Some patients find that diet and exercise is not a viable option; for these patients, anti-obesity drugs or “weigth loss pills” can be option under careful medical superision. Some prescription weight loss drugs are stimulants, which are recommended only for short-term use, and thus are of limited usefulness for extremely obese patients, who may need to reduce weight over months or years.
FDA approves weight-management drug Qsymia in July 2012
The combination of phentermine and topiramate, brand name Qsymia (formerly Qnexa) was approved by the U.S. FDA on July 17, 2012, as an obestity treatment complementary to a diet and exercise regimen.
Cost of Qsymia – Generic combination versus Brand name
The manufacturer cost of Qsymia retailed through various pharmacies is approximately &160.00 per month. Due to this steep price, some patients of W8MD Medical Weight Loss Centers requested if they can try the generic combination (Phentermine and Topiramate) as both the ingredients are generic and we had good success in trying the generic combination. Since each of these two components can be obtained for about a dollar a pill each, with a total monthly cost of $60.00 USD to $90.00 depending the number of pills, it works out much cheaper to do the generic combination of Phentermine and Topiramate compared to the brand price, but we offer both the options.
Here is the information from the FDA regarding Qsymia weight loss medication.
The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management.
The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.
“Obesity threatens the overall well being of patients and is a major public health concern,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet. Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches.
Qsymia must not be used during pregnancy because it can cause harm to a fetus. Data show that a fetus exposed to topiramate, a component of Qsymia, in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate). Females of reproductive potential must not be pregnant when starting Qsymia therapy or become pregnant while taking Qsymia. Females of reproductive potential should have a negative pregnancy test before starting Qsymia and every month while using the drug and should use effective contraception consistently while taking Qsymia.
The safety and efficacy of Qsymia were evaluated in two randomized, placebo-controlled trials that included approximately 3,700 obese and overweight patients with and without significant weight-related conditions treated for one year. All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity.
The recommended daily dose of Qsymia contains 7.5 milligrams of phentermine and 46 mg of topiramate extended-release. Qsymia is also available at a higher dose (15 mg phentermine and 92 mg of topiramate extended-release) for select patients.
Results from the two trials show that after one year of treatment with the recommended and highest daily dose of Qsymia, patients had an average weight loss of 6.7 percent and 8.9 percent, respectively, over treatment with placebo. Approximately 62 percent and 69 percent of patients lost at least five percent of their body weight with the recommended dose and highest dose of Qsymia, respectively, compared with about 20 percent of patients treated with placebo.
Patients who did not lose at least three percent of their body weight by week 12 of treatment with Qsymia were unlikely to achieve and sustain weight loss with continued treatment at this dose. Therefore, response to therapy with the recommended daily dose of Qsymia should be evaluated by 12 weeks to determine, based on the amount of weight loss, whether to discontinue Qsymia or increase to the higher dose. If after 12 weeks on the higher dose of Qsymia, a patient does not lose at least five percent of body weight, then Qsymia should be discontinued, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.
Qsymia must not be used in patients with glaucoma or hyperthyroidism. Qsymia can increase heart rate; this drug’s effect on heart rate in patients at high risk for heart attack or stroke is not known. Therefore, the use of Qsymia in patients with recent (within the last six months) or unstable heart disease or stroke is not recommended. Regular monitoring of heart rate is recommended for all patients taking Qsymia, especially when starting Qsymia or increasing the dose.
The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a Medication Guide advising patients about important safety information and elements to assure safe use that include prescriber training and pharmacy certification. The purpose of the REMS is to educate prescribers and their patients about the increased risk of birth defects associated with first trimester exposure to Qsymia, the need for pregnancy prevention, and the need to discontinue therapy if pregnancy occurs. Qsymia will only be dispensed through specially certified pharmacies.
Vivus Inc. will be required to conduct 10 postmarketing requirements, including a long-term cardiovascular outcomes trial to assess the effect of Qsymia on the risk for major adverse cardiac events such as heart attack and stroke.
The most common side effects of Qsymia are tingling of hands and feet (paresthesia), dizziness, altered taste sensation, insomnia, constipation, and dry mouth.
Qsymia is marketed by Vivus Inc. in Mountain View, Calif.
Orlistat Orlistat (Xenical) weight loss medication reduces intestinal fat absorption by inhibiting pancreatic lipase. Some side-effects of using Orlistat include frequent, oily bowel movements (steatorrhea). But if fat in the diet is reduced, symptoms often improve. Originally available only by prescription, it was approved by the FDA for over-the-counter sale in February 2007. On 26 May 2010, the U.S. Food and Drug Administration (FDA) has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. Of the 40 million users of Orlistat worldwide, 13 cases of severe liver damage have been reported.
