| |
A new electronic early detection system utilized by the Food and Drug Administration logged 125 primary reports of unsafe food or animal feed in the first seven months of operation, keeping the potentially dangerous food out of the mouths of consumers, according to PR Newswire.
Mandated by Congress, the Reportable Food Registry requires manufactures, processors, packers and distributors to report any safety problems with food for humans and pets, and animals. The reports help the FDA locate hazardous foods in the supply chain.
Notable cases so far include:
- In February 2010 – Hydrolyzed vegetable protein HVP was recalled, even though there were no reports of illness. More than 1,000 reports from industry on products with HVP led to the removal of 177 food products from store shelves.
- In November 2009 – Foods containing sulfites were recalled because they were not properly labeled. That led to the removal of two nationally distributed side dishes. Again there were no reports of illness.
- Salmonella was present in 37 percent of the 125 hazardous reports.
- Undeclared allergens were found in 35 percent of recalled food products.
- Listeria monocytogenes, a virulent food-borne pathogen and bacterium, made up 13 percent of reports.
- Among reports – There were 14 for animal feed or pet food; a dozen for seafood; 11 for spices and seasonings; and 10 for dairy products.
The legislation creating the food registry in 2007 requires industry to report any food for animals or humans that could reasonably present a probability of serious adverse health consequences or death. The reporting has to be done within 24 hours of the discovery of the problem and must be relayed to the FDA. Dietary supplements and infant formula do not have to be reported because they fall under a different mandatory reporting system. Also exempt are drugs and medical products or reports from consumers.
Interestingly any indication that a food product has been contaminated sparked a suspicion that it could be intentional, and the FDA must immediately notify the Department of Homeland Security. Florida food recall lawyers can help those who have experienced illness or harm from consuming contaminated food products.
A Food and Drug Administration’s (FDA) advisory panel on Tuesday, July 21, recommended that the agency withdraw marketing approval of Avastin, a blockbuster breast cancer drug. The reason – the panel found that breast cancer patients saw no apparent benefit from taking Avastin.
The recommendation should not affect the drug being marketed for treating four other types of cancer -kidney, lung, colon, and brain cancers.
You may recall that Avastin received a fast-track approval from the FDA in February 2008. Part of that approval included a requirement to conduct post-approval clinical trials to ensure the drug was safe and effective.
In the clinical trial that brought the drug approval, Avastin was combined with the drug, paclitaxel, to be used in women with advanced or metastatic breast cancer. Women experienced a slowed progression of cancer, also known as progression-free survival for five months plus. The bottom line for these women was they did not gain more life however. Follow-up clinical studies have failed to replicate the initial findings. In fact, because of pharmaceutical medical complications from Avastin, survival was actually shorter for those taking it. The advisory panel voted 12 to 1 that the FDA should rescind marketing approval for Avastin.
That is bad news for Roche subsidiary, Genentech, the drug’s manufacturer. Genentech believes the drug should continue to be offered as one option for women. Since its approval, Avastin has been a blockbuster for the company, with annual sales of about $6 billion, making it the best-selling cancer drug. The FDA does not have to follow the advisory panel’s recommendations, but usually does, and is expected to issue a formal decision by September 17.
The Consumer Product Safety Commission (CPSC) has announced a voluntary recall of jewelry made in China that contains the toxic metal, Cadmium. The jewelry includes 19 styles of kids’ lockets, necklaces, bracelets, and earrings, some containing the words Best, Friends or Forever and/or BFF, according to an article in the Columbus Dispatch. About 137,000 pieces of the jewelry were sold at Justice and Limited Too stores between November 2008 and February 2010 for about $7 to $16.
Cadmium is a toxic metal and a carcinogen that can hinder brain development in the very young and lead to kidney problems and bone softening. An independent third party laboratory had evaluated the jewelry styles at the time of their manufacture and determined they were in compliance. The problem is that the CPSC has no set standard for cadmium. It is currently under development.
