Are Drug Companies Using Medical Staff to Circumvent Off-Label Promo Rules?

Drug companies may be using employees known as medical science liaisons (MSLs) to get around rules that prohibit the promotion of unapproved drug uses, The Wall Street Journal reported today. Because MSLs are considered medical – not sales staff – they are allowed to discuss off-label uses of medications with doctors and other health professionals.

According to the Journal, MSLs are often doctors or pharmacists. They call on doctors to discuss the science behind a medicine, including unapproved uses. More Are Drug Companies Using Medical Staff to Circumvent Off-Label Promo Rules?

FDA Seizes Generic Drugs Produced by Caraco Pharmaceutical Labs

U.S. Marshals, at the request of the U.S. Food and Drug Administration (FDA), seized drug products manufactured by Caraco Pharmaceutical Laboratories Limited. The products were seized at Caraco’s Michigan facilities in Detroit, Farmington Hills, and Wixom and also include ingredients held at these facilities.

“The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public,” she added, said the FDA. More FDA Seizes Generic Drugs Produced by Caraco Pharmaceutical Labs

PowerPlus Generators Recalled for Fire Hazard

Big Muddy Sports, of Perryville, Mo. is recalling about 450 PowerPlus Generators that pose a fire risk.

The recalled PowerPlus Generators are red with a black frame. The model number (BM7200 Power+) is printed on the side of the unit. Recalled units have a date of manufacture of 02/2009 labeled on the fuel tank. They were sold at Buchheit retail stores in Illinois and Missouri during May 2009 for about $700. More PowerPlus Generators Recalled for Fire Hazard

Toy Maker Fined For Lead Paint, Other Violations

OKK Trading of Commerce, California, has agreed to pay a $665,000 civil penalty for failing to comply with a 30-year old ban on lead paint on toys, as well as violating other federal child safety standards, the U.S. Consumer Product Safety Commission (CPSC) announced.

The penalty settlement, which has been provisionally accepted by the Commission, resolves CPSC staff allegations that from November 2007 through August 2008, OKK Trading knowingly imported and sold toys with paints that contained lead levels that exceeded legal limits. In 1978, a federal ban was put in place that prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings. Lead can be toxic if ingested by young children and can cause adverse health consequences. More Toy Maker Fined For Lead Paint, Other Violations

Nestle E. Coli Cookie Dough Plant Legally Kept Records from FDA During Past Inspections

Officials at a Nestle USA facility in Virginia legally refused on several occasions to give Food & Drug Administration (FDA) officials access to certain records during inspections, The Wall Street Journal reported today. The Nestle facility in Danville, Virginia produced Toll House cookie dough that has been implicated in a multistate outbreak of E. coli O157:H7.

Last Friday, the FDA warned consumers not to eat any varieties of Prepackaged Nestle Toll House refrigerated cookie dough following reports of people infected with E. coli O157:HY in dozens of states. At the time, the agency said that dozens of E. coli illnesses might be related to consumption of raw cookie dough. That same day, Nestle recalled 300,000 cases of those cookie dough products. More Nestle E. Coli Cookie Dough Plant Legally Kept Records from FDA During Past Inspections

DEWALT Framing Nailer Recall

Distributor DEWALT Industrial Tool Company, of Towson, Maryland has voluntarily recalled about 9,000 DEWALT D51825 and D51850 Framing Nailers, the U.S. Consumer Product Safety Commission (CPSC) just announced.

The DEWALT Nailers have been recalled because the bump action trigger on the framing nailers could have been incorrectly assembled during production, which would allow the nailer to eject a fastener unexpectedly or cause the trigger lock-off not to function. This potential assembling error can pose a serious injury hazard to the user or bystander. To date, no injuries or incidents have been reported. More DEWALT Framing Nailer Recall

Piroxicam Linked to Serious Skin Reactions, GI Problems, Health Canada Says

The labeling for piroxicam has been updated in Canada to reflect increased risk of serious skin reactions and gastrointestinal problems relative to other similar drugs. Health Canada said in a release issued yesterday that piroxicam should no longer be used to treat short-term pain and inflammation.

Piroxicam, sold in the U.S. both generically, and under the brand name Feldene, is a prescription drug in the family known as non-selective non-steroidal anti-inflammatory drugs (NSAIDs), and is used to relieve pain and inflammation. More Piroxicam Linked to Serious Skin Reactions, GI Problems, Health Canada Says

Another Beef Recall over E. coli Contamination Concerns

JBS Swift Beef Company, of Greeley, Colorado, is recalling approximately 41,280 pounds of beef products that may be contaminated with the E. coli O157:H7 pathogen, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) announced. The recall is a Class I, which means this a health hazard situation in which there is a reasonable probability that use of the product will cause serious, adverse health consequences or death.

The beef products—listed below—were produced on April 21 and 22, 2009, and shipped to distributors and retail establishments in Arizona, California, Colorado, Florida, Illinois, Michigan, Minnesota, Nebraska, Oregon, South Carolina, Tennessee, Utah, and Wisconsin. The problem was discovered through FSIS microbiological sampling and an investigation into the distribution of other products. More Another Beef Recall over E. coli Contamination Concerns

Caterer Linked To Three North Dakota Salmonella Outbreaks

A caterer from North Dakota has been linked to three separate outbreaks of Salmonella poisoning. The Jamestown Sun reported that the North Dakota Department of Health is looking into a third food-borne illness outbreak connected to an unlicensed caterer, citing State Epidemiologist Kirby Kruger.

The third outbreak has been associated with a wedding held Saturday, June 20, 2009, in McClusky, N.D., said the Jamestown Sun, adding that the Department of Health has received 15 reports of people falling ill following a wedding catered by Aggie Jennings. Four people have required medical care; no hospitalizations have been reported, said the Jamestown Sun. More Caterer Linked To Three North Dakota Salmonella Outbreaks

Nestle Cookie Dough E. coli Outbreak Sees First Lawsuit

Yesterday we wrote that Nestle Toll House cookie dough has been associated with 70 cases of E. coli O157:H7 in 30 states. Now, the Associated Press (AP) is reported that a family from Denver has sued Nestle USA in federal court. The family alleges their six-year-old daughter, Madison, contracted the dangerous, sometimes deadly E. coli bacteria from eating raw Nestle Toll House cookie dough.

Cindy Sedbrook said her daughter was near kidney failure in May when doctors concluded that Madison’s symptoms—bloody diarrhea and vomiting—were caused by E. coli bacteria, said the AP. The lawsuit was filed this week, said the AP, and seeks $50,000 to $100,000 in damages for hospital bills. More Nestle Cookie Dough E. coli Outbreak Sees First Lawsuit

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Defective Chinese Drywall Misery

It's estimated that more than 500 million pounds of possibly deficient Chinese drywall entered America between 2004 and 2008. An Associated Press statement said that was enough material to build about 100,000 homes. If you or a loved onehas been experiencing problems with corroding metals, foul odors, or sinus and respiratory ailments, your home may have been built with Chinese drywall. Get the facts!
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