Previous changes

May 2024 — minor update. Other drugs known to lower blood pressure added to the interactions section for baclofen in the prescribing section, in line with the manufacturers updated SPC for baclofen.

March 2024 — minor update. Hypertonia added as a symptom of withdrawal, and undesirable effects added in line with manufacturers updated SPC for baclofen.

May to June 2019 — new topic. The evidence base has been reviewed in detail, and recommendations are clearly justified and transparently linked to the supporting evidence.

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 June 2024.

HTAs (Health Technology Assessments)

No new HTAs since 1 June 2024.

Economic Appraisals

No new economic appraisals relevant to England since 1 June 2024.

Systematic reviews and meta-analyses

No new systematic reviews or meta-analysis which reach the CKS threshold for inclusion since 1 June 2024.

Primary evidence

No new primary evidence which reaches the CKS threshold for inclusion published since 1 June 2024.

New policies

No new national policies or guidelines since 1 June 2024.

New safety alerts

No new safety alerts since 1 June 2024.

Changes in product availability

No changes in product availability since 1 June 2024.

Differential diagnosis

The differential diagnoses of cerebral palsy include:

• Brain tumour — suggested by acute presentation with headache, other signs and symptoms of raised intracranial pressure (such as early morning vomiting), seizures, and focal neurological deficits following initially normal development.
• Dystonia — suggested by the onset of muscular deformity after several years of normal development. Presents with sustained periods of muscle contraction and dystonia (movements can be abrupt and violent). Contractures are absent. There may be a positive family history.
• Muscular dystrophy — suggested by weakness at birth, or in some cases, normal development until around 3 years of age, followed by progressive loss of function and muscle weakness. There is no spasticity, but contractures may develop. There may be a positive family history. Subtypes include Duchenne's, Becker's, and limb-girdle muscular dystrophy. 
• Myelodysplasia — suggested by associated spinal defect and lack of sensation below specific spinal segment. Usually non-spastic.
• Spinal muscular atrophy — suggested by floppiness at birth and progressive weakness. There is no spasticity, but contractures may develop.
• Spinal stenosis/tethered cord — suggested by progressively worsening neurological function.

Basis for recommendation

This information is based on the National Institute for Health and Care Excellence (NICE) guideline Cerebral palsy in under 25s: assessment and management [NICE, 2019b], the BMJ Best Practice guide Cerebral palsy [BMJ Best Practice, 2023], and expert opinion in a review article Managing common symptoms of cerebral palsy in children  [Sewell, 2014].

How should I manage a child with suspected cerebral palsy?

• Refer any child with features suggestive of neurological disorders other than cerebral palsy (CP) to a specialist in paediatric neurology.
• Children with suspected CP should be referred to a child development service for a multidisciplinary assessment, in order to facilitate early diagnosis and intervention:
  • Refer all children with risk factors for CP who exhibit abnormal motor features urgently to a child development service.
  • Refer all children to a child development service for further assessment if they have:
    • Delayed motor milestones.
    • Persistent toe walking.
• While awaiting referral:
  • If any associated features of CP have been reported, such as chest infection, constipation, gastro-oesophageal reflux, or pain, use clinical judgement to manage appropriately. For more information, see the CKS topics on Cough - acute with chest signs in children, Constipation in children, GORD in children, and Analgesia - mild-to-moderate pain.
  • Depending on the level of clinical suspicion, consider providing information on CP to the parents/carers. Patient information leaflets are available from the NHS, and SCOPE.

How should I manage a child with confirmed cerebral palsy?

