WARNINGS, MONITORING OF FLU VACCINES RECOMMENDED BY FDA
In the fall and winter of the year, Americans are urged to get their flu shots. Many see this as an excellent idea and willingly comply. Others are not so certain it’s needed and don’t fall into line to get flu shots for a variety of reasons.
Persons who are leery of accepting flu shots have additional reasons to bypass them this year based on the recent recommendations of a U.S. Food and Drug Administration panel. In a safety review recently released by the FDA’s Division of Antiviral Products, a stronger label warning was urged for two popular flu drugs for which a variety of complaints have been received. It also urged stricter monitoring of children taking these flu medications.
Tamiflu and Relenza are the two drugs for which stronger warnings and monitoring were recommended. Tamiflu, produced by Roche, is approved both as a preventative and a treatment for flu in adults and children aged 1 year and older. Relenza, made by GlaxoSmithKline, is approved as both a flupreventative and a treatment in adults and children aged 5 years and older.
According to the FDA safety review, there have been 596 reported cases of psychiatric behavior associated with Tamiflu use. Most of these cases happened among patients aged 21 or younger. The majority (75 percent) occurred in Japan. Fifty-nine of the cases were classified as delirium with impulsivebehavior and self-injury. Delirium, delusions, hallucinations or psychosis accounted for another 225 cases. In total, five children died “as a result of falls from windows or balconies or running into traffic,”the safety review found, and three adults committed suicide, all in Japan.
The FDA safety review also reported that in cases involving Relenza, again mostly in Japan, there have been 115 reports of “delirium with impulsive behavior and self-injury in which the patient expressed ‘fear’ and attempted to flee or expressed a desire to ‘jump,’” the agency said. There were no deaths associated with Relenza.
Both drug manufacture’s defended their product in statements following the hearing. “According to data analyzed from two U.S. claims databases of more than 150,000 patients, there is no increased risk for neuropsychiatric events in influenza patients treated with Tamiflu compared to untreated influenza patients,” the Roche statement said. The GlaxoSmithKline company statement said, “We believe the current Relenza U.S. prescribing information accurately reflects the safety profile of the drug,” adding that there was “no conclusive evidence of a causal association between Relenza and neuropsychiatric events.”
The best way to battle the flu this season is to keep your body healthy. This can be achieved with a good diet, exercise and Chiropractic or Acupuncture treatments from your local, natural, healthcare providers. Good health comes from within.