Symptoms Developed Within Just One Day Of Lemtrada Injections, And Can Lead To Patient Death Or Permanent Disability Says FDA
(Posted by Tom Lamb at DrugInjuryWatch.com)
In late November 2018 this FDA Drug Safety Communication was issued, "FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)", which included some basic facts about these serious side effects in the Data Summary section:
In nearly 5 years since FDA approved Lemtrada (alemtuzumab) in 2014 to treat relapsing [multiple sclerosis (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 thirteen cases reported in FAERS included seven with hemorrhagic stroke, one with both hemorrhagic stroke and dissection of both vertebral arteries, one with ischemic stroke, one with ischemic stroke and dissection of bilateral carotid and right vertebral arteries, two with dissection that involved the right carotid and left vertebral arteries, and two with unspecified type of stroke. One patient who suffered hemorrhagic stroke died. Twelve of the 13 cases reported that these adverse events occurred within one day after administration of a Lemtrada dose.
Accordingly, the FDA recently mandated a Lemtrada label change, which includes an increased risk of strokes warning being added to the "Black-Box Warning" for Lemtrada.
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Elsewhere in the November 29, 2018 Lemtrada FDA Drug Safety Communication there is this important information for patients receiving intravenous infusions for their relapsing forms of multiple sclerosis (MS):
Patients or their caregivers should seek emergency treatment as soon as possible if the patient experiences signs or symptoms of a stroke or tears in the lining of the head and neck arteries, called arterial dissection, which can include:
• Sudden numbness or weakness in the face, arms, or legs, especially if it occurs on only one side of the body
• Sudden confusion, trouble speaking, or difficulty understanding speech
• Sudden trouble seeing in one or both eyes
• Sudden trouble with walking, dizziness, or loss of balance or coordination
• Sudden severe headache or neck pain
Most patients taking Lemtrada who developed stroke or arterial dissection, developed symptoms within 1 day of receiving Lemtrada. One patient reported symptoms that occurred 3 days after treatment.
Besides the expanded Black-Box Warning for Lemtrada , a new part -- 5.3 Stroke and Cervicocephalic Arterial Dissection -- was added to the WARNINGS AND PRECAUTIONS section of the current Full Prescribing Information, or drug label, for Lemtrada (accessed 12/4/18).
The intravenous MS drug Lemtrada is manufactured and distributed by Genzyme Corporation.
We will continue to monitor the safety profile of Lemtrada, watching for significant developments reported in the medical literature or by means of future FDA drug safety warnings.
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