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FDA issues warning over Noxafil dosing errors

The U.S. Food and Drug Administration has issued a warning to people in New Mexico and nationwide about the potential for dosing errors when switching between two different formulations of Merck's oral antifungal drug, Noxafil. The agency has received 11 reports of dosing errors involving the medication since 2013, when Merck put a delayed-release tablet on the market.

The FDA approved both an oral suspension and a delayed-release formulation of Noxafil, which is used to fight Aspergillus and Candida fungal infections in patients with weakened immune systems. Milligram dosing is not interchangeable between the two versions because the body absorbs them at different rates. As a result, each formulation requires a change in dose. According to the dosing error reports, some patients have received either too much or too little of the drug when the incorrect formulation was prescribed to them by a physician or dispensed to them by a pharmacy. One patient died, and a second patient had to be hospitalized.

According to the FDA, the dosing errors occurred because the doctors and pharmacists involved were not aware that the two Noxafil formulations could not be substituted for each other. To reduce the risk of future dosing errors, the agency recommends that doctors specify the drug formulation, strength and frequency for every Noxafil prescription they issue to patients.

Prescription medication errors can lead to overdoses, underdoses or dangerous drug interactions. New Mexico residents who have been the victim of a pharmaceutical error may wish to discuss their legal options with an attorney, which could include the filing of a medical malpractice lawsuit against the at-fault doctor or pharmacist.

Source: Modern Medicine, "FDA warns about dosing errors with antifungal," Christine Blank, Jan. 7, 2016

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