Genentech and The U.S. Food and Drug Administration, the American counterpart to the Saudi Food and Drug Authority (SFDA) notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with rituximab who has not previously received treatment with a TNF antagonist.

Rituximab is authorized for the treatment of B-cell non-Hodgkin's Lymphoma (NHL), previously untreated B-cell chronic lymphocytic leukemia (B-CLL), stage B or C, and rheumatoid arthritis (RA) in combination with methotrexate to reduce signs and symptoms in adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies.

PML is a rare, progressive, demyelinating disease of the central nervous system that usually leads to death or severe disability. PML is caused by activation of the JC virus. JC virus resides in latent form in 40-80% of healthy adults. The factors leading to activation of the latent infection are not fully understood.

Considerations for Healthcare Professionals:

· Physicians should consider PML in any patient being treated with rituximab who presents with new onset neurologic manifestations (i.e. cognitive impairment, motor deficit, speech and vision impairment) and should be immediately referred for neurological consultation.

· Information to date suggests that patients with RA who receive rituximab have an increased risk of PML.

· The overall reporting incidence of PML in patients with rheumatoid arthritis receiving rituximab is rare (3 reports in approximately 100,000 rheumatoid arthritis patients that have been exposed).

· Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated.

· Discontinue rituximab if PML is present.

· Inform patients of the signs and symptoms of PML so they are aware of and able to notify their healthcare professional if they experience any unusual signs or symptoms.

Information for Patients:

· Be aware that PML has been reported in patients using rituximab.

· If you are taking rituximab and you develop new problems with your memory, ability to think, see, hear, talk or walk, you should contact your doctor or pharmacist immediately.

· Do not stop or change medicines that have been prescribed without first talking with your doctor or pharmacist.

Report Adverse Drug Reactions to the Saudi FDA

The SFDA urges both healthcare professionals and patients to report side effects from the use of botulinum toxin products to the SFDA either online, by regular mail or by fax, using the following contact information :

National Pharmacovigilance Center (NPC)

Saudi Food and Drug Authority-Drug sector

3292 Northern Ring Road

Al Nafal District

Riyadh 13312 – 6288

Kingdom of Saudi Arabia

Email :

Website:

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