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Gablofen

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Gablofen

Gablofen

Gablofen Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

Gablofen (baclofen) is used to treat severe spasticity, a very intense tightness of muscles that may cause pain and uncontrollable spasms of the arms, legs, hands, and feet. Gablofen is also used to manage severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and older. Gablofen belongs to a class of drugs called skeletal muscle relaxants. The most common adverse reactions in patients with spasticity of spinal origin were sleepiness, dizziness, nausea, low blood pressure, headache, convulsions, and hypotonia (low muscle tone). The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, sleepiness, chills, urinary retention, and hypotonia.

Gablofen is administered by the intrathecal route, meaning it is administered via spinal catheter or lumbar puncture. There are no data to indicate significant interactions with Gablofen and other drugs. Gablofen must not be discontinued abruptly. Abrupt discontinuation of Gablofen, regardless of the cause, has resulted in serious medical conditions and even death. Gablofen has not been studied in pregnant women and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Gablofen is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Gablofen, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Our Gablofen (baclofen) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Gablofen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Spasticity of Spinal Cord Origin

Commonly Observed in Patients with Spasticity of Spinal Origin

In pre- and post-marketing clinical trials, the most commonly observed adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia.

Associated with Discontinuation of Treatment

8/474 patients with spasticity of spinal cord origin receiving long term infusion of intrathecal baclofen in pre- and post-marketing clinical studies in the U. S. discontinued treatment due to adverse reactions. These include: pump pocket infections (3), meningitis (2), wound dehiscence (1), gynecological fibroids (1) and pump overpressurization (1) with unknown, if any, sequela. Eleven patients who developed coma secondary to overdose had their treatment temporarily suspended, but all were subsequently re-started and were not, therefore, considered to be true discontinuations.

Fatalities

[see WARNINGS AND PRECAUTIONS].

Incidence in Controlled Trials

Experience with intrathecal baclofen obtained in parallel, placebo-controlled, randomized studies provides only a limited basis for estimating the incidence of adverse reactions because the studies were of very brief duration (up to three days of infusion) and involved only a total of 63 patients. The following events occurred among the 31 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials: hypotension (2), dizziness (2), headache (2), dyspnea (1). No adverse reactions were reported among the 32 patients receiving placebo in these studies.

Events Observed during the Pre- and Post-marketing Evaluation of Intrathecal Baclofen

Adverse events associated with the use of intrathecal baclofen refl ect experience gained with 576 patients followed prospectively in the United States. They received intrathecal baclofen for periods of one day (screening) (N = 576) to over eight years (maintenance) (N = 10). The usual screening bolus dose administered prior to pump implantation in these studies was typically 50 mcg. The maintenance dose ranged from 12 mcg to 2,003 mcg per day. Because of the open, uncontrolled nature of the experience, a causal linkage between events observed and the administration of intrathecal baclofen cannot be reliably assessed in many cases and many of the adverse reactions reported are known to occur in association with the underlying conditions being treated. Nonetheless, many of the more commonly reported reactions - hypotonia, somnolence, dizziness, paresthesia, nausea/vomiting and headache - appear clearly drug-related.

Adverse experiences reported during all U.S. studies (both controlled and uncontrolled) are shown in Table 1. Eight of 474 patients who received chronic infusion via implanted pumps had adverse experiences which led to a discontinuation of long term treatment in the pre- and post-marketing studies.

Table 1: INCIDENCE OF MOST FREQUENT ( ≥ 1%) ADVERSE EVENTS IN PATIENTS WITH SPASTICITY OF SPINAL ORIGIN IN PROSPECTIVELY MONITORED CLINICAL TRIALS