Lorcaserin Lorcaserin (Belviq) weight loss medication was approved June 28, 2012 for obesity with other co-morbidities. The average weight loss by study participants was modest, but the most common side effects of the drug are considered benign.
An excerpt from the Bloom 1 Study conducted by Arena Pharmaceuticals and later submitted for FDA approval:
At the end of Year 1 of the BLOOM trial, using Intent-to-Treat with Last Observation Carried Forward analysis (ITT-LOCF), the proportion of patients achieving at least 5% body weight loss in the lorcaserin group (47.5%) was more than twice that achieved by the placebo group (20.3%). Nearly three times as many patients achieved at least 10% weight loss in the lorcaserin group (22.6%) than in the placebo group (7.7%). Lorcaserin patients who completed the first year of the trial according to the protocol lost an average of 8.2% of their baseline weight, or approximately 18 pounds, at the end of Year 1 as compared to approximately 7 pounds in the placebo group. In Year 2, patients who continued to take lorcaserin were significantly better able to maintain their Year 1 weight loss than those who were switched to placebo.
In Year 1, lorcaserin caused significant decreases in waist circumference, BMI, glycemic parameters, high-sensitivity C-reactive protein, and fibrinogen levels compared to placebo. Total cholesterol, LDL cholesterol and triglyceride levels at Year 1 were significantly lower in the lorcaserin group than in the placebo group. Lorcaserin did not increase heart rate or blood pressure; rather, heart rate, systolic blood pressure and diastolic blood pressure decreased slightly but significantly with lorcaserin treatment compared to placebo. Quality of life, measured by the Impact of Weight on Quality of Life-Lite questionnaire, improved in both treatment groups, with a greater improvement in the lorcaserin group than in the placebo group.
At the end of Year 1, 55.4% of patients in the lorcaserin group and 45.1% of patients in the placebo group remained enrolled in the study, and 7.1% and 6.7% of patients, respectively, discontinued the study due to an adverse event. Among the most frequent adverse events reported with lorcaserin were headache (18.0% vs. 11.0%, lorcaserin vs. placebo); dizziness (8.2% vs. 3.8%); and nausea (7.5% vs. 5.4%). The rates of serious adverse events were similar in both treatment groups. The rates of depression and the incidence of anxiety and suicidal thoughts were low in both treatment groups. Lorcaserin caused no significant increase compared to placebo in the incidence of new cardiac valvulopathy.
Sibutramine (Reductil or Meridia) is an anorectic or appetite suppressant, reducing the desire to eat. Sibutramine may increase blood pressure and may cause dry mouth, constipation, headache, and insomnia.
In the past, it was noted by the US that Meridia was a harmless drug for fighting obesity. The US District Court of the Northern District of Ohio rejected 113 cases complaining about the negative effects of the drug, stating that the clients lacked supporting facts and that the representatives involved were not qualified enough. According to new research, however, it is clear that the drug is injurious to health.
Rimonabant for weight loss
Rimonabant weigth loss medication (Acomplia) is a recently developed anti-obesity medication. It is cannabinoid (CB1) receptor antagonist that acts centrally on the brain thus decreasing appetite. It may also act peripherally by increasing thermogenesis and therefore increasing energy expenditure.
Weight loss with Rimonabant, however, has not been shown to be greater than other available weight-loss medication. Due to safety concerns, primarily psychiatric in nature, the drug has not received approval in the United States or Canada, either as an anti-obesity treatment or as a smoking-cessation drug.
Sanofi-Aventis has received approval to market Rimonabant as a prescription anti-obesity drug in the European Union, subject to some restrictions. However, in October 2008, the European Medicines Agency (EMEA) recommended that Acomplia no longer be available in UK. One month later, Sanofi-Aventis decided it would no longer study rimonabant for any indication.
Exenatide For Weight Loss
Exenatide (Byetta) is a long-acting analogue of the hormone GLP-1, which the intestines secrete in response to the presence of food. Among other effects, GLP-1 delays gastric emptying and promotes a feeling of satiety. Some obese people are deficient in GLP-1, and dieting reduces GLP-1 further.
Byetta for weight loss
Byetta is currently available as a treatment for Diabetes mellitus type 2. Some, but not all, patients find that they lose substantial weight when taking Byetta. Drawbacks of Byetta include that it must be injected subcutaneously twice daily, and that it causes severe nausea in some patients, especially when therapy is initiated. Byetta is recommended only for patients with Type 2 Diabetes. A somewhat similar drug, Symlin, is currently available for treating diabetes and is in testing for treating obesity in non-diabetics.Pramlintide (Symlin) is a synthetic analogue of the hormone Amylin, which in normal people is secreted by the pancreas in response to eating. Among other effects, Amylin delays gastric emptying and promotes a feeling of satiety.
