RRMS Patients May Look To Alternatives To Lemtrada

Lemtrada Stroke Lawsuit News

The enhanced restrictions being placed on anti-RRMS drug Lemtrada are concerning to patients that have run out of options

Wednesday, November 6, 2019 - Patients suffering from the advanced stages of relapse-remitting multiple sclerosis (RRMS) should look to anti-seizure drug Mavenclad before resorting to Lemtrada given the extreme adverse side effects Lemtrada carries. The U.S. Food and Drug Administration (FDA) has recently approved Mavenclad (cladribine) to treat relapsing forms of multiple sclerosis (MS) in adults when other therapies have proved inadequate. According to the FDA, Billy Dunn, M.D., director of the Division of Neurology Products in the FDA Center for Drug Evaluation and Research told the agency: "The approval of Mavenclad represents an additional option for patients who have tried another treatment without success." Mavenclad demonstrated its effectiveness by decreasing the number of relapses in RRMS patients as well as slowing the progression of the disease in a clinical trial of 1300 RRMS patients. Patients in the study had at least one RRMS remission within the previous 12 months. While safer than Lemtrada, Mavenclad carries a boxed warning and should not be used by women who are pregnant. Women should avoid Mavenclad if they will be sexually and not using birth control within 6 months from the date of staring the drug.

In spite of being the most effective drug on the market to fight RRMS, Lemtrada's side effects are so severe that Europe's Medicine's Agency (EMA) placed additional restrictions on the availability of the drug limiting it to only highly active RRMS patients. According to the EMA's drug safety committee, "Lemtrada (alemtuzumab) should be given only to people with highly active relapsing-remitting multiple sclerosis (RRMS)." Lemtrada is now allowed only when no other drug has worked and if the patient's multiple sclerosis is rapidly worsening. The prospective patient is also required to have had at least two relapses in the previous 12 months and suffered brain damage. Lemtrada stroke attorneys represent American families and offer a free consultation with no obligation to file a lawsuit claim.

Lemtrada's restrictions are due to the severe, life-threatening side effects, including the likelihood of experiencing a paralyzing stroke, that Lemtrada patients have suffered and have been reported to the FDA. According to DrugWatch.com, "In November 2018, the FDA released a safety communication warning about a rare but serious risk of stroke and tears in the lining of the arteries in the head and neck with Lemtrada. These tears are called arterial dissections. These conditions can lead to permanent disability or death. Most of the people who suffered these complications developed symptoms within one day of receiving the drug. One patient had symptoms three days after treatment." 12 of the 13 reported cases of arterial dissection occurred within 24 hours of receiving a Lemtrada infusion. Lemtrada is administered to patients in two, five-day treatments, one year apart for two consecutive years. In extreme cases, the third treatment in year three is permitted. Lemtrada patients also have a 50-50 chance of developing serious, life-threatening autoimmune disorders, Including "kidney, liver and thyroid problems, and immune thrombocytopenic purpura, a condition in which the body attacks platelets," according to DrugWatch. Lemtrada patients should be screened for pre-existing conditions before beginning treatments and monitored closely for at least three days afterward.

In response to the need for an alternative treatment of last resort for RLMS patients, the FDA approved "Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease." Like Lemtrada and Tecfidera, Mavenclad is recommended as a drug of last resort when other RLMS drugs have failed. Mavenclad has performed well in clinical trials consisting of over 1300 RLMS patients that have had at least one relapse episode within the last 12 months. According to the FDA, "Mavenclad significantly decreased the number of relapses experienced by these patients compared to placebo. Mavenclad also reduced the progression of disability compared to placebo." Mavenclad carries an FDA boxed warning due to the drug's potential to cause fetal harm. Women who are pregnant or will be sexually active and do not use birth control within 6 months from the date of staring Mavenclad should not use the drug.

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