Tysabri Case Evaluation Criteria

Tysabri (Natalizumab) is a drug used to treat relapsing multiple sclerosis (MS) to reduce the frequency of flare-ups and delay progression of physical disability and Crohn’s disease in adults. It belongs to a class of drugs known as immunomodulators that are designed to work by stopping cells in the immune system from causing damage to the body.

FDA: Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008.

Alerts and Risk: After the FDA initially approved Tysabri, the manufacturer took the drug off the market due to reports of a rare, but serious brain infection called PML (Progressive Multifocal Leukoencephalopathy). But the drug returned to the market after the drug maker included a risk-minimization program (TOUCH) with mandatory patient registration and periodic follow-up to identify any possible cases of PML as soon as possible.

The risk for PML increases with the number of doses received. Risk also is higher among patients treated with immune-suppressing therapy before using Tysabri. Because of this risk, Tysabri is usually recommended for patients who cannot tolerate or have not responded to other MS treatments.

On January 20, 2012, the FDA issued this Tysabri Safety Communication to inform the public that Tysabri patients who are infected with the JC virus have a higher risk of PML, and they should undergo a blood test to check for anti-JC virus antibodies

Lawsuit Focus:

  • Failure to warn patients that the risk of PML increases with longer Tysabri use.

Adverse reactions:

  • PML (signs and symptoms include)
  1. Infections
  2. Headache
  3. Fatigue
  4. Depression
  5. Joint pain, weakness of the legs and arms that gets worse
  6. Menstrual problems
  7. Loss of coordination, clumsiness
  8. Loss of language ability (aphasia)
  9. Memory loss
  10. Vision problems
  • Liver toxicity
  • Hypersensitivity
  • Immunosuppresion/infections

Risk-factors for PML on Tysabri include:

  • People who have taken immunosuppressant drugs before
  • People who have used Tysabri for at least two years.
  • People who are infected with the JC virus

Case Review Focus Areas:

  1. Whether the patient was prescribed Tysabri? Reason for prescription?
  1. Was the patient using other oral Immunosuppressant prior to being placed on Tysabri?
  1. Did the patient have any preexisting conditions (Infected with JC virus) allergies or contraindications for Tysabri (Other drug interactions )?
  1. Dosage and Intake details (to be included under pharmacy log)

Necessary Pharmacy Information:

  1. What was the injury due to Tysabri? (PML, immunosupression/infections, liver toxicity etc)
  2. When and where was the injury diagnosed? Whether hospitalized? Dates of hospitalization.
  3. Treatment/management. Any complications
  4. Follow-up visits for treatment/management of injury.
  5. Outcome/prognosis. Resolution of injury?
  6. Medical History positive for anti-JC virus (JCV) antibodies, weakened immune system or people taking drugs that suppress their immune system, etc

Specific Focus

Identify and report cases with the following scenarios:-

  1. No Injuries: Patient took Tysabri but did not develop any injuries
  2. No Tysabri intake: Patient was given a different drug and not Tysabri. Hold case and communicate to client.
  3. Tysabri contraindicated in patient but still prescribed
  4. Any medical/surgical history, social history that could have had an effect on the injury

Missing Record Communication:

Identify and report on missing medical records/pharmacy bills

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable. This will also help in following up and retrieving the records.

Missing Records are presented in the following format