The FDA recently issued a communication warning the public about tainted peanut products. These products are available for purchase in stores and by ambulant and street vendors and pertain mostly to adobo (fried peanuts with garlic) and nilaga (boiled) peanuts. According to the FDA, some of these products were tested and found to be contaminated with the cancer-causing fungi Aflatoxin B1, a byproduct of mold.
The Turkish police department announced they had made a significant discovery pertaining to the counterfeiting of certain medications, some of which are used as cancer treatments. As a result, 56 individuals have been arrested and the counterfeit drugs were identified as being exported to the United States as part of an organized crime ring.
Recently the FDA issued a drug concern on their website asking all prescription drug manufacturers to limit the milligram dosage of their acetaminophen tablets to 325 milligrams each or less. According to the press release, the limitation is referring to medications that are manufactured as part of an intended combination therapy.
For the first time, the FDA approved a combination therapy for melanoma. The treatment, which is marketed by GlaxoSmithKline, consists of Dabrafenib (Tanfinlar) and Trametinib (Mekinist). As stand-alone treatments, each drug received their single treatment approval from the FDA in 2013 for use in the treatment of metastatic or unresectable melanoma. The drugs are prescribed with the confirmation of a companion diagnostic test and can only be used on patients with the BRAF V600E or the V600K melanoma mutation.
Teva Pharmaceutical Industries Ltd announced in a January 9 press release that it had appointed Erez Vigodman as the company’s new President and CEO. Vigodman is set to begin his duties effective February 11, 2014. Vigodman succeeds the interim President and CEO, Eyal Desheh, who will return to his previous position as Group EVP and Chief Financial Officer.
The FDA issued a safety warning to the public on January 9, 2014 addressing the safety concerns they have regarding over-the-counter sodium phosphate drugs, which are used to treat constipation. According to the FDA website, using more than one directional dosage of these medications over the course of 24-hours, can lead to serious health risks including harm to the heart and kidneys, and could even lead to death. Taking a higher dose than the recommended amount may produce the same results, even if taken once a day.
The FDA issued a policy of voluntarily decreasing the antibiotics used in livestock to only those deemed medically necessary. However, because the use of antibiotics prophylactically is considered medically necessary, no great change is anticipated from this policy.
Pradaxa (dabigatran), a relatively new anticoagulant used to treat non-valvular atrial fibrillation is being reassessed for safety by the FDA. Pradaxa is a fixed dose medication that is given twice daily and competes with Coumadin (warfarin), a more commonly used anticoagulant. Patients on Coumadin must have their blood monitored regularly, whereas Pradaxa does not require therapeutic monitoring.
Jerusalem-based Teva Pharmaceutical Industries Ltd. announced in a January 3 report it will be launching the 2mg and 4 mg versions of the authorized generic of Detrol® LA (Tolterodine Tartrate extended-release capsules) for the US market.