Source | Reuters

By Susan Heavey

WASHINGTON (Reuters) - Sanofi-Aventis SA’s antibiotic Ketek should no longer be used to treat sinusitis and bronchitis, U.S. officials warned on Monday, saying the controversial drug was too risky to treat those diseases.

Ketek, which will remain on the market to treat pneumonia, will also carry stronger warnings about possible side effects such as blurred vision and loss of consciousness, the U.S. Food and Drug Administration said.

The FDA also said the drug will carry a “black box” warning — the strongest possible — against its use by patients with a disease known as myasthenia gravis that causes muscle weakness.

The warning follows a year-long FDA investigation into reports of severe liver damage and death in some Ketek patients that sparked debate over the drug’s safety and the agency’s handling of its approval.

The concerns also triggered a Senate Finance Committee investigation led by Iowa Republican Sen. Charles Grassley, and an FDA advisory panel recommendation for limited use in December.

“FDA has determined that the balance of benefits and risks for Ketek do not support continued approval of Ketek for these generally nonserious and often self-limited illnesses,” said Dr. John Jenkins, director of the FDA’s Office of New Drugs.

Pneumonia is a more serious illness that generally does not clear up without antibiotic treatment, Jenkins said.

Ketek, known generically as telithromycin, already comes with a bold warning for possible liver damage. Jenkins said officials saw no need to strength it.

Still, the FDA has received one additional report of possible liver complications. Previously, the FDA reported 13 cases of severe liver failure that included five deaths.

Sanofi officials, in a statement, defended Ketek’s continued use against pneumonia as “an important option in the therapeutic anti-infection arsenal and responds to a medical need in that area.”

Analysts had largely anticipated the FDA’s ruling, which comes before Sanofi releases its latest results on Tuesday. Various research notes also said this also factored into their expectations for Ketek, which saw U.S. sales of about $71 million last year.

Shares of Paris-based Sanofi were up 30 cents at $44.08 in early afternoon trade on the New York Stock Exchange.

The FDA announcement also came a day ahead of a House Energy and Commerce subcommittee hearing on Tuesday on drug safety issues, including Ketek.

Grassley, who was scheduled to testify, has repeatedly criticized the agency for withholding information about Ketek’s approval.

“When a spotlight was turned on the questionable way in which Ketek got approved … the FDA was held accountable,” Grassley said on Monday. He has sponsored a bill aimed at improving FDA’s safety oversight.

The agency cleared the drug in 2004 even though an investigation found a key safety study was tainted by fraud. FDA officials said other data provided adequate reassurance.

FDA spokeswoman Susan Cruzan said the agency had no comment on the committee hearing. The agency in the past has said it followed protocol in approving the antibiotic and was cooperating with the senator’s investigation.

Source | Reuters Health

Women who use a contraceptive patch appear to be more than twice as likely to develop a dangerous blood clot in their veins as those who use an oral contraceptive, new research shows.

Dr. Alexander M. Walker and colleagues, from i3 Drug Safety in Auburndale, Massachusetts, note that it was not known if users of the patch system ran the same risk of stroke, heart attack and venous blood clots as users of oral contraceptives.

They point out that the FDA changed the labeling for the patch contraceptive system in 2005 to warn of a possible increased risk of so-called “thrombotic events,” because of a higher average circulating estrogen levels with the product.

The investigators’ study, reported in the journal Obstetrics and Gynecology, involved 49,000 women using the Ortho Evra patch and 202,000 who used oral contraceptive pills between April 2002 and December 2004.

The researchers found that the occurrence of blood clots or “venous thromboembolism” in patch users was 2.2-times higher than in pill users: 40.8 vs. 18.3 cases per 100,000 women per year.

Because heart attacks and strokes were so rare, the researchers could not tell from their data if the risk of these outcomes was any different, statistically speaking, between the pill and the patch users.

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Source | Bloomberg.com

By Justin Blum

Scientists who have worked at the U.S. Food and Drug Administration and criticized agency decisions are now helping Congress fashion legislation to tighten product-safety rules.

