Serious Adverse Events Are Linked To Botulinum Toxin Products:
The FDA will require labeling for the botulinum toxin products BOTOX®, Myobloc®, Dysport® to include a “Black Box Warning,” alerting doctors and patients of the serious and life-threatening side effects that these products can trigger. A Black Box Warning is the strongest warning that the FDA can require a prescription drug to include in its labeling.
Botulinum Toxin Products Labeling Change:
BOTOX®, Myobloc®, and Dysport® all contain the same toxin that causes botulism. The FDA has mandated the Black Box Warning following reports that the effects of the botulinum toxin may spread from the injection site to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
In its News Release, the FDA stated that these side effects have been reported most frequently in children with cerebral palsy and being treated with the products for muscle spasticity, an unapproved use of the drugs. Side effects have also been reported in adults treated both for approved and unapproved uses.
The updated labeling changes will also include safety information alerting doctors that BOTOX®, Myobloc®, and Dysport® are not interchangeable. The lack of interchangeability presents the potential for serious safety risks such as overdosing of patients.
What You Can Do To Protect Your Legal Rights:
Since 1984, the Law Firm of Eric H. Weinberg has represented hundreds of individuals injured by dangerous and defective drug products. The firm has played a leading role in the litigation of high-profile drug lawsuits including Vioxx, Baycol, and blood products. We are ready to help you. If you believe that you or a family member was injured as a result of BOTOX®, Myobloc®, Dysport® therapy please submit a Free Case Evaluation Form, or call us toll free at 1-877-934-6274.
To learn more about the Law Practice of Eric H. Weinberg, please see Drug Lawsuit Lawyer and Food Poisoning Lawyer.
May 5th, 2009
On January 23, 2009, Stonewall Kitchen of York, Maine, recalled seven dessert sauces because the products have the potential to be contaminated with the life-threatening foodborne pathogen, Clostridium botulinum. Stonewall Kitchen warns consumers not to consume the recalled sauces, even if they do not look or smell spoiled.
Products subject to the recall:
According to a company press release, the products were distributed nationwide to consumers through the nine Stonewall Kitchen Company Stores, Stonewall Kitchen’s direct-to-consumer division (catalog/internet) and through their wholesale division. Products could have been purchased individually or within a gift basket. This recall affects all product codes and expiration dates for:
Stonewall Kitchen Chocolate Hazelnut Sauce (SKU 161312) – round glass jar, 12 oz.
Stonewall Kitchen Chocolate Peanut Butter (SKU 161211) – round glass jar, 12 oz.
Stonewall Kitchen Coffee Caramel Sauce (SKU 161204) – round glass jar, 13 oz.
Stonewall Kitchen Dulce de Leche Sauce (SKU 161214) – round glass jar, 12.5 oz.
Barefoot Contessa Espresso Dulce de Leche (SKU 542313) – round glass jar, 10.5 oz.
The following list of products was distributed nationwide to consumers through A-Hold Corporation (Stop & Shop and Giant stores). This recall affects all product codes and expiration dates for:
Simply Enjoy Coffee Caramel Sauce – square glass jar, 13 oz.
Simply Enjoy Chocolate Peanut Butter Sauce – square glass jar, 12 oz.
Clostridium botulinum toxin can cause botulism, a serious and sometimes life-threatening condition. The toxin cannot be removed by cooking or freezing. To learn more please click Symptoms and Complications of Botulism.
The above information has been posted as a courtesy by Food Poisoning Lawyer, Eric H. Weinberg. Please read carefully, and keep yourself and your loved ones safe!
For information concerning recent food poisoning outbreaks and food poisoning litigation, please see Peanut Butter Lawsuit, Listeria Lawyer, and Salmonella Lawyer.
February 3rd, 2009
On January 16, 2009, K-Fat Inc., Brooklyn, NY, recalled “Golden Dragon Fish brand Frozen Cooked Mackerel Fish” because the product was processed uneviscerated. As a result, the product may be contaminated with Clostridium botulinum spores, which can lead to the potentially fatal foodborne illness known as botulism.
Recalled “Golden Dragon Fish brand Frozen Cooked Mackerel Fish” comes in an uncoded 250G plastic bag and basket and is a product of Vietnam. “Golden Dragon Fish brand Frozen Cooked Mackerel Fish” was sold in New York and New Jersey.
Consumers are warned to not consume this product.
Uneviscerated, salt-cured, whole fish products have been linked to the following fatal botulism outbreaks in the past.
United States, 1981 – 1087: Three outbreaks of botulism causing 3 deaths and 11 illnesses are linked to Kapchunka, an uneviscerated, salt-cured, air-dried whole whitefish.
