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Lioresal Intrathecal

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Lioresal Intrathecal

SIDE EFFECTS

Baclofen has been shown to have general CNS depressant properties, causing sedation, somnolence, and respiratory and cardiovascular depression.

The most commonly reported adverse events with LIORESAL Intrathecal (baclofen injection) in clinical trials were drowsiness, weakness in the lower extremities, dizziness and seizures.

Adverse drug reactions from clinical trials are listed in the table below according to system organ classes in MedDRA. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: very common ( ≥ 1/10); common ( ≥ 1/100, < 1/10); uncommon ( ≥ 1/1,000, < 1/100); rare ( ≥ 1/10,000, < 1/1,000); very rare ( < 1/10,000), including isolated reports.

Adverse events associated with the delivery system (e.g. mass at the tip of the catheter, catheter dislocation with possible complications, pocket infection, meningitis, overdose due to wrong manipulation of the device) have been reported, whereby in some cases a causal relationship with baclofen cannot be excluded (see WARNINGS). These are in addition to those listed below. In a fatal case of a child (causality with baclofen uncertain), inflammatory signs in the posterior horns and signs of arachnoiditis in proximity of the catheter tip were observed. This corresponds to observations in dogs, where chronic inflammatory reactions to the foreign body of the catheter were observed, independently of baclofen concentration.

Incidence of Most Frequent Adverse Events in US Clinical Trials

Adverse Event Number of patients reporting events (%)
Screening
(N= 244)
Titration
(N= 214)
Maintenance
(N=214)
Somnolence 13 (5.3%) 11(5.1%) 18 (8.4%)
Weakness, Lower Extremities 1 (0.4%) 11(5.1%) 15 (7.0%)
Dizziness 6 (2.4%) 5 (2.3%) 12(5.6%)
Convulsion 1 (0.4%) 4 (1.9%) 11 (5.1%)
Headache 0 (0%) 3 (1.4%) 9 (4.2%)
Nausea/Vomiting 3 (1.2%) 5 (2.3%) 3 (1.4%)
Numbness/Itching/Tingling 2 (0.8%) 1 (0.5%) 8 (3.7%)
Hypotension 3 (1.2%) 0 (0%) 5 (2.3%)
Vision Blurred 0 (0%) 2 (0.9%) 5 (2.3%)
Constipation 0 (0%) 2 (0.9%) 5 (2.3%)
Hypotonia 2 (0.8%) 3 (1.4%) 2 (0.9%)
Dysarthria 0 (0%) 1 (0.5%) 6 (2.8%)
Coma (Overdose) 0 (0%) 4 (1.9%) 3 (1.4%)
Lethargy 1 (0.4%) 0 (0%) 4 (1.9%)
Weakness, Upper Extremities 1 (0.4%) 0 (0%) 4 (1.9%)
Hypertension 1 (0.4%) 2 (0.9%) 2 (0.9%)
Dyspnea 1 (0.4%) 2 (0.9%) 1 (0.5%)

In addition to the more common adverse events reported above, the following adverse events were observed during clinical trials elsewhere or reported by clinicians.

Metabolism and nutritional disorders

Uncommon: Dehydration, weight loss, albuminuria and hyperglycemia

Psychiatric disorders

Common: Depression, anxiety, agitation

Uncommon: Suicide ideation and suicide attempt, hallucinations, paranoia, euphoric mood

Nervous system disorders

Common: Confusional state, disorientation, insomnia, sedation, paresthesia, fatigue, lethargy

Uncommon: nystagmus, ataxia, memory impairment.

Eye disorders

Common: Accommodation disorder, diplopia

Cardiac disorders

Uncommon: Bradycardia

Rare: pulmonary embolism.

Vascular disorders

Uncommon: Deep vein thrombosis, flushing, pallor

Gastrointestinal disorders

Common: Dry mouth, diarrhea, decreased appetite, increased salivation

Uncommon: Ileus, hypogeusia, dysphagia

Respiratory, thoracic and mediastinal disorders

Common: Respiratory depression, pneumonia,

Renal and urinary disorders

Common: urinary incontinence, urinary retention.

