Latest News

150 Toyota drivers continue to report sudden acceleration every week

Toyota says it receives about 150 reports of sudden unintended acceleration every week, with most of the complaints coming through the the company’s customer-service hotline. The good news is that  six months ago, the car manufacturer was receiving more than 5 times that amount. The bad news is that about 600 Toyota drivers a month throughout the U.S. still report instances and events in which their vehicles accelerated unexpectedly. Toyota customers have also filed thousands of complaints with federal regulators, but not nearly as many as they have called in directly to the manufacturer. The National Highway Traffic Safety Administration says ... Read More

FDA records raise new concerns about Gardasil safety

Parents in Virginia are worried following the release of a new report that links the Gardasil vaccine to 16 deaths and nearly 4,000 adverse events. Currently, the vaccine, which protects against four types of human papillomavirus (HPV) linked to cervical cancer, is required for girls in the state prior to entering the sixth grade, unless parents object. Last week, Judicial Watch, a government watchdog group, obtained reports from the U.S. Food & Drug Administration (FDA) that contain extensive new documentation of deaths and adverse events linked to the Gardasil vaccine. The FDA report documents incidents that occurred between May 2009 ... Read More

FDA’s new rule may discourage switching brand name with generic

A new final rule announced last week by the Food and Drug Administration (FDA) may help prevent automatic formulation switching from a brand name drug to a generic by pharmacists and insurance companies. The new rule, which goes into effect in March 28, 2011, was established to clarify what safety information must be reported during clinical trials of investigational drugs and biologics. The new rule replaces current practices of reporting any and all adverse reactions experienced during clinical trials once the drug is complete. It requires companies sponsoring the new drugs or medical products to report within 15 days any safety ... Read More

Experimental diabetes drug performs well in clinical trials

An experimental new diabetes drug, lixisenatide, combined with Lantus, helped patients better control the level of sugar in their blood, according to results from a phase three clinical trial sponsored by Sanofi-Aventis SA. Lantus is the No. 1 best selling insulin in the world in both sales and units. The lixisenatide study sought to establish the efficacy and safety of using both lixisenatide and Lantus together. The clinical trials involving 311 patients in Asia with Type 2 diabetes showed those who had a difficult time keeping their blood sugar levels within safe limits with basal insulin alone, were helped by ... Read More

FDA accuses Tylenol maker of not promptly fixing quality problems

A Johnson & Johnson manufacturing plant will begin shipping bottles of grape-flavored children’s Tylenol this week as the drug company’s chief executive faces a congressional committee to explain how the once-trusted company could have let its quality standards go so far downhill as to result in massive recalls of over-the-counter J&J medicines over the past year. Food and Drug Administration (FDA) investigators uncovered a recurring “failure to investigate and correct product problems in a prompt and thorough manner,” at the company’s McNeil Consumer Healthcare manufacturing plants, agency principal deputy Joshua Sharfstein told lawmakers at the hearing. The problems were of ... Read More

Georgia paper company fined after plant worker loses fingers

The Occupational Safety and Health Administration has cited McDuffie Box Co. Inc. of Thomson, Georgia, for a number of safety violations following a factory incident that severed the fingers of an employee. Proposed penalties total $47,550. OSHA’s investigation found that the machine involved in the amputation incident lacked the proper machine guarding required by OSHA to prevent such an accident from occurring. Investigators also found a number of other violations concerning the lack of emergency stops on the factory machines, a lack of forklift training for workers, and inoperable horns on the forklift. The fines include one for a willful ... Read More

FDA, CSPC urge parents to stop using dangerous sleep positioners

Parents and caregivers of infants are being warned not to put babies in sleep positioning products because of the risk of death due to suffocation. The warnings were issued by both the Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CSPC) after reviewing reports of 12 known infant deaths associated with the products. Sleep positioners are thin mats or wedges used to either elevate the baby’s head or keep the baby in a desired position while sleeping. They are often used with infants under 6 months of age. Some manufacturers claim the products help prevent Sudden Infant ... Read More

Airline faces nearly $5 million in FAA fines for improperly trained pilots

The Federal Aviation Administration (FAA) has proposed a $4,855,000 civil penalty against Evergreen International Airlines of McMinnville, Ore., a global cargo airline company, for allegedly using pilots on 232 flights who had not been trained in accordance with an FAA-approved training program. The questionable flights were made between Feb. 19 and July 9, 2009, on aircraft equipped with a new flight management system (FMS). The differences between the new FMS and the old system were significant enough to require specific training for pilots who were flying the aircraft. The FAA alleges Evergreen did not complete its FAA-approved training for pilots ... Read More

Researchers increasingly concerned over sports-related brain injuries

Perhaps it’s the record numbers of troops returning home from the Middle East with traumatic brain injuries. Or maybe it’s the tragic TBI-related deaths and injuries of young athletes, such as University of Pennsylvania football player Owen Thomas, who took his own life last spring while dealing with his debilitating symptoms of his condition. Whatever the reasons, traumatic brain injury awareness is growing across the country, and an unprecedented level of attention has fallen upon head trauma in football and other aggressive contact sports. With football season in full swing from high school and college campuses to the NFL, researchers ... Read More

Brand name Keppra vs. generic: ‘They don’t seem to be the same’

Switching from a brand name drug to a generic is considered safe for most people, but surveys conducted by the Epilepsy Foundation show that this practice could be dangerous to patients who suffer from seizure disorders. Participants in the survey reported that their seizures were controlled with the brand-name antiepileptic drugs (AEDs) but after switching to a generic, their seizures returned. Some experienced other adverse events such as headaches, mood swings, and potentially dangerous rashes. The issue with AED formulation switching has come into the spotlight lately, not long after the Food and Drug Administration (FDA) approved levetiracetam, generic versions ... Read More