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Hypersensitivity reactions reported with fidaxomicin
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Officials with the division of anti-infective products at the FDA reported hypersensitivity reactions associated with the Clostridium difficile drug fidaxomicin.
There were no hypersensitivity reactions identified during the drug’s development, they wrote in a brief report in Clinical Infectious Diseases. There were 11 cases reported to the FDA in the postmarketing period since fidaxomicin (Dificid, Cubist Pharmaceuticals) was approved in May 2011. There also was one case reported in the literature.
The FDA reports included six cases of facial, tongue or throat swelling, four cases of a diffuse rash and one case of burning sensation in the throat. The case reported in the literature had a purpuric rash on the lower extremities. The time to hypersensitivity event after beginning fidaxomicin ranged from 1 hour to 7 days.
Three of the cases reported a history of macrolide allergy. Eight of the cases were not receiving concomitant medications. In the remaining four cases, fidaxomicin was implicated as the probable cause of the hypersensitivity. In 10 of the cases, hypersensitivity resolved. For nine of these cases, hypersensitivity resolved after discontinuing fidaxomicin. It is unclear whether fidaxomicin was discontinued in the other case.
These findings have led to revisions of the contraindications, warnings and precautions, and adverse reactions sections of the drug’s labeling. The revisions advise that known hypersensitivity to fidaxomicin is a contraindication, and warn about the hypersensitivity reactions associated with the drug. They also warn that a macrolide allergy history could be considered before prescribing fidaxomicin.
The recommended dose for fidaxomicin is 200 mg twice daily.
Disclosure: The researchers report no relevant financial disclosures.
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