HEALTH

SDI: Rx antivirals drop close to 60%

BY Michael Johnsen

PLYMOIUTH MEETING, Pa. SDI’s Vector One: National shows that for the week ended May 8, the number of new antiviral prescriptions dispensed at retail pharmacies was 118,578 — a 59% drop compared with approximately 277,000 new prescriptions the week before.

Tamiflu accounted for 90% of the market’s new prescriptions last week, SDI stated Tuesday

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PATH, WaterAid America report that diarrheal disease is overlooked

BY Michael Johnsen

WASHINGTON PATH and WaterAid America released two reports Tuesday finding that the international aid community and developing-country governments are not targeting diarrheal disease, a leading killer of children under age 5 worldwide that is responsible for the deaths of nearly 1.6 million children annually.

“The global health community knows what is necessary to save the lives of children suffering from diarrheal disease,” stated John Wecker, director of the Immunization Solutions and Rotavirus Vaccine Program at PATH. “And now is the time to educate policymakers, donors and international and national leaders about the need to implement the solutions to prevent and treat the most severe causes.”

According to the reporters, there are more lifesaving prevention and treatment solutions for diarrheal disease than any other major childhood killer, including safe water; improved sanitation and hygiene; breastfeeding and optimal complementary feeding; rotavirus vaccines; zinc treatment; and oral rehydration therapy/oral rehydration solution.

The reports coincide with a World Health Organization review of data from studies of vaccines to prevent rotavirus — a common and lethal diarrheal disease — from clinical trials in Africa and Asia. The WHO will consider a global recommendation that every country introduce rotavirus vaccines into its routine immunization schedule based on this data.

“While diarrheal disease is a global killer, today the burden is greatest in developing nations in Africa and Asia where access to clean water, sanitation, and urgent medical care may be limited,” stated Nancy Bwalya-Mukumbuta, program manager at WaterAid in Zambia. “The international aid system and developing-country governments need to come together with a strong voice and respond to diarrheal disease, one of the leading causes of child mortality, in a targeted manner.”

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FDA destroys steroid products sold as supplements

BY Michael Johnsen

ROCKVILLE, Md. The U.S. District Court for the Eastern District of Michigan, Southern Division, on Monday entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements.

“The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury,” stated Michael Chappell, FDA’s acting associate commissioner for regulatory affairs. “It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace.”

At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”

Based on laboratory tests, the FDA determined that the products contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to assure that the ingredients do not present a significant or unreasonable risk of illness or injury. Specifically, the condemned Methyl 1-D and Methyl 1-D XL contained 1,4,6-androstatriene-3,17-dione, also known as “ATD” or 1,4,6-etioallocholan-dione. The condemned Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione (also known as “6-OXO”). Both of these substances are steroids that inhibit the activity of the enzyme aromatase and may be found in dietary supplements promoted to boost testosterone levels. 

The FDA has no scientific information concerning the safety of the condemned products or their ingredients and, thus, cannot determine whether they represent a hazard to consumers. Under the circumstances, consumers who use or have used the products should discuss their use with their health care professionals.

The FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products’ use. 

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