• Children with CP should receive specialist management via a local integrated multidisciplinary team.
  • Depending on local availability, this may incorporate paediatric medicine, nursing care, physiotherapy, occupational therapy, speech and language therapy, dietetics, podiatry, and psychology. 
  • Such teams can also enable access to other specialist services, including paediatric neurodisability; neurology; neurorehabilitation; respiratory, gastroenterology, and surgical specialist care; orthopaedics; orthotics and rehabilitation services; social care; visual and hearing specialist services; and teaching support for preschool and school-age children, including portage (home teaching services for preschool children). 
• The key responsibilities of a general practitioner in the management of a child with CP are:
  • Coordinating care where necessary.
  • Identifying associated problems early (and managing/referring where appropriate).
  • Providing support to the child and/or their parents/carers.
• Referral from primary care may involve notifying the multidisciplinary team of any newly recognised issues so that they can manage or refer accordingly, or direct referral to an appropriate specialist, depending on local arrangements for accessing the required services.
• Be aware that common issues for which a primary care physician may be the first point of contact include:
  • Problems with eating, drinking, and swallowing — the child or young person should be referred to a specialist with training in assessing and treating dysphagia if there are clinical concerns about: 
    • Coughing, choking, gagging, altered breathing pattern, or change in colour, while eating or drinking.
    • Recurrent chest infection.
    • Mealtimes regularly being stressful or distressing for the child or young person or their parents or carers.
    • Prolonged meal duration.
  • Concerns about speech, language and communication — during routine reviews, it is appropriate to assess speech, language, and communication, including speech intelligibility. If concerns are noted or raised by the parent/carer, the child or young person should be assessed by a speech and language therapist within the local multidisciplinary team.
  • Nutritional status — this should be regularly reviewed in children and young people with cerebral palsy, including measurement of height and weight (where possible). If there are concerns about oral intake, growth, or nutritional status, assessment and nutritional interventional support from a dietitian should be offered. If oral intake is still insufficient to provide adequate nutrition after assessment and nutritional interventions, the child or young person should be referred for assessment for enteral tube feeding by a specialist within the multidisciplinary team with relevant expertise.
  • Drooling — be aware that factors that may affect drooling include positioning, medication history, reflux, and dental issues. The local integrated multidisciplinary team should be made aware of any issues and may determine the need for anticholinergic medication such as glycopyrronium bromide (oral or by enteral tube), transdermal hyoscine hydrobromide, or with, input from specialist services, trihexyphenidyl hydrochloride for children with dyskinetic cerebral palsy. GPs may subsequently be involved in prescribing these medications under local shared care arrangements. Other specialist interventions that may be offered to relieve drooling include high-dose botulinum toxin A injection to the salivary glands and salivary gland surgery.
  • Pain — condition-specific causes of pain in people with CP include musculoskeletal problems, increased muscle tone, muscle fatigue and immobility, constipation, vomiting, and gastro-oesophageal reflux disease. Children and young adults with CP may also experience other common types of pain such as back pain, headache, abdominal pain, dental pain, and dysmenorrhea. Ask about signs of pain and related discomfort, distress, and sleep disturbance at every contact.
    • Recognise that assessing the presence and degree of pain in children and young people with CP can be challenging, especially if there are difficulties with communication, registering or processing sensory information, or there is a learning disability.
    • If the cause of pain is not clear after routine assessment, the child or young person should be assessed by the specialist multidisciplinary team.
    • If the cause of pain is identified and pain is mild to moderate, consider a 'stepped approach' trial of simple analgesia (such as paracetamol and/or ibuprofen). For more information, see the CKS topic on Analgesia - mild-to-moderate pain. Treat identified reversible causes of pain in line with usual guidance.