Adverse Event Percent
N=576 Screeninga
Percent
N=474 Titrationb
Percent
N=430 Maintenancec
Hypotonia 5.4 13.5 25.3
Somnolence 5.7 5.9 20.9
Dizziness 1.7 1.9 7.9
Paresthesia 2.4 2.1 6.7
Nausea and Vomiting 1.6 2.3 5.6
Headache 1.6 2.5 5.1
Constipation 0.2 1.5 5.1
Convulsion 0.5 1.3 4.7
Urinary Retention 0.7 1.7 1.9
Dry Mouth 0.2 0.4 3.3
Accidental Injury 0.0 0.2 3.5
Asthenia 0.7 1.3 1.4
Confusion 0.5 0.6 2.3
Death 0.2 0.4 3.0
Pain 0.0 0.6 3.0
Speech Disorder 0.0 0.2 3.5
Hypotension 1.0 0.2 1.9
Ambylopia 0.5 0.2 2.3
Diarrhea 0.0 0.8 2.3
Hypoventilation 0.2 0.8 2.1
Coma 0.0 1.5 0.9
Impotence 0.2 0.4 1.6
Peripheral Edema 0.0 0.0 2.3
Urinary Incontinence 0.0 0.8 1.4
Insomnia 0.0 0.4 1.6
Anxiety 0.2 0.4 0.9
Depression 0.0 0.0 1.6
Dyspnea 0.3 0.0 1.2
Fever 0.5 0.2 0.7
Pneumonia 0.2 0.2 1.2
Urinary Frequency 0.0 0.6 0.9
Urticaria 0.2 0.2 1.2
Anorexia 0.0 0.4 0.9
Diplopia 0.0 0.4 0.9
Dysautonomia 0.2 0.2 0.9
Hallucinations 0.3 0.4 0.5
Hypertension 0.2 0.6 0.5
a Following administration of test bolus
b Two month period following implant
c Beyond two months following implant
N=Total number of patients entering each period
%=% of patients evaluated

In addition to the more common (1% or more) adverse reactions reported in the prospectively followed 576 domestic patients in pre- and post-marketing studies, experience from an additional 194 patients exposed to intrathecal baclofen from foreign studies has been reported. The following adverse reactions, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported:

Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilatation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and ptosis.

Digestive System: Flatulence, dysphagia, dyspepsia and gastroenteritis.

Cardiovascular: Postural hypotension, bradycardia, palpitations, syncope, arrhythmia ventricular, deep thrombophlebitis, pallor and tachycardia.

Respiratory: Respiratory disorder, aspiration pneumonia, hyperventilation, pulmonary embolus and rhinitis.

Urogenital: Hematuria and kidney failure.

Skin and Appendages: Alopecia and sweating.

Metabolic and Nutritional Disorders: Weight loss, albuminuria, dehydration and hyperglycemia.

Special Senses: Abnormal vision, abnormality of accommodation, photophobia, taste loss and tinnitus.

Body as a Whole: Suicide, lack of drug effect, abdominal pain, hypothermia, neck rigidity, chest pain, chills, face edema, fl u syndrome and overdose.

Hemic and Lymphatic System: Anemia.

Spasticity of Cerebral Origin

Commonly Observed

In pre-marketing clinical trials, the most commonly observed adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients included: agitation, constipation, somnolence, leukocytosis, chills, urinary retention and hypotonia.

Associated with Discontinuation of Treatment

Nine of 211 patients receiving intrathecal baclofen in pre-marketing clinical studies in the U.S. discontinued long term infusion due to adverse reactions associated with intrathecal therapy.

The nine adverse reactions leading to discontinuation were: infection (3), CSF leaks (2), meningitis (2), drainage (1), and unmanageable trunk control (1).

Fatalities

Three deaths, none of which were attributed to intrathecal baclofen, were reported in patients in clinical trials involving patients with spasticity of cerebral origin. See WARNINGS on other deaths reported in spinal spasticity patients.

Incidence in Controlled Trials

Experience with intrathecal baclofen obtained in parallel, placebo-controlled, randomized studies provides only a limited basis for estimating the incidence of adverse reactions because the studies involved a total of 62 patients exposed to a single 50 mcg intrathecal bolus. The following events occurred among the 62 patients receiving intrathecal baclofen in two randomized, placebo-controlled trials involving cerebral palsy and head injury patients, respectively: agitation, constipation, somnolence, leukocytosis, nausea, vomiting, nystagmus, chills, urinary retention, and hypotonia. Events Observed during the Pre-marketing Evaluation of Intrathecal

Baclofen

Adverse events associated with the use of intrathecal baclofen reflect experience gained with a total of 211 U. S. patients with spasticity of cerebral origin, of whom 112 were pediatric patients (under age 16 at enrollment). They received intrathecal baclofen for periods of one day (screening) (N= 211) to 84 months (maintenance) (N= 1). The usual screening bolus dose administered prior to pump implantation in these studies was 50 - 75 mcg. The maintenance dose ranged from 22 mcg to 1,400 mcg per day. Doses used in this patient population for long term infusion are generally lower than those required for patients with spasticity of spinal cord origin.