The scientists include David Ross, who said in an interview that FDA supervisors forced him to retract a recommendation that the antibiotic Ketek, made by Sanofi-Aventis SA, was probably too dangerous to be used for treating two common respiratory infections. The drug was approved in 2004 and had $148 million in sales in 2005.

Ross is one of four current or former employees of the FDA who are working with Congress on bills intended to create more stringent drug safety rules. One change being proposed would create a new office to monitor the safety record of drugs after they’re on the market. Next week, several of the critics may describe their concerns at a congressional hearing on the FDA.

“I felt like if I didn’t do something and people got hurt, I wouldn’t be able to stand it,'’ said Ross, 48, who worked at the FDA for a decade before resigning in November. “I’m getting a chance to say what the problems are, and I’m getting a chance to fix them.'’

Legislation proposed by Senators Charles Grassley, an Iowa Republican; Edward Kennedy, a Massachusetts Democrat; and other lawmakers would give the FDA greater authority to restrict the use of drugs with side effects and require the registration of drug-company clinical trials.

Scientists’ Clout

The proposal to create a separate group within the FDA with power to monitor the safety of drugs after they are on the market was inspired by the FDA whistleblowers, Grassley said. They told him the scientists who oversee reports about drug side effects lack the clout to alert doctors and the public about what they have identified.

“Without the benefit of whistleblowers, would I even know that the office of drug safety is under the thumb of the office of new drugs and needs to be separated?'’ Grassley said in an interview. He said the critics have suggested that the approval group may not be aggressive in recalling or restricting the use of drugs it allowed onto the market.

The 12,000-employee FDA regulates products that account for more than $1.5 trillion in annual sales, or more than a 10th of the U.S. economy. Besides food and medicine safety, the agency writes and enforces rules on cosmetics and medical devices such as heart defibrillators.

Vioxx, Ketek

The FDA’s oversight of drug safety has come under lawmakers’ scrutiny in the past three years after studies linked antidepressants to suicide risk for children and painkillers to elevated chances of heart attacks. Merck & Co., based in Whitehouse Station, New Jersey, withdrew its top-selling pain drug Vioxx in September, 2004 after a company study showed the drug’s use was tied to higher heart attack and stroke risks.

The FDA critics helping lawmakers include David Graham, an FDA medical officer who questioned the health risks of Vioxx years before its withdrawal. Ross and John Powers, former FDA medical officers, raised challenges to the agency’s oversight of Ketek, sold by Paris-based Sanofi.

Another FDA employee talking to Congress is Victoria Hampshire, who in 2003 identified safety problems with a Wyeth medicine for dogs, ProHeart 6. She was forced from her veterinary medicine job to another position after Wyeth said she had a possible conflict of interest. She was later cleared of wrongdoing by the FDA. Wyeth withdrew the drug in 2004.

FDA’s Response

The FDA won’t comment on the pending legislation or employees’ role in creating it, said spokeswoman Kathleen Quinn in an e-mail. The agency supports “employees’ communicating their personal opinions,'’ without necessarily agreeing, she said.

The drug agency last week pledged to strengthen safety monitoring. It is proposing a test program to examine side effects of new medications after 18 months of sales. Drugmakers say new legislation isn’t needed.

“The U.S. drug safety surveillance system at the FDA is the best in the world,'’ said Alan Goldhammer, deputy vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers of America, the industry’s trade group in Washington.

Some of the FDA employees said they have responded to requests to discuss their cases with Senate aides for Grassley and Kennedy, as well as with Christopher Dodd, a Democrat from Connecticut, and Michael Enzi, a Republican from Wyoming. In the House, the critics have talked with staff for Democratic Representatives Henry Waxman of California and Ed Markey of Massachusetts.

Safety Review

Ross said some of his suggestions were shaped by the way the FDA responded to his findings about Ketek when he was a medical team leader. He wrote in a safety review that the drug’s risks appeared too great to allow approval for treatment of bronchitis and sinusitis, two common respiratory infections.

“I was called into my division director and told to `soften my review,”’ Ross said. He changed the wording to be more “neutral,'’ he said. “When I made scientific arguments, they were ignored when there was an economic argument for the company.'’

