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Regulatory Focus™ > News Articles > 11 > FDA Warns of Rare but Serious Risks Linked to MS Drug Alemtuzumab

FDA Warns of Rare but Serious Risks Linked to MS Drug Alemtuzumab

Posted 29 November 2018 | By Zachary Brennan 

FDA Warns of Rare but Serious Risks Linked to MS Drug Alemtuzumab

The US Food and Drug Administration (FDA) on Thursday warned that 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 Sanofi’s Lemtrada (alemtuzumab).

In the nearly five years since FDA approved Lemtrada to treat relapsing forms of MS, the agency said it identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada. But this number includes only reports submitted to FDA, so additional cases may have occurred.

The thirteen cases reported in the FDA Adverse Event Reporting System (FAERS) included one patient who suffered hemorrhagic stroke and died. Twelve of the 13 cases reported symptoms within one day of receiving Lemtrada.

“Most of the cases reported to FDA in FAERS did not provide sufficient detail to allow a full assessment of individual risk factors. However, the occurrence of these adverse events within one day of Lemtrada administration suggests an association,” FDA said.

“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,” FDA added.

Alemtuzumab is also approved under the brand name Campath, which was approved in May 2001 to treat B-cell chronic lymphocytic leukemia (B-CLL), a type of cancer. The Campath drug label will also be updated to include these risks in the "Adverse Reactions" section under "Postmarketing Experience," the agency noted.


Tags: FAERS, Lemtrada, MS

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