The U.S. Consumer Product Safety Commission (CPSC), in cooperation with the firms named below, announced two voluntary product recalls because of fire and burn hazards.

In the first recall, about 73,000 Sony VAIO TZ-series Notebook Computers, made in Japan and manufactured by Sony Electronics Inc., of San Diego, California are being recalled because irregularly positioned wires near the computer’s hinge and/or a dislodged screw inside the hinge can cause a short circuit and overheating.  This design flaw poses a burn hazard to consumers and Sony has received 15 reports of overheating, including one consumer who suffered a minor burn.  Although most reports indicate 73,000 computers have been recalled, the Associated Press is reporting that the recall involves 440,000 Sony VAIO computers. Continue »

Federal regulators have ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections. The Food & Drug Administration (FDA) ordered the new labeling under authority it was granted with the passage of the Food and Drug Administration Amendments Act of 2007.

Humira, Cimzia, Enbrel and Remicade are known as tumor necrosis factor (TNF) blockers. They are used to treat rheumatoid arthritis, Crohn’s disease and other conditions. The drugs work by suppressing the immune system. It has long been known that people taking TNF blockers run a risk of developing opportunistic infections, and the prescribing information for the drugs has included this information. But now the FDA says that current warnings are inadequate. Continue »

Although the Food and Drug Administration (FDA) has deemed the highly controversial toxin, Bisphenol A (BPA), safe for use in baby bottles and food containers, government toxicologists maintain and reiterate their safety concerns about BPA use in those products.

Last month, the Washington Post and Associated Press reported that the FDA said BPA does not pose a health hazard when used in food containers.  In response, the National Toxicology Program repeated its initial findings, which were issued in April.  The group reports that BPA’s “risks to humans cannot be ruled out.” according to a new AP report, stating that there is “some concern” BPA can cause developmental problems in the brain and hormonal systems of infants and children. Continue »

While a defibrillator shock may provide a lifesaving nudge, the Associated Press reports that such a shock from an implanted heart defibrillator may also be linked to future problems and early death.  The government-funded study revealed that heart failure patients were far more likely to die within four years following defibrillator activity than patients who were not shocked.

Experts urge patients to immediately advise their doctors if they experience defibrillator triggering.  Likewise, doctors are urged to review their patients’ condition to determine if the condition has worsened and if tests or medication changes are required.  “We need to think about everything else we possibly could do to make them as healthy as they can be,” said the study’s lead author, Dr. Jeanne Poole of the University of Washington.  The study’s findings appear in today’s New England Journal of Medicine. Continue »

Poorly maintained power lines have been blamed for three destructive California wildfires that occurred last year. Now, state regulators are considering levying financial penalties against San Diego Gas & Electric and Cox Communications, the companies that owned the power lines.

Power lines are not a frequent  cause of wildfires in the state - The New York Times reports that they are implicated in about 2 to 3 percent of such blazes.  But when power lines do cause wildfires, the results can be devastating.  That’s because the lines sit on high towers located on remote, windy and hard-to-access terrain. Continue »

Off-label use of Medtronic’s Infuse Bone Graft has been linked to serious, life-threatening complications in some patients.  According to a new report in The Wall Street Journal, there is some evidence that Medtronic may have promoted the off-label use of the Infuse Bone Graft.  Promoting the off-label use of a medical device is illegal, although doctors are allowed to use a device anyway they see fit.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.  According to Medtronic’s Website, the Infuse Bone Graft  provides a scaffolding where new bone can grow.  Continue »

involved stealing hundreds of bodies and selling body parts and tissue to medical companies.  Today, the AP is reporting that the two brothers—Louis and Gerald Garzone—who ran a funeral home and crematorium involved in the body trafficking scheme admitted they sold cadavers as part of the fraudulent operation.

Mastromarino sold human remains under the company name Biomedical Tissue Services, located in New Jersey.  Bodies were taken from funeral homes; tissue and body parts were often diseased and previously rejected.  The scheme came to light in October 2005, when  Regeneration Technologies, Inc. a Florida-based processor of orthopedic, cardiovascular and other biologic implants, announced that the company, along with the Food and Drug Administration (FDA), issued a voluntary recall of allograft implants. The grafts were processed from donor tissue received from Biomedical Tissue Services, and was initiated due to questions raised with respect to donor documentation received from Biomedical Tissue. Continue »

It seems that newer medical techniques that are used in hip and knee replacements require revisions at a greater rate that older, established methods.  British researchers report that one in about 75 people required repeat hip and knee replacements in the three years following the original procedure.  The study was published in the journal PLoS Medicine.

The revision rates were even higher for patients who had new surgical techniques called hip resurfacing and unicondylar knee replacements.  Researchers said that these findings are raising concerns about the procedures.  “On the basis of our data, consideration should be given to using hip resurfacing only in male patients and unicondylar knee replacement in elderly patients,” Jan van der Meulen of the London School of Hygiene and Tropical Medicine and colleagues wrote. Continue »

Pfizer has launched a new TV ad campaign for Lipitor - one that does not feature a celebrity endorsement.  Pfizer had come under a great deal of criticism for TV spots that featured artificial heart pioneer  Robert Jarvik. Critics said that in the ads it appeared that Dr. Jarvik - who is not a medical doctor - was giving medical device.

In February, the Jarvik-lipitor ad campaign came under scrutiny from a Congressional committee examining consumer drug advertising and questions if the ads misrepresented Jarvik and his credentials.  While Jarvik does have a medical degree he is neither a cardiologist, nor is he licensed to practice medicine.  John D. Dingell, the Michigan Democrat who chairs the House Energy and Commerce Committee, raised questions about Jarvik’s credentials to recommend Lipitor.  Continue »

The U.S. Food and Drug Administration (FDA) announced the recalls of two food items due to possible contamination with Listeria monocytogenes.

According to the FDA, Trans-Ocean Products Inc. of Bellingham, Washington, has recalled its four-oz. Cracked Pepper Style Smoked Salmon.  The smoked salmon was sold in three supermarket chains in seven states: Brookshire Brothers in Texas and Louisiana; Price Choppers in New York, Pennsylvania, Massachusetts and Vermont; and Giant Eagle in Ohio and Pennsylvania. The Trans-Ocean Cracked Pepper Style Smoked Salmon is sliced cold-smoked salmon with black pepper.  The salmon is vacuum packaged and is sold in a resealable purple plastic pouch that bears the brand name Trans Ocean Products, with the lot number 54933-2.  The lot number is printed in ink jet on the back panel of the package, to the right of the center of the packaging.  Consumers who have purchased the salmon are being advised to return the recalled salmon to the place of purchase for a full refund.  Trans-Ocean Products can be reached toll-free at 800-290-2722. Continue »