On Dec. 15, a panel of FDA advisers said the drug shouldn’t be routinely prescribed for the two conditions because of risks of liver damage and death. The panel suggested keeping the drug on the market only for treating pneumonia, a more severe illness. The FDA hasn’t acted on the recommendation.

Sanofi’s chief medical officer, Doug Greene, said in a statement issued after the FDA panel meeting that the company would discuss the matter with the FDA. He said Sanofi considers patient safety its “highest priority.'’

Reviews Online

In a recent meeting with staff for Grassley and Dodd, Ross said he suggested that all FDA staff reviews of medications be posted on the agency’s Web site. Powers said congressional aides have sent him draft legislation for comment.

“Some FDA managers refuse to even admit there’s a problem,'’ said Powers, who quit in October as the lead medical officer for antimicrobial drug development and resistance initiatives. “Its kind of like alcoholism. You have to admit you have a problem before you can do something about it.'’

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Product testing by several states has now confirmed that Peter Pan peanut butter and certain Great Value brand peanut butter are the sources of the foodborne illness outbreak of Salmonella Tennessee that began in August 2006. To date 329 individuals have become ill from consuming the contaminated peanut butter, and 51 of those persons were hospitalized.

The outbreak is ongoing. All products containing Peter Pan brand peanut butter and all jars of Great Value brand peanut butter bearing a product code that begins “2111″ are potentially contaminated. Potentially contaminated products include 3/4 ounce and 1.1 ounce single serving packs of Peter Pan brand peanut butter. All of these products contain peanut butter that was manufactured in ConAgra’s Sylvester, Georgia plant. Retailers and institutions possessing the products described should not serve or sell them. Any consumer possessing any of these products should discard them.

Symptoms of foodborne illness caused by salmonella include fever, diarrhea, and abdominal cramps. In persons with poor underlying health or weakened immune systems, salmonella can invade the bloodstream and cause life-threatening infections. Individuals who have recently eaten any products containing Peter Pan peanut butter or Great Value brand peanut butter from a jar bearing a product code beginning 2111 and who have experienced any of these symptoms should contact their doctor or health care provider immediately and report the illnesses to their state or local health authorities. Similarly, institutional food establishments and other food service providers who have received reports of illness from consumers after they consumed one of these products are encouraged to share that information with their local health department.

ConAgra has recalled these products from stores and ceased production in their Sylvester, Georgia processing plant until the exact cause of contamination can be identified and eliminated. FDA is continuing to work closely with the Centers for Disease Control and Prevention, and with states and local officials to identify how the contamination occurred in order to prevent similar foodborne illness outbreaks.

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Source | FDA

The Food and Drug Administration (FDA) is warning consumers not to use certain jars of Earth’s Best Organic 2 Apple Peach Barley Wholesome Breakfast baby food because of the risk of contamination with Clostridium botulinum, a bacterium which can cause botulism, a life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

The affected product was sold in single individual jars and in variety packs (which contains 4 jars of the apple peach barley in the pack along with other varieties). The food is part of the firm’s “2nd Vegetables, Fruits and Blends” line intended for babies 6 months and older. The food was distributed through retail stores and sold through the Earth’s Best website. If consumers have any of the specified jars in their home, they should not use it and destroy it immediately. No illnesses have been reported to FDA or the manufacturer to date in connection with this problem.

The affected baby food is as follows:

Botulism, a potentially fatal form of food poisoning, usually causes illness within 18-36 hours of exposure. Initial indication of illness in infants is decreased frequency or absence of stools. Other signs and symptoms noted are poor feeding, weak suck, lethargy, listlessness, weak cry, decreased body tone, and diminished overall movement. Difficulty with swallowing may be evident as secretions drooling from the mouth. This may be followed by decreased respiratory effort which may lead to respiratory arrest from airway occlusion from unswallowed secretions. Older populations who may be consuming the product as part of a pureed diet might experience symptoms such as blurred vision, dizziness, dry mouth, and progressive weakness from head to legs. Constipation and urinary retention are also common. Caregivers or people observing these problems should seek immediate medical attention for those affected.

