Amgen recalls nearly 1 million U.S. bottles of heart drug Corlanor over possible contamination

Amgen, a California-based biopharmaceutical company, is voluntarily recalling nearly 1 million bottles of Corlanor (ivabradine), a heart medicine, because of possible contamination, according to the Food and Drug Administration. The development raises concerns for patients who depend on the drug to manage their cardiac symptoms. 

The move comes alongside a recall involving another of Amgen's medicines.

What happened?

Amgen started the recall June 4 because of the "presence of foreign substance." On June 23, the FDA categorized it as a Class II recall, which means it's a temporary or moderate-risk situation that could cause short-term or reversible health effects. 

Among the products covered are 934,577 bottles of 5-milligram Corlanor packaged in 14-tablet and 60-tablet sizes and 7.5-mg Corlanor in 60-tablet sizes.

A recall alert from the California State Board of Pharmacy stated that there was "a low-frequency event of an unexpected foreign matter in the reserve sample of one of the identified lots" and that it was found on the medication's coating. Tests found that the foreign matter does not pose a clinical risk to patients. 

Amgen also pulled 30-, 60-, and 90-mg doses of Sensipar in 30-tablet bottles, according to the FDA. 

Why does it matter?

Corlanor is commonly prescribed for adults with chronic heart failure and for children at least six months old who have stable heart failure symptoms linked to an enlarged heart.

Sensipar is used to treat calcium- and parathyroid-related disorders.

In late June, European Union regulators moved to pull authorization for Tavneos, Amgen's vasculitis drug, after determining its benefits were "no longer proven to outweigh its risks."

What's being done?

Amgen initiated the recall process, and the FDA published actions and information in its records. That allows patients, pharmacies, health systems, distributors, and other supply-chain partners to identify and remove affected bottles from circulation.

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