(RxWiki News) The US Food and Drug Administration (FDA) has expanded the approval of a multiple sclerosis (MS) medication to treat the condition in children.
This medication is found under the name Gilenya (fingolimod). The FDA approved it to treat relapsing MS in children and adolescents who are at least 10 years old. This is the first medication approved to treat MS in children.
Fingolimod has been used to treat adults with relapsing MS since 2010, when the FDA first approved it.
MS is a condition in which the protective layer surrounding the nerves deteriorates and is destroyed. Eventually, the brain cannot communicate with the rest of the body. MS affects an estimated 8,000 to 10,000 children and adolescents in the US, according to the FDA.
Common side effects of Gilenya may include headache, diarrhea, cough, flu, inflammation of the sinuses, back and stomach pain, and pain in the arms and legs.
This medication can cause serious side effects, which is why it must be dispensed with a medication guide. Fingolimod can cause the heart rate to slow down (especially after the first dose) and may increase the risk of serious infections. Other serious side effects include shortness of breath and liver problems.
Novartis manufactures Gilenya.