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Tumor Necrosis Factor Inhibitor Recall

While the FDA has approved multiple tumor necrosis factor inhibitors, a number of them have been recalled because of problems related to packaging and distribution. There has not been health-related recalls, but some clinical studies link the drugs to an increased risk of developing cancer.

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As of 2014, the FDA has approved five tumor necrosis factor (TNF) inhibitors for market sales: 1

  • Cimzia (certolizumab pegol)
  • Enbrel (etanercept)
  • Humira (adalimumab)
  • Remicade (infliximab)
  • Simponi and Simponi Aria (golimumab)

To date, recalls have been issued for selected lots of Enbrel, Humira and Simponi products.

Bulk Cardinal Health Care TNF Inhibitor Recall

In 2008, approximately 11,000 units of more than 170 drug products were recalled by Cardinal Health Care, a pharmaceutical distribution company. Included in the recall were several lots of Humira pens and syringes and Enbrel autoinjectors, vials and syringes.

Cardinal Health stated that a defective refrigerated storage unit may have jeopardized the drugs, resulting in potential product instability. Distribution of the recalled items was limited to selected states in the Southern U.S., including Alabama, Georgia, Missouri, Mississippi, South Carolina, Tennessee and West Virginia. 2

Humira Recalls

In March 2010, multiple lots of Humira Psoriasis Starter Packages were recalled by Abbott Laboratories due to improper packaging. According to an FDA report, the recall affected single-use pens designed for subcutaneous use. Some of the device packages were assembled in a way that did not consistently adhere to the recommended dosages for initial use. Nearly 12,000 starter packages distributed throughout the United States, Bermuda and the Caymen Islands were affected. 3

In April 2011, Abbott Laboratories recalled another 80,000 cartons of Humira pen cartons due to the possibility of broken glass in the packaging that could harm users. The pens had been distributed across the United States, including Puerto Rico. 4

Simponi Recall

In February 2011, Centocor Ortho Biotech issued a recall for one lot of Simponi, which was packaged in 50 mg, single-dose SmartInject devices. 5 The FDA’s recall notice reports that the delivery system in affected devices may not have been properly calculated, and the products may deliver incomplete dosages of the drug. 6

FDA Investigations anti-TNF treatment

Although the FDA has not issued any recalls due to the health risks of anti-TNF treatments, ongoing clinical studies and investigations have discovered that patients who take TNF inhibitors have an increased chance of developing various forms of cancer, including melanoma and a rare white-blood cell cancer known as Hepatosplenic T-Cell Lymphoma (HSTCL).

If you or a loved one has suffered from adverse effects of TNF inhibitors, you should seek professional advice to better understand your legal options.

  1. González-Rivera, Tania C. Anti-TNF. (Updated June 2012). American College of Rheumatology. Accessed Aug. 4, 2014
  2. U.S. Food and Drug Administration. Enforcement Report for January 13, 2010. (Jan. 13, 2010.). Accessed Aug. 5, 2014. from https://www.fda.gov/
  3. U.S. Food and Drug Administration. Enforcement Report for March 10, 2010. (March 10, 2010). Accessed Aug. 5, 2014. from https://www.fda.gov/
  4. U.S. Food and Drug Administration. Enforcement Report for April 27, 2011. (April 27, 2011). Accessed Aug. 5, 2014. from https://www.fda.gov/
  5. Petrochko, Cole. Recall Puts TNF Inhibitor in Short Supply. (Feb. 21, 2011). MedPage Today. Accessed Aug. 5, 2014.
  6. U.S. Food and Drug Administration. Enforcement Report for April 13, 2011. (April 13, 2011). Accessed Aug. 5, 2014. from https://www.fda.gov/