The manufacturer, Tween Brands, acknowledged the lack of a standard in a press release, but conceded that the levels were so high they would be out of any possible standard for safety. The Associated Press in January did a series of reports that found some of the kids’ jewelry had up to 91 percent cadmium. The CPSC has since confirmed the findings.
Consumers affected by the child product recall can take the jewelry back to the stores for a full refund or you can contact Tween Brands at 1-800-934-4497.
A salmonella recall covering Feline’s Pride pet food recall has been expanded, according to Consumer Affairs. The raw food with ground bone recall now includes all Natural Chicken formula in 2.5 pound bags that was produced in mid- June and shipped throughout the rest of the month. No illnesses have been reported among pets.
Look for the cat food in plastic containers that does not have a code. The food is sold frozen to consumers nationwide on an as-ordered basis. Consumers who handle this food have to take special care too. To avoid becoming infected with Salmonella, you are advised to wash your hands thoroughly and do not touch your hands to your mouth. Also, wash counters with warm water and soap as well as cutting boards and knives. That is good advice any time you are handling meat or fish, but especially pet food which meets less stringent quality standards.
Humans can contract the infection, salmonellosis, which includes nausea, vomiting, cramps, diarrhea, fever, and headache. Those with a compromised immune system, including babies and the elderly, should avoid handling this pet food.
A pet who contracts Salmonella, may have diarrhea, fever, vomiting, abdominal pain, and become lethargic. An infected pet can also become a carrier infecting humans and other animals.
The Food and Drug Administration is working in cooperation with Feline’s Pride on the investigation and is urging all consumers who experience symptoms of salmonella infection to contact their nearest FDA office. Consumers with questions should contact the company at (716) 580-3096, Monday -Friday from 10 a.m. – 4 p.m. EDT.
Anyone who has experienced salmonella poisoning from packaged manufactured food, even pet food, may have a product liability claim against the company and may seek compensation for medical costs and lost time at work. Contact an experienced Jacksonville product liability attorney for advice on how to protect your rights.
With thousands of lawsuits pending against GlaxoSmithKline PLC over the controversial diabetes drug, Avandia, the company agreed to pay about $460 million to resolve the outstanding suits on Wednesday, July 14. A www.bloomberg.com article reports that ten-thousand lawsuits will be settled for about $46,000 each. The actions alleged that GSK hid the dangers of heart damage from patients who took the drug. GSK, the United Kingdom’s biggest drugmaker, was poised to begin the first Avandia trial in a Philadelphia federal court in October.
No doubt GSK analyzed the downside. At potentially a half-million dollars per case, it will end out paying ten cents on the dollar.
The timing is not coincidental. A Food and Drug Administration advisory panel recently met to discuss whether the drug’s risk of increasing heart attacks outweighs its ability to control blood sugar levels and whether the drug should be kept on the market. All but three members said it should either be removed or the label on Avandia needs to be changed.
Testifying was a former FDA official who accused the company of withholding a study linking Avandia use to heart attacks. Dr. Rosemary Johann-Liang has been deposed by many lawyers in pending suits against GSK and the FDA may consider the information she provided to lawyers in determining whether Avandia should stay be recalled.
This is the second wave of settlement for GSK over Avandia heart trouble side effects. The first wave of 700 lawsuits was settled by Glaxo for about $60 million. There are still about 3,000 claims pending.
Avandia was once the best selling diabetes pill which generated about $3 billion annually for GSK. Even after a 2007 report linking Avandia to a 43 percent increase in the risk of heart attacks, the drug generated $1.1 billion in 2009 for GSK.
In March, Glaxo set aside $3.5 billion to settle legal and other disputes.
Dieters frequently look to pills to attack the fat as a quick and easy alternative to the old standbys – diet and exercise.
