July 9, 2009
Sandy G.
Data finds links to fatal overdoses; agency orders new safety study
From ConsumerAffairs.com
Perhaps partly satisfying its critics, the U.S. Food and Drug Administration (FDA) says it is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The agency said the actions were taken because of data linking propoxyphene and fatal overdoses.
The consumer group Public Citizen has been calling on the FDA to ban Darvon altogether, saying that the “old pain killer is a plain old killer.”
Instead, the agency is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed.
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~Sandy G.
CONSUMERAFFAIRS.COM Tags:
U.S. FOOD AND DRUG ADMINISTRATION (FDA),
STRONGER WARNING LABELS ON DARVON / DARVOCET,
FATAL OVERDOSES,
NEW SAFETY STUDY,
REDUCE THE RISK OF OVERDOSE IN PATIENTS USING PAIN MEDICATIONS,
PROPOXYPHENE,
PUBLIC CITIZEN CONSUMER GROUP,
POTENTIAL FOR OVERDOSE,
MEDICATION GUIDE,
DRUGS,
ANALGESICS,
PHYSICIANS,
PRESCRIBING DRUGS,
PRESCRIPTIONS,
PATIENT HISTORIES,
MEDICAL TREATMENT DECISIONS,
WARNINGS AND DIRECTIONS STATED WITHIN THE DRUG’S LABEL,
DR. JANET WOODCOCK,
FDA’S CENTER FOR DRUG EVALUATION AND RESEARCH,
PRESCRIBERS AND PATIENTS,
POTENTIAL RISKS,
PAIN THERAPY,
DR. SIDNEY WOLFE,
PUBLIC CITIZEN’S HEALTH RESEARCH GROUP,
FOOD AND DRUG ADMINISTRATION (FDA) ADVISORY COMMITTEE,
FEDERAL DRUG ABUSE WARNING NETWORK (DAWN),
DEATHS RELATED TO THE USE OF PROPOXYPHENE,
BENEFIT-TO-RISK RATIOS,
25 TOP-SELLING DRUGS IN THE COUNTRY,
PHARMACEUTICALS,
CENTERS FOR MEDICARE & MEDICAID SERVICES,
THE VETERANS HEALTH ADMINISTRATION,
PAIN RELIEVERS,
FOOD DRUG AND COSMETIC ACT,
SAFETY LABELING CHANGES,
CITIZEN PETITION,
FDA DENIED A CITIZEN PETITION REQUESTING A PHASED WITHDRAWAL OF PROPOXYPHENE,
OPIOIDS,
TREATMENT FOR PAIN,
SIDE EFFECTS,
LIGHTHEADEDNESS,
DIZZINESS,
SEDATION,
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VOMITINGEntry Filed under: CONSUMER INFORMATION, NEWS
