A medicine used to treat and help prevent the flu may put patients at risk for a rare but life-threatening condition in which the skin peels off the body in sheets, according to the Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research. The agency notified the public that it has approved safety label changes for Relenza (zanamivir) Inhalation Powder for oral inhalation. The Adverse Reactions section of the drug’s new safety label now includes a risk of rash, including serious cutaneous reactions (e.g. erythema multiforme, Stevens Johnson Syndrome, SJS, and toxic epidermal necrolysis, TEN).
Relenza is a medicine used to treat and/or prevent both influenza A and B. It belongs to a group of medicines called neuraminidase inhibitors and works by targeting the influenza virus and preventing it from spreading inside the body. Rashes and allergic reactions were listed as rare side effects of the medication, but the new label specifically identifies more severe types of rashes, SJS and TEN.
SJS is a severe allergic reaction to medication. It has been linked to thousands of over-the-counter and prescription drugs including anti-inflammatory medications, antibiotics and antiviral drugs. SJS presents with a rash on the skin that blisters over, causing the skin to peel away. Blisters can also form on the eyes and internal organs leading to blindness and vision problems and even death. The most serious form of SJS is TEN.