    • If there is any doubt, or a trial of analgesia is unsuccessful, seek advice from the local multidisciplinary team or an appropriate pain specialist.
    • Where spasticity causes pain and/or impacts function, multidisciplinary specialist involvement may include input from a network of specialists, and management may include physiotherapy, occupational therapy, orthotics, medication (such as oral diazepam or baclofen, Botulinum toxin type A, or intrathecal baclofen), or surgery (orthopaedic or neurosurgery).
  • Sleep disturbances — recognise that parents and carers have the primary role in identifying sleep disturbances in children and young people with CP.  In order to assess sleep disturbances, consider using sleep questionnaires or diaries.
    • Optimise sleep hygiene for children and young people with cerebral palsy.
    • Manage any identified treatable causes of sleep disturbances.
    • If no treatable cause is found, a trial of melatonin (off license) may be appropriate, particularly if there are problems with falling asleep. This should be initiated by a specialist.
    • Do not offer regular sedative medication to manage primary sleep disorders in children with cerebral palsy without seeking specialist advice.
    • The child or young person should be referred to specialist sleep services for multidisciplinary team assessment and management if there are ongoing sleep disturbances.
  • Mental health problems — children and young people with cerebral palsy should be referred for specialist psychological assessment and ongoing management if there are concerns about their mental health or if they experience persistent emotional and/or behavioural difficulties. Routine behavioural difficulties can be managed within the multidisciplinary team, with onward referral to specialist services if difficulties persist. Medications prescribed by a specialist to treat mental health problems in children and young adults with CP may subsequently be prescribed by a GP under a local shared care arrangement.
  • Gastro-oesophageal reflux disease — for information on management, please see the CKS topic on GORD in children. Use clinical judgement to determine whether specialist referral is appropriate. If there is a marked change in the pattern of any vomiting, assess for a clinical cause.
  • Constipation — Children and young people with CP should receive regular clinical assessments for constipation. For information on management, please see the CKS topic on Constipation in children. Use clinical judgement to determine whether specialist referral is appropriate.
  • Epilepsy — urgently refer following local protocols if new-onset or worsening seizures are reported. For more information on general management, see the CKS topic on Epilepsy. GPs may subsequently be involved in prescribing anticonvulsant medications under local prescribing arrangements.
• Note: If the child has a learning disability, see the CKS topic on Learning disabilities for specific advice on management.
• Where medication initiated by a specialist is subsequently to be prescribed in primary care as part of a shared care arrangement, the GP should have received clear guidance relating to:
  • Monitoring of beneficial and any adverse effects.
  • Dosage and dose titration (if appropriate). 
  • Length of course of medication.
  • Review intervals. 
  • Second-line or alternative choice medications (if appropriate). 
  • Plans for stopping the medication (if applicable).
• Other roles of a primary care physician in the general care of a child with CP can include:
  • Providing information to the parents/carers about:
    • Local and regional services available (such as sports clubs, voluntary organisations, respite care, and specialist schools).
    • Support groups (including psychological and emotional support for the child or young person and their parents or carers and siblings).
    • Resources available and access to financial, respite and hospice services, social care, and other support for children and young people and their parents, carers, and siblings.
    • Obtaining a formal carer's assessment of their own needs (including their physical and mental health). Carers should be encouraged to register themselves as a carer, for example, with their own GP. 
    • Transition from child to adult care. For more information, see the NICE guideline on Transition from children’s to adults’ services for young people using health or social care services.
    • Cerebral palsy and its prognosis and management. Patient information leaflets are available from the NHS, and SCOPE.
  • Ensuring that the child or young person and their parents or carers are provided with information, by a professional with appropriate expertise, about topics relevant to them, which may potentially include menstruation, fertility and contraception, sex and sexuality, and parenting.

