FDA issues warning for ALR dietary supplement
ROCKVILLE, Md. The Food and Drug Administration Tuesday afternoon warned consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine. Sibutramine, a controlled substance with risks for abuse or addiction, is a potent drug that poses potential safety risks, the agency stated.
“Sibutramine is the active ingredient in an FDA-approved prescription drug used as an appetite suppressant for weight loss,” stated Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “But when present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate … and may present a significant risk for people with a history of heart disease, heart failure, irregular heartbeats or stroke.”
Venom HYPERDRIVE 3.0 is marketed by Applied Lifescience Research. On Dec. 24, ALR initiated a recall of all lots of Venom HYPERDRIVE 3.0 after the FDA laboratory analysis showed samples of the product contained undeclared sibutramine. Although ALR Industries claims on its Web site that only “trace amounts” of sibutramine were found in this product, the FDA laboratory tests showed that Venom HYPERDRIVE 3.0 contains a significant amount of sibutramine per dosage unit.
The product was sold via distributors and in retail stores nationwide, as well as in Canada, Poland, Sweden, Hungary, South Africa, the Netherlands, Australia, France and the United Kingdom. The product was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743.
Consumers who have this product should stop taking it immediately and contact their healthcare professional if they have experienced any adverse effects.
Abbott to commence cash tender offer for Advanced Medical Optics
ABOTT PARK, Ill. Abbott will commence on Tuesday a cash tender offer for all outstanding shares of common stock of Advanced Medical Optics at $22 per share on Jan. 27, in a deal worth approximately $2.8 billion, the company announced Monday.
Abbott and AMO announced the proposed merger earlier this month. “With AMO, Abbott is enhancing and strengthening its diverse mix of medical device businesses and gaining a leadership position in another large and growing segment,” stated Miles White, Abbott chairman and CEO, in announcing the deal Jan. 12. “Additionally, Abbott’s significant global presence will help drive growth opportunities for this business, especially in international markets, where favorable demographics are driving demand for advanced eye care procedures and products.”
The transaction is subject to customary closing conditions, including antitrust clearances. Abbott and AMO expect the transaction to close in the first quarter of 2009.
Patients give OTC heartburn medications positive reviews in new study
WASHINGTON New research from the Consumer Healthcare Products Association and The Nielsen Company indicates 94% patient satisfaction with available over-the-counter heartburn medications and estimates that OTC heartburn therapies save patients an average total of $174 each in office visits and medication costs annually, the two organizations announced Monday.
In addition, CHPA and Nielsen attribute $757 million in annual savings to the U.S. healthcare system based on fewer office visits — all good news for millions of Americans who suffer from heartburn as well as an overburdened healthcare system.
“This is wonderful news for consumers. This study points to a high level of satisfaction plus costs savings among those who turn to OTC heartburn medicines for symptom relief,” stated Linda Suydam, president, CHPA. “The overall findings reflect the evolution of heartburn treatments as the availability of effective over-the-counter treatment options have expanded over the past 15 years.”
“The savings these OTC medicines provide to the U.S. healthcare system are equally significant,” stated Jim Mansfield, The Nielsen Company and one of the study’s authors. “Ongoing research into health outcomes and the cost of lost work time and misdiagnosis holds the potential to identify additional — yet substantial — savings.”
The study, “Benefits of Over-the-Counter Heartburn Medication to Consumers and the Healthcare System,” was conducted in 2008 and is based on online and written survey responses from nearly 10,000 U.S. consumers who use OTC heartburn medication.
The research was conducted using NielsenHealth’s Upper GI Ailment Panel data related to consumer satisfaction with the full range OTC heartburn remedies, including antacids, H2-blockers and proton pump inhibitors. Researchers used a combination of consumer data compiled by Nielsen and provider data compiled by WoltersKluwer Health’s Dynamic Claims to estimate cost savings.