New Food Warning….
FDA is warning consumers to avoid eating tomalley in American lobster (also called Maine lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause paralytic shellfish poisoning (PSP). These types of lobster are harvested from the Atlantic Ocean from Northeastern Canada to South Carolina . The FDA advisory applies only to tomalley — the soft, green substance found in the body cavity of the lobster that functions as the liver and pancreas. Cooking does not eliminate the PSP toxins.
New Type of Genetic Test Approved for Breast Cancer Patients
FDA has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). The SPOT-Light HER2 CISH test kit measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells.
FDA Requests Stronger Warnings on Fluoroquinolone Antimicrobial Drugs
FDA has notified makers of fluoroquinolone antimicrobial drugs that a “boxed warning“ in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary and a guide must be made available to patients that explains possible side effects. Fluoroquinolones are approved to treat or prevent certain bacterial infections.
Pharmaceuticals Gets Flagged
Xiadafil VIP Tablets Seized After Company Refuses to Recall Product
U.S. marshals have seized nearly $74,000 worth of Xiadafil VIP tablets (lots 6K029 and 6K209-SEI) distributed by Florida-based SEI Pharmaceuticals Inc. Although this product is marketed as a dietary supplement to treat erectile dysfunction and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.
Consumer Health Information
› Making Sense of Vytorin Concerns
products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.
FDA Revises Process for Responding to Drug Applications
FDA is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. The agency will no longer issue “approvable” or “not approvable” letters when a drug application is not approved. Instead, it will issue a “complete response” letter that lets a company know the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.