Less than one year after the U.S. Food and Drug Administration (“FDA”) approved the Omontys (peginesatide) injection, pharmaceutical company Affymax, Inc. (“Affymax”) and its partner, Takeda Pharmaceutical Co. (“Takeda”), voluntarily recalled the anemia treatment for kidney dialysis patients after reports of fatal allergic reactions.
Since its approval by the FDA in March 2012, more than 25,000 kidney dialysis patients have used Omontys to treat anemia stemming from chronic kidney disease. Omontys was favored over other similar drugs because it only had to be infused once a month as opposed to other anemia drugs that often must be given more than a dozen times per month. Omontys also broke the previous monopoly that Amgen’s Epogen and Aranesp had on treating anemia in dialysis clinics. Notably, Epogen and Aranesp have also run into their own safety problems, including an increased risk of heart attacks and strokes associated with the overuse of the drugs.
Unfortunately, on February 23, 2013, the FDA revealed that it had received nineteen reports of anaphylaxis, three to five of which resulted in death. Other patients required prompt medical attention, including resuscitation, or hospitalization. Anaphylaxis is a severe allergic reaction. While the severity of the reaction varies from person to person, symptoms include flushing of the skin, hives, swelling of the tongue and throat, and difficult swallowing and breathing. Symptoms can be life-threatening or fatal.
According to the New York Times, approximately 0.02% of patients treated with Omontys have experience a fatal reaction following the first intravenous administration. Overall, approximately 2 out of every 1,000 patients had a hypersensitivity reaction. These reactions were surprising given that no cases of hypersensitivity were recorded in any of the clinical trials. As a result, the original Omontys warning label contained no warning of possible allergic reactions. By August 2012, however, the FDA was receiving reports about severe allergic reactions to the drug. Additionally, by Fall 2012, Affymax contacted the FDA about adding an updated warning label, cautioning of the risk of severe allergic reaction.
Notably, both the FDA and the drug companies reported that the serious allergic reactions occur within 30 minutes of the drug being administered for the first time. There have been no reports of such allergic reactions in subsequent doses or in patients that completed their dialysis sessions. In fact, according to the press release issued by the drug companies, the most common adverse reactions in clinical studies of patients treated with Omontys were dyspnea, diarrhea, nausea, cough, and arteriovenous fistula site complication.
Due to the severity of the public health risk, Affymax and Takeda issued a statement that no new or existing patients should receive Omontys, and all lots of the drug, sold in 10mg and 20mg vials, have been recalled. In addition, the director of the FDA’s office of compliance, Howard Sklamberg, said in a statement “due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys. As a result, the February 23, 2012 FDA recall notice instructs all dialysis organizations to discontinue use immediately.
Chronic kidney disease affects millions of people in the United States each year. Specifically, according to a 2011 report addressing chronic kidney disease in Texas, as of 2008 approximately 33 million people in the United States (16% of the population) had chronic kidney disease. As of 2008, almost 44,000 Texans were receiving dialysis or had received a kidney transplant. In fact, the End-Stage Renal Disease incidence rate in Texas exceeds the national rate.
The San Antonio attorneys at Carabin & Shaw Law Firm are committed to informing the public of dangerous products and product recalls, including those drugs used to treat chronic kidney disease. If you have been injured by a dangerous pharmaceutical drug, please contact us today at 1-800-862-1260.
Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots – Serious Hypersensitivity Reactions, February 23, 2013, U.S. Food and Drug Administration
Anemia Drug Is Recalled After Allergic Reactions, by Andrew Pollack, New York Times
Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection, February 23, 2013, U.S. Food and Drug Administration
Addressing Chronic Kidney Disease In Texas, 2012, Texas Department of State Health Services