How should I manage an adult with confirmed cerebral palsy?

Note: When managing an adult with cerebral palsy (CP), adapt communication methods and information resources to take account of the needs and understanding of the person and their family or carers (if appropriate). 

• Adults with cerebral palsy (CP) should ideally be able to access a network of specialist services that (depending on local availability) may include advocacy support, learning disability services, mental health services, orthopaedic surgery (and post-surgery rehabilitation), rehabilitation engineering services (centres that design, develop, and adapt technological solutions to overcome challenges to function, activity, and participation for people with disability), rehabilitation medicine or specialist neurology services, secondary care expertise for managing comorbidities (such as respiratory, gastrointestinal, and urology services), social care, specialist therapy services (such as physiotherapy, occupational therapy, speech and language therapy, podiatry, and dietetics), and wheelchair services. Be aware that some of these services may be provided by charities.
• Adults with CP who have complex needs should be offered an annual review of clinical and functional needs by a healthcare professional with expertise in neurodisabilities. 
• The severity of CP will have been assessed by specialists involved in the person's care. The gross motor function classification system (GMFCS) is a 5‑level clinical classification system that describes the gross motor function of people with cerebral palsy based on self-initiated movement abilities. People assessed as level I are the most able and people assessed as level V are dependent on others for all their mobility needs.
• Reassessment by the multidisciplinary team may be required at different points in an adult's life to ensure that changing needs are met, for example, during pregnancy and parenting, if the person experiences decreased mobility, and/or if there is loss of care and support from a parent.
• The key responsibilities of a general practitioner in the management of an adult with CP are:
  • Coordinating care.
  • Identifying associated problems early (and managing/referring where appropriate).
  • Providing support to the person and/or their family/carers. 
• When caring for an adult with CP:
  • Recognise any barriers to the person accessing primary care, including communication difficulties, mental health problems, fear of stigma, lack of motivation, exhaustion, and practical issues such as access to transport and buildings. Consider extending appointment times if necessary. Ensure that the person has an advocate, if required.
  • Refer adults to a service within the multidisciplinary team experienced in the management of neurological impairments if the person's ability to carry out their usual daily activities deteriorates or a neurosurgical or orthopaedic procedure is being considered that may affect their ability to carry out their usual daily activities. 
• Be aware that medical issues commonly experienced by people with cerebral palsy, that may be reported to/noted in primary care include:
  • Communication difficulties.
    • Speech and communication needs in adults with CP may change with time and social circumstances. Ask adults with cerebral palsy (and their families and carers, if agreed) about any changes in their hearing, speech, and communication.
    • Refer adults with CP who have communication difficulties to speech and language therapy services to assess their need for intervention.
  • Pain.
    • Common causes of pain in people with CP include musculoskeletal problems, increased muscle tone, muscle fatigue and immobility, constipation, vomiting, and gastro-oesophageal reflux disease.
    • Assess for the presence, severity, and location of pain using pain assessment tools including observational or descriptive pain scales.
    • Be aware that some people with CP have difficulty communicating or are unable to communicate that they are in pain.
    • Treat any identified underlying causes of pain. For more information, see the CKS topics on Analgesia - mild-to-moderate pain, Constipation, and Dyspepsia - proven GORD.
    • Seek specialist advice where appropriate.
    • If the person has problems participating in physical activities because of pain or joint problems that do not respond to any other treatments, consider referring them to a musculoskeletal specialist or an orthopaedic surgeon with experience and expertise in managing musculoskeletal problems in adults with cerebral palsy.
  • Abnormal muscle tone.
    • Be aware that the severity of symptoms may fluctuate in response to health, social and emotional wellbeing, and environmental factors. Specific factors that may exacerbate spasticity or dystonia include bladder problems (for example, urinary tract infection or bladder stones); constipation; emotional distress; pain; posture; pressure sores; changes in home or work environments, including seating; and medication changes and side effects. Address any modifiable factors that may be exacerbating the person's spasticity or dystonia. For further information, see the CKS topics on Analgesia - mild-to-moderate pain, Constipation, Urinary tract infection (lower) - men, and Urinary tract infection (lower) - women.
