Tamiflu investigation leaves business continuity planners confused In a statement the FDA explained the reason for the investigation, stating that “In the safety review mandated by the BPCA (Best Pharmaceuticals for Children Act) a number of adverse event reports [have been] identified associated with the use of Tamiflu in children 16 years of age or younger. These adverse event reports were primarily related to unusual neurologic or psychiatric events such as delirium, hallucinations, confusion, abnormal behavior, convulsions, and encephalitis. These events were reported almost entirely in children from Japan who received Tamiflu according to Japanese treatment guidelines (very similar but not identical to U.S. treatment guidelines). The review identified a total of 12 deaths in pediatric patients since Tamiflu's approval. All of the pediatric deaths were reported in Japanese children. In many of these cases, a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions, and/or lack of adequate detail in the reports.” “The review also identified severe skin reactions (like allergic reactions) in some pediatric patients. These events were not all reported in Japanese children and have also been reported in adults. Severe skin reactions in all age groups are currently being reviewed in more detail.” Some reporting in national media may have left business continuity planners concerned that there is an immediate risk that the drug will be withdrawn. This is extremely unlikely. According to the FDA it will be up to two years before research into the contraindications is complete and it would be very unusual for any change in allowable drug usage to occur before then. Business continuity managers can rest relatively secure in the knowledge that any drugs they have stockpiled will be usable for at least the next ‘flu season. More information on the FDA investigation
•Date: 18th Nov 2005 • Region: US/World • Type: Article •Topic: BC general |
