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FDA Adds Additional Requirements and Stronger Warnings to Propoxyphene
The US Food and Drug Administration (FDA), on July 7, 2009, announced additional
requirements for propoxyphene manufacturers to strengthen the drug’s boxed warning
and to create a medication guide for patients. The agency’s actions involved a response
to new data on fatal overdoses linked to pain medications containing propoxyphene,
such as Darvon and Darvocet (FDA Web Site).
The FDA indicated that in cases of overdose, propoxyphene use can lead to fatal
adverse events. It noted, however, that most of the deaths attributed to propoxyphene
in its database involved cases where patients ingested multiple drugs. As a result,
the FDA is examining how Americans are using medications containing propoxyphene
and in what combinations.
The agency also defended its position in not removing propoxyphene medications from
the market, despite petitions for the opposite action from the consumer group Public
Citizen in February, 2006. Its rationale included the observation that very few
alternatives to propoxyphene exist for treating mild to moderate pain without similar
adverse effects. The FDA stated that it stands committed to the appropriate treatment
of pain. According to Janet Woodcock, MD, Director of the FDA’s Center for Drug
Evaluation and Research, propoxyphene remains an acceptable choice for the treatment
of mild to moderate pain provided that the drug is taken as directed.
Cerilliant offers certified solution standards of propoxyphene and its metabolite
norpropoxyphene as well as their labeled analogs. Cerilliant also provides certified
solution standards for a wide variety of opioid analgesics used in pain management
therapies, including fentanyl,
methadone,
tramadol and numerous opiates. Click on the links below to view these featured
Snap-N-Shoot® or Snap-N-Spike™ solution standards:
Cerilliant
Certified Drug Standards of Propoxyphene and Norpropoxyphene
Cerilliant
Certified Opiate Drug Standards
Cerilliant
Certified Opioid Drug Standards
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