    • Consider prescribing enteral (by mouth or feeding tube) baclofen as the first-line drug treatment for adults with CP and generalised spasticity causing functional impairment, pain, or spasms. For more information, see the section on prescribing information. If enteral baclofen is ineffective or not tolerated, refer the person to a tone or spasticity management service, where other interventions may be offered, including Botulinum toxin type A injections, intrathecal baclofen, and selective dorsal rhizotomy. When considering a treatment for abnormal muscle tone, discuss with the person and document their treatment goals.
    • In addition, consider referring adults with spasticity in a limited number of muscle groups that is affecting their care (such as hygiene or dressing), causing pain, or impairing activity and participation for botulinum toxin type A treatment.
    • Refer people with problematic dystonia (for example, affecting function, pain, or participation) to a tone or spasticity management service to consider treatment options, which may include enteral anti-dystonic drug treatments, Botulinum toxin type A injections, intrathecal baclofen, and deep brain stimulation.
  • Bone and joint disorders.
    • Because of abnormal musculoskeletal development, adults with CP are more likely to have bone and joint disorders. Refer to a specialist orthopaedic or musculoskeletal service if a bone or joint disorder is suspected and causing pain or affecting posture or function. These may include osteoarthritis; cervical instability or spondylosis (including athetosis); spinal deformity (including scoliosis, kyphosis, and lordosis); subluxation of the hips, wrist, and shoulders; biomechanical knee problems; and abnormalities of the foot structure.
    • Be aware that low bone mineral density is common in adults with CP, particularly in people with reduced mobility or reduced weight bearing, taking anticonvulsants or proton pump inhibitors. Factors that may increase fracture risk include needing help with moving (especially hoisting), history of falls, low BMI, history of low-impact fractures, and other medical factors that may adversely affect bone health (such as steroid use). If the person has two or more risk factors for fracture, consider referral for a dual-energy X‑ray absorptiometry (DXA) assessment, particularly if they have had a previous low-impact fracture.
    • Consider referral for specialist assessment and management, for example, to a rheumatology, endocrinology, or bone health service, if the person has a high fracture risk or a positive DXA result.
  • Mental health problems.
    • Ask the person (and their family and carers, if agreed) if they are concerned about factors including mood, irritability, behaviour, social interaction, sleep, and/or general level of function.
    • Take into account factors that might affect the identification, assessment, and management of mental health problems, such as communication difficulties; learning disabilities; impaired neuropsychological and executive functions; comorbidities, particularly epilepsy and pain; and side effects and drug interactions of multiple medicines (polypharmacy).
    • Discuss with the person (and their family and carers, if agreed) if physical problems such as pain, or frustration from communication difficulties or lack of stimulation, are contributing to emotional distress or challenging behaviour.
    • Manage any identified mental health problems/behavioural difficulties as appropriate. For more information, see the CKS topics on Attention deficit hyperactivity disorder, Autism in adults  Depression,  Generalized anxiety disorder, and Insomnia. 
    • Seek specialist advice if there is any uncertainty about management.
  • Nutritional problems.
    • Where possible, offer adults with CP a regular weight/BMI check and identify people who may be at risk of undernutrition or obesity.
    • Discuss with the person (and their family and carers, if agreed) whether they have difficulties with eating or if there have been any changes in their eating habits or bowel function. Ask about changes in appetite, changes in the person's ability to feed themselves, constipation, coughing or choking when eating, food refusal, increased frequency of chest infections (which may be related to swallowing difficulties or gastro-oesophageal reflux), and increased length of meal times.
    • Consider that factors that may affect appetite, eating habits, or weight include changes in carer support, depression, pain, reduced physical activity, and side effects of medications.
    • Refer to a relevant clinical specialist, such as a dietitian or speech and language therapist, if assessment suggests the person has difficulties with eating or malnutrition.
  • Respiratory disorders.
    • Adults with severe CP may have risk factors for respiratory impairment, such as aspiration pneumonia, chronic cardiorespiratory disorders (for example, cor pulmonale or pulmonary circulation hypertension), chronic suppurative lung disease, kyphoscoliosis, poor saliva control, and recurrent chest infections. Consider spirometry assessment for people suspected to be at high risk of respiratory impairment. Refer people with persistent or multiple signs and symptoms of respiratory impairment, or risk factors for respiratory impairment, to specialist services.
    • Offer vaccinations to adults with CP in line with the national immunisation programme. For further information, see the CKS topics on Immunizations - pneumococcal and Immunizations - seasonal influenza.
    • Refer people with recurrent chest infections and suspected dysphagia to a speech and language therapist with training in dysphagia, to assess swallowing.
    • If a person with CP is at high risk of lower respiratory tract infection, consider referral to physiotherapy for a prophylactic chest care review. 
