Eprex Recall Issued by Johnson & Johnson Due to Potency Issue

About 200,000 syringes of Johnson & Johnson’s anemia drug Eprex, which is known here as Procrit, have been recalled worldwide because of potency issues. However, none of the recalled lots of the drug were distributed to the United States. 

Johnson & Johnson announced the Eprex recall last week, indicating that most of the syringes affected have likely already been used, leaving only about 6,300 on the market.

Internal quality testing on samples from the recalled Eprex lots revealed that some batches were less potent than they are supposed to be. However, there have been no reports of adverse events associated with the low-potency Eprex injections.

Eprex is distributed worldwide by Janssen Pharmaceuticals, a division of Johnson & Johnson. Various divisions of the worldwide pharmaceutical maker have been plagued by manufacturing and production issues in recent years, which have resulted in the recall of many different Johnson & Johnson drugs.

The recall only affects two lots of Eprex that were sold in 17 different countries outside the U.S., including the United Kingdom, Canada, Albania, Australia, Belgium, Egypt, France, Germany, Ireland, Israel, Italy, New Zealand, Portugal, Russia, Spain, Sweden and Taiwan. The recalled Eprex syringes contain expiration dates of January 2012.

Eprex/Procrit (Epoetin alfa) is prescribed to patients with kidney disease, anemia, HIV and cancer to stimulate bones to increase the production of red blood cells. It is also prescribed to patients preparing to undergo major non-heart surgery to reduce the number of transfusions such patients must receive.

Johnson & Johnson generated $1.9 billion in sales last year from Eprex and Procrit.

In 2007, the FDA issued a public health advisory indicating that side effects of Procrit and similar anemia drugs could increase the risk of injury or death at high doses. The FDA required that the drugs add a “black box warning” in the United States alerting patients to the risk of blood clots, strokes, heart attacks and death. The black box warning is the strongest label warning the FDA can require of a medication.

In February 2010, the FDA announced that it was restricting the prescription of Procrit and other similar anemia drugs under a risk evaluation and mitigation strategy (REMS). Doctors and hospitals that wish to prescribe the drugs in the United States now have to undergo special training to identify high risk users and negative side effects.  Cancer patients using the drugs are of special concern, because some studies indicate that the drugs can stimulate tumor growth.