FDA: Painkillers with opioids must have overdose warning on package
ROCKVILLE, Md. Manufacturers of painkillers containing an opioid must strengthen labels for the drugs due to the risk of overdose, the Food and Drug Administration has ordered.
The FDA announced Tuesday that it would require the strengthened warnings in light of data linking propoxyphene and fatal overdoses. The drug has been on the market since 1957.
“Physicians need to be aware of the risk of overdose when prescribing these drugs,” FDA Center for Drug Evaluation and Research director Janet Woodcock stated. “They should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug’s label.”
The agency rejected a petition from the group Public Citizen calling for a phased withdrawal of the drug, saying that the benefits of the drug outweighed the risks.
CVS Caremark renews distribution agreements
SAN FRANCISCO McKesson has renewed its distribution agreement to supply CVS Caremark with branded and generic drugs, the company announced on Monday.
“CVS Caremark’s decision to renew its agreement with McKesson is reflective of the trusted relationship between our two companies and the value McKesson has delivered to CVS Caremark over the years,” stated Paul Julian, EVP, group president for McKesson. “McKesson’s comprehensive supply chain solutions help CVS Caremark ensure the highest levels of product availability and product integrity, empowering CVS Caremark to provide outstanding pharmaceutical care and further strengthen its competitive position.”
In related news, the retail giant also announced that it has renewed its distribution agreement with Cardinal Health. CVS Caremark said Cardinal Health will supply pharmaceuticals to its national network of retail pharmacies through mid-2013.
“We have a long-standing partnership with CVS Caremark, and we are proud to continue this important relationship,” said George Barrett, vice chairman of Cardinal Health and CEO of the Healthcare Supply Chain Services segment. “The footprint of the agreement is expected to be fundamentally the same as our existing relationship.”
Additional terms of the agreement were not disclosed.
FDA rejects application of pain-relief drug
PALATINE, Ill. The Food and Drug Administration has rejected an approval application for a pain-relief drug.
Acura Pharmaceuticals and King Pharmaceuticals announced that the FDA had issued a letter turning down their application for Acurox (oxycodone HC1, USP and niacin, USP), an immediate-release drug designed to relieve moderate to severe pain.
The companies said the letter expressed concerns about the potential abuse deterrent benefits of the drug. One of the drug’s ingredients, oxycodone, is a opiate-derived controlled substance popular with drug abusers.