    • Prophylactic antibiotics for lower respiratory tract infections may be initiated by a respiratory specialist with expertise in neurodisability management if the person is at high risk of respiratory impairment. These may then be prescribed by a primary care physician as part of a shared care arrangement.
    • Be aware that adults with cerebral palsy are at increased risk of respiratory failure. Symptoms may include breathlessness, changes in behaviour (such as irritability or inability to concentrate), daytime drowsiness, worsening epilepsy, headaches on waking, increasing frequency of chest infections, poor sleep pattern, and sleep apnoea.
    • Home-based non-invasive ventilation for adults with cerebral palsy and respiratory failure may be appropriate. Seek specialist advice where there is uncertainty.
  • Gastro-oesophageal reflux disease — for information on management, please see the CKS topic on Dyspepsia - proven GORD. Use clinical judgement to determine whether specialist referral is appropriate. 
  • Constipation — for information on management, please see the CKS topic on Constipation. 
  • Epilepsy — urgently refer if new-onset or worsening seizures are reported. For more information on general management, see the CKS topic on Epilepsy. GPs may subsequently be involved in prescribing anticonvulsant medications under local prescribing arrangements.
• Note: If the person has a learning disability, see the CKS topic on Learning disabilities for specific advice on management.
• Where medication initiated by a specialist is subsequently to be prescribed in primary care as part of a shared care arrangement, the GP should have received clear guidance relating to:
  • Monitoring of beneficial and any adverse effects.
  • Dosage and dose titration (if appropriate). 
  • Length of course of medication. 
  • Second-line or alternative choice medications (if appropriate). 
  • Review interval. 
  • Plans for stopping the medication (if applicable).
• Other roles of a primary care physician in the general care of a person with CP may include:
  • Ensuring that the person and their families and carers are provided with information about:
    • Their local network of specialist services.
    • Support groups.
    • Cerebral palsy and its prognosis, and management. Patient information leaflets are available from the NHS, and SCOPE.
  • Coordinating regular review.
    • Where appropriate, the person can direct the frequency of review and which services should be involved based on their needs and preferences. 
    • People with complex needs (such as GMFCS levels IV and V, communication difficulties, learning disabilities, residents in long-term care settings or in the community without sufficient practical and social support, and/or multiple comorbidities) should be offered an annual review of their clinical and functional needs by a healthcare professional with expertise in neurodisabilities. 
    • If the person (or their family/carer) consents, a GP should receive updated clinical information following review.
  • Giving information about national screening services (for example, breast, colon, and cervical cancer screening) and encouraging the person to attend screening appointments.
    • Explain that screening services will make arrangements to ensure that they are accessible to people with CP.
  • Providing advice on physical activity.
    • Discuss with the person (and their families or carers, if agreed) the importance of physical activity in maintaining general fitness and physical and mental health.
    • Provide information on accessible local services that support people with CP to take part in physical activity.
    • Consider referral to services with experience and expertise in neurological impairments that can provide support with physical activities (including sport) and tasks of daily living, which (depending on local availability) may include physiotherapy, occupational therapy, orthotic and functional electronic stimulation services, rehabilitation engineering services, and/or wheelchair services.
  • Addressing concerns about vocational skills and independent living.
    • Assess for any factors that may be affecting participation, and arrange appropriate intervention via the local specialist team, if appropriate.
    • If the person has complex physical, cognitive, language, or sensory needs, consider referral to occupational therapy services to assess functional needs and provide individualised support.
    • Refer adults with cerebral palsy who would like to work, or who are already working, to a professional with expertise in vocational skills and independent living (for example, an occupational therapist).
  • Ensuring that the person and their family members and carers are aware of their right to a care and support needs assessment in line with the Care Act 2014, and discussing with them the type of support available.
  • Coordinating care (where necessary) when people with cerebral palsy transfer from hospital to home.
    • For further information, see the  NICE guideline on Transition between inpatient hospital settings and community or care home settings for adults with social care needs. 
  • Assisting with advance care planning — be aware that advance care planning may be appropriate at any age, or stage of health in people diagnosed with serious and/or chronic illness. The goal is to help ensure that they receive medical care that is consistent with their values, goals, and preferences.