Many diabetics are deficient in Amylin. Currently, Symlin is only approved to be used along with insulin by Type 1 and Type 2 diabetics. However, Symlin is currently being tested in non-diabetics as a treatment for obesity. A drawback is that Symlin must be injected at mealtimes.
Metformin For Weight Loss
Metformin In people with Diabetes mellitus type 2, the drug metformin (Glucophage) can reduce weight. Metformin limits the amount of glucose that is produced by the liver as well as increases muscle consumption of glucose.
Other drugs Other weight loss drugs have also been associated with medical complications, such as fatal pulmonary hypertension and heart valve damage due to Redux and Fen-phen, and hemorrhagic stroke due phenylpropanolamine.Many of these substances are related to amphetamine.
Unresearched nonprescription products or programs for weight loss are heavily promoted by mail and print advertising and on the internet. The US Food and Drug Administration recommends caution with use of these products, since many of the claims of safety and effectiveness are unsubstantiated.
Individuals with anorexia nervosa and some athletes try to control body weight with laxatives, diet pills or diuretic drugs, although these generally have no impact on body fat.Products that work as a laxative can cause the blood’s potassium level to drop, which may cause heart and/or muscle problems. Pyruvate is a popular product that may result in a small amount of weight loss. However, pyruvate, which is found in red apples, cheese, and red wine, has not been thoroughly studied and its weight loss potential has not been scientifically established.
ZGN-433 is undergoing initial human trials, starting in early 2011.
Alternative medicine Most supplements and alternative medicine has insufficient evidence to support or oppose its use.
Conjugated linoleic acid for weight loss: It is claimed to reduce body fat. It is possibly effective. The side effects include ppset stomach, nausea, loose stools.
Green tea extract for weight loss: The claim is that it helps decrease appetite, and increases metabolism, fat cell death. There is insufficient evidence to evaluate this in studies. Side effects of this medication include Dizziness, insomnia, agitation, nausea, vomiting, bloating, gas, diarrhea
Khat weight loss supplement: The claim is that it reduces appetite. It’s long term use (high dosage) may cause liver damage, heart problems
Lipoic acid for weight loss: The claim is that it increases glucose absorption in muscles rather than fat.
ECA Stack for weight loss: The claim is that it increases metabolism. Side effects include severe skin reactions, irritability, nervousness, dizziness, trembling, headache, insomnia, profuse perspiration, dehydration, itchy scalp and skin, vomiting, hyperthermia, irregular heartbeat, seizures, heart attack, stroke, or death.
Raspberry ketone for weight loss: The claim is that it increases norepinephri
ne-induced lipolysis. There are no large studies to show clinical evidence in humans.
How can W8MD Medical Weight Loss Centers Help?
As our weight loss physicians are specially educated and experienced in managing weight, prescribe appropriate weight loss medications, provide dietary, nutritional and exercise counseling and guidance, with insurances accepted for the visits, you can lose weight safely and effectively without spending much for safe and effective weight loss.
Risks and Benefits
While there are risks and benefits to almost anything in life, one benefit you will find at Dr. Tumpati’s W8MD Medical Weight Loss Center is knowledgeable staff that will take the time to review these medications with you. Ultimately it is up to you and your health provider to safely add medication to any weight loss program. Medications are only useful for those already on a healthy lifestyle program who are not losing weight as expected. They are especially beneficial for people with BMI of 27 or greater, who are concerned about their weight, disease risk and current health status.
VLCD and LCD Low Calorie, Low Carbohydrate Balanced and Affordable Meal Replacements
We offer 800 calorie very low calorie diets with or without meal replacement. We also offer 1000-1500 calorie Low Calorie Diets with or without meal replacements along with appropriate medications for fast and safe weight loss under careful medical supervision and your insurance might cover the cost of the visits.
We carry delicious and the most affordable Protein Meal Replacements with protein bars, shakes, smoothies, soups, and other weight loss supplements that can safely be used as liquid meal replacements lose the weight on your own although it is a bit more time consuming and can potentially be frustrating to do the calorie counting.
No matter which program you choose, we are excited to be on your team. Numerous programs place emphasis on vitamin pills or herbs. They may promote certain medications, injections or surgery. Our programs are so flexible they work with any program you may be on. For example, you may want to add medication to the benefits of Weight Watchers® or Jenny Craig®. Any program you use that is effective for you can be continued.
At Dr. Tumpati’s W8MD Medical Weight Loss Center we put the person first above all else. When you are first, you can’t lose. We will give the choices with no obligations, setup fees or mandatory products, with insurances accepted for weight loss visits.
Two Convenient Locations in Greater Philadelphia in North East Philadelphi and King Of Prussia
This is so affordable compared to $325.00 consultations from some of the “Cash Only” weight loss clinics!