FDA Confirms 13 Cases of Progressive Multifocal Leukoencephalopathy in Patients Receiving Natalizumab (Tysabri) for Multiple Sclerosis

The FDA announced earlier this fall that it had confirmed 13 cases of progressive multifocal leukoencephalopathy (PML) in patients receiving natalizumab (Tysabri) monotherapy for multiple sclerosis. There were no reported confirmed cases in patients receiving natalizumab for Crohn’s disease, an indication the FDA approved in January 2008. However, according to the FDA, less than 2% of natalizumab use in the U.S. has been for Crohn’s patients.

The first reports of PML from Tysabri surfaced in 2005. Because of the risks of PML, Tysabri is now only prescribed through a program developed by the FDA and the drug’s manufacturer called The TOUCH Prescribing Program.

The FDA said the risk for developing PML appears to increase with the number of natalizumab infusions received. The 13 patients who developed PML received an average of 12 to 35 monthly infusions per patient. The average number of infusions received before the diagnosis of PML was 25.

Read the full story on MedPage Today.

About the <span>Author</span>

About the Author

Tom D'Amore is the founder of D'Amore Law Group and a trial attorney with over 30 years of experience representing injured people and their families across the West Coast, securing more than $325 million in recoveries. He handles cases involving car accidents, trucking accidents, construction injuries, medical malpractice, and sexual abuse. Licensed in Oregon, Washington, and California, Tom is the only NBTA board-certified truck accident attorney in Oregon. He is a national Board of Governors member, past Executive Committee member, and past Budget and Audit Chair of the American Association for Justice, as well as past President of the Oregon Trial Lawyers Association and an Eagle member of the Washington State Association for Justice.

Related Blog Posts

Plaintiffs win first Xarelto trial

In early December of 2017, a Philadelphia jury found that the pharmaceutical manufacturers are responsible for a woman’s injuries after taking Xarelto, a blood-thinning medication. Bayer and Johnson &...

A short guide to avoiding hospital mistakes

About 1.7 million hospital-acquired infections cause or contribute to 99,000 deaths each year. That makes preventable medical mistakes the sixth leading cause of death in the United States. Some...

Prenatal Exposure to Valproate Increases Risk of Autism

Valproate is a a chemical compound used as an anticonvulsant in the treatment of epilepsy. A presentation recently delivered at the annual meeting of the American Epilepsy Society advised...

What Drugs Cause the Most Emergency Hospitalizations for Senior Adults?

An adverse drug event (“ADE”) requiring hospitalization typically occurs when a properly administered drug causes an adverse reaction (such as an allergic reaction), or a patient accidentally overdoses on...

Patients in California Being Treated for Macular Degeneration Blinded by Eye Injections of Avastin

The media is reporting that five patients being treated at the Veterans Affairs Medical Center in Los Angeles, California, for wet age-related macular degeneration (AMD) have been blinded following eye...

Strategies to Avoid Injuries and Deaths from Hospital-Acquired Infections

In the United States, the Centers for Disease Control and Prevention estimates that roughly 1.7 million hospital-acquired infections, from all types of microorganisms, including bacteria, combined, cause or contribute...

Hospital Acquired Conditions Not Reimbursed by Medicaid or Medicare Often Constitute Medical Malpractice in Oregon

Medicaid recently announced a policy of not paying for certain medical conditions typically not present on admission, but only acquired in the hospital due to poor care, and thus...

Electronic Prescriptions As Likely to Contain Errors as Handwritten Ones

According to a paper recently published in the Journal of American Medical Information Association, by Dr. Karen Nanji of Massachusetts General Hospital in Boston, more than 10% of electronic...

Infant’s Death From Drug Overdose Highlights Risks of Increasing Reliance on Electronic Health Records

Genesis Burkett, a premature baby born 16 weeks early, recently died from a massive overdose of sodium chloride. The cause of the medical error was traced to a pharmacy...

Cardiac Stent Manufacturers Provide Majority of Funding to Society of Cardiac Angiography and Interventions

In the latest in a series of articles about disquieting financial ties between the medical community and the drug & medical device industry, ProPublica exposes that The Society for...