Hain Celestial Group initiated a recall of the food on February 9th. The recall is ongoing. Production and distribution of the product has been suspended as FDA and the company work to determine the source of the problem. Hain Celestial Group distributed 4,072 cases of the specified individual jars consisting of 24 jars per case and 38,298 variety packs with the specified jars.

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Source | FDA

FDA Update on Salmonella Outbreak Linked to All Peter Pan Peanut Butter and Certain Lot Numbers of Great Value Brand Peanut Butter

Product testing by several states has now confirmed that Peter Pan peanut butter and certain Great Value brand peanut butter are the sources of the foodborne illness outbreak of Salmonella Tennessee that began in August 2006. To date 329 individuals have become ill from consuming the contaminated peanut butter, and 51 of those persons were hospitalized.

The outbreak is ongoing. All products containing Peter Pan brand peanut butter and all jars of Great Value brand peanut butter bearing a product code that begins “2111″ are potentially contaminated. Potentially contaminated products include 3/4 ounce and 1.1 ounce single serving packs of Peter Pan brand peanut butter. All of these products contain peanut butter that was manufactured in ConAgra’s Sylvester, Georgia plant. Retailers and institutions possessing the products described should not serve or sell them. Any consumer possessing any of these products should discard them.

Symptoms of foodborne illness caused by salmonella include fever, diarrhea, and abdominal cramps. In persons with poor underlying health or weakened immune systems, salmonella can invade the bloodstream and cause life-threatening infections. Individuals who have recently eaten any products containing Peter Pan peanut butter or Great Value brand peanut butter from a jar bearing a product code beginning 2111 and who have experienced any of these symptoms should contact their doctor or health care provider immediately and report the illnesses to their state or local health authorities. Similarly, institutional food establishments and other food service providers who have received reports of illness from consumers after they consumed one of these products are encouraged to share that information with their local health department.

ConAgra has recalled these products from stores and ceased production in their Sylvester, Georgia processing plant until the exact cause of contamination can be identified and eliminated. FDA is continuing to work closely with the Centers for Disease Control and Prevention, and with states and local officials to identify how the contamination occurred in order to prevent similar foodborne illness outbreaks.

####

FDA Additional Information

Q and A - Peter Pan & Great Value Peanut Butter Salmonella Outbreak and Product Recall

February 16, 2007 – Update on Salmonella Outbreak and Peter Pan Peanut Butter and Great Value Peanut Butter

February 14, 2007 - FDA Warns Consumers Not to Eat Certain Jars of Peter Pan Peanut Butter and Great Value Peanut Butter — Product May be Contaminated With Salmonella

CDC Salmonellosis - Outbreak Investigation, February 2007

Photos: Peter Pan and Great Value Peanut Butter

FDA’s Pilot Program to Better Educate Consumers about Recalled Food Products

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Source | MedPage Today

Trasylol (aprotinin), a drug designed to limit operative blood loss, was associated with a 48% increase in risk of dying within five years of coronary artery bypass surgery, researchers here reported.

In a multi-center, observational study of 3,876 bypass patients, the five-year mortality rate was 20.8% of the patients given Trasylol, versus 15.8% for those treated with aminocaproic acid and 14.7% for those who received Cyklokapron (tranexamic acid), said Dennis T. Mangano, Ph.D., M.D., of the Ischemia Research and Education Foundation here.

These results, published in the Feb. 7 issue of the Journal of the American Medical Association, mark the second analysis of data from the same international registry that linked Trasylol with increased mortality. The first analysis reported that Trasylol increased perioperative risk of death, acute renal failure, myocardial infarction, stroke, and encephalopathy.

Dr. Mangano concluded that taken together there was now evidence of both perioperative and long term risk. “Therefore, continued use of aprotinin in this population does not appear prudent, given that safer alternatives-aminiocaproic acid and tranexamic acid-are available,” he added.

The patients were treated at 62 international centers from Nov. 11, 1996 to Dec. 7, 2006. The researchers assessed survival at six weeks after the index hospitalization, six months, and annually for five years following surgery.

Among the findings:

1,072 patients received Trayslol, 834 received aminocaproic acid, and 442 received Cyklokapron.
At five years there were 223 deaths in Trayslol group, 132 in the aminocaproic acid arm and 65 in the Cyklokapron group.
The five-year hazard ratio for death in the Trayslol arm was 1.48 (95% CI, 1.13-1.93, P=0.005).

