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Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury. Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster viruses have also been reported during treatment. Advise patients to...
The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraception during fingolimod treatment and for 2 months after discontinuation.
Monitor patients closely for skin cancers. Advise patients to seek urgent attention if they develop signs or symptoms of serious infections.
Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
New advice for extended early monitoring for those with significant bradycardia or heart block after first dose.
Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced for patients with pre-existing cardiac disorders.
Healthcare professionals should report any suspected adverse effects relating to fingolimod (Gilenya▼) or other treatments for multiple sclerosis, including suspected adverse effects occurring after discontinuation, via the Yellow Card Scheme.
Find drug safety updates issued by MHRA
In January 2016, letters were sent to healthcare professionals regarding fingolimod (Gilenya▼) and erlotinib (Tarceva)
Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenya▼) and efavirenz (Sustiva).
Despicable people who create sexually explicit ‘deepfakes’ will face prosecution under a new law announced by the government today (16 April 2024).
A summary of letters and drug alerts recently sent to healthcare professionals.
Information on the reporting, investigation and management of acute flaccid paralysis (AFP) and acute flaccid myelitis (AFM).
Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the specific batches of Concerta XL 18mg and 36mg prolonged release tablets mentioned in this notification.
Product Safety Report for Esapharma Movate Steroid Cream presenting a serious chemical risk.
Statement by Ambassador Barbara Woodward at the UN Security Council meeting on Libya.
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