FDA serves warrant at N.J. company amid peanut concerns
ROCKVILLE, Md. U.S. Marshals executed an inspection warrant Wednesday at a company that refused to give the Food and Drug Administration access to distribution documents concerning possibly contaminated peanuts from now-defunct Peanut Corporation of America.
The FDA said that Westco Fruit and Nuts refused to give the agency access to its documents or recall products following an FDA request. PCA removed hundreds of lots of peanut products from the market over concerns of contamination with Salmonella bacteria following inspections of its plants in Georgia and Texas. The Irvington, N.J.-based company, also known as Westco/Westcott, received three shipments of oil roasted salted redskin jumbo peanuts from PCA’s Blakely, Ga., processing plant.
“FDA’s enforcement action against Westco Fruit and Nuts is an appropriate step toward removing potentially harmful products from the marketplace, especially when, as in this case, a company is unwilling to share information FDA needs to ensure food safety,” FDA acting associate commissioner for regulatory affairs Michael Chappell said. “The FDA uses all appropriate legal means necessary to obtain information and fully investigate firms or individuals who put the health of consumers at risk.”
The FDA originally requested that the company recall all products containing peanuts from PCA on March 23. Three days later, the agency issued a formal notice to Westco/Westcott requesting access to records concerning distribution of products containing PCA peanuts. The company declined both requests.
The agency has not received reports of sickness resulting from Westco/Westcott products.
New antidepressant drug now available in the United States
BRIDGEWATER, N.J. A new therapy for treating major depressive disorder in adults has become available in the United States, the drug’s manufacturer announced Tuesday.
Sanofi-Aventis U.S. said that Aplenzin (bupropion hydrobromide) extended-release tablets differed from other branded and generic bupropion antidepressants because it provides a unique HBr salt extended-release formulation.
“For patients who show little clinical improvement on lower doses of bupropion, there is a need to take higher doses to treat major depressive disorder,” Duke University Medical Center consulting professor of psychiatry and behavioral sciences Prakash Masand said in a statement. “Aplenzin offers patients and physicians an alternative option which only requires one tablet, once a day at the highest bupropion dose. This provides a simple, convenient option for patients that currently need to take two to three tablets daily.”
The Food and Drug Administration originally approved the drug in April 2008. Sanofi licensed the drug from Biovail Corp. in December and markets it in the United States, including Puerto Rico.
The ASA, MedicAlert join forces to create 24-hour protection system for patients with autism, related illnesses
TURLOCK, Calif. The Autism Society of America and MedicAlert will collaborate to create a 24-hour protection system for people with autism-related illnesses and their families.
The ASA and MedicAlert said Tuesday that they would offer the system through the MedicAlert + Safe and Sound program.
“We are delighted by our new relationship with ASA,” MedicAlert president and CEO Martin Kabat said. “MedicAlert was originally founded to protect children in times of medical emergencies, and we believe this program goes right to the heart of our mission and history.”
Each person enrolled in the program will be given a personalized medical ID and wallet card to provide identification information, details on critical medical conditions and life-threatening allergies for emergency responders.