I think this will not help weight loss. People should read and check with doctor before taking this drug.
First formula to lose weight is to eat less and exercise more. But, no one wants to do that everyone wants to take a pill because we have ZERO self-control or will power.
Another formula to lose weight is: Keep a Food Journal, Don’t Skip Meals, and Eat In
What is new diet drug Qsymia?
Qsymia, made by Vivus Inc., receives market approval on the heels of Arena’s Belviq (lorcaserin), the diet pill cleared by the FDA in late June. Before these two new drugs, the last prescription weight-loss pill to be green-lit by the government was Roche’s Xenical (orlistat) 13 years ago, in 1999.
Diet pills have had a spotty history with the FDA, largely because of safety problems involving the heart. Other drugs — most notably fenfluramine, used in the popular weight-loss combination fen-phen — have been withdrawn from the market for such hazards, and new drugs have had to clear a high bar for consideration. The new pill, formerly known as Qnexa (the FDA asked Vivus to change the name to avoid confusion with another drug on the market), will be available by the fourth quarter of this year, according to the company’s president, Peter Tam. Here’s what you need to know.
Who can take Qsymia?
The drug is approved for obese adults with a body mass index, or BMI, of 30 or higher. It can also be used by overweight adults, with a BMI of 27 or higher, if they have at least one weight-related condition such as high blood pressure, Type 2 diabetes or high cholesterol.
How Qsymia works in our body
Qsymia is a combination of two existing drugs: phentermine, an appetite-suppressing stimulant that has long been used for short-term weight loss, and topiramate, an anti-seizure medication used to treat epilepsy that makes people feel fuller after eating. Some doctors have already been prescribing the two drugs together for weight loss. Researchers say the key to Qsymia’s success is that it targets multiple brain pathways that trigger overeating.
How much weight will I lose after taking Qsymia?
It varies. In clinical trials, overweight and obese patients taking Qsymia for a year lost differing amounts of weight: on average, patients taking a middle dose of the drug lost 8.4% of their body weight; on a higher dose, patients lost 10.6%.
Most of the weight came off in the first three months, so doctors should monitor patients at that point to see if the drug is working. The FDA notes that people who don’t lose at least 3% of their body weight by three months are unlikely to go on to lose any significant weight, so they should either be counseled to discontinue the drug or to try a higher dose (Qsymia will be available in two doses). If patients still don’t lose at least 5% of their weight after three additional months on the higher dose, they should quit taking Qsymia. The drug is designed to be used in conjunction with traditional weight-management strategies like diet and exercise. “This is not a magic pill. Patients can’t take it and think that’s all they have to do. It needs to be used with a lifestyle modification program,” W. Timothy Garvey, chair of the department of nutrition sciences at the University of Alabama-Birmingham, who studied Qsymia, told USA Today.
Does not use for cosmetic weight Loss?
Doctors stress that because of the potential risks of the drug, dieters should not use the drug for cosmetic weight loss. “It’s not for patients who want to lose a few pounds,” Tam told USA Today. Of course, concerns remain that once the drug is on the market, doctors can prescribe it to all comers. To prevent that, Qsymia will be available only by mail order at first, so that physicians can’t dispense it from their offices. It will also be available in specialized pharmacies that register for the right to sell the drug, where pharmacists have been educated about Qsymia’s risks and can pass that information along to patients and doctors.
Risks of Qsymia
Some people after taking this show signs of heart problems and birth defects. In trials, some people taking Qsymia had an increased heart rate as well as a condition called metabolic acidosis, which can lead to hyperventilation, fatigue and anorexia. One of the ingredients in Qsymia, topiramate, has also been linked in previous studies to birth defects including cleft lip and cleft palate in women who take it during pregnancy.
Safety concerns led the FDA to reject Qsymia’s first bid for approval in 2010, but the agency and Vivus have now put in place strategies to reduce risk: for example, women of child-bearing age who want to take Qsymia must test negative for pregnancy before starting the drug and are expected to use contraception and take a pregnancy test once a month while on the drug. Worries remain, though: in a Vivus trial, 34 women on Qsymia became pregnant even though they were instructed to use contraception. (The company says no birth defects occurred.)
Patients’ heart rate should also be monitored regularly while taking Qsymia. People with recent or unstable heart disease or stroke are not recommended to take the drug because of the potential heart risks. Vivus has also agreed to continue monitoring Qsymia users for side effects after the drug reaches market; in particular, it will conduct a long-term cardiovascular outcomes trial to assess the effect of Qsymia on major events like heart attack and stroke.