Reproduction system and breast disorders

Common: Sexual dysfunction

Skin and subcutaneous tissue disorders

Common: Urticaria, pruritus, facial and/or peripheral edema

Uncommon: Alopecia, hyperhidrosis

Musculoskeletal and connective tissue disorders

Common: Hypertonia

General disorders and administration site conditions

Common: Asthenia, pyrexia, chills, pain

Uncommon: Hypothermia

Adverse Drug Reactions From Spontaneous Reports And Literature Cases (frequency not known)

The following adverse drug reactions have been derived from post-marketing experience with LIORESAL Intrathecal via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. Adverse reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness.

Nervous system disorders: dysphoria

Respiratory, thoracic and mediastinal disorders: bradypnea

Read the Lioresal Intrathecal (baclofen injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

There is little experience with the use of LIORESAL Intrathecal in combination with systemic medications to predict specific drug-drug interactions, although it is suggested that the low baclofen systemic exposure observed after intrathecal administration could reduce the potential for pharmacokinetic interactions (see CLINICAL PHARMACOLOGY).

Drug-Drug Interactions

Levodopa/ Dopa Decarboxylase (DDC) inhibitor (carbidopa)

Concomitant use of oral LIORESAL and levodopa (alone or in combination with a DDC inhibitor, carbidopa) resulted in increased risk of adverse events such as visual hallucinations, confusional state, headache and nausea. Worsening of the symptoms of Parkinsonism has also been reported. Thus, similar interaction can be anticipated for intrathecal LIORESAL.

Anesthetics

Concomitant use of intrathecal baclofen and general anesthetics (e.g. fentanyl, propofol) may increase the risk of cardiac disturbances and seizures. Thus, caution should be exercised when anesthetics are administered to patients receiving intrathecal LIORESAL.

Morphine

The combined use of morphine and intrathecal baclofen was responsible for hypotension in one patient. The potential for this combination to cause dyspnea or other CNS symptoms cannot be excluded.

The co-administration of other intrathecal agents with LIORESAL Intrathecal has not been tested and the safety of these combinations is unknown.

Alcohol and other compounds affecting CNS

The central nervous system depressant effects of alcohol and other compounds affecting the CNS (e.g. analgesics, neuroleptics, barbiturates, benzodiazepines, anxiolytics) may be additive to the effects of LIORESAL Intrathecal. Increased sedation may occur when LIORESAL Intrathecal is taken concomitantly with other drugs causing CNS depression, including other muscle relaxants (such as tizanidine), synthetic opiates, hypnotics, anxiolytics or alcohol (see PRECAUTIONS - Driving and using machines). The risk of respiratory depression is also increased. Careful monitoring of respiratory and cardiovascular functions is essential, especially in patients with cardiopulmonary disease and respiratory muscle weakness.

Tricyclic antidepressants

When using oral baclofen, concurrent treatment with tricyclic antidepressants may potentiate the effect of LIORESAL, resulting in pronounced muscular hypotonia. In addition, concomitant use of tricyclic antidepressants can cause sedation, drowsiness and potentiate the effects of LIORESAL resulting in pronounced muscular hypotonia. Therefore, caution is advised when using LIORESAL Intrathecal in this combination.

Lithium

Concomitant use of oral baclofen and lithium resulted in aggravated hyperkinetic symptoms. Caution should be exercised when LIORESAL Intrathecal is used concomitantly with lithium.

Antihypertensives

Since concomitant treatment with oral LIORESAL and antihypertensives is likely to increase antihypertensive effects, it is recommended that blood pressure is checked and if necessary, the dosage of antihypertensive medication adjusted accordingly.

Last reviewed on RxList: 1/10/2014
This monograph has been modified to include the generic and brand name in many instances.

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