Magazine article Drug Topics

Beware of Inflammatory Masses from Implantable Infusion Systems

Magazine article Drug Topics

Beware of Inflammatory Masses from Implantable Infusion Systems

Article excerpt

The recent recall of Medtronic's implantable intrathecal infusion systems due to the occurrence of inflammatory masses has underscored the need for physicians, pharmacists, and patients to be aware of the problem and monitor for it accordingly.

Although the incidence of inflammatory masses associated with implanted intrathecal infusion systems has increased, it is still relatively low at 0.49%. Marc Lapointe, Pharm.D., has worked with this population of patients for about 10 years. Out of an estimated 50 or more patients in his practice, Lapointe said he is aware of three patients who developed inflammatory masses.

Intrathecal therapy is used to treat patients with chronic pain or severe spasticity. By the time patients turn to intrathecal therapy, they have already tried and failed oral medications, surgery, or other methods of treatment. Implantable intrathecal pumps deliver continuous infusions of medications to the intrathecal space. Studies have indicated that patients treated this way have significantly less pain than with prior treatments.

Patients with severe spasticity have also responded well to intrathecal therapy. Spasticity can be caused by cerebral palsy, multiple sclerosis, stroke, or damage to the brain or spinal cord. Intrathecal baclofen (Lioresal Intrathecal, Novartis) is indicated for spasticity and is approved for use in implantable intrathecal systems. Lapointe has worked with the Medtronic intrathecal systems since they were in clinical trials for spasticity therapy. He is also an associate professor with the colleges of medicine and pharmacy at the Medical University of South Carolina and director of the translational research unit for the university.

Because intrathecal therapy delivers drugs directly to the intrathecal sac, intrathecal doses are 100 to 1,000 times lower than oral doses, LaPointe said. As a result, patients usually experience fewer and milder adverse effects.

But the intrathecal systems have some drawbacks. Implanting the systems requires surgery, which has inherent risks and is costly-the procedure can cost $20,000 or more per patient. There are also issues with mechanical mishaps and failures. The Medtronic intrathecal systems have been recalled several times in the past for various mechanical issues.

The latest recall is based on reports of inflammatory masses that may occur at or near the distal tip of intrathecal catheters. …

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