The U.S. Food and Drug Administration has approved Belviq, the first new weight-loss drug to win FDA approval in more than a decade. Specifically, the FDA approved the powerful appetite suppressant for adults’ use in combination with strict diet and exercise programs; in clinical trials, Belviq proved safe and effective for patients with body mass indexes (BMI) of 30 or higher. Thirty is the clinical threshold for “morbid obesity.” The FDA also approved it for use by adults with BMIs of 27 or above who also suffer at least one weight-related health problem, like diabetes or high cholesterol.
FDA officials stressed it is not approved for children’s use. Experts in heath administration have also stressed that behavior modification and psychotherapy must complement patients’ use of Belviq.
Public Enemy No. 1
Weight loss is big business in the health fields. In 2010, for the first time in American history, obesity ranked first among the preventable causes of death in the United States, eclipsing smoking, which had ranked as Public Enemy No. 1 for nearly five decades. Ironically, the United States seems obsessed with exercise and fitness because more than two-thirds of all Americans are overweight or clinically obese.
Promising Results in Trials
Patients using it must exercise their patience as well as their bodies because the new drug does not offer a quick fix to obesity. One clinical trial measured subjects’ results over 52 weeks; another monitored participants for 104 weeks. 47 percent of patients with a BMI of over 30 lost at least 5 percent of their total body weight; only 23 percent of patients taking placebos reach the 5 percent benchmark. More than 8,000 people participated in the trials.
A Few Safety Precautions
Arena Pharmaceuticals agreed to post cautions on the labels, warning patients that if they do not lose 5 percent of their body weight after 12 weeks of treatment, they should discontinue using the drug because they probably will not benefit from its long-term use. The manufacturer also will warn users that Belviq may cause radical serotonin imbalance which will trigger symptoms similar to hypermania or ADHD, including agitation, heavy sweating, fever, muscle spasms, diarrhea, tremors, or mental health changes; they especially cautioned people taking serotonin re-uptake inhibitors (the most common antidepressants) to discuss their risks with physicians before starting Belviq.
Health administrators for weight loss programs agree that Belviq is an exciting new addition to the options available. For those patients who have struggled with weight loss for years, Belviq may offer a new solution