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.
Pfizer confirms it will acquire Wyeth
NEW YORK Pfizer on Monday confirmed speculation that the pharmaceutical giant would acquire Wyeth with an announcement that the two companies have entered into a definitive merger agreement.
The deal: Pfizer will acquire Wyeth in a cash-and-stock transaction currently valued at $50.19 per share, or a total of approximately $68 billion. The boards of each company have approved the combination.
“The combination of Pfizer and Wyeth provides a powerful opportunity to transform our industry,” stated Jeffrey Kindler, Pfizer chairman and CEO. “It will produce the world’s premier biopharmaceutical company, whose distinct blend of diversification, flexibility and scale positions it for success in a dynamic global healthcare environment. The new company will be an industry leader in human, animal and consumer health. With our combined biopharmaceuticals business, it will lead in primary and specialty care, as well as in small and large molecules. Its geographic presence in most of the world’s developed and developing countries will be unrivaled.”
Wyeth’s established presence in biologics — which includes Prevnar (diphtheria CRM197 protein), a pneumococcal vaccine for infants, and Enbrel (etanercept), an arthritis remedy — was cited as one of the key attractions to Pfizer in making the acquisition.
Even with a diverse stable of product offerings in growing therapeutic areas, a strong product pipeline and a premier global footprint, it is expected that no drug will account for more than 10% of the combined company’s revenue in 2012, Pfizer stated. Pfizer currently fields the leading prescription therapy worldwide, Lipitor (atorvastatin), which is expected to go off patent in 2010.
The combined company will offer customers and patients a broad range of products for every stage of life — with top-tier portfolios in such key therapeutic areas as cardiovascular, oncology, women’s health, central nervous system and infectious disease, and a diverse product portfolio that includes 17 blockbuster products with more than $1 billion each in annual revenue. Pfizer will be the second-largest specialty care provider, with products including the world’s leading biologic, Enbrel; Prevnar, the world’s largest-selling vaccine; Sutent (sunitinib malate) for cancer; Geodon (zyprasidone hydrochloride) for schizophrenia; and Zyvox (linezolid) for infection. The transaction also builds upon Pfizer’s position as a global leader in animal health, with strong product lines in attractive segments for companion animals, biologics and anti-infectives.
The combination also brings together a robust pipeline of biopharmaceutical research and development projects, including programs in diabetes, inflammation/immunology, oncology and pain, as well as significant opportunities in Wyeth’s Alzheimer’s disease pipeline, which has a number of compounds in development, including phase three biotech compound Bapineuzumab. These will be added to the exciting agents currently in early and later stage development at Pfizer for Alzheimer’s disease, illustrating the breadth and depth the new company will be able to use in targeting the diseases that most affect patients.
Under the terms of the transaction, each outstanding share of Wyeth common stock will be converted into the right to receive $33 in cash and 0.985 of a share of Pfizer common stock, subject to the terms of the merger agreement. Based on the closing price of Pfizer stock as of Jan. 23, the stock component is valued at $17.19 per share.
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.