This is what my doctor sent me yesterday and wondered if anyone else got this information given to them.
A patient in California died in her sleep on the night after her first dose in late November. Complete details are not available yet but it seems likely that she developed a lethal heart arrythmia in her sleep. She had high blood pressure and was taking a beta blocker and calcium channel blocker. It is likely that the combination of the drugs she was taking, especially the beta blocker , and perhaps pre-existent heart disease coupled with the effects of the first dose of Gilenya caused her death. We also learned of a case of a young man who was taking a medication that can cause slowing of the heart whose heart stopped beating 20 hours after his first dose of Gilenya. Fortunately he was in the hospital on a cardiac monitor and was successfully resuscitated.
At this time, ~ 28,000 people have received Gilenya and these are the only two known serious heart complications. However we are not sure how good the reporting is of complications. The second case I described above was not reported to the FDA and Norvartis but the treating doctors just published a report on the case, which is how we learned about this case.
I am recommending to patients with any pre-existent heart condition that they take their first dose of Gilenya as an inpatient with cardiac monitoring for 24 hours.
Love to hear your thoughts from anyone about this, Liz.