Important Safety Information

Signs of Underdose and Overdose

It is very important to watch for the warning signs that you are receiving too much, too little, or no baclofen. Both you and your caregivers must be familiar with these signs and what to do if you see them. Follow your doctor’s instructions on emergency care.

Warning Signs of Underdose

If you experience one or more of the signs of baclofen underdose, call your doctor immediately for emergency care. Warning signs for underdose include:

  • Itching 
  • Tingling sensation
  • Blood pressures changes
  • Spastic or stiff muscles
  • High fever
  • Changed mental state

If not treated, underdose can quickly turn into baclofen withdrawal. Symptoms of withdrawal are high fever, changed mental status, and muscle stiffness. In rare cases withdrawal may result in loss of function of many vital organs and death. Avoid withdrawal by watching for the signs of underdose and taking action.

Warning Signs of Overdose

If you experience one or more of the signs of baclofen overdose, call your doctor immediately. The signs of baclofen overdose include:

  • Drowsiness
  • Lightheadedness
  • Slow and shallow breaths
  • Seizures
  • Loss of consciousness
  • Hypothermia (lower than normal body temperature)

How to Stay Safe

  • Know the warning signs and what to do, and make sure all your caregivers know, too.
  • Keep all your scheduled refill visits so you do not run out of intrathecal baclofen.
  • Always carry your Emergency Medical Information card from Medtronic. This pocket-sized card includes warning signs, what to do, and contact information. Your doctor can order copies from a Medtronic representative.
  • Get the Pump Partner app for your smartphone, so you will have quick and easy access to important safety information including warning signs.
 

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.