Cardiovascular Systems Inc. (CSI) has initiated a recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical. According to the recall notice, Thomas Medical has received reports of fracturing or stretching occurring when the ViperSheath Sheath Introducer is in use.

The ViperSheath Sheath Introducer is a long-coil reinforced, kink-resistant catheter sheath that facilitates percutaneous, or through the skin, entry of an intravascular device. The device was developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI. Continue »

Prilosec and Nexium reduce the anti-clotting effects of Plavix, according to a Public Health Advisory issued by the U.S. Food & Drug Administration (FDA). As a result, patients at risk for heart attacks or strokes who use Plavix to prevent blood clots will not get the full effect of this medicine if they are also taking Prilosec or Nexium. The agency warned yesterday that patients who take Plavix should use different medications to treat acid reflux, such as Mylanta or Zantac.

Prilosec inhibits the drug metabolizing enzyme (CYP2C19) which is responsible for the conversion of Plavix into its active form (active metabolite), the FDA said. New studies compared the amount of Plavix’s active metabolite in the blood and its effect on platelets (anti-clotting effect) in people who took Plavix and Prilosec versus those who took Plavix alone. A reduction in active metabolite levels of about 45 percent was found in people who received Plavix with Prilosec compared to those taking Plavix alone. The effect of Plavix on platelets was reduced by as much as 47 percent in people receiving Plavix and Prilosec together. These reductions were seen whether the drugs were given at the same time or 12 hours apart, the agency said. Continue »

Following several bus accidents in recent years that have left many dead and scores injured, the commercial bus industry has been under fire for its safety record. The Obama administration announced yesterday that it plans on proposing safety regulations for long-distance buses, reported the Associated Press. The proposal will include stronger standards for the vehicles’ roofs, as well as seatbelts.

In 1968, the National Transportation Safety Board (NTSB) first announced a recommendation to add seat belts to large nationwide buses; however, today, most buses do not offer seatbelts, an issue cited in many deadly accidents. The NTSB is the agency that investigates serious transportation crashes and issues and has been the most persistent in calling for safety improvements such as: Three-point seat belts, stronger windows, stronger roofs, heat sensors, fire suppression devices, increased driver certification requirements, training, and more vigorous inspection and monitoring of bus companies. Continue »

News media are reporting that the U.S. Food and Drug Administration (FDA) has issued warning letters to Shire PLC and Eisai Co Ltd about drug promotions for Dacogen and Fosrenol. The warning letters state that the Dacogen (Eisai) and Fosrenol (Shire) promotions understate the risk and overstate the benefits of the medications.

The FDA said that a customer-intended promotional card created by Eisai “presents numerous claims that misleadingly overstate the efficacy” of Dacogen, reported Reuters. Dacogen is a medication used in the treatment of the blood disorders myelodysplastic syndromes. The letter, dated November 6, also stated that Eisai’s campaign “omits material risks associated with Dacogen treatment.” Continue »

The use of Negative Pressure Wound Therapy systems have been associated with deaths and serious complications, the U.S. Food & Drug Administration (FDA) warned yesterday. In a health alert posted on its Web site, the FDA said it will continue to monitor adverse events associated with Negative Pressure Wound Therapy systems, and will make available any new information that might affect their use.

Negative Pressure Wound Therapy helps various types of open wounds heal by creating a negative pressure (vacuum) at a well-sealed wound site. The vacuum helps remove fluids and infectious materials and draw wound edges together. Negative Pressure Wound Therapy is most commonly used with burns, flaps, ulcers and grafts, but it is contraindicated for several types of injuries, including wounds where there are exposed nerves, organs and vasculature. Continue »

The Tennessee Valley Authority (TVA) is stating that most of the coal ash “deemed critical” following last year’s historic spill, has been cleaned up, said WDEF. The authority said some two-thirds of the “critical” spill has been cleaned out of the Emory River

The catastrophic fly ash spill took place last December and released an unimaginable 5.4 million cubic yards of toxic coal sludge, dumping toxins into Tennessee’s Emory and Clinch rivers and the 300 acres surrounding the TVA’s Kingston plant. An Environmental Protection Agency (EPA) report states that some “potentially toxic pollutants,” such as mercury and arsenic, found in coal ash, could present serious problems. Continue »

A norovirus outbreak has ruined more than one cruise vacation. Now a new study suggests that keeping public restrooms on cruse ships clean could go a long way in preventing norovirus among passengers and crew.

Unfortunately, the study, which was published in the journal “Clinical Infections Diseases” found that public bathrooms on cruise ships are not being cleaned properly. What’s more, the U.S. Centers for Disease Control and Prevention (CDC), which runs a cruise ship sanitation program, is not doing a very good job of detecting the dirty cruise ship bathrooms. Continue »

Phthalates, chemicals that enable flexibility in plastics and vinyls, are again, being linked to adverse health outcomes, this time in boys. According to WebMD, women exposed to high phthalate levels during pregnancy may give birth to boys who express behaviors that are less typically masculine.

For instance, said WebMD, boys born by women who were exposed to high phthalate levels, tend to play less with “trucks and other male-typical toys or to play fight,” citing an emerging study. Phthalates are known in testing to cause reproductive disturbances such as decreased sperm count, infertility, and reproductive tract malformations. Continue »

Communities around the Indian Point nuclear power plant in Westchester, NY have higher-than-normal rates of thyroid cancer, according to a study released Monday. The study found that rates of thyroid cancer in the four counties surrounding the Indian Point nuclear plant – Orange, Putnam, Rockland and Westchester – were the highest in New York state, and among the highest in the United States.

The Indian Point nuclear power plant is located just north of New York City. The two nuclear reactors there went online in1973 and 1976. The plant, originally run by Consolidated Edison, is now owned and operated by Louisiana-based Entergy, a $13 billion company which runs nuclear plants in four other states. Entergy is awaiting renewal of the licenses for Indian Point’s two reactors, one of which expires in 2013 and the other in 2015. Continue »

The number of firms offering Chinese drywall “solutions” has exploded in recent months, prompting a group of U.S. Senators to ask the Federal Trade Commission (FTC) to crack down on such scams. It’s important to remember that no Chinese drywall remediation or testing protocols have been established as yet, so any claims that a particular company has found a fix for the Chinese drywall problem are questionable at best.

In a letter to FTC Chairman Jon Leibowitz, Senators Mary Landrieu, (D-La), Bill Nelson (D-Fla.), David Vitter (R-La.), Thad Cochran (R-Miss.), Roger Wicker (R-Miss.) and Jim Webb (D-Va.), raised concerns about deceptive practices that prey on consumers with defective drywall and asked the Commission to fully investigate and prosecute companies engaging in these activities. Continue »