Over the past few of weeks, warnings have been issued about side effects of two MS treatments.
First, the U.S. Food and Drug Administration warned about a “slight” risk of seriously worsening MS symptoms if someone who is using the disease-modifying therapy Gilenya (fingolimod) stops using it. The FDA’s alert said the worsening symptoms could “result in permanent disability,” but the alert failed to provide details about how rare these problems are.
About a week later, the FDA issued another warning. This one was about Lemtrada (alemtuzumab). The risk is a severe stroke that may involve tears in arteries in the neck and head. In this case, however, the FDA was specific about how many strokes had been reported by people treated with Lemtrada and when they occurred:
“In nearly 5 years since FDA approved Lemtrada (alemtuzumab) in 2014 to treat relapsing MS, we identified 13 worldwide cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection. These 13 cases reported in the FDA Adverse Event Reporting System (FAERS) database occurred within 3 days of administration of the drug to patients with MS. Ten of the cases occurred in the U.S. and three occurred in Europe.”
The FDA went on to say that it didn’t have enough information for it to fully assess individual risk factors, but “the occurrence of these adverse events within one day of Lemtrada administration suggests an association.”
Knee-jerk reactions?
Unsurprisingly, there was a quick response to this news on social media sites. Some of it came from people treated with Lemtrada who reported that they were among those who suffered strokes following, or during, their treatment. Their comments generated others, many of them along the lines of, “I wish I’d known about this before my treatment,” or, “Now, I’m not sure that I want to use this treatment.” But others cautioned restraint, saying there are side effects with every medication. These writers also reminded us that there are several side effects that have been much more frequently reported with Lemtrada.
I wrote about the Gilenya warning a few days after it was issued, similarly advising that “all disease-modifying treatments have the possibility of side effects, and some are more serious than others. We who use the treatments should always be doing so with our eyes wide open and fully informed of the risks.”
MS treatment benefits outweigh risks for me
Shortly after that I wrote a post to bring everyone up to date on my own experience with Lemtrada. (I’m at eight months past round two.) I’m pleased to say it’s been positive.
We all know, or should know, that these DMTs carry a certain level of risk. It’s up to us, in consultation with our neurologists, to make a serious risk-benefit analysis before we start any treatment. We should proceed only if we believe the benefit outweighs the risk. We also must be willing to accept the risk if a problem occurs. One other thing: We need to be sure to read beyond the headlines of the warnings that we receive. Be sure to read the full alert so you can get a complete picture of the magnitude of the concern.
If you think about it, we probably run a higher risk of incurring a serious disability each time we get into an automobile than we do from using a medication that’s designed to prevent our disability from becoming worse.
(A version of this post first appeared as one of my columns on the MS News Today website).
