Tysabri Side Effects

Tysabri may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• extreme tiredness
• joint pain or swelling
• pain in arms or legs
• swelling of the arms, hands, feet, ankles, or lower legs
• muscle cramps
• stomach pain
• diarrhea
• heartburn
• constipation
• gas
• weight gain or loss
• depression
• night sweats
• painful, irregular, or missed menstruation (period)
• swelling, redness, burning, or itching of the vagina
• white vaginal discharge
• frequent or painful urination
• sudden need to urinate right away
• difficulty controlling urination
• tooth pain
• cold sores

Some adverse side effects of Tysabri are very serious:

• sore throat, fever, cough or other signs of infection
• rash
• hives
• itching
• difficulty breathing
• chest pain
• dizziness
• chills
• flushing
• yellowing of the skin or eyes
• nausea
• vomiting
• unusual darkening of the urine

Using this drug has been linked to progressive multifocal leokoencephalothapy which has in turn led to deaths.

Warnings & Recalls for Tysabri

Before receiving Tysabri injections:

• Tell your doctor if you’re allergic to natalizumab, which is the active ingredient in Tysabri or any other medications.
• Be sure to tell your doctor what medications you’re taking, including prescription and nonprescription as well as what vitamins and supplements that you’re taking.  Tell your doctor if you have ever been treated with medications that weaken the immune system, including azathioprine, cyclophosphamide, methotrexate, mitoxantrone, and mycophenolate mofetil.  Also tell your doctor if you are taking or if you have ever taken any other medications that affect the immune system such as adalimumab, cyclosporine, etanercept, glatiramer, infliximab, interferon beta-1a, medications for cancer, mercaptopurine, oral steroids such as dexamethasone, methylprednisolone, prednisolone, and prednisone.  Also sirolimus and tacrolimus.
• If you have John Cunningham’s syndrome, talk to your doctor before taking Tysabri as it can lead to progressive multifocal leokoencephalothapy.
• Tell your doctor if you’re pregnant or plan on becoming pregnant or are nursing.

On January 2012, the FDA initiated a drug safety communication citing the risks of progressive multifocal leokoencephalothapy, which is an irreversible condition which can lead to death.  In 2006, the manufacturers of Tysabri had launched a voluntary recall of the drug citing this condition when used with interferon beta-1a, another immunosuppressant.

Tysabri Treatment and Use

Tysabri | Natalizumab is a drug that’s used for the treatment of multiple sclerosis and Crohn’s disease.  Its derived from a humanized monoclonal antibody.  Tysabri is co-marketed by Biogen Idec and Élan and is administered by intravenous infusion every 28 days.  Tysabri is believed to work by reducing inflammatory immune cells’ abilities to attach to and pass through the cell layers of the lining of intestines and the blood-brain barrier.  Tysabri has been proven to be effective in treating MS and Crohn’s disease and it prevents relapse, cognitive decline and vision loss.  It had been approved by the FDA in 2004 but had been retracted from the market by the two co-manufacturers because of cases of a rare neurological condition called progressive multifocal leokoencephalothapy when administered with interferon beta-1a, which is another immunosuppressive drug that’s used for the treatment of MS.  After changes with what drugs Tysabri can be co-administered with, the drug was returned back into the market in 2006 under a special program for prescriptions.  In 2008, Biogen Idec had publicly announced that Tysabri has a potential to be an anti-cancer drug after clinical trials.

Other Names for Tysabri

Natalizumab Injectable

Lawsuits & Legal Information for Tysabri