When alemtuzumab, a drug sold under the trade names Lemtrada and Campath, was first introduced as a treatment for two serious diseases, it was billed as a vital medical advancement that could transform lives.
Unfortunately, patients taking Lemtrada to treat multiple sclerosis found that the drug carries a rare but serious side effect that could result in permanent disability and even death.
Learn more about how Lemtrada and Campath work, their side effects, and why patients are looking into filing lawsuits against the maker of the drugs.
What is Lemtrada?
Lemtrada is a drug given as an intravenous infusion to treat people with relapsing multiple sclerosis. According to the National Multiple Sclerosis Society, the relapsing form of MS is when a person with the disease suffers from inflammatory attacks on the central nervous system. It is characterized by new or worsening neurologic symptoms that come with clearly defined attacks.
Lemtrada works by causing the depletion of white blood cells. This is important in treating MS because the disease involves attacks by the immune system against the nervous system.
The drug is given intravenously for five consecutive days at the start of treatment with a follow-up of three consecutive a year later. Because of its safety profile, the drug is “reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS,” according to the official prescribing sheet.
History of Lemtrada and Campath Lawsuits
Although the drug alemtuzumab is more prominently known as a treatment for MS, it was first approved by the U.S. Food and Drug Administration (FDA) in 2001 to treat B-cell chronic lymphocytic leukemia. It was sold under the brand name Campath.
Campath was marketed as a treatment for cancer for more than a decade until its drugmaker Genzyme was acquired by Sanofi. Sanofi decided to reintroduce the drug as Lemtrada for the treatment of MS.
Genzyme, now a Sanofi company, applied to market Lemtrada for the treatment of MS in 2012. The FDA refused to grant the approval, pending modification of the application. In 2013, the FDA had questions about whether the risks outweighed the benefits of the drug.
But by November 2014, the FDA had approved Lemtrada for the treatment of relapsing MS. People within Genzyme and some physicians praised the decision.
“The unmet need in MS remains high,” Dr. Edward Fox, Director of the Multiple Sclerosis Clinic of Central Texas, said in a press release. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment.”
Lemtrada Side Effects
Lemtrada carries the risk of many side effects for patients taking the drugs. According to the clinical trials, the most common adverse reactions were:
- Urinary tract infection
- Thyroid gland disorders
- Fungal infection
- Pain in extremity
- Back pain
- Oropharyngeal pain
- Abdominal pain
While all of these occurred in at least 10 percent of patients, there are also rarer but more serious side effects. These include:
- Immune thrombocytopenia
- Glomerular nephropathies
- Thyroid disorders
- Autoimmune hepatitis
- Other autoimmune cytopenias
- Suicidal behavior
Alemtuzumab Connected to Deadly Strokes
One of the most serious side effects associated with Lemtrada is stroke and tears in the artery linings. In November 2018, the FDA issued a safety announcement warning that patients who took Lemtrada for MS have experienced serious cases of stroke and tears in the lining of the arteries in the head and neck. This can lead to permanent disability or death.
In the five years since the FDA approved Lemtrada in 2014, there have been at least 13 cases of ischemic and hemorrhagic stroke or arterial dissection that started quickly after treatment with alemtuzumab. The FDA warned that there could be more unidentified cases.
As a result of these findings, the FDA required a new warning on the drug labels of Lemtrada and Campath to reflect the potentially deadly side effect. Drugs containing alemtuzumab now carry an additional black box warning, the most prominent warning issued by the FDA.
Symptoms of stroke include sudden numbness in the face or extremities, sudden confusion or trouble speaking, sudden vision issues in one or both eyes, sudden trouble with balance or coordination, and severe headache or pain in the neck.
Attorneys Exploring Lemtrada and Campath Lawsuits
The controversy surrounding drugs containing alemtuzumab has led attorneys across the country to explore cases against Genzyme and Sanofi. Patients who have taken Lemtrada or Campath and have developed serious and unexpected side effects may be eligible to file a lawsuit.
This isn’t the first time Lemtrada has been the subject of legal disputes. In 2013, a law firm launched a class action against Sanofi over claims that the pharmaceutical company offered misleading statements about the safety and efficacy of the drug, according to Reuters. The lawsuit was brought after the FDA was reluctant to approve the drug to treat MS.
However, in light of the news that the FDA, attorneys believe patients taking Lemtrada or Campath could also file lawsuits against the drugmakers. If you or a loved one were seriously injured by a drug containing alemtuzumab, contact a qualified attorney immediately to learn more about your options.
- Drugs.com. “Genzyme Provides Update on U.S. Lemtrada Filing“, Drugs.com, https://www.drugs.com/nda/lemtrada_120827.html. Accessed March 26, 2019.
- FDA. “FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)“, U.S. Department of Health and Human Services, https://www.fda.gov/Drugs/DrugSafety/ucm624247.htm. Accessed March 26, 2019.