Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin Advanced Practice Nurse.
On November 29, 2018 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 or MS shortly after they received Lemtrada, active ingredient 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.
Alemtuzumab is also approved under the brand name Campath, which was approved in May 2001 to treat B-cell chronic lymphocytic leukemia. The Campath drug label will also be updated to include these risks in the Adverse Reactions section under Postmarketing Experience.
Health care professionals should advise patients at every Lemtrada infusion to seek immediate emergency medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. The diagnosis is often complicated because early symptoms such as headache and neck pain are not specific. Promptly evaluate patients who complain of symptoms consistent with these conditions.
Since FDA approval of Lemtrada in 2014 to treat relapsing forms of MS, we identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection occurring shortly after the patient received Lemtrada. This number includes only reports submitted to FDA, so additional cases we are unaware of may have occurred. Twelve of these cases reported symptoms within 1 day of receiving Lemtrada and one reported symptoms occurring 3 days after treatment. As a result, we have added a new warning about this risk in the Warnings and Precautions section of the prescribing information in the drug label. We have also added the risk of stroke to the existing Boxed Warning.
To help FDA track safety issues with medicines, we urge health care professionals to report side effects involving Lemtrada, Campath or other medicines to the FDA MedWatch program at www.fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at email@example.com.
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- FDA Drug Safety Communication: FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
- FDA Drug Safety Podcast: FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab) (MP3 - 2.7MB)