Omontys is an injectable drug used to treat anemia in dialysis patients with chronic kidney disease. It was manufactured by Affymax, Inc. and Takeda Pharmaceutical Company.
Following reports of serious hypersensitivity and allergic reactions, including anaphylaxis, caused by Omontys, Affymax and Takeda issued a voluntary recall of the drug. For help filing a claim, contact our Omontys lawyers today.
Reported Complications of Omontys
The most serious complication of Omontys is anaphylaxis, a severe, potentially life-threatening allergic reaction. It causes your immune system to release a flood of chemicals that can escalate into anaphylactic shock, which occurs when your blood pressure drops suddenly and your airways narrow, blocking breathing.
Dialysis centers in the United States submitted 19 reports of anaphylaxis caused by Omontys. This high rate of severe allergic reactions led to the drug being recalled. The drug manufacturers instructed that Omontys should not be provided to any new patients, and the FDA warned that all current treatments with Omontys should be immediately stopped.
Other complications include hypersensitivity and less severe allergic reactions. Omontys is also associated with muscle pain, upper respiratory infections, and adverse cardiovascular reactions, such as hypertension or stroke. These side effects, however, are less prevalent than allergic reactions.
Complications from Omontys can be so severe that fatal reactions have been reported in patients following just the first dose of intravenous administration. Serious hypersensitivity, allergic reactions, and anaphylactic shock have occurred within just 30 minutes of the drug’s administration. Any negative reactions you’ve experienced after taking Omontys should be documented and discussed with your lawyer.
Was Omontys Recalled?
On February 23, 2013, Affymax and Takeda voluntarily recalled all lots of Omontys. The companies also issued a letter to healthcare professionals instructing that no new or existing patients should receive Omontys as treatment.
Since its launch, Omontys was administered to over 25,000 patients. Reports indicated that prior to the recall, fatal reactions occurred in approximately 0.02% of patients following the first dose of intravenous administration. The rate of incidence for hypersensitivity reactions reached approximately 0.2%, a third of which were serious in nature, including anaphylaxis requiring prompt medical intervention.
All lots of Omontys were included in the recall, including:
- 10 mg Multi-Doe vials – Lots C18685, C18881, C19258
- 20 mg Multi-Dose vials – Lots C18686, C18696
To learn how these recalls might impact your case, contact an Omontys attorney at our firm.
Contact an Experienced Omontys Attorney Today
If you wish to file a lawsuit against the drug manufacturers, certain criteria must be met, all of which can be explained by an experienced Omontys lawyer.
Potential clients must have taken the recalled medication. If you have chronic kidney disease, you must be on dialysis as well.
We are no longer reviewing cases of anaphylactic shock caused by Omontys, but we will look into cases where patients experienced other injuries as a result of the medication. Injuries could include stroke, hypertension, and others. We are reviewing these on a case-by-case basis.
In most cases, lawsuits are filed when severe injuries resulted in hospitalization.