Europe's FDA is Reviewing Lemtrada's Stroke Side Effect
Governments around the world look to the US Food and Drug Administration as to which drugs could potentially cause patient harm
Monday, April 15, 2019 - On April 12, 2019, anti-multiple sclerosis seizure drug Alemtuzumab, better known by the brand name Lemtrada, manufactured and marketed by Sanofi, has been put under review by the European Medicines Agency (EMA). Reports to the agency have claimed that patients suffered from "immune-mediated conditions and problems with the heart and blood vessels of those taking the medicine, including deaths" according to Europe's Regulatory Affairs Professional Society. In addition to Lemtrada, Alemtuzumab is also market under the brand names Campath, MabCampath and Campath-1H. The Mayo Clinic describes Lemtrada as a drug that helps to slow down the MS relapse rates and treat the disease's symptoms of "slurred speech, fatigue, dizziness, tingling or pain in parts of your body, and problems with sexual, bowel and bladder function." Lemtrada stroke lawyers offer a free consultation and no obligation to file a claim against Lemtrada makers Sanofi.
If you or a loved one has experienced a stroke or sudden death after taking a diabetes treatment you should consult a Lemtrada diabetes stroke attorney to see if you qualify to file a claim against Sanofi for negligence in failing to adequately warn patients of the risk. You may be entitled to reimbursement for medical expenses, loss of wages pain and suffering and any other related expense or damages.
While Alemtuzumab is under review by the European Medicines Agency (EMA) doctors are being advised to discontinue its use in all patients except those with the most extreme cases of relapsing-remitting multiple sclerosis according to Raps.org news. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is examining the damage to the arteries that are being linked by the US Food and Drug Administration to Lemtrada. Such blood vessel damage occurs usually within 24 hours of a Lemtrada infusion and leads to debilitating and paralyzing strokes. The EMA also cites Lemtrada as capable of causing " bleeding in the lungs, heart attack, cervicocephalic arterial dissection (tears in the lining of the arteries in the head and neck); severe neutropenia (low levels of neutrophils, a type of white blood cell that fights infections). In addition to treating recurring seizure's from multiple sclerosis, Lemtrada also is used to treat certain types of cancer.
The FDA's Alemtuzumab warning cites that the drug can cause loss of mental capacity, paralysis and death in addition to stokes. 99% of patients affected have symptoms within the first 24 hours. In November of 2018, Sanofi was forced by the FDA to upgrade Lemtrada's "black boxed warning" to include the risks of paralysis from stroke and sudden death from heart attack. A black boxed warning is the most serious a drug can be forced to carry and is reserved for drugs that can in and of themselves cause serious injury and death when used as directed. Doctors that continue to use Lemtrada during the European review must monitor patients for the early warning signs of a stroke such as "numbness in the hands, fingers, and feet, mental fog, slurred speech, double vision, balance issues and dizziness, and severe headaches."
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No-Cost, No-Obligation Lemtrada Lawsuit Case Review If You or a Loved One Suffered from Lemtrada Stroke Complications
OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.