Navigation Links
FDA Mandates Tougher Warnings for Pain Pills

Drugs like Darvon, Darvocet have been linked to fatal overdoses

TUESDAY, July 7 (HealthDay News) -- Concerns about the possibility of fatal overdoses led U.S. health officials Tuesday to take several steps to limit the risk of using pain medications containing propoxyphene, including Darvon and Darvocet.

Manufacturers must strengthen the labels of propoxyphene-containing products by adding boxed warnings that emphasize the potential for overdose and developing medication guides to be given to each person filling or refilling a prescription.

The manufacturers must also conduct a new safety study to assess unanswered questions, such as how propoxyphene affects the heart when taken at higher-than-recommended doses, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, said during a news conference.

The FDA is also working with several health-care organizations to collect additional safety data on these products, Woodcock said, adding that "the data we accumulate could result in additional regulatory action."

Woodcock also announced that the FDA has denied a petition from the consumer advocacy group Public Citizen asking for a phased withdrawal of products containing propoxyphene.

"The reason for the denial is that FDA has determined that propoxyphene is an acceptable option for relief of mild-to-moderate pain when taken as directed," she said. "Moreover, FDA recognizes that other options clinicians might have for pain management come with their own safety concerns."

Propoxyphene-containing products have been linked to fatal overdoses, FDA officials said. Between 1959 and 2005, 91 deaths attributed to an overdose of these products have been recorded in the adverse-events database, said Dr. Gerald Dal Pan, head of the FDA's office of surveillance and epidemiology.

But that database would not necessarily register information on deliberate overdosing, Woodcock said.

Last month, European regulators called for the withdrawal of dextropropoxyphene from the market because people taking the 50-year-old drug have been dying from overdoses.

Dextropropoxyphene, which is called propoxyphene in the United States, is an opioid widely used to treat mild to moderate pain. It was first introduced in the United States in 1957 under the brand name Darvon and is marketed today by a wide number of generic drug makers.

Last week, an FDA advisory panel recommended that the popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, be banned.

Darvocet contains acetaminophen.

More information

The U.S. Food and Drug Administration has more on propoxyphene.

SOURCES: July 7, 2009, teleconference with Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Gerald Dal Pan, M.D., director, office of surveillance and epidemiology, U.S. Food and Drug Administration

Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. ACM Helps Medicaid Programs Comply With Federal Deficit Reduction Act Mandates
2. New Study: Health Insurance Mandates on Employers Hurt Low-Income Employees
3. CAHI Releases Updated Health Insurance Mandates in the States
4. Most Companies Oppose Single-Payer Health Care System, State Coverage Mandates
5. FDA Mandates Black Box Warning for Some Antibiotics
6. Economic Stimulus Bill Mandates Electronic Health Records for Every Citizen without Opt-out or Patient Consent Provisions
7. Economic Stimulus Bill Mandates Electronic Health Records for Every American by 2014 - With No Opt-out Provision
8. Refuting Misconceptions About Health Insurance Mandates
9. FDA Mandates New Warnings for Botox
10. Controlling Risk Mandates Health Insurance Reviews
11. Blood Pressure Tougher to Tame in Winter
Post Your Comments:
(Date:11/25/2015)... San Mateo, CA (PRWEB) , ... November 25, 2015 , ... ... $15,000 in prizes were awarded to winners of the Create Real Impact awards. ... and creative expression to help stem the tide of distracted and reckless driving, the ...
(Date:11/24/2015)... ... November 24, 2015 , ... Dr. Todd S. Afferica, a ... services to many of his patients. Dr. Afferica now uses the BIOLASE WaterLase iPlus ... amount of time the doctor uses other traditional cutting tools, such as the scalpel ...
(Date:11/24/2015)... , ... November 24, 2015 , ... ... launched their Black Friday sale a week early, offering 40% off select bras ... the intimate apparel industry through both mobile fit technology and the latest fashion, ...
(Date:11/24/2015)... IL (PRWEB) , ... November 24, 2015 , ... ... are national leaders when it comes to several aspects of orthopedic care. They ... joint replacements, orthopedic surgeries and general orthopedic care. , Becker's Hospital Review ...
(Date:11/24/2015)... ... November 24, 2015 , ... Brillouin Energy Corp. Congress ... the developer of renewable energy technologies capable of producing commercially useful amounts of ... that its WET™ and HHT™ Boiler System reactor core modules were presented to ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... , Nov. 25, 2015 /PRNewswire/ ... "Company") (NYSE: MR ), a ... medical devices worldwide, today announced that ... general meeting of shareholders at the ... Grand Century, 193 Prince Edward West Road, ...
(Date:11/25/2015)... Pennsylvania , November 25, 2015 - ... Continuing Medical Education (CME) --> ... Continuing Medical Education (CME) --> ... Care Continuing Medical Education (CME) ... medical information products and services, will feature latest diagnostic imaging textbooks ...
(Date:11/25/2015)... , Frankreich, November 25, 2015 ... heute bekanntgegeben, dass sie eine Lizenz für das Patent ... Poxel, CNRS, UCBL und ENS-Lyon innehaben, an Enyo Pharma ... von FUI AAP8 ins Leben gerufenen und von Edelris ... wurde FXR als ein Behandlungsziel für HBV identifiziert, und ...
Breaking Medicine Technology: