Obesity drug withdrawn following trial showing heart attack, stroke risk
SILVER SPRING, Md. Clinical trial data indicating an increased risk of heart attack and stroke has led to the removal from the market of an obesity drug made by Abbott, the Food and Drug Administration said Friday.
The FDA said the drug maker voluntarily withdrew the drug Meridia (sibutramine) following a required post-marketing trial showing that the drug increased by 16% the risk of nonfatal heart attacks and strokes, the need for resuscitation after the heart stopped and death.
“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achive on this drug to their risk of heart attack or stroke,” FDA office of new drugs director John Jenkins said. “Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their healthcare provider about alternative weight loss and weight-loss maintenance programs.”
The FDA approved Meridia in 1997 for weight loss and maintenance of weight loss in obese people and some overweight people with other risks for heart disease, based on clinical trial data showing that people taking the drug lost at least 5% of their body weight compared with those taking placebo who relied on diet and exercise alone.
GNC highlights endurance selection
PITTSBURGH GNC on Thursday announced it would highlight its new “Endurance Wall,” which includes as many as 50 SKUs, at two upcoming endurance events.
“The GNC endurance selection is an amazing array of products designed to meet the specific needs of serious athletes across all sports and activities. No matter what their level of experience, GNC has the right product,” stated Tom Dowd, EVP store operations and development.
The new wall will house the on-course drinks for the Ironman World Championship in Kona, Hawaii, on Oct. 9, and from the Bank of America Chicago Marathon on Oct. 10.
“GNC supports a wide range of athletic events around the country, but these two events symbolize the GNC Live Well premise –– that all athletes, whether professionals or serious amateurs, can participate in open events that provide an opportunity for them to demonstrate that their training, with its highs and lows, is worth it all,” stated Dave Sims, GNC VP direct marketing and two-time Hawaii Ironman participant.
In Kona, the PowerBar Ironman Perform is the on-course drink for the race. GNC’s Kona store is only two blocks from the start/finish line and the bike and run components of the race go past it on the way out and coming back. More than 1,800 participants are expected in the Hawaii Ironman event, with thousands more cheering them on.
In Chicago, Gatorade’s G Series Pro 02 endurance formula is the on-course drink for the 33rd running of the marathon. In addition to on-course availability, marathoners and spectators alike will be able to find G Series Pro 02 at GNC stores in the area. As well as the thousands of spectators in downtown Chicago, there will be 38,000 runners, including more than 20,000 from outside Illinois.
Professional Therapy MuscleCare gets ECRM best new product award
LAS VEGAS Professional Therapy MuscleCare last month was awarded “best new product” at the ECRM Health Management EPPS held here. The award, sponsored by Drug Store News, is presented to the manufacturer that collects the most “best new product” votes from retailers attending the event.
As part of its initial rollout, MuscleCare has penned a sponsorship deal with the International Federation of Sports Chiropractic, a group of sports chiropractors from 30 countries that treat Olympic and nationally ranked athletes.
The company fields two topical pain-relief products — topical Professional Therapy MuscleCare extra-strength roll-on gel and Professional Therapy MuscleCare ointment — and presently has distribution through Duane Reade and CVS.com. The products contain camphor and menthol to relax tissue and increase the flow of healthy blood, and nutrients in order to reset the muscle to its normal resting length and promote healing.
"The topical pain-relief industry has long been lacking in safety and efficacy, and I have gone to great lengths and conducted a thorough clinical study to change that," stated Chris Oswald, CEO of Professional Therapy MuscleCare, when debuting the product earlier this year.
The retail price is $19.99 for the roll-on gel and $25.99 for the ointment.