diet craze. Combining two old diet pills, phentermine and fenfluramine, appeared to produce better results than prior regimens. Millions of people begged doctors for prescriptions.
But by 1997 reports of heart valve damage finally pushed the FDA to request withdrawal of fenfluramine and dexfenfluramine (Redux) which had been approved only the year before. The bust phase of the phen-fen fiasco was more spectacular than previous diet pill disasters.
Ephedra (also known as ma huang) was the next big thing. This Chinese herbal medicine was eventually banned from OTC weight loss products because of reports of heart rhythm irregularities, hypertension, strokes and death.
Hope springs eternal, so no doubt the new diet pills will get tremendous media attention and millions of people will badger their physicians for prescriptions hoping to shed pounds effortlessly. So what’s the straight and skinny on the new diet pills?
Qsymia [yes…it is a tongue twister! The company says to pronounce it kyoo-sim-EE-uh] is getting a lot of buzz. The pill is a combination of the diet drug phentermine and an antiseizure medicine called topiramate. It has been approved for obese patients, defined as a body mass index of at least 30. The merely overweight (defined as having a BMI of at least 27) should only be able to get a prescription for Qsymia if they also have some other weight-related health problem such as diabetes, hypertension or elevated cholesterol levels.
How good is Qysmia? According to ConsumerReports.org, Qsymia “appears to help people drop a few pounds. In studies, obese and overweight people who took Qsymia for one year lost 3.5 to 9.3 more pounds than those who took a placebo. But that small benefit is probably not worth the risks of birth defects, heart attacks, and strokes. In fact, two years ago the FDA rejected the drug, then called Qnexa, due to these concerns, and it is not clear why the FDA reversed course this time, since those side effects are still an issue.”
Other side effects of Qsymia may include:
• Suicidal thoughts, depression, anxiety, insomnia
• Increased heart rate
• Vision problems, eye pain, glaucoma,
• Impaired concentration, confusion, memory problems
• Trouble finding the right word when speaking
• Dry mouth, unpleasant taste
• Changes in kidney function (creatinine elevation)
• Constipation
• Nerve changes including sensation of burning, tingling or prickling
• Dizziness
If Qsymia sounds a bit daunting, what about the other new diet drug, Belviq? The first thing to know is that the FDA is concerned enough about an abuse potential that the U.S. Drug Enforcement Admininistration (the DEA) has to decide how to categorize the drug. That will take several months.
How good is Belviq at helping people shed pounds? People on the drug experienced weight loss on average about 3 to 3.7 percent greater than those subjects receiving a placebo. That’s something, but hardly earth shattering. And what about adverse drug reactions?
Belviq Side Effects:
• Headache, insomnia
• Dizziness
• Digestive upset, nausea, Diarrhea, constipation
• Fatigue
• Cold symptoms, cough, sore throat, sinus congestion
• Urinary tract infection
• Fluid retention
• Lowered blood sugar (in diabetics)
• Back pain and muscle spasms
• High blood pressure
• Cognitive dysfunction, difficulty with concentration, memory problems
So, what’s an overweight person to do? It should be fairly obvious by now that there is still no magic weight loss pill that will help us shed pounds quickly and easily with no changes in eating behavior, no exercise and no side effects. It is unlikely that there will ever be such a pill.
Sustained weight loss requires changing our relationship with food. We have to learn that sugar and simple carbohydrates (crackers, pretzels, and chips) will pack on the pounds. But so will lots of other foods as well. And portion size does matter! So does exercise.
For those who really have a weight problem that cannot be controlled through diet and exercise at home, we recommend the Structure House Weight Loss Program [they have recently started underwriting our radio show]. These folks have been helping overweight people make meaningful changes in their lives for 35 years. To learn more about Wellspring at Structure House check out this link or call 800-553-0052.
Losing weight is important for self esteem and good health. Getting weight under control can lower blood pressure, blood sugar and reduce the risk for heart disease. Just don’t expect a pill to do it for you. Know that sustained weight loss is possible, but it will require changing your relationship with food!
The People's Perspective on Medicine