With U.S. obesity rates at 35 percent of the population, and showing no sign of slowing, investors are pinning their hopes on a new blockbuster drug as a trio of weight loss medications are being revealed this week. But if the past is any indication, dieters should have their antenna up concerning any miracle weight loss formulations.
The drugs have all been seen before in different combinations. Based on an Associated Press story, Vivus Inc.’s pill, Qnexa, will receive an FDA review July 12, Monday. A public hearing will follow to review data. Arena Pharmaceuticals Inc.’s, lorcaserin, is planning to have an FDA review and approval in September, while Orexigen Therapeutics Inc.’s Contrave will be the subject of a December panel.
According to FDA guidelines, the drugs need to reduce total body weight by at least five percent after one year.
Fen-Phen
Let’s not forget the all too distant past. Wyeth’s diet pill-drug combination, fen-phen, was recalled in 1997 after it was found to be linked to heart-valve damage and lung problems. The drugs had been seen before but not in that combination. Diet drug, fenfluramine, was half of the fen-phen combination. The other drug, phentermine never received FDA approval.
Acomplia
In 2008, Acomplia, made by Sanofi-Aventis was discontinued because of a suspected link to psychiatric side effects, depression, and suicidal thoughts.
Meridia
Meridia, made by Abbott Labs, was pulled from the market in Europe over the suspected links to heart attack risks.
Alli
Alli works by limiting the amount of fat the body can absorb. It is still on the market, but in May, the FDA warned about the prescription drug in Alli, Xenical, and its link to liver damage.
Are we about to see a repeat of the past?
Qnexa combines an amphetamine with an anticonvulsant. Contrave mixes an antidepressant with an anti-addiction drug. Lorcaserin acts on serotonin receptors.
While investors are anxious, dieters should be anxious and wary. We’ve seen this before as St. Augustine product liability lawyers and have tried to help receive compensation for individuals permanently injured from diet drugs and several other types of pharmaceuticals. Ultimately it is the consumer who is the final clinical trial participant, sometimes to their own permanent detriment.
Consumers who rely on the over-the-counter (OTC) pain formula of Tylenol may want to make another choice.
Johnson & Johnson announced yet another in a string of product recalls on Thursday, July 8, when the company recalled 21 more lots of Tylenol due to a musty or moldy odor, a Reuters story reports.
This is reportedly a follow-up to a January recall of 53 million bottles for the same problem. J&J, and its subsidiary, McNeil Healthcare, had received complaints from consumers about the smell last year which was eventually traced to a chemical, TBA, found in the wooden pallets that ship and store the packaging for Tylenol and other pain medications. The problematic manufacturing plant is in Las Piedras, Puerto Rico.
One has to wonder about quality control throughout J&J. This is the fifth recent recall for McNeil, the FDA is investigating, as is a congressional committee. Just this year, the McNeil factory, located in Ft. Washington, Pennsylvania, was closed following an FDA investigation that found a hole in the ceiling, filthy conditions, and bacterial contamination in formulations for children.
Back in November, 2008, the problems began for J&J with a recall of 12,000 bottles of Mylicon OTC infant anti-gas formula for potential metal fragments in some bottles.
Since then recalls have included:
- September 2009- some infant and children’s Tylenol recalled for possible bacterial contamination
- November 2009 – Tylenol Arthritis recalled for mildew odor linked to stomach pain, vomiting, and diarrhea
- December 2009 – Expansion of Tylenol Arthritis cap recall for odor problem
- January 2010 – 53 million bottles of Tylenol, Motrin and Rolaids, Benadryl, and St. Joseph’s Aspirin recalled for musty odors
- April 2010 – Children and infant pain reliever recall including Tylenol, Motrin, Zyrtec and Benadryl
- June 2010 – Benadryl, Tylenol gels recalled due to musty odor
Jacksonville pharmaceutical litigation lawyers are concerned with the recent spate of Tylenol recalls. Please be sure that any of the above recalled products are properly disposed of and not used.
