An Arizona salmonella outbreak may have started at a Yuma County charity event.  The Yuma County Public Health Department expects final results next week of state tests concerning recent salmonella cases.   “We’re still waiting on numbers, test results from the state.  I’m kind of on hold with them,” said Becky Brooks, health department director.  Preliminary test results confirmed the presence of salmonella in tri-tip cuts served at the February 2 Hospice of Yuma roping roundup, barbecue, and western dance that were later donated to Crossroads Mission.

Although Brooks said she does not know exactly when final results will come in, she hopes to have something early next week.  While waiting, the health department is continuing its investigation into how the meat became tainted.   “We’re investigating all kinds of leads and information.  Anything I would give you now would be pure speculation.  We hope to have the full picture very soon.”  Brooks did say that, based on the information they had, the bacteria likely did not come from the meat’s original source.   “If it had been the vendor or the meatpacking… everyone at the event would have been ill and that wasn’t the case,” Brooks said. (more…)

The U.S. Food and Drug Administration (FDA) is looking at how it tells the public about safety concerns with foods, prescription drugs, medical devices, and other products it regulates, the agency’s commissioner said on Thursday.  “How we communicate what we do is as important as what it is we are doing,” Dr. Andrew von Eschenbach told the first meeting of a new advisory panel on risk communication.  “Quite candidly, if one looks at external data there has been an erosion of trust.  Some of that is not necessarily because people believe we are doing the wrong thing, but basically because perhaps they need to better understand and appreciate what we are doing,” he added.

The FDA issues warnings about drug side effects, recalls of tainted food, and defective medical devices.  Often the agency issues press releases to the media or releases statements on its Web site.  In recent years, the agency has started making public announcements about potential risks of medicines before officials determine whether the problems are drug-related.  Some experts worry that the warnings create confusion or balance is lacking when it comes to information about the product’s benefits.  Von Eschenbach said the FDA would consider changing the way it explains product risks to the media and the public. (more…)

Kickbacks from the makers of hip implants and other joint replacements to orthopedic surgeons are so prevalent that it has become nearly impossible to eliminate the illegitimate practice, an assistant inspector general with the Health and Human Services Department told a Senate panel yesterday.  Unfortunately, the practice of kickbacks is taking a toll on patients, who are often implanted with low quality devices because surgeons are influenced by such kickbacks.

Those allegations were part of testimony taken yesterday at a hearing of the Senate Special Committee on Aging.  The hearing followed a probe of the orthopedic-device industry by U.S. prosecutors that resulted in a settlement for $311 million last September. The government said the companies handed out excessive consulting agreements, lavish trips and other perks to reward surgeons who used their products. Among the companies involved in that settlement was Stryker Corp., which recalled some of its hip implant components earlier this month.  Stryker was also the recipient of two FDA warning letters in the past year, detailing contamination issues and other problems at its plants in New Jersey and Cork, Ireland. (more…)

Shockingly, nursery products were involved in over 66,000 injuries to children that involved emergency room visits in 2006, up11% from 2005, according to the Consumer Product Safety Commission (CPSC). The agency said in a report yesterday that the number of injuries to infants and children under age five involving cribs, high chairs, walkers, and other items rose by 6,600 from 59,800 in 2005. CPSC spokeswoman Julie Vallese said that safety officials are not sure why nursery-product injuries increased after experiencing a decline in 2005. “We cannot identify the reason for the increase but it is a concern for the agency,” Ms. Vallese said.

The report said the incidents weren’t necessarily caused by product failures. For instance, falls were the leading cause of injuries related to nursery products, with head injuries accounting for 42% of all injuries. The report didn’t provide injury data from 2007, a year plagued by an unprecedented number of product recalls that has forced Congress to consider the first overhaul of federal product-safety legislation in a generation. The CPSC also reported that in the years from 2002 through 2004, 241 children died from injuries linked to cribs, baby baths, play yards, strollers, and other nursery equipment. While approximately 40% of the deaths during the three-year period involved cribs, the deaths were not always caused by the cribs, according to the report. CPSC researchers excluded deaths for which coroners listed Sudden Infant Death Syndrome as a cause or where no information was available about how the death occurred. According to Vallese, the death figures—which lag behind injury statistics—are generally collected from death certificates and are collected separately from the injury figures. (more…)

Faulty Ford cruise control switches are the subject of yet another consumer safety warning.  Thursday, the government warned owners of about 4.6 million recalled Ford vehicles to bring their cars and trucks in immediately to dealerships to disconnect the cruise control switch systems because they have been linked to engine fires.  The National Highway Traffic Safety Administration (NHTSA) issued the consumer advisory to owners of some Ford, Lincoln, and Mercury sport utility vehicles, pickup trucks, vans, and passenger cars that have not yet been repaired as the owners have not yet responded to past recalls.  The recalls affect Ford’s popular F-Series pickup trucks, prompting hundreds of complaints and dozens of lawsuits over engine fires. Three deaths have been connected to the fires and Ford has struggled to produce enough parts to correct the problem.