In general, Farzan Filsoufi, M.D., associate professor and associate chief of cardiac Surgery at Mount Sinai Medical Center in New York, agreed with the conclusions by Dr. Mangano and colleagues, but he cautioned that as with other recent Trasylol studies, this one was limited by its observational design and lack of randomization. Dr. Filsoufi was not involved in the study.

Dr. Filsoufi’s comment echoed that of T. Bruce Ferguson, Jr., M.D., of the Brody School of Medicine at East Carolina University in Greenville, N.C.

The perioperative observational study findings “seemed to conflict with findings from several dozen randomized trials, two meta-analyses, a Cochrane Collaboration summary on aprotinin use, and an evaluation by the Food and Drug Administration,” Dr. Ferguson wrote in an editorial that accompanied Dr. Mangano’s study.

Dr. Ferguson noted that Trasylol use “has never been uniformly standardized, but generally has been reserved for patients in whom the surgical team anticipated a higher risk for intraoperative blood loss.”

The latest analysis from Dr. Mangano and colleagues included 3,876 of the 4,374 patients included in the perioperative analysis. And seven of the original 69 participating international center were dropped from the five-year analysis, a potential limitation that Dr. Mangano said reduced the cohort size by 11%. But, he said, it had little effect on the findings because “the in-hospital mortality by study group was similarly distributed among the 62 centers participating in this study versus the seven centers that did not.”

Dr. Mangano said selection bias — Trasylol was likely to have been given to patients with more complex or advanced disease — was unlikely to affect or explain the excess mortality because since data were corrected by propensity analysis. Moreover the association with Trasylol and lack of association for the other two agents persisted in among patients with risk factors for in-hospital renal, cardiovascular, and cerebrovascular events.

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Source | USA TODAY

An expensive drug given to coronary artery bypass surgery patients to prevent excessive bleeding is linked to an increased risk of dying as long as five years after the operation, researchers have reported.

More than 4 million patients worldwide have received aprotinin, sold as Trasylol, since 1985, the scientists write in the Journal of the American Medical Association. The Food and Drug Administration approved Trasylol for use in coronary bypass surgery patients in 1993. Last year, it was used 246,000 times in the U.S., the researchers say.

Trasylol has been under scrutiny for at least a year and has raised anew concerns about monitoring the safety of drugs once they’re on the market. The new study is a followup to one the authors published in January 2006 that linked Trasylol to serious kidney problems, heart attacks and strokes in patients undergoing coronary bypass surgery. Another study, posted online in January 2006 and published in March, also linked Trasylol to kidney trouble.

The studies spurred the FDA to convene an advisory panel, which in September voted unanimously that Trasylol should stay on the market. The next week, the FDA announced it had just learned of another study, by Trasylol maker Bayer, which the company had not mentioned at the advisory panel meeting. That study suggests that Trasylol might increase the risk of serious kidney damage, death, heart failure and strokes, the FDA said in December, when it announced updated labeling for the drug. The label now warns about kidney problems and says that Trasylol should be used only in coronary bypass surgery patients who are at an increased risk for excessive bleeding.

The new, multi-center international study compared the death rates of four groups of patients who had undergone bypass surgery: 1,072 given Trasylol, 834 given aminocaproic acid; 442 given tranexamic acid and 1,374 who didn’t receive any medication to prevent excessive bleeding. Patients who got aprotinin were about 50 percent more likely to die in the five years after surgery than patients who received no drug. Neither of the other drugs was linked to a significantly higher risk of death than no treatment.

Trasylol costs $1,300 per use, compared with $44 for aminocaproic acid and $11 for tranexamic acid, says lead author Dennis Mangano, head of the Ischemia Research and Education Foundation in San Bruno, Calif. Before his first study came out in January 2006, says Mangano, about half of U.S. coronary bypass surgery patients received Trasylol. But, he says, use of the drug dropped 37.5 percent in the first half of 2006.

“I think that clinicians are going to pay attention, and I think the use of the drug will drop again,” he says.