Dose

• For children:
  • Baclofen treatment is usually initiated and managed by specialists.
  • Baclofen is usually started at a very low dose (approximately 0.3 mg/kg per day) in 2 to 4 divided doses, then slowly titrated up at one-week intervals. The usual maintenance range is 0.75 to 2 mg/kg body weight. The maximum daily dose is 60 mg/day (40 mg/day in children below 8 years of age).
• For adults:
  • Oral baclofen treatment should be started with a low dose that is gradually increased over about 4 weeks to achieve the optimum therapeutic effect.
  • The recommended dosing regimen for adults is initially 5 mg, 3 times a day, gradually increasing to a maintenance dose that is usually up to 60 mg daily in divided doses. Maximum dose is 100 mg per day.
  • Review treatment if there is no benefit within 6 weeks of achieving the maximum dose.
  • If eGFR is less than 15 mL/minute/1.73 m², there may be risk of toxicity—only use if the potential benefit outweighs the risk, use smaller doses (e.g. 5 mg daily by mouth) and if necessary increase dosage interval. Monitor for signs and symptoms of toxicity.
  • When stopping baclofen, discontinue by gradual dose reduction over at least 1–2 weeks (longer if withdrawal symptoms occur).

[NICE, 2022; BNF, 2024; BNFC, 2024; EMC, 2024a; EMC, 2024b]

Contraindications and cautions

• Do not prescribe baclofen to people with:
  
  • Active peptic ulceration.
  • Hypersensitivity to baclofen or any of the excipients. (Some preparations of baclofen tablets contain lactose so people with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should avoid those preparations.)
• Prescribe baclofen with caution to people:
  • With cerebrovascular disease.
  • With hypertension.
  • With Parkinson's disease.
  • With respiratory, hepatic, or renal impairment.
  • With a history of peptic ulceration.
  • With bladder sphincter hypertonia.
  • With epilepsy.
  • With psychiatric disorders (psychotic disorders, depressive or manic disorders, alcoholism, confusional states, or risk factors for suicide)  — may be exacerbated by baclofen.
  • Who have a history of substance misuse — misuse, abuse, and dependence have been reported.
  • With porphyria.
  • Taking certain other drugs.
  • Who rely on spasticity to sustain upright posture and balance.
  • Who are elderly — may be more susceptible to side effects.

[BNF, 2024; BNFC, 2024; EMC, 2024a; EMC, 2024b]

Adverse effects

• The most commonly reported adverse effects of baclofen are drowsiness and nausea.
  • These occur mainly at the start of treatment, often if the dose is increased too rapidly. They are often transitory and may be eased by reducing the dose. If nausea persists, it may help to take it with food or a milky drink.
• Other common adverse effects include confusion, constipation, depression, diarrhoea, dizziness, dry mouth, euphoria, hallucination, headache, hyperhidrosis, hypotension, paraesthesia, skin reactions, urinary disorders, vision disorders, and vomiting.
• Symptoms that may occur on abrupt withdrawal include anxiety, confusional states, mania or paranoia, psychosis, convulsions, dyskinesia, tachycardia, hyperthermia, and temporary aggravation of spasticity and hypertonia. Treatment should be gradually discontinued over 1 to 2 weeks to avoid this.

[BNF, 2024; BNFC, 2024; EMC, 2024a; EMC, 2024b]

Drug interactions

Key drug interactions with baclofen include:

• Alcohol, anxiolytics, opiates, and hypnotics — agents causing central nervous system depression may exacerbate the drowsiness effects of baclofen.
• Tricyclic antidepressants — can enhance the muscle relaxant effects of baclofen, resulting in profound muscle hypotonia. Tricyclic antidepressants can also cause drowsiness, which may be additive when taking baclofen.
• Antihypertensives, diuretics, and other drugs known to lower blood pressure — may potentiate the hypotensive effect of baclofen. It may be necessary to adjust doses of antihypertensive drugs.
• Levodopa — there are reports of hallucination, confusion, headache, and nausea, as well as worsening parkinsonism with concomitant treatment.
• Lithium — people taking both lithium and baclofen should be monitored for severe aggravation of hyperkinetic symptoms, especially in people with Huntington's chorea.

[BNF, 2024; BNFC, 2024; EMC, 2024a; EMC, 2024b]

Pregnancy and breastfeeding

Pregnancy

The manufacturer advises use only if the potential benefit outweighs risk as studies in animals have shown reproductive toxicity. There have also been reports of drug withdrawal syndrome, including postnatal convulsions, in neonates after intra-uterine exposure to oral baclofen.

Breastfeeding

The manufacturer advises that the active substance passes into breast milk, but that quantities are likely to be too small to be harmful.

[BNF, 2024; BNFC, 2024; EMC, 2024a; EMC, 2024b]