Health Highlights: July 2, 2005
Chinese Supplement a Risk to Diabetics: FDA Enclosed Bed Systems Pose Suffocation Threat Bill Would Offer Coverage for Anti-Anxiety Drugs FDA Scientist Warned of Viagra-Blindness Link: Report Some Defibrillator Recalls Classified as Most Serious
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Chinese Supplement a Risk to Diabetics: FDA
The U.S. Food and Drug Administration is warning consumers not to take a Chinese dietary supplement that contains a diabetes drug that could cause life-threatening reactions in certain people.
Liqiang 4 Dietary Supplement Capsules contain glyburide, a drug that is used to lower blood sugar, and is safe when used as labeled in FDA-approved medications. People who have low blood sugar or those with diabetes can receive dangerously high amounts of glyburide by consuming Liqiang 4. Consumers should immediately stop using these products and seek medical attention, especially if they are being treated with diabetes drugs or have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities, the FDA said Friday.
The product is sold as part of a shrink-wrapped two bottle set. One of the 90 capsule bottles is labeled Liqiang 4 Dietary Supplement Capsules, the other bottle is promoted as a "bonus pack" of Liqiang 1. The FDA said it is evaluating Liquang 1 and other versions of this product to determine their composition and safety.
The product is manufactured by Liqiang Research Institute, China, and marketed throughout the United States in herbal stores and through mail order by Bugle International of Northridge, Calif., the agency said.
Enclosed Bed Systems Pose Suffocation Threat
Vail Products Inc. of Toledo, Ohio, is recalling about 5,000 enclosed or canopied bed systems -- models 500, 1000 and 2000 -- used by hospitals, nursing homes and other institutions because the beds pose an entrapment and suffocation hazard to patients.
So far, there have been 30 reported entrapments, resulting in at least eight deaths, the U.S. Food and Drug Administration said. Patients using these beds can become trapped between the side-rail and mattress, or between the canopy and mattress.
The beds are used as an alternative to physical or drug restraint to reduce falls or other injuries among patients with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders, the FDA said.
Hospitals, nursing homes and other institutions should stop using these beds and transfer patients to alternative bed systems, the FDA said. Consumers using these beds at home should consult with their doctors about other options.
Under this recall, Vail Products is not retrieving or replacing the bed systems. Instead, the company is offering new warning labels and instruction manuals to those who have no choice but to continue using the beds. Vail said it mailed the manuals and labels to customers on June 23 and 24, the FDA said.
There's more information in this FDA Public Health Notification.
Bill Would Offer Coverage for Anti-Anxiety Drugs
Federal lawmakers said Friday that they would seek to extend Medicare's prescription drug benefit to include a class of drugs commonly used to treat anxiety, insomnia and seizures.
The benefit, which begins Jan. 1, currently excludes coverage of the category of drugs called benzodiazepines. But mental health experts say the drugs are sometimes the most effective therapy for patients, and that a sudden switch to other drugs could be life-threatening, according to the Associated Press.
Xanax, Valium, and Ativan are among the most widely used benzodiazepines.
"This glitch in the Medicare law threatens the health of our beneficiaries," said Rep. Benjamin Cardin, D-Md., who is sponsoring the bill to strike the exclusion, along with Rep. Jim Ramstad, R-Minn. "The administration recognizes the problem, but it does not have the authority to fix it. Congress does, and I hope that we can pass this bill soon."
Last week, the AP reported that the new Medicare rules would force elderly and disabled Medicare recipients to find other coverage to pay for benzodiazepines or change to other medications.
FDA Scientist Warned of Viagra-Blindness Link: Report
More than a year before news broke that the erectile dysfunction drug Viagra was possibly linked to a rare form of blindness, a U.S. Food and Drug Administration safety officer alerted superiors to the possibility, the Washington Post reported Friday.
The unidentified safety officer had been monitoring adverse event reports and told supervisors in April 2004 that doctors and users should be warned of the findings, she reportedly told congressional investigators. But the FDA issued no public warnings or changes to the drug's label until a scientific journal reported last month of the possible link, the newspaper said.
On Monday, Pfizer issued a statement saying it had no evidence in trials involving 13,000 people of a link between Viagra and a form of blindness called non-arteritic anterior ischemic optic neuropathy (NAION). That followed a report in last month's Journal of Neuro-Ophthalmology, which examined seven cases where men suffered NAION within 36 hours of taking Viagra, the Post said.
The FDA has said it has 38 reports of NAION among Viagra users and five additional reports among users of other impotence drugs, the newspaper said.
In response to the latest report, Consumer's Union, publisher of Consumer Reports, renewed a call for congressional reform of the FDA's drug monitoring system. "The fact the agency responsible for drug safety knew for a year that Viagra was linked to blindness, but did nothing with that information, is a clear indication that the system is broken," a spokesman said in a prepared statement.
Some Defibrillator Recalls Classified as Most Serious
The U.S. Food and Drug Administration has applied its most serious recall rating to two Guidant Corp. defibrillator models that have been found to malfunction.
Guidant, on June 17, announced that its defibrillators had been linked to two deaths in which the devices didn't work properly.
The FDA has given Class 1 recall status to Prizm 2 DR (made before April 16, 2002) and Contak Renewal 1 and 2 defibrillators (made before August 26, 2004), both the FDA and the company announced Friday. A recall in this category involves a malfunctioning device that could cause "serious adverse health consequences or death," the agency said in a statement. The firm's own investigation found these devices can shortcircuit while attempting to deliver an electric shock to the heart. Some 42,000 devices are affected, of which 20,600 are still implanted, the FDA said.
A less severe class 2 recall status was given to a number of other Guidant models, including the Ventak Prizm AVT, Vitality AVT, Renewal AVT, Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF, the FDA said. While faulty products in this category could cause medically reversible problems, the "probability of serious adverse health consequences is remote," the agency said. Memory errors and component failures are possible among the more than 60,000 devices in this category that have been produced.
As a precautionary measure, the FDA said, Guidant has recommended that doctors discontinue implanting these devices until further notice. Among patients with devices that have already been installed, the company recommends that they continue to visit their doctors at normal three-month intervals and immediately report any sign of malfunction.