Egypt, 1991: Two botulism outbreaks resulting in 91 illnesses and 18 deaths are linked to Faseikh. Faseikh is made by fermenting uneviscerated fresh mullet, followed by a salt-curing.
To learn more, see Botulism Symptoms, or please visit our additional site www.foodpoisoning.com.
The Law Firm of Eric Weinberg represents victims of food poisoning outbreaks throughout the country. To contact us, please call our toll free number at 1-877-934-6274, or click on Free Case Evaluation. To learn more about our law firm please see Food Poisoning Lawyer.
For information concerning recent food poisoning outbreaks and food poisoning litigation, please see Peanut Butter Lawsuit, Listeria Lawyer, and Salmonella Lawyer.
February 3rd, 2009
The U.S. Food and Drug Administration (FDA) is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel & Charles LeBlanc Fisheries Ltd., CAP-PELÈ, New Brunswick, Canada, because the fish may contain the Clostridium botulinum (C. botulinum) toxin. Consumers are warned not to consume the product.
C. botulinum toxin can cause botulism, a serious and sometimes life-threatening condition. The toxin cannot be removed by cooking or freezing.
According to the FDA, the fish were imported into the United States and sent to the following Florida distributors:
According to the FDA website:
The fish were packed in 30-pound, white plastic pails with green plastic lids. The brand name “Michel & Charles LeBlanc Fisheries Ltd.,” appears on the side of the pails, as does the phrase “Product of Canada.” One hundred seventy-three (173) 30 lb. pails of fish were distributed. The fish may have been repacked or sold loose by retailers in Florida.
The FDA considers any ungutted fish over five inches in length that is salt-cured, dried, or smoked, such as the ungutted, salt-cured alewives/gaspereaux fish, to be adulterated because it could contain the C. botulinum toxin. The Florida Department of Agriculture and Consumer Services discovered the ungutted alewives/gaspereaux fish from Michel & Charles LeBlanc Fisheries Ltd. being sold in stores and alerted the FDA. The FDA prohibits the sale of this adulterated product in the United States.
To date, there have been no reported illnesses associated with this product. However, consumers who have purchased ungutted, salt-cured alewives/gaspereaux fish in Florida should contact the place of purchase to determine if the fish they bought originated from Michel & Charles LeBlanc Fisheries Ltd. If the fish were from this company or if the source of the fish cannot be determined, consumers should immediately discard the fish and any foods made with these fish.
Symptoms of botulism poisoning can begin from six hours to 10 days after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth and muscle weakness that affects first the shoulders and then moves progressively down the rest of the body. Botulism poisoning can also cause paralysis of the breathing muscles which can result in death unless assistance with breathing (mechanical ventilation) is provided.
Individuals who show these symptoms and who may have recently eaten alewives/gaspereaux fish should seek immediate medical attention.
To learn more, see botulism symptoms, or please visit our additional site www.foodpoisoning.com.
The Law Firm of Eric Weinberg represents victims of food poisoning outbreaks throughout the country. To contact us, please call our toll free number at 1-877-934-6274, or click on Free Case Evaluation. To learn more about our law firm please see Food Poisoning Lawyer.
For recent outbreak and food recall news, please see Salmonella Outbreak Ohio and Minnesota, Listeria Bacon Bit Recall, and Listeria Burrito Recall.
December 15th, 2008
New York State Agriculture Commissioner Patrick Hooker issued a consumer alert on October 6, warning consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp., of Long Island City, NY, because it was uneviscerated and could be contaminated with Clostridium botulinum spores. The bacterium Clostridium botulinum can cause the life-threatening illness known as botulism.
According the the FDA alert:
Uneviscerated fish is prohibited under New York State Department of Agriculture and Markets’ regulations because Clostridium botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish. Uneviscerated fish has been linked to outbreaks of Botulism poisoning.
Because the fish is uneviscerated, the product may become contaminated with Clostridium botulinum spores, which can cause Botulism, a serious and potentially fatal food-borne illness. Symptoms of Botulism include blurred or double vision, general weakness, poor reflexes, difficulty swallowing and respiratory paralysis.
The “Frozen Salted Croaker” was sold in Hicksville and Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags. The FDA has advised consumers to not eat this product.
For more information about botulism, please visit our additional website www.foodpoisoning.com.
The Law Firm of Eric Weinberg represents victims of food poisoning outbreaks throughout the country. If you believe that you are the victim of foodborne botulism, please call us toll free at 1-877-934-6274, or click on Free Case Evaluation. To learn more about our practice, please see Food Poisoning Lawyer.
To learn more about recent food recalls, outbreaks, and legal news, please see Illinois E. coli Lettuce, Michigan E. coli Lettuce, Vermont E. coli Lawyer, and Salmonella IHOP.
October 12th, 2008
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Serious Adverse Events Are Linked To Botulinum Toxin Products:
