FDA to probe Gilenya patient death
pharmafile | December 21, 2011 | News story | Sales and Marketing | FDA, Novartis, gilenya
The FDA is investigating Novartis’s new multiple sclerosis treatment Gilenya after a patient died within hours of taking the drug.
The US regulator was sent a post-marketing report by Novartis regarding a patient who died 24 hours after taking the first dose of Gilenya (fingolimod).
The FDA said that it couldn’t conclude whether the drug resulted in the patient’s death, and would be working with the firm to investigate the case.
The patient had completed six hours of monitoring after the first dose without incident – which all patients must undertake when they first use the drug – but died less than a day after the first dose.
The regulator said in a statement: “At this time, FDA continues to believe that Gilenya provides an important health benefit when used as directed, and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label.”
As well as Novartis’s drug, the patient was also treated with metoprolol, a beta blocker, and amlodipine, a calcium channel blocker, the FDA added.
Gilenya does have some serious side effects, and may cause patients to have a slow heart rate (bradycardia) after the first dose of the drug, but in most cases this returns to normal within the first month.
These effects usually do not cause symptoms, but they can cause dizziness, fatigue, and palpitations.
The FDA said that if a patient experiences any of these symptoms, they should contact a health professional immediately.
Ben Adams
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