FDA takes action against unapproved hydrocodone manufacturers
WASHINGTON The Food and Drug Administration is taking action against manufacturers of unapproved prescription drug products containing hydrcodone, a narcotic widely used for the treatment of pain and suppressing coughs.
The agency has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved to approved drugs.
“Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs,” said Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “A case in point—no hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age.”
Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before Oct. 31. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before Dec. 31, and must cease further shipment in interstate commerce on or before March 31, 2008. Further legal action could be taken against those failing to meet these deadlines.
Vector One finds antidepressant scripts for teens fell in last four years
YARDLEY, Pa. Total prescriptions of antidepressant drugs for teenagers age 13 to 17 decreased nearly 18 percent between July 2003 and July 2007, according to Verispan’s Vector One.
On the other hand, antidepressant prescriptions for patients 18 and older have grown about 13 percent during the same four-year period.
Verispan’s Physician Drug & Diagnosis Audit reports that visits by teenagers to physicians for depression decreased 23 percent in the past four years. Visits by teenage males dropped by 5 percent more than females. The percentage of teenage visits to doctors for depression where a prescription was issued dropped from 85 percent in the 12 months ending July 2004 to 69 percent in the 12 months ending July 2007.
NFID and CDC to spend $5 million on flu information
WASHINGTON The National Foundation for Infectious Diseases and the Centers for Disease Control will spend about $5 million combined to spread the word about obtaining a flu vaccination, according to PRWeek. There will be about 132 million doses of the vaccine for this flu season and these two organizations want to make sure they do not go to waste.
Both realize that the money they’re spending is not a lot, but they hope it’s a start to help prolong the season of vaccinations by months compared to previous years. Previously, the season for vaccinations essentially ended with the Thanksgiving holiday, explained Len Novick, executive director of the NFID. But with the addition of the week’s events, both groups are hoping to better spread awareness efforts deeper into the year and help keep the issue relevant through the New Year. Also, the goal is to spread the word to people who usually do not receive a flu vaccination. This is aimed at hopefully controlling the spread of the virus.
The CDC also plans on working with the Department of Health and Human Services and the Centers for Medicare and Medicaid Services. The NFID plans on working with the American Medical Association and the American Academy of Pediatrics, as well as the American Association of Retired Persons.