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Iron Replacement Drug Feraheme May Get Black Box Warning for Fatal Cardiac Events

By November 5, 2010July 18th, 2019Dangerous Drugs

The iron replacement drug Feraheme (Ferumoxytol) has been associated with “life-threatening” events, including heart problems, and may get a black box warning. The U.S. Food and Drug Administration approved Feraheme last year to treat iron-deficiency anemia in adults with chronic kidney disease. Financial analysts are concerned that reports of fatal events associated with Feraheme will hurt the drug’s sales. As a dangerous drug liability attorney, I am more concerned that this drug will hurt patients, and I urge patients taking this drug to educate themselves about its risks.
AMAG Pharmaceuticals, Feraheme’s maker, met with the FDA in September to discuss safety concerns about the drug. Fatal and life-threatening problems including hypersensitivity and cardiac events occurred in 146 cases, out of more than 155,000 patient exposures to the drug. Some patients had adverse reactions associated with hypersensitivity, like itching, rash, hives and wheezing. Some also had hypotension, or abnormally low blood pressure, which can cause dizziness, fainting and seizures; and chronic renal failure, the progressive loss of kidney function. The FDA and AMAG are discussing label changes to alert doctors and patients to these dangers, as well as an extension of the 30-minute period for observing patients after the drug has been administered.
Feraheme’s sales have declined lately, and AMAG is restructuring its business to improve its profits, cutting 24 percent of its workforce. It may be that AMAG had more employees than it needed, but the firing of trained professionals in its workforce could subject the company, and the patients who use its drugs, to more problems. When employees are spread more thinly, they can lose sight of important quality and safety issues, allowing dangerous drugs to make it through the quality control process, and patients can get hurt. I have seen enough cases in my work as a drug defect lawyer to say that making money is often a higher priority for companies than patient safety. It’s good that AMAG is talking with the FDA about how to protect patients, and I hope that losing 24 percent of its workforce will not thwart whatever protections they put in place.

Even though FDA regulations are important, patients should know that drug companies do not answer only to the FDA. Under the same laws that require food, toys and other consumer products to be safe, drug makers also are responsible to the people who use their drugs. Patients who have been hurt by medications that manufacturers falsely represented as safe can sue the drug manufacturers, seeking to make them pay for the harm they caused. The defective medication lawyers at Carey, Danis & Lowe specialize in helping patients who have been harmed by prescription or over-the-counter medications. We can advise you about recovering compensation from the company that caused your injury for medical expenses, lost wages, permanent injuries and pain and suffering. The law recognizes that you should not have to pay those costs yourself if they were imposed upon you through no fault of your own.
If you have been hurt by a defective medication, please call Carey, Danis & Lowe for a free consultation, toll-free, at 1-877-678-3400 or contact us through our website.