Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Company Recalls Frozen Berry Mix Linked to Hepatitis Outbreak
A frozen berry mix linked to an outbreak of hepatitis A that has affected at least 34 people in five states has been recalled by Townsend Farms of Oregon, the U.S. Food and Drug Administration said Tuesday.
The recall involves the company’s frozen Organic Antioxidant Blend, which is packaged under the Townsend Farms label at Costco and under the Harris Teeter brand at those stores, the Associated Press reported.
The recall came three days after federal officials first announced a suspected link between the frozen berry mix and the illnesses in Arizona, California, Colorado, New Mexico and Nevada. The FDA, which is inspecting Townsend Farms’ processing facilities, did not explain why there was not an immediate recall.
The outbreak involves a strain of hepatitis A rarely seen in North or South America, but which is found in North Africa and the Middle East, according to the Centers for Disease Control and Prevention.
Last week, a lawyer for Townsend Farms said the frozen berry product associated with the outbreak includes pomegranate seeds from Turkey, the AP reported.
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No Misconduct or Fraud in Avandia Study: FDA
A review found no serious misconduct or fraud in a controversial clinical trial that minimized safety issues involving the diabetes drug Avandia, according to U.S. Food and Drug Administration experts.
The FDA team said they supported the findings of the review by Duke University researchers, who determined that any errors made by drug maker GlaxoSmithKline had no effect on the conclusions of the company’s clinical trial of Avandia, The New York Times reported.
The FDA experts’ opinion was posted Monday on the FDA website, along with a critical memo by FDA scientist Dr. Thomas Marciniak, who originally raised concerns about the Glaxo study. Marciniak questioned whether the review by the Duke researchers was truly objective because it was financed by Glaxo.
In 2010, the FDA imposed tight restrictions on the use of Avandia after several analyses showed that the drug significantly increased the risk of heart attack. The drug was removed from the market in Europe.
The conflicting viewpoints were posted on the FDA website in advance of a two-day meeting of an FDA advisory panel scheduled to begin Wednesday. The panel will discuss the issue and recommend to the FDA whether to widen access to Avandia, keep the current restrictions in place, or take the drug off the market, The Times reported.