Lemtrada (alemtuzumab) FDA issues risk of stroke warning
Posted: Thu Nov 29, 2018 8:20 pm
Hi,
Yet another FDA warning on a common treatment. Some may look at the incidence as very low, but, imagine how hard it would be to get any event recognised as due to the treatment. Many other cases have probably gone unreported and there's no way to track them.
https://www.fda.gov/Drugs/DrugSafety/ucm624247.htm
"The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab). These problems can lead to permanent disability and even death. As a result, we have added a new warning about these risks to the prescribing information in the drug label and to the patient Medication Guide. We have also added the risk of stroke to the existing Boxed Warning, FDA’s most prominent warning."
Regards,
Yet another FDA warning on a common treatment. Some may look at the incidence as very low, but, imagine how hard it would be to get any event recognised as due to the treatment. Many other cases have probably gone unreported and there's no way to track them.
https://www.fda.gov/Drugs/DrugSafety/ucm624247.htm
"The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab). These problems can lead to permanent disability and even death. As a result, we have added a new warning about these risks to the prescribing information in the drug label and to the patient Medication Guide. We have also added the risk of stroke to the existing Boxed Warning, FDA’s most prominent warning."
Regards,