US Pharm. 2007;32(12):44.
Over $300,000 of Drugs and Supplements Seized
At the behest of the FDA, U.S. Marshals seized more than $300,000 worth of products, including an antifungal product sold as NC Solution, other drugs for human or animal use, dietary supplements, and ingredients of those products. Some lacked FDA approval, and all were stored under grossly unsanitary conditions. NC Solution is considered a drug because it is intended for the diagnosis, cure, or treatment of disease in people or animals. A new drug product must be shown to be safe, effective, and approved by the FDA. The company did not have this approval
"The action taken Wednesday is the culmination by the FDA to get the firm to follow the law," said Margaret O'K. Glavin, FDA associate commissioner for regulatory affairs.
The FDA recommends that consumers who purchased any of these products, including NC Solution, contact their health care provider about discontinuing their use whether or not adverse reactions have been experienced.
Suspension of Trasylol Marketing Requested
The FDA announced that Bayer Pharmaceuticals Corporation has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery. The FDA requested the suspension to ensure patient safety based on outcomes in preliminary results from a Canadian study that suggested an increased risk for death when using the drug. Researchers at the Ottawa Health Research Institute and other regulatory agencies are undertaking a thorough analysis of data to better understand the risks and benefits of Trasylol.
Because there are few treatment options for patients at risk for excessive bleeding during cardiac surgery, the FDA is working with Bayer to phase out Trasylol in a way that does not cause shortages of other drugs used for this purpose. Since individual doctors may identify specific cases where benefit outweighs risk, the FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.
FDA Selects Risk Communication Advisory Committee
The FDA has selected 15 voting members to serve on its Risk Communication Advisory Committee. The Committee will advise the FDA about how best to communicate the risks and benefits of using FDA-regulated products to the public. "Communicating effectively about the safety and effectiveness of drugs and other medical products is one of the central roles of [the] FDA," said Randall Lutter, PhD, deputy commissioner for policy.
Experts were chosen from the fields of risk communication, risk perception, decision analysis, communication, social marketing, health literacy, journalism, and other behavioral and social sciences. Public members include those who can provide the perspective of users of FDA-regulated products. Members have been assigned to serve for periods ranging from one to four years.
Dietary Supplements Seized
U.S. Marshals seized approximately $71,000 of goods from FulLife Natural Options of Boca Raton, Florida, at the request of the FDA. The company markets and distributes Charantea Ampalaya Capsules and Charantea Ampalaya Tea. Although labeled as dietary supplements, FulLife promoted the products for treating diseases such as diabetes, anemia, and hypertension. These claims are evident in FulLife's labeling, promotional literature, and Web site.
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US Pharm. 2007;32(12):44.