FDA wants terbutaline to carry boxed warning label
SILVER SPRING, Md. — An asthma drug widely available as a generic should not be used for preventing or treating preterm labor in pregnant women, the Food and Drug Administration warned.
The drug, terbutaline, is available as a tablet and an injectable. The drug does not have FDA approval for the treatment or prevention of preterm labor, but often is prescribed off-label for pregnancy-related issues. The agency said it had received reports of dangerous side effects in mothers who had taken the drug for such reasons, including death, but that there was no evidence that use of the drug improved outcomes for infants. The agency is requiring the drug to carry a boxed warning label, the strongest form of labeling, warning against use of the drug for complications related to pregnancy.
“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” FDA Division of Reproductive and Urologic Products director Scott Monroe said. “It is important for patents and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”
Under the law, a drug company only can market a drug to prescribers and consumers for the uses it has FDA approval for, but doctors still can prescribe it for unapproved uses.
Study: Homeopathic shoppers buy more
Homeopathy products, especially in the cough-cold space, appear to be doing very well. That’s good news in and of itself, but according to recent Boiron research, it gets better: People who place homeopathy in their market baskets tend to buy more by the time they get to the checkout.
“Overall, our research shows that 27% of shoppers have successfully used a natural/alternative over-the-counter medicine in the past, while 55% have not but are interested in trying,” said John Durkin, Boiron VP sales and marketing. “This suggests a substantial opportunity to increase sales,” he said. Consumers who buy homeopathic products are more valuable shoppers, Durkin added, across all channels. “Specifically in drug stores, baskets with homeopathic medicines have an average value of $42 in comparison to $21 for those that don’t,” Durkin said, citing SpinScan “Shopper Insights” for the year ended June 26, 2010.
But homeopathy isn’t selling better because it’s homeopathy, per se. Rather, it’s more of a right-place-right-time scenario. Recommended use for all of kids’ cough-cold medicines were scaled back to older than 4 years old for many allopathic formulations. That had many parents in search of a solution that was priced right, worked and could be recommended for use in their children. The answer turned out to be homeopathy.
“The past issues with pediatric cold medicines have been great for homeopathy and the natural segment,” said Michele Boisvert, president of Homeolab USA, which offers a number of pediatric cough-cold products under the Kids Relief brand. “There is certainly an increased amount of homeopathic and natural offerings on the shelves today for consumers to choose from. Now with recent recalls, it leaves the door wide open for natural options.”
Walk a mile in these shoes … then buy ’em
HOOFDORP, Netherlands — Sneaker and sports apparel manufacturer ASICS in March will open a new flagship store here, on the Stadhouderskade, at the entrance of greater Amsterdam’s most popular running path, the Vondelpark.
Beyond the basic sneaker-purchasing experience, the 6,458-sq.-ft. store touts several exclusive features, including:
Running Lab, which offers extensive body analyses, including foot shape, leg alignment, running technique, strength and endurance, and customized advice on how to improve technique and performance;
Foot ID, a high-tech system that combines static and dynamic measurements to ensure proper shoe selection based on customers’ individual biomechanical profiles; and
Running Club, which includes running clinics and features changing room facilities complete with lockers, showers and towel service.
“[This] is more than a store,” said Fernando Pina Mulas, who leads ASICS European retail operations. “It will offer the full ASICS running experience and help us build a strong relationship with our customers.”
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