They are brand new cars that already have recall orders. The federal government is recalling, in cooperation with Chrysler, about 22,000 SUVs and trucks to fix a defective brake tube that can lead to the loss of brake fluid.
According to a Huffington Post article, the 2010 Chrysler vehicles included are the Dodge Nitro, Dodge Ram, Jeep Liberty, and Jeep Wranglers. Chrysler owners should be notified in August.
Meanwhile the National Highway Traffic Safety Administration, in cooperation with Ford Motor Company, is recalling about 30,000 Transit Connect vans. The problem there is in the inadequate pushpins that hold the liners above the head of the driver. They need to be replaced because the pushpins do not meet federal standards for head protection in a crash. The Ford recall should begin in July and covers all of the Transit Connect vehicles sold in the United States made from December 2008 through May 2010.
Ford can be reached at 866-436-7332. NHTSA can be reached at 888-327-4236.
To determine if your car is included in the defective vehicle recall, check the driver-side door jamb. The sticker there lists the date of assembly.
Chrysler is still emerging from bankruptcy it filed last year.
The Food and Drug Administration (FDA) is preparing to tackle a review of the drug, Avandia, but meanwhile, European regulators are launching their own look into the safety of the GlaxoSmithKline Plc’s (GSK) diabetes pill. That is not good news for Avandia which was at one time Glaxo’s second-best selling drug.
According to a Reuters article, sales have plunged over the last three years since the controversy over its link to an increased risk of stroke and cardiovascular problems have surfaced.
Prompted by new studies, the European Medicines Agency (EMA) will review the risks and benefits of the drug. At a committee meeting, July 19, the EMA will decide whether to remove Avandia from the market, suspend sales, or review its approval.
“The EU reviewing the dossier is somewhat of a surprise,” Royal Bank of Scotland analyst Michael Leacock tells Bloomberg.
GSK officials have vigorously defended the drug calling it “an important treatment option for appropriate Type 2 diabetes patients.”
“Since 2007, we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia,” VP Murray Stewart tells the Philadelphia Inquirer, “and together they show that this medicine does not increase the overall risk of heart attack, stroke or death.”
An FDA staff review of the drug, posted in preparation for Tuesday’s advisory meeting, finds there are problems with the handling of the clinical trial. Called RECORD, critics say the RECORD trial was too short in length and the underlying data was misinterpreted.
Drug makers, doctors, attorneys, and medical malpractice plaintiffs are watching the result of the Tuesday meeting as shares for GSK fell upon the news of the two inquiries on Friday, July 9.
Cadmium has been found in trinkets for children distributed from doctor and dentist offices.
The Consumer Product Safety Commission (CPSC) is recalling nearly 70,000 charm bracelets and rings. For the fourth time this year, the CPSC has announced a recall of children’s jewelry and products containing cadmium, a known carcinogen. Cadmium is particularly toxic if ingested by young children and can cause kidney effects. The toys have been given away at doctor and dentist offices since June 2005 up until March of this year.
The metal has been seen increasingly in children’s trinkets since a 2008 federal law banned lead from children’s jewelry. Since then, the Associated Press reports, Chinese manufacturers have substituted cadmium for lead. AP tested some jewelry and found it contained as much as 91 percent cadmium by weight.
Other cadmium recalls have included Disney-type jewelry sold at Wal-Mart, and the “Best Friends” charm bracelet sold at Claire’s. In June, the Shrek movie theme glasses given away at McDonalds had cadmium in the pigment.
In the latest recall, parents are told to throw away “Children’s Happy Charm Bracelets” and 2,200 rings with a football shape charm and adjustable band. The bracelets are made of colorful beads and the charms come in the shape of a butterfly, moon, or sun.
Jacksonville child product liability attorneys are pleased that the distributor, SmileMakers Inc., of Spartanburg, South Carolina, reported to be a subsidiary of Staples Inc., is working cooperatively with the CPSC on launching the voluntary recall.
|
|
