Gilenya is used to treat Multiple Sclerosis (MS) and works to decrease the frequency of relapse symptoms. It is an immunosuppressant that keeps immune cells trapped in the lymph nodes so they cannot reach the central nervous system. Since its approval in 2010, Gilenya has been used by more than 30,000 people worldwide. In one year, sales for Gilenya were $291 million.
One of the known side effects of Gileyna is bradycardia, a slowed heart rate that is thought to return to normal after stopping taking the drug.
In 2011, the FDA announced that it was investigating deaths that were thought to have been caused by Gilenya. In 2012, the European Medicines Agency also announced that it was investigating the drug. Both agencies had reports of patients dying after their first dose of Gilenya. One patient died within 24 hours of receiving the drug, while the manufacturer, Novartis AG, confirmed that 10 more deaths had occurred in Gilenya patients; six of these fatalities were unexplained, three were caused by heart attack and one was cause by a disruption of heart rhythm.
It is now advised the doctors monitor patients after being administered Gileyna, and to perform an echocardiogram before and after to ensure heart health. Doctors were also advised to monitor blood pressure and heart rate.
Serious side effects may include:
- Slow heart rate, dizziness, feeling very weak or tired
- Chest pain, pounding heartbeats or fluttering in your chest
- Sudden numbness or weakness, severe headache, problems with speech or walking
- Wheezing, chest tightness, trouble breathing, cough with yellow or green mucus
- Fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat
- Swelling, warmth, redness, oozing, itchy rash, or other signs of skin infection
- Nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
- Vision problems, blurred vision, eye pain, increased sensitivity to light, or having a blind spot or shadows in the center of your vision (vision problems may occur 3 to 4 months after you start taking Gilenya)
- Less serious Gilenya side effects may include:
- Headache, tired feeling
- Back pain
- Stuffy nose, sinus pain, or cough