U.S. drug regulators approved another new weight-loss pill July 17. It's the second approval in the last month, and may be the more effective of the two. Together, they are the first new prescription weight-loss drugs in the last 13 years. The newest drug, called Qsymia, is made by Vivus Inc. The Food and Drug Administration (FDA) announced the first approval in late June. That drug, Belviq, is made by Arena Pharmaceuticals. Qsymia is a combination of 2 drugs already on the market. Phentermine suppresses the appetite. Topirimate makes people feel satisfied and full longer. In the 1990s, doctors often prescribed phentermine along with a different drug, fenfluramine, for weight loss. But in 1997 the combination was linked to heart-valve problems. Fenfluramine was withdrawn from the market. The FDA is requiring further safety testing of Qsymia after approval. In prior studies, people who took the drug for a year lost 7% to 9% of their body weight. That's about double the 3% to 3.9% lost in studies of Belviq. The Associated Press wrote about the FDA decision.
By Mary Pickett, M.D.
Harvard Medical School
What Is the Doctor's Reaction?
In the last month, the Food and Drug Administration (FDA) has approved two new weight-loss drugs. Neither one is a miracle cure.
The FDA had earlier rejected Belviq because it caused tumors in animals. In June, it was approved. However, it won't be available for another half year while the FDA considers what restrictions it will place on the drug. At high doses, it causes hallucinations, like the street drug LSD. There is concern that it may be used like a drug of abuse.
The other drug, Qsymia, was approved this week. This pill combines two drugs that are already on the market, phentermine and topiramate (Topamax). Last year the FDA said it would not approve Qsymia because there was "no long-term safety information." This year, with two years of safety data instead of one year, the FDA has given approval.
But how long do you need to take this drug? For that matter, how long do you need to take Belviq? If you choose either of these new drugs, you are supposed to take them "forever." If you don't, the small amount of weight they help you to lose will come back. Qsymia will be available only through a restricted program. The program must ensure that women taking this drug are using reliable birth control because Qsymia can cause birth defects.
There is no good drug on the market that can help people lose weight.
First, we can take over-the-counter drugs off your list. These include dietary supplements and pills that suppress your appetite. They don't have a strong effect on weight loss, but they cause side effects.
Prescription weight-loss drugs do get some results, but every one of them has drawbacks.
Weight loss figures listed below are compared with a group that took placebo (fake) pills. People in the studies also made diet and exercise changes. The available drugs are:
- Belviq (lorcaserin)
- Weight loss: Half of the people who use this drug lose 5% of body weight, if they are obese to begin with. Half lose less weight than this. Hardly anyone loses more than 5%. People with diabetes lose less weight with this drug.
- Side effects: depression, migraine, memory lapses, lack of focus, low blood sugar reactions, fatigue and (in men) painful erections that last for many hours and may require emergency room treatment
- Qsymia (phentermine plus topamax)
- Weight loss: an average of 15 extra pounds lost in the first year
- Side effects: memory loss, suicidal feelings, heart rhythm problems and birth defects.
- Adipex or Ionamin (phentermine)
- Weight loss: an extra 2 to 13 pounds after 1 to 4 years
- Side effects: rapid heartbeat, high blood pressure, restlessness, anxiety and diarrhea.
- Xenical or Alli (orlistat)
- Weight loss: an extra 6 pounds after 1 to 4 years
- Side effects: oily stool, grease spots on underwear and uncomfortable urges to have a bowel movement in up to 1 out of 3 people who take it. Orlistat also may decrease the absorption of vitamins from food.
- Acomplia (rimonabant) (available in some European countries)
- Weight loss: an extra 10 pounds after 1 to 4 years
- Side effects: depression, anxiety or insomnia in up to 1 out of 4 users. Rimonabant increases suicide risk.
Meridia (sibutramine) was withdrawn from the market in 2010. Studies showed its long-term use caused heart attacks and strokes.
The new drugs may cost more than $1,000 a year. Cost is one reason that a lot of users don't stick with weight-loss medicines. Fewer than 10% of people stay with orlistat for at least a year. Fewer than 2% of people stay with any weight-loss drug for 2 years.
What Changes Can I Make Now?
As old-fashioned as it sounds, diet and exercise are still the best way to lose weight.
- Exercise regularly.
- Reduce portion sizes.
- Choose lower-calorie foods, and make sure they are nutritious.
- Increase your fruits and vegetables. These should take up half your plate.
- Eliminate "junk foods."
- Reduce sugars in your diet. Drink no sodas.
- Eat regular meals and don't skip meals.
- Get enough sleep. This aids weight loss.
For the right person, obesity surgery can be a successful treatment. I rarely recommend weight-loss surgery. It is not an easy way out of obesity. Complications and side effects are common.
Overall, surgery has more benefits than risks for young people with extreme obesity – a body mass index (BMI) of 45 or higher. A woman in her early 40s who has a BMI of 45 could add 2½ to 3 years to her life expectancy by having surgery. For older patients and for men, the benefit is smaller.
What Can I Expect Looking to the Future?
Losing weight is hard work. If a company ever invented a drug for weight loss that is both safe and effective, we would be in "Fat City." So are we there yet?
In a word, no. If a drug is our answer to obesity, researchers are going to have to keep working on it.
