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Join AALAS in recognizing all technicians as "Heroes Behind the Science" during International Laboratory Animal Technician Week (January 27–February 2, 2008).

FDA News: November 5, 2007

FDA Requests Marketing Suspension of Trasylol

The U.S. Food and Drug Administration (FDA) today announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.

On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

FDA News: November 1, 2007

More than $300,000 of Drugs and Dietary Supplements Seized
Some lacked FDA approval, maintained under unsanitary conditions

At the request of the U.S. Food and Drug Administration, on Wednesday, U.S. Marshals seized more than $300,000 worth of product, including NC Solution, an antifungal product, and other drugs for human or animal use, dietary supplements, and ingredients to make those products because some lacked FDA approval and all were maintained under grossly unsanitary conditions by General Therapeutics Corp., of St. Louis, Mo.

The FDA considers NC Solution to be a drug because it is intended for the use in the diagnosis, cure, or treatment of disease in people or animals. NC Solution is also a new drug because it is not generally recognized as safe and effective for its intended uses.

Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by the FDA. The company does not have approval for NC Solution.

"The action taken Wednesday is the culmination of the concerted efforts by the FDA to get the firm to follow the law when it comes to manufacturing safe products for consumers," said Margaret O'K. Glavin, FDA Associate Commissioner for Regulatory Affairs.

In August and September, FDA inspectors found that the company was still manufacturing drugs and dietary supplements under unsanitary conditions, including insects and rodent filth on and around manufacturing equipment, despite a warning by FDA of serious violations in 1999. Following the 1999 inspection, a company official told the FDA in January, 2000, it would stop manufacturing drugs.

The FDA recommends that consumers who have any products manufactured by General Therapeutics, including NC Solution, consult their health care provider about discontinuing use and if they have experienced any adverse events that they suspect are related to the product's use.

Catherine L. Hanaway, U.S. Attorney for the Eastern District of Missouri, filed the complaint requesting the seizure, and her office will continue to coordinate with the FDA to ensure proper disposal of the seized items. The FDA's action against the company is consistent with the agency's initiative on unapproved drugs which pose potentially harmful risks to consumers.

European Food Safety Authority: Evaluation of nutrient sources in food supplements and food—an update 31/10/2007 During 2005 EFSA received approximately 500 dossiers relating to nutrient substances added to food supplements and foods currently on the market in the European Union (EU). Under current EU legislation[1], a scientific opinion from EFSA on the safety of such nutrient sources is required prior to any approval of their continued use in food supplements and/or fortified foods and/or foods for particular nutritional purposes. Read more...