FDA to review possibilities of adverse Tamiflu effects
WASHINGTON With flu season in full swing, the Food and Drug Administration is set to review reports of brain effects in children who used Tamiflu during the past eight years.
The panel, according to USA Today, will review reports that cite the medication caused more than 1,800 children to exhibit abnormal behavior. Fifty-five of the children affected by the medication were U.S. residents.
Twenty-two of the U.S. reports were considered “serious,” with symptoms such as convulsions, delirium or delusions, says Terry Hurley, spokesman for drugmaker Roche Laboratories.
The FDA approved Tamiflu in 1999.
While none of the U.S. cases resulted in death, Hurley said, five deaths have been reported in Japan, as a result of neurological or psychiatric problems. The children were under the age of 16. “Four were fatal falls, and one was encephalitis in a patient with leukemia,” Hurley said.
In addition, in people ages 17 to 21, there were two deaths in Japan, one a “fatal accident with abnormal behavior,” Hurley said, and the second as a result of a brain infection known as encephalopathy. Seven adult deaths attributed to neuropsychiatric problems also have been reported in Japan.
While the medication has been thought to be the cause of these fatalities, Roche’s spokesman refuted by saying that there is no evidence Tamiflu caused the episodes, and notes that similar symptoms have been reported in flu patients who had not taken Tamiflu. he added that the company is doing further studies to assure this.
Japan has been the major market for Tamiflu, accounting for 75 percent of the 48 million prescriptions written, USA Today said in their report. Hurley said in E-mail that 1,745 of the 1,808 reports of problems associated with Tamiflu are in Japan. He said 81 percent of all reports were “defined as non-serious.”
In the U.S., Hurley said, 2.85 million Tamiflu prescriptions have been written since 1999. A year ago Roche added a warning to its package insert label saying “people with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu,” and that their behavior should be monitored.
Gene Logic receives milestone payment from Pfizer for drug repositioning
GAITHERSBURG, Md. Gene Logic has reached a collaboration milestone, triggered by the filing of a patent application for a new use of an existing Pfizer drug candidate to treat solid tumors. Gene Logic’s Drug Repositioning Division discovered the new use for the unapproved drug candidate.
Under its drug repositioning agreement with Pfizer, Gene Logic has been seeking new therapeutic applications for selected drug candidates that are no longer in active development. The terms of the agreement provide for payment by Pfizer to Gene Logic of success-based milestones per compound and royalties on the commercialization of drugs whose repositioning results from Gene Logic’s Drug Repositioning Program. Gene Logic will receive a small initial milestone payment as a result of the filing of the patent application.
“We are pleased to see our Drug Repositioning Program yielding potentially valuable intellectual property for Pfizer. Our goal is to apply our drug repositioning capabilities to complement our partners’ internal pipeline development efforts,” Charles L. Dimmler, III, Gene Logic’s chief executive officer and president, said. “By finding new indications for de-prioritized, clinical stage drug candidates, our partners have another route to build value in their pipeline. We consider the filing of this patent application by Pfizer to be a substantive validation that our systematic approach to drug repositioning is working effectively.”
MedCenter system features monthly, not weekly pill boxes
CINCINNATI With more and more patients forgetting to take their medications daily, technology has been developed to help these patients remember to take their medications each day and on time. The newest product on the market is the MedCenter System, a reminder system that combines a monthly medication organizer with an alarm clock that verbally reminds users to take their pills.
Unlike most weekly pill boxes, the MedCenter system consists of 31 daily date-specific pill boxes with four compartments so that the users can organize pills by daily dose times. Each day, the user visually matches the day of the months’ box with the clock’s large LCD date. At each dosage time, the talking alarm clock will remind the user to take his medication.
Many national retailers are already stocking the new product, ($69.95), including Kroger pharmacies. In addition, it’s available online at www.medcentersytems.com or amazon.com. More product information is available online www.medcentersystems.com.
“As my parents begin to age and their medications increased in number, they needed reminders to make certain that they took them properly,” said the inventor Martin Cooper. “The MedCenter system gives my brothers and me peace of mind that Mom and Dad are taking their medication properly.”