From Thursday onwards all formulations of the blood thinner heparin shipped in the US will be only 90 per cent the strength of previous version, according to the FDA.
The Food and Drug Administration (FDA) issued the statement last week to remind physicians of the change, which comes about as a result of the revised United States Pharmacopeia’s (USP) monograph that became effective on October 1.
The monograph, which makes it easier to detect the impurities thought responsible for a significant number of deaths over the last few years, dictates that from now on heparin is less potent which, the agency said, should be considered when using it.
John Jenkins from the FDA’s office of new drugs told the Chicago Tribune that: "Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin.”
APP adds “N” for new to label
APP Pharmaceuticals, which along with B Braun Medical, Baxter and Hospira are the remaining players in the US heparin market, said that it supports the implementation of the new monograph and welcomes the work done by the FDA.
The Illinois based firm said that it will add an “N” to the expiration date of all new heparin vials to allow users to clearly differentiate new formulations from old stocks already held by hospitals and surgeries.
Company CEO Thomas Silberg said that: “From safety and quality measures in the manufacturing process, to helping prevent medical errors with cap, label and bar code enhancements, we remain committed to our promise of consistent supply and unparalleled quality.”
These thoughts were echoed by CSO Christopher Bryant, who said AAP will “continue our collaborative work with the FDA to develop the best industry solutions for implementing and meeting these new USP standards and provide customers with greater confidence in the purity of their Heparin product.”
APP is also making an advisory webinar, “Readiness for New USP Standard for Unfractionated Heparin,” that it launched late last month available through its website