Media release                                                                                   27 September 2007

Ritalin SR to be funded for some patients

PHARMAC is providing funded access to the Ritalin SR brand of methylphenidate for those people who have experienced clinical difficulties in changing to Rubifen SR, another brand of methylphenidate.

Medical Director Dr Peter Moodie says the move is an appropriate and prudent response after Medsafe advised of a safety issue for some people who had changed brands. Medsafe, which is the Government agency with responsibility for monitoring medicine safety, has not raised concerns for people who have successfully changed to Rubifen SR.

Medsafe’s advice was based on reports provided to the Centre for Adverse Reactions Monitoring (CARM), the Otago University-based organisation that tracks adverse reactions to medicines. About 6000 people take long-acting methylphenidate, and CARM had received 88 reports of adverse reactions since February 2007.

“We have taken this advice on board and have taken the responsible step of making Ritalin SR available for people who have had adverse reactions to Rubifen SR,” says Dr Moodie.

“It is important to stress that the advice relates specifically to patients who have changed brand and experienced an adverse reaction. No safety issues have been raised in relation to people who have changed brands and are well managed on Rubifen SR.”

“This is an interim measure while Medsafe seeks further information from the supplier of Rubifen SR and we will await with interest the outcome of that process.”

Dr Moodie says PHARMAC is writing to all doctors who prescribe methylphenidate to inform them about the issue. In addition, PHARMAC is contacting consumer groups and people who have reported adverse events to PHARMAC and CARM.

The mechanism requires doctors to provide information to PHARMAC about the patient’s adverse reaction to Rubifen SR. Funding will be provided for Ritalin SR for patients who demonstrate an adverse reaction to Rubifen SR.

Dr Moodie says PHARMAC will continue to take guidance from Medsafe on any further steps.

ENDS

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