Important Safety Information

Benefits and Risks

Explore the benefits and risks of treatment with a baclofen pump, and then talk with your doctor about what they may mean for you.

Less Medication Needed

At doses high enough to be effective for some patients, oral baclofen can cause side effects such as drowsiness, confusion, dizziness, weakness, or nausea. A baclofen pump delivers the medicine directly to the fluid flowing around the spine. When medicine is placed right where it is needed, you need less, which may help minimize some of the possible side effects that may accompany oral baclofen.

Try It First

A screening test provides you and your doctor with an opportunity to discover whether your body will respond to the treatment before you proceed with surgery.

Programmed for Your Needs

Your pump will be programmed to deliver the exact dose you need, and can even vary the amount of medication at different times of day. Let’s say you need more baclofen at night to reduce spasticity so you can sleep better, and less in the morning when spasticity is making transfers easier. Your doctor could adjust the timing of your doses to meet your needs. Programming can also vary from day to day to match your scheduled activities. For example, you might need less or more baclofen on the day of a physical therapy appointment.

Dr. Koelbel

Why programmability is important (Dr. Stephen Koelbel, physical medicine and rehabilitation specialist)

Long-term Spasticity Management

Treatment with a baclofen pump won’t cure severe spasticity or the medical condition causing it, but it may help control your spasticity long term.1,2

Can Be Reversed

A baclofen pump does not change your body, and the system can be removed at any time by surgically removing the pump.

Established Treatment

Doctors have been prescribing the baclofen pump since 1992, when it was approved by the FDA in the United States. The same Medtronic pump is also used to deliver pain medication for many patients worldwide. More than 280,000 patients have been implanted with a Medtronic pump. Medtronic, the world’s largest medical-device manufacturer, is also the leader in heart pacemakers. Your Medtronic infusion system can be programmed and refilled in clinics across the United States and around the world.

Risks Associated with the Baclofen Pump

Please follow your doctor’s instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don’t run out of medication (intrathecal baclofen) and to understand the early symptoms of baclofen withdrawal. Some people are at more risk than others for baclofen withdrawal; consult with your doctor.

Dr. Koelbel

Some of the risks and complications associated with the use of the baclofen pump and catheter (Dr. Koelbel)

Side effects associated with ITB Therapy (the baclofen pump) usually are temporary and can be managed by adjusting the dosage of intrathecal baclofen (the drug contained in the pump).

The most common side effects include:

  • Loose muscles
  • Sleepiness
  • Upset stomach
  • Nausea/vomiting
  • Headache
  • Dizziness

Pump failure may cause an overdose or underdose of intrathecal baclofen. The signs and symptoms of an overdose include:

  • Drowsiness
  • Lightheadedness
  • Difficulty breathing
  • Seizures
  • Loss of consciousness or coma

The signs and symptoms of an underdose include:

  • Increase or return of spasticity
  • Itching
  • Low blood pressure
  • Lightheadedness
  • Tingling sensation

Following are possible device complications:

  • The catheter or pump could move within the body or push through the skin.
  • The pump could stop because the battery has run out or because of component failure.
  • The catheter could leak, tear, kink, or become disconnected resulting in an underdose or abrupt cessation of intrathecal baclofen. An abrupt stop of intrathecal baclofen can lead to:
    • High fever
    • Altered mental status
    • Returned spasticity
    • Muscle rigidity
    • Death, in rare cases

It is important to note that the pump will sound an alarm when the pump needs to be replaced, filled with baclofen, or if there is a problem with the pump.

Always inform a healthcare professional that you have an implanted infusion system before any medical or diagnostic procedure (e.g., MRI, diathermy, etc.).

For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed® Infusion System Information.Talk with your doctor about the benefits and risks of this treatment for you.

Important Safety Information

Reference
  1. Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years experience. J Neurosurg. 1992;77:236-246.
  2. Albright AL, Gilmartin R, Swift D, et al. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003;98:291-295.

 

 

The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.

IMPORTANT SAFETY INFORMATION FOR ITB THERAPY (Intrathecal Baclofen Therapy)

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.

The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced, or if there is a problem with the pump. You or your caregiver should always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.

For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.

This therapy is not for everyone. Please contact your doctor. A prescription is required.

Lioresal® is a registered trademark of Medtronic, Inc.

USA Rx Only Rev 0913

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.