News -FDA Approves Weight Loss Drug Qsymia
The U.S. Food and Drug Administration has approved the diet drug Qsymia, the agency's latest move to give doctors and their patients more tools to fight excessive weight gain as obesity rates continue to bulge in the U.S. and around the world. An advisory panel voted 20 to two to approve the drug in February, the first time the FDA voted to approve a weight-loss drug in more than a decade. Originally known as Qnexa, the FDA required Vivus, the manufacturer of the drug, to change its name in order to prevent its confusion with other drugs with similar-sounding names. Data presented by the company showed that it helped patients lose about 10 percent of their body weight. The committee's recommendation and Tuesday's approval by the FDA drew both praise and criticism, reflecting concern over the drug's side effects as well as the need to give patients more choices beyond diet, exercise and bariatric surgery.
Considering the heavy toll of obesity in our society, this agent has tremendous potential," said Dr. Chip Lavie, medical director of cardiac rehab and prevention at the Ochsner Medical Center in New Orleans. I do think it will help a subpopulation lose weight. However, I am concerned that mass marketing of this drug will perpetuate the magic bullet approach to weight loss, which is limiting and does not address the root problem," said Dr. Gerard Mullin, an associate professor at Johns Hopkins School of Medicine.
About one-third of Americans are obese, and many have chronic, expensive medical conditions as a result, such as heart disease, diabetes and arthritis. Until recently, the array of available options has been frustratingly sparse for many doctors and their patients: diet, exercise and, for those overweight enough to qualify, bariatric surgery. "I think it's clear from current research that there are problems with weight-regulating mechanisms in the brain that make it difficult for people to lose and maintain weight," said Dr. Louis Aronne, director of the Comprehensive Weight Control Program at New York Presbyterian Hospital. "We need to come to that realization that we're better off treating people who are obese than blaming them. “Weight loss was a struggle for Meg Evans, a 63-year-old mother of four in San Diego, until she took Qsymia. She said she was the quintessential jock in high school and college: physically active, involved in sports and always staying fit and trim. After she had her children, she started to put on weight. Evans said she tried several diets over the years and continued to stay active, playing goalie for her soccer team. But she couldn't seem to get the scale to tick downward. "My weight was inching up and up, and by 2007, I was at 230 pounds. I was not OK with that," she said.
When her doctor told her for the first time that her blood pressure was high, Evans realized it was time to try something different. Her doctor recommended that she enroll in the clinical trials for Qsymia, and she readily agreed. She started taking the drug in February 2008 and also worked with a counselor once a week to develop a diet and exercise plan. "Once I did those three things, I started losing that weight," Evans said. By March 2009, she had lost 48 pounds. She said the only noticeable effect of the drug was that it decreased her hunger pangs. "Honestly, I thought I was on the placebo. I really thought I was doing it myself," she said. "For me, there was just not that need to eat. Qsymia is a combination of two FDA-approved drugs: phentermine, a stimulant related to the amphetamines that suppresses the appetite, and topiramate, a drug used to treat migraines and epilepsy that has weight-loss side effects. Vivus emphasizes that the drug is intended to be used in combination with diet and exercise.
In June, the FDA approved another diet drug, lorcaserin or Belviq. The drug is also an appetite suppressant and intended for patients who are obese and have one additional weight-related health problem, such as high blood pressure, type 2 diabetes or high cholesterol. However, studies of Belviq found that patients lost about 4 percent of their body weight, compared with the 10 or 12 percent lost by Qsymia patients But Qsymia is not without drawbacks. When Qsymia's manufacturer, Vivus, initially submitted the drug for approval in 2010, the FDA voted it down, citing concerns over the potential for dangerous heart problems, birth defects and cognitive effects such as mental fogginess or lack of concentration in patients taking the drug.
The 2012 panel voted to approve the drug only with Vivus' assurances that the company would provide detailed information to physicians about the risks of the drug and how to manage them. Still, doctors are mixed in their concern over the potential for side effects, particularly in light of the history of diet drugs, such as fen-phen, approved by the FDA, then withdrawn from the market over concerns about heart risks and other dangerous side effects. "Honestly, I won't be surprised if adverse effects over time result in a reversal of the approval," said Dr. David Katz, director of the Yale Prevention Research Center. "But in the interim, it will help some people lose weight, and many others will try it, dislike it and stop, and gain the weight back." Evans said she's gained about 20 pounds since she stopped taking Qsymia in 2009. She said the gain is due in part to an injury to her Achilles tendon that has kept her from being as active as she was. But she said she would definitely consider taking it again to help her bring her weight down. "Just to know that it's available if I need it, that's a real nice little prize," she said.
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