Popular Painkiller in Short Supply at Hospitals Following Hospira Recall
February 13, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
Hospira, Inc. earlier this week announced on the U.S. Food and Drug Administration (FDA)'s website the voluntary recall of multiple lots of ketorolac tromethamine injection due to contamination by floating particles. Hospira said that more than 60 lots, distributed in the U.S. from February 2013 to December 2014 and in Singapore from January to July 2014, were affected by the particulate, identified as calcium-ketorolac crystals.
Though Hospira has not received any reports of adverse events associated with these lots, the company said such events could include localized inflammation, allergic reaction, granuloma formation or microembolic effects, or delay of therapy due to particulates blocking the infusion of solution.
In the wake of this recall, which Hospira informed customers about in January 2015, the FDA has placed ketorolac tromethamine on its drug shortages list.
Fresenius Kabi AG, the only other supplier of ketorolac tromethamine to the US market, has stepped up production of its version of the drug, a spokesperson for the company told the Wall Street Journal (WSJ). Hospira supplies approximately 95 percent of the U.S.
“Now that there is a supply interruption for ketorolac, Fresenius Kabi is currently the only remaining supplier to meet customer and patient needs in the U.S.,” the Fresenius spokesman said.
Ketorolac tromethamine is a type of analgesic, or pain medication, referred to as a nonsteroidal anti-inflammatory drug (NSAID). Doctors prescribe the drug for the treatment of short-term moderate to severe pain, often before or after medical procedures or surgery. Another reason doctors prescribe the drug is because it can reduce the amount of opioid medication a patient needs. Opioids come with uncomfortable side effects, such as constipation, as well as a risk of abuse.
Hospira has experienced a number of manufacturing problems in the past few years. In 2010, the company received several warning letters from the FDA regarding compliance issues at its North Carolina plant. In February 2013, Hospira reported it received from the FDA a list of ten objectionable conditions at its medical device quality systems at its headquarters in Lake Forest, Ill., according to Reuters. May 2013 saw the company receive another warning letter from the FDA, this one regarding a plant in India, reported Forbes. In October 2014, the company received a warning letter about its manufacturing facility in Australia, reported the WSJ.
Despite the Hospira’s recent track record, Pfizer Inc. announced earlier this month that it would purchase Hospira for $17 billion. Pfizer does not seem concerned with Hospira’s manufacturing problems. “The proposed acquisition of Hospira demonstrates our commitment to prudently deploy capital to create shareholder value and deliver incremental revenue and EPS growth in the near-term,” said Ian Read, chair and chief executive of Pfizer in a statement.
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