In a statement responding to the new study, Bayer said that doctors tend to give Trasylol to the sickest of patients, which could skew findings about the drug’s safety. Based on its initial review, “Bayer believes that the results of this study should not serve as a basis for affecting the use of aprotinin . . .”

Keyvan Karkouti, lead author of the other paper last year linking Trasylol to kidney problems, called Mangano’s new report “a good paper, and it definitely raises more questions and concerns.”

In Canada, says Karkouti, an anesthesiologist at the University of Toronto, only bypass patients at the highest risk of bleeding — 5 percent of bypass patients at his hospital — receive Trasylol. Trasylol has been shown to be more effective than no treatment in that group, Karkouti says, but trials comparing its generic competitors with a placebo in high-risk patients haven’t been done, because no drug company stands to gain from such a study.

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Source | Reuters

ConAgra Foods Inc. (CAG.N: Quote, Profile, Research) will take a charge of $50 million to $60 million in the current quarter related to its peanut butter recall, the company said on Tuesday. It also forecast annual growth of 8 percent to 10 percent in earnings per share in fiscal 2008 through 2010.

The announcement of the charge, which works out to 6 cents to 8 cents per share, comes less than a week after ConAgra recalled its Peter Pan brand peanut better and the Great Value brand peanut butter it makes for Wal-Mart Stores Inc. (WMT.N: Quote, Profile, Research) due to possible contamination with the salmonella bacteria.

Shares of ConAgra, which also makes Healthy Choice meals and Swiss Miss hot chocolate, fell less than 1 percent to $25.71 in early electronic trading.

ConAgra said its previous 2007 earnings guidance of $1.28 to $1.33 per share, excluding special items, would need to be adjusted downward for the impact of the recall. However, even including the recall charge, 2007 earnings will likely still be toward the low end of the $1.28 to $1.33 range because several units are performing better than planned, it said.

The comments from the Omaha, Nebraska-based food company came just hours before its chief executive, Gary Rodkin, was scheduled to discuss the company’s plans at a meeting with analysts and investors.

ConAgra said it would have more details about the financial impact of the recall when it reports fiscal third-quarter results on March 22.  

For fiscal 2008 through 2010, ConAgra forecast 2 percent to 3 percent annual sales growth and 8 percent to 10 percent earnings per share growth, excluding special items.

ConAgra said it expects profit margin to expand and return on invested capital to improve during the 2008-2010 period.

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Source| The Exponent Online
By Mike Westervelt

Statewide outbreaks of Salmonella prompted Purdue officials to remove a brand of peanut butter from dining facilities.

The Centers for Disease Control have reported 288 cases of the illness nationally. Thirteen cases have been confirmed in Indiana. Health officials said jars of Peter Pan peanut butter are linked to the outbreak.

Kathy Manwaring, assistant director of dining services, said the University used the brand in On the Go! locations.

“We got the message (Monday) that we are not to use any Peter Pan peanut butter,” said Manwaring.

She said that when the recall was announced last weekend, it was not clear that it applied to single serve portions, which are the only instances where Peter Pan is used at dining services. Manwaring said Purdue primarily uses Jif peanut butter in the main dining areas.

The Indiana State Department of Health is urging consumers to be aware of the recall. Lynae Granzow, epidemiologist for the department, said the recall applies to every jar of Peter Pan peanut butter and specific jars of Great Value, a Wal-Mart brand. She said Great Value jars with the lid product code 2111 should not be consumed.

She said students who recently consumed a suspected brand should be alert to health effects. Symptoms include vomiting, diarrhea, fever, cramps, nausea and gas. They usually last about 48 to 72 hours.

“At this point, if you haven’t become ill already, there isn’t much concern,” said Granzow. “But you should stop eating the peanut butter.”

She said the state department was notified of a potential outbreak Dec. 20. She said it was quickly identified as Salmonella tennessee.

“We were able to identify these cases. Three were identified … and were matched to the national outbreak,” said Granzow. “The (Food and Drug Administration) is investigating the plant in which the infection was found.”

She said this is the first case where Salmonella is suspected to be contained within peanut butter.

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