FDA gives weight loss drug Belviq the go-ahead June 29,2012. (Photo: AP/File)
It's not a secret that African-Americans bear the brunt of the obesity epidemic in the U.S.
According to the Centers for Disease Control and Prevention, 22.4 percent of African-American children ages 6 to 17 are obese. In terms of adults, according to the Office of Minority Health, African-American women have the highest obesity rates in the country — a whopping 50 percent are obese. And 37 percent of Black men over the age of 20 are obese.
And while exercising more often, eating healthier foods and cutting portions are the most recommended ways to lose weight, a new diet pill hopes to aid the fight against obesity. Recently, the FDA approved Belviq, a pill that is taken twice a day that suppresses appetite and revs up metabolism.
In a press release, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said, "Obesity threatens the overall well-being of patients and is a major public health concern." She added, "The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition."
According to NPR Shots, the drug is only approved for those who are obese, which is defined as having a Body Mass Index (BMI) of 30 and higher. It is also approved for those who are overweight with a BMI of 27 or more and who also have at least one weight-related issue such as diabetes, high levels of "bad" cholesterol or hypertension (high-blood pressure). In terms of side effects, they can vary, but people without diabetes reported nausea, dry mouth, fatigue and constipation. Folks with diabetes reported low-blood sugar, back pain and cough.
So how well does it work?
It isn't the magic bullet to help drop a significant amount of weight — the results are very modest. Time.com wrote:
According to clinical trial data submitted by Arena [the drug's manufacture] to the FDA, nearly half of dieters without Type 2 diabetes who used the medication lost at least 5 percent of their starting weight — or an average of 12 lbs. — over a year, compared with 23 percent of those taking a placebo. For best results, dieters are advised to use the medication together with a healthy diet and exercise program. The approved labeling for Belviq also recommends that people discontinue the drug if they fail to lose 5 percent of their body weight after 12 weeks; longer treatment is unlikely to lead to meaningful weight loss.
So is it safe?
In 2010, tests showed that Belviq caused tumors and heart valve problems in rats, so the FDA didn't approve it, but this time around, Arena resubmitted data that showed little risk among humans when they took a lower dose. Yet the FDA isn't requiring the manufacture to monitor heart valve issues in the study's participants — they are only requiring that Arena provide a study after the pill is on the market to see if it increases the risk of strokes and heart attacks.
And for some health experts, this raises some flags and questions whether the potential risks are worth it given that the pill only helps people lose very little weight.
Sidney Wolfe, director of the health research group at Public Citizen, a consumer group, told USA Today, "Its benefits are really small, and practically everyone on the advisory committee agreed that there wasn't enough evidence to rule out clinically significant heart valve disease." He added that the drug "will expose large numbers of obese patients, already at risk of cardiovascular disease, to the added risk of damaged heart valves."
Look for the pill to be available in the next four to six months.
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