In recent days the FDA have issued a safety announcement about Lemtrada (alemtuzemab).
Rare but serious cases of stroke and blood vessel wall tears in the vessels of the head and neck have occurred in patients with MS shortly after they commenced treatment with Lemtrada. Problems such as these can lead to permanent disability or death. As a result of this the FDA have added a new warning about the risks to the prescribing information in the drug label and also to the patient medication guide. They have also added the risk of stroke to the existing Boxed Warning the FDAs most prominent alert.
It is suggesting the patients are care givers seek immediate medical aid if any symptoms of a stroke or tear occur. In the cases reported so far most patients taking Lemtrada experienced the symptoms within one day of receiving the drug. One patient reported symptoms 3 days after taking Lemtrada.
The FDA is suggesting that health care professionals should advise patients at EVERY Lemtrada infusion to seek immediate medical aid if they experience the symptoms of stroke or vessel tear.
It is nearly 5 years since the FDA approved Lemtrada in 2014. The 13 worldwide cases specified are those that have been reported to the FDA. It states that there could be other unreported cases of which they are unaware. It stresses that all healthcare professionals have a responsibility to report side effects
See further information at fda.gov.
Posted in: MS News