Lemtrada's Risks Exceed The Black Box Warning

Multiple Sclerosis patients are required to join a risk management program before receiving Lemtrada

Tuesday, June 18, 2019 - When a drug or medical device's safety profile is more deadly than a black boxed warning can adequately convey, the Food and Drug Administration can require the maker to implement and administer a Risk Evaluation and Mitigation Strategy (REMS) Program. Such a program is designed for drugs and medical devices that have recorded a disproportionate number of adverse event reports in spite of the black boxed warning. The FDA requires physicians to take this additional step to ensure that patients know that they may be better off avoiding using this particular medical device or taking this particular drug. Sanofi has been ordered to implement such a REMS Program to inform Lemtrada patients of the risks. Lemtrada lawsuits handled by national attorneys for arterial dissection and stroke offer a free consultation before filing a claim.

The Lemtrada website explains how to take the drug as well as the potential adverse side effects the drug may cause. Lemtrada is administered via an Intravenous (IV) infusion and given to Relapse Recurring Multiple Sclerosis (RRMS) patients in 8 doses over 2 years. During the first round, Lemtrada is given on five consecutive days. In round 2 one year later, three doses are required. Because of the toxic nature and adverse safety profile of the drug, patients are required to have tried at least two other anti-RRMS drugs prior to Lemtrada. The Lemtrada patient handbook offers excellent guidance for new Lemtrada patients in order to help them to prepare for the ordeal they may have to endure. The Lemtrada patient handbook warns:

"LEMTRADA can cause serious side effects including autoimmune problems, infusion reactions, stroke, tears in your arteries that supply blood to your brain (carotid and vertebral arteries), some kinds of cancers, thyroid problems, low blood counts (cytopenias), inflammation of the liver, serious infections, inflammation of the gallbladder without gallstones (acalculous cholecystitis), and swelling of lung tissue (pneumonitis). "

Sanofi, maker of Lemtrada seems to willingly comply with FDA orders to make sure that new patients take the adverse side effects warning seriously in order to make an informed decision as to whether or not the drug is right for them. Potential Lemtrada patients are required to enroll in the "LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program," prior to receiving Lemtrada infusions. Patients can receive more complete information and enroll in the Risk Evaluation Program at https://www.lemtradarems.com/.

The Lemtrada (REMS) Program has been designed by Sanofi working hand in hand with the US Food and Drug Administration in order to diagnose each unique individual and make sure Lemtrada's benefits outweigh its risks. Patients should be aware of the serious risks of suffering a stroke as well as fatal autoimmune issues, infusions reactions, and malignancies. A patient's blood counts, serum creatinine levels, and urinalysis must be monitored for the first 48 months after Lemtrada treatments end. "LEMTRADA causes serious and life-threatening infusion reactions as well as an increased risk of malignancy including thyroid cancer, melanoma, and lymphoproliferative disorders." Doctors prescribing Lemtrada treatment should be prepared to perform a battery of tests on their patients before, during and after Lemtrada treatment.

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No-Cost, No-Obligation Lemtrada Lawsuit Case Review If You or a Loved One Suffered from Lemtrada Stroke Complications

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