FDA Warns Companies Promoting Chelation Products
The U.S. Food and Drug Administration is cracking down against the makers of over-the-counter chelation products, which help flush toxic metals from the body and are often sold over the Internet. Manufacturers tout them as a treatment for conditions like autism, heart disease, macular degeneration, and Alzheimer's disease, by linking toxic metals to these conditions. On Thursday, the FDA issued eight warning letters to companies marketing chelation products, saying that claims about using such products to treat medical conditions violate federal law. "What we're telling consumers is that any chelation therapy marketed over the counter is suspect," Michael Levy, director of the FDA's Division of New Drugs and Labeling Compliance, said during a briefing with reporters. The FDA has approved some chelation products to be prescribed in cases of heavy metal poisoning, Reuters reports. But none are approved for sale over the counter or via the Internet. Often, they're marketed as dietary supplements with varying dosages and forms, including capsules, liquid drops, and sprays. The products could cause dehydration, kidney failure, or death, according to the FDA. The agency says it issued the warnings in response to increased product promotion and availability to consumers. If the companies don't correct the violations detailed in the letters, their products could be seized.
Rethinking the Safety of Bone Loss Drugs
About five million Americans—most of whom are postmenopausal women—take bisphosphonate drugs in an effort to reduce bone loss and prevent life-threatening fractures of the hip or spine due to osteoporosis; yet these drugs appear to slightly increase the risk of rare thigh-bone fractures, says the U.S. Food and Drug Administration. On Wednesday, the agency ordered that a warning be stamped on the label of all bisphosphonates—which include Boniva, Actonel, and Fosamax—and officials said the risk of these rare fractures were highest in those who took the drugs for five years or more, according to data provided by the American Society for Bone Mineral Research Task Force. This raises a larger issue: How long is it safe to be on these drugs, and should some folks consider stopping after a few years?
"We're very actively evaluating this issue," said FDA medical officer Theresa Kehoe at a press conference yesterday. But she added that the agency isn't ready to make specific recommendations on whether patients should take breaks or "drug holidays" from bisphosphonates after a few years of use, or stop the drugs altogether, writes U.S. News's Deborah Kotz. A rare, painful deterioration of the jaw bone has also been associated with bisphosphonates, though osteoporosis experts emphasize that, for those with the disease, the drugs' benefits still far outweigh the risks. "For every 1,000 patients that we treat for 10 years, we'll prevent 100 major fractures" while causing one thigh fracture and one case of jaw bone deterioration, says Steven Cummings, an osteoporosis researcher who directs the San Francisco Coordinating Center, a nonprofit research group. But experts don't know for certain if bones continue to benefit from the medications beyond the five or 10 year mark. "We don't have long-term studies, since the first of these drugs, Fosamax, was only approved 15 years ago," says Bess Dawson-Hughes, director of the bone metabolism laboratory at Tufts University in Boston. "Our concerns are conceptual at this point." [Read more: Rethinking the Safety of Bone Loss Drugs.]
New Electronic Medical Records Software Could Improve Your Health
A majority of primary care physicians, still keep track of patients' health histories by scribbling hand-written notes in a paper chart—despite research suggesting that these handwritten flowsheets aren't just inefficient, but extremely vulnerable to errors. Some say the solution lies in simply switching to electronic medical records, family physician Kenny Lin writes for U.S. News.