About 9.6 million Ford vehicles have been recalled since 1999 and about five million have been fixed, raising concerns about the remaining vehicles on the road, between four and five million. NHTSA said they have received approximately 60 complaints of engine fires in the Ford vehicles since August 2007.  Ford said they supported the action and dealers would soon offer a more permanent fix.  “We absolutely want everybody to come in as soon as they can because we can eliminate the risk of fire for anyone with a vehicle in this recall,” said Ford Motor Co. spokesman Wes Sherwood. He said the company would have an “ample supply” of the replacement parts by June. (more…)

The U.S. Consumer Product Safety Commission (CPSC), in cooperation with the Munire Furniture, Inc. of Piscataway, NJ, announced a voluntary recall of its Majestic Curved Top and Flat Top Cribs, Essex Cribs, Brighton/Sussex Cribs, and Captiva Cribs.  The recall involves about 24,000 defective cribs that pose a fall hazard.

The wooden cribs fail to meet the federal safety standards for cribs. The four support brackets on the mattress support spring are too long and the brackets prevent the spring from lowering to the full 26 inch minimum height in its lowest position, allowing children inside to crawl over the railing, which poses a fall hazard. (more…)

Baxter Heparin, implicated in hundreds of life-threatening reaction in the US, is now subject to a full-scale recall.   The massive Baxter Heparin recall was announced yesterday, the same day the Food & Drug Administration (FDA) said it completed an inspection of a Chinese plant that supplies raw ingredients for Baxter Heparin. Despite finding problems during that inspection, the FDA still has not determine what is responsible for the tainted Baxter Heparin.

Baxter International recalled 9 lots of its Heparin in January, following reports of 100 allergy type reactions in patients who had received the drug.  According to the Baxter Heparin recall notice sent out at the time, a variety of reactions were been reported in relation to the recalled Heparin, including abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, lacrimation increased, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli.  Since the January recall, Baxter Heparin has been implicated in more than 400 reactions, including four deaths. (more…)

The Lipitor patient information insert does not list cognitive issues among its side effects; however, anecdotal reports linking statins—like Lipitor—to mental problems go back years and some doctors are voicing concerns that in some patients, statins like Lipitor may help hearts but hurt minds.  According to the vice chairman of medicine at New York Presbyterian Hospital, Dr. Orli Etingin, “This drug makes women stupid.”

Lipitor—generically called atorvastatin—is a statin, one of a group of drugs that lower cholesterol and certain fats in the blood by inhibiting a key enzyme that helps produce cholesterol.  Etingin told of a typical patient in her 40s unable to concentrate or recall words.  Tests found nothing wrong, but when the woman stopped taking Lipitor, the symptoms disappeared; when she resumed Lipitor, they returned.  “We really need more studies, particularly about cognitive effects and women,” Etingin said.

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A top drug safety official told lawmakers on Wednesday that the US Food and Drug Administration (FDA) needs more inspectors and a comprehensive computer database to better track products entering the US from the burgeoning group of drug manufacturers, brokers, and distributors currently doing business here.  The FDA focuses on domestic companies, with about 1,200 inspections conducted annually in the US; however, only about 300 foreign facilities are inspected annually and, of these, about 10 percent of the firms shipping pharmaceuticals here, said Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research.

Foreign inspections were especially relevant following ongoing and heightened concerns about the blood thinner heparin.  Two weeks ago, the drug was linked to four deaths and adverse reactions in over 400 patients, with some reports indicating 400 reactions.  Millions of patients take heparin annually to avoid potentially life-threatening blood clots. (more…)

Tainted Baxter Heparin has now sickened more than 400 people in the US, and investigators are trying to determine if the raw material for the Baxter Heparin became contaminated in a supply chain that originates from Chinese slaughterhouses.  The owner of the factory, known as Changzhou SPL—which supplies much of the active ingredient in Baxter’s Heparin—claims its supply chain is safe, it buys raw material from only two reputable wholesalers, and audits their 10 to 12 suppliers.

Heparin is a blood thinner administered in surgery and other critical care areas to prevent blood clots, is crucial in dialysis and heart surgery, and is used for the bedridden.  Heparin is administered to millions of patients yearly; Baxter manufactures about half of all multiple-dose heparin vials sold in the U.S.  Heparin is made from pig intestines from which mucous membrane is collected and cooked, producing dry crude heparin which is then sold to companies—like Baxter—that produce the final product.  Some feel as much as 70 percent of China’s crude heparin comes from small factories in poor villages, which act as heparin production centers, some for years.  Experts say the small, unregulated factories could pose dangers because they do not have the same controls and rules as large slaughterhouses, which also produce crude heparin. (more…)