Because of the open, uncontrolled nature of the experience, a causal linkage between events observed and the administration of intrathecal baclofen cannot be reliably assessed in many cases. Nonetheless, many of the more commonly reported reactions - somnolence, dizziness, headache, nausea, hypotension, hypotonia and coma - appear clearly drug-related.

The most frequent ( ≥ 1%) adverse reactions reported during all clinical trials are shown in Table 2. Nine patients discontinued long term treatment due to adverse reactions.

Table 2: INCIDENCE OF MOST FREQUENT ( ≥ 1%) ADVERSE EVENTS IN PATIENTS WITH SPASTICITY OF CEREBRAL ORIGIN

Adverse Event Percent
N=211 Screeninga
Percent
N=153 Titrationb
Percent
N=150 Maintenancec
Hypotonia 2.4 14.4 34.7
Somnolence 7.6 10.5 18.7
Headache 6.6 7.8 10.7
Nausea and Vomiting 6.6 10.5 4.0
Vomiting 6.2 8.5 4.0
Urinary Retention 0.9 6.5 8.0
Convulsion 0.9 3.3 10.0
Dizziness 2.4 2.6 8.0
Nausea 1.4 3.3 7.3
Hypoventilation 1.4 1.3 4.0
Hypertonia 0.0 0.7 6.0
Paresthesia 1.9 0.7 3.3
Hypotension 1.9 0.7 2.0
Increased Salivation 0.0 2.6 2.7
Back Pain 0.9 0.7 2.0
Constipation 0.5 1.3 2.0
Pain 0.0 0.0 4.0
Pruritus 0.0 0.0 4.0
Diarrhea 0.5 0.7 2.0
Peripheral Edema 0.0 0.0 3.3
Thinking Abnormal 0.5 1.3 0.7
Agitation 0.5 0.0 1.3
Asthenia 0.0 0.0 2.0
Chills 0.5 0.0 1.3
Coma 0.5 0.0 1.3
Dry Mouth 0.5 0.0 1.3
Pneumonia 0.0 0.0 2.0
Speech Disorder 0.5 0.7 0.7
Tremor 0.5 0.0 1.3
Urinary Incontinence 0.0 0.0 2.0
Urination Impaired 0.0 0.0 2.0
a Following administration of test bolus
b Two month period following implant
c Beyond two months following implant
N=Total number of patients entering each period. 211 patients received drug; (1 of 212) received placebo only

The more common (1% or more) adverse reactions reported in the prospectively followed 211 patients exposed to intrathecal baclofen have been reported. In the total cohort, the following adverse reactions, not described in Table 2, and arranged in decreasing order of frequency, and classified by body system, were reported:

Nervous System: Akathisia, ataxia, confusion, depression, opisthotonos, amnesia, anxiety, hallucinations, hysteria, insomnia, nystagmus, personality disorder, reflexes decreased, and vasodilitation.

Digestive System: Dysphagia, fecal incontinence, gastrointestinal hemorrhage and tongue disorder.

Cardiovascular: Bradycardia.

Respiratory: Apnea, dyspnea and hyperventilation.

Urogenital: Abnormal ejaculation, kidney calculus, oliguria and vaginitis.

Skin and Appendages: Rash, sweating, alopecia, contact dermatitis and skin ulcer.

Special Senses: Abnormality of accommodation.

Body as a Whole: Death, fever, abdominal pain, carcinoma, malaise and hypothermia.

Hemic and Lymphatic System: Leukocytosis and petechial rash.

Read the entire FDA prescribing information for Gablofen (Baclofen Injection) »

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