FDA seizes over $300,000 of product from General Theraputics
ROCKVILLE, Md. The Food and Drug Administration on Wednesday directed the seizure of more than $300,000 worth of product, including NC Solution, an antifungal product, and other drugs for human or animal use, dietary supplements and the ingredients to make those products because some lacked FDA approval and all were maintained under what the FDA defined as “grossly unsanitary conditions” by General Therapeutics of St. Louis, Mo.
“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,” stated Margaret Glavin, FDA associate commissioner for regulatory affairs.
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.
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 providers about discontinuing use and if they have experienced any adverse events that they suspect are related to the product’s use.
Catherine 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.
At-home liver damage test now available in the U.K.
LONDON Livercheck.com.uk on Tuesday announced the U.K. launch of a liver blood at-home test “to throw a vital lifeline to the millions of [British] drinkers who are potentially at risk from liver disease.”
LiverCheck is the first home blood-liver test available in the U.K., and aims to identify liver damage resulting from excessive consumption of alcohol.
“There is little doubt in my mind that it has the potential to save lives,” stated Rajiv Jalan of the University College London. “If someone knew their liver was damaged and likely to get worse, they would do something about it. Checking the health of the liver could avoid them getting to the stage where they are doing themselves real harm without knowing about it.”
Biden introduces legislation to curb dextromethorphan abuse
WASHINGTON Sen. Joseph Biden, Jr., D-Del., on Wednesday introduced the Dextromethorphan Abuse Reduction Act of 2007, legislation aimed to curb the rise in medicine abuse, including the misuse of cough and cold medicines containing dextromethorphan.
“It’s not just pot or LSD or cocaine we have to worry about, teens across the country are abusing over-the-counter cough-and-cold medicines to get high, sometimes with deadly consequences,” Biden stated.
The Dextromethorphan Abuse Reduction Act, co-sponsored by Sens. Chuck Grassley, R-Iowa, Dick Durbin, D-Ill., and Diane Feinstein, D-Calif., prohibits the unregulated sale of the bulk form of dextromethorphan; prohibits the sale of dextromethorphan-containing products to buyers under 18 years old—a move already voluntarily taken by several major retail stores, including many national food, drug and mass chains; and provides robust funding for prevention and educational programs to combat OTC and prescription drug abuse. “This legislation will attack this problem from all sides—education, enforcement and restricted access—and is the right move to protect our kids,” Biden said.
“The trend of teens looking to the medicine cabinet to get high with prescription and over-the-counter medicines is very troubling,” noted Linda Suydam, president of the Consumer Healthcare Products Association. “The leading makers of over-the-counter cough medicines have been working to raise awareness about this problem and are pleased to see such strong leadership from the U.S. Senate on this issue.”
The bill is supported by the Food Marketing Institute, CHPA, National Association of Chain Drug Stores, Partnership for a Drug-Free America and Community Anti-Drug Coalition of America.
Dextromethorphan produces hallucinogenic, PCP-like effects when taken in excessive quantities and its misuse causes a rapid heartbeat, high blood pressure, seizures, brain damage, elevated body temperatures and sometimes death. Teens often refer to this practice as “Robotripping”—a term derived from the cough medicine Robitussin, which contains dextromethorphan.
According to Biden’s office, recent studies reveal the widespread nature of the problem. Children ages 9 to 17 are the fastest growing group of recreational users of dextromethorphan. The Partnership for a Drug-Free America estimates that 2.4 million teens, or 1 in 10, got high on OTC cough medicines in 2005.
“The abuse of dextromethorphan–especially by teenagers–is a serious concern, and our industry is committed to doing its part to combat this problem. We will continue working closely with Senator Biden and his colleagues as the Dextromethorphan Abuse Reduction Act moves forward in Congress,” NACDS president and chief executive officer Steve Anderson said in a statement on Thursday. “Many in our industry have already taken voluntary steps to restrict the sale of products containing dextromethorphan to underage teens. Through increased prevention, awareness and law enforcement, we can achieve the goal of stopping dextromethorphan abuse, while ensuring that safe and effective medicines valued by consumers remain readily available for legitimate use.”