FDA warns makers of unapproved narcotics

From CNN:

Seeking to remove unapproved drugs from the marketplace, the Food and Drug Administration on Tuesday ordered nine companies to stop manufacturing narcotics whose therapeutic claims have not been proved.

The FDA's warning letters notified the companies they may be subject to legal action if they do not stop manufacturing and distributing "prescription unapproved products" that include high-concentrate morphine sulfate oral solutions and immediate-release tablets containing morphine sulfate, hydromorphone or oxycodone.

This action does not include oxycodone capsules. All of these drugs are used for pain relief and are forms of previously approved medications.

The agency says this is not a recall, but is instead a warning to manufacturers. The companies have 60 days to pull these pain-relief drugs from the market. Distributors have 90 days to stop shipping them.

If these drugs are not off the market by those deadlines, a company could face seizure of the narcotics and legal action.

Although the FDA does not know whether these drugs are unsafe, it has not approved them so cannot certify that the products are 100 percent safe and effective.

"Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."

The FDA believes Americans have access to plenty of legal narcotics for pain relief and removing these unapproved drugs will not create a shortage.

Consumers who may be concerned that they are taking any unapproved drug products should refer to the FDA's Unapproved Drugs Web page, which includes a list of manufacturers of these products. Those who find they are taking unapproved drugs should see their health care professionals for treatment options.

Posted: 4/1/2009 1:46:00 PM

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TVA planning ash spill health monitoring, research

From The Miami Herald:

The Tennessee Valley Authority will use an independent university research group to guide health monitoring of residents and verify cleanup of contaminated areas from a massive coal ash spill, the agency's top executive said Tuesday.

"TVA is developing a plan to respond to individual health concerns, including a process for determining whether there are health effects that may be related to ash released," TVA President and CEO Tom Kilgore told a U.S. House Transportation subcommittee in Washington.

Since 5.4 million cubic yards of coal ash spilled 100 days ago from a breached storage area at TVA's Kingston Fossil Plant, about 40 miles west of Knoxville, residents have been wrestling with conflicting health data and warnings from government agencies and activist groups.

"We need more information and increased communications," resident Sarah McCoin, a member of the Tennessee Coal Ash Survivors Network, told the subcommittee. "Many families fear they are poisoning their children by remaining in their homes and they do not have the resources to pay for testing those children. They need help, they need answers."

Knoxville-based TVA, the nation's largest public utility, is working out a contract with Tennessee-based Oak Ridge Associated Universities to develop health testing protocols for physicians and possibly arrange clinics.

ORAU vice president Donna Cragle, the consortium's director of occupational exposure and worker health, couldn't say when the testing might begin. "There are a lot of things we have to do in order to put the program together and do it well," she said. "We are working as fast as we can to make it happen."

ORAU, an education and research consortium of 100 universities including Georgia Tech, Duke, Tennessee, Tulane, Johns Hopkins and Vanderbilt, has provided similar screenings of Cold War nuclear workers for the Department of Energy. Those screenings led to millions of dollars in payouts for workers suffering respiratory problems from beryllium exposure.

Anda Ray, TVA's top environmental officer, said ORAU will call in toxicologists to design a series of medical tests focusing on health problems that could result from toxins in coal ash.

Those include metals such as selenium, which can damage the nervous system, and arsenic, which has been linked to numerous health problems, including cancer.

ORAU will provide the protocol to local doctors and the public, then look for health trends.

The Oak Ridge group also will review results of air, water and soil monitoring from government agencies and outside groups to independently verify accuracy and determine whether the cleanup has been thorough enough.

Posted: 4/1/2009 1:42:00 PM

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