GlaxoSmithKline and Merix settle extended dispute over advertising practices
CHICAGO According to court documents filed last month, Merix Pharmaceutical and GlaxoSmithKline have settled a three-year dispute over advertising and competition practices for an undisclosed amount. “In exchange for certain consideration, the settlement agreement calls for Merix to dismiss with prejudice its claims against GSK, with each side to bear its own costs, expenses and attorneys’ fees,” the court documents, filed Sept. 2, read.
Merix had filed suit in March 2005 charging that certain advertising claims made by GlaxoSmithKline in support of its cold sore remedies Abreva and Valtrex may be false and misleading, using unreliable test data to promulgate advertising claims in an intentional effort to deceive doctors and the public.
McNeil rebrands Advanced Imodium Multi-Symptom Relief
FOR WASHINGTON, Pa. McNeil Consumer Healthcare on Thursday rebranded its Imodium Advanced Imodium Multi-Symptom Relief to better position the brand as the fastest anti-diarrheal medicine that also relieves symptoms of gas, cramps, bloating and pressure.
Imodium Multi-Symptom Relief combines loperamide hydrochloride with simethicone for relief of diarrhea, as well as the gas, cramps, bloating and pressure that nearly 65 percent of diarrhea sufferers can also experience. Loperamide HCl works in the small and large intestines by slowing the increased motility and reducing the increased secretion of fluid and electrolytes that occur with diarrhea. Simethicone acts in the stomach and intestines by altering the surface tension of gas and mucus bubbles, enabling them to group together. This action accelerates the passage of gas through the intestine.
Acute diarrhea is the second most commonly reported illness in the United States after respiratory infections. Diarrhea affects people of all ages, with the average adult suffering four bouts of acute diarrhea per year, and 22 million people reporting experiencing diarrhea at least once a month. Acute diarrhea also affects the travel plans of up to 10 million travelers each year.
Common causes of acute diarrhea include many medications, food intolerance, excessive caffeine or alcohol consumption and premenstrual syndrome.
FDA issues warning on Ayurvedic medicines: some potentially harmful
ROCKVILLE, Md. The Food and Drug Administration on Thursday warned consumers to use caution when deciding to use Ayurvedic medicines. Ayurvedic medicine is a traditional system of healing arts that originated in India that involves using products such as spices, herbs, vitamins, proteins, minerals and metals.
According to FDA, some preparations combine herbs with minerals and metals and are commonly sold on the Internet or in stores represented as Indian or South Asian alternatives.
“Consumers should know that Ayurvedic products are generally not reviewed or approved by the Food and Drug Administration,” Mike Levy, director of the Division of New Drugs and Labeling Compliance in the Office of Compliance, part of FDA’s Center for Drug Evaluation and Research, said. “Consumers need to be on guard when purchasing any product using the Internet, especially medical products.”
The presence of metals in some Ayurvedic products makes them potentially harmful, the FDA noted. A study published in the Aug. 27 issue of the Journal of the American Medical Association demonstrated that one-fifth of U.S.-manufactured and Indian-manufactured Ayurvedic products bought on the Internet contained detectable lead, mercury or arsenic.
Researchers found 25 Web sites selling Ayurvedic products. After identifying 673 products, they randomly selected 230 for purchase. Of those, they received and analyzed 193 products. Nearly 21 percent were found to contain detectable levels of lead, mercury or arsenic, the agency reported.
“This issue has been and will continue to be a priority for FDA,” Levy said. In light of recent reports, FDA is re-evaluating its existing import alert and considering possible enforcement actions related to Ayurvedic products manufactured in the United States.