Valproate is one of the most commonly prescribed medications for epileptic seizures suffered by individuals with Rett syndrome. Valproate products have been approved by the FDA.
Information on some of the more serious and more common adverse events associated with use of valproate products are listed below.
Anyone worried about the side effect profile of trofinetide should have a read.
Valproic acid may cause serious or life-threatening damage to the liver that is most likely to occur within the first 6 months of therapy.
Valproic acid can cause serious birth defects (physical problems that are present at birth), especially affecting the brain and spinal cord and can also cause lower intelligence and problems with movement and coordination, learning, communication, emotions, and behavior in babies exposed to valproic acid before birth.
Valproic acid may cause serious or life-threatening damage to the pancreas. This may occur at any time during your treatment.
Valproic acid may help to control your condition but will not cure it. Continue to take valproic acid even if you feel well. Do not stop taking valproic acid without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood or if you find out that you are pregnant. If you suddenly stop taking valproic acid, you may experience a severe, long-lasting and possibly life-threatening seizure. Your doctor will probably decrease your dose gradually.
Cardiovascular
Common (1% to 10%): Edema, hypertension, hypotension, palpitations postural hypotension, peripheral edema, tachycardia, vasodilation
Psychiatric
Very common (10% or more): Nervousness Common (1% to 10%): Abnormal dreams, agitation, anxiety, aggression, confusion, depression, emotional lability, hallucinations, insomnia, personality disorder, thinking abnormalities
Respiratory
Very common (10% or more): Flu syndrome, respiratory infection Common (1% to 10%): Bronchitis, dyspnea, epistaxis, increased cough, pharyngitis, pneumonia, rhinitis, sinusitis
Dermatologic
Very common (10% or more): Alopecia Common (1% to 10%): Discoid lupus erythematosus, dry skin, ecchymosis, furunculosis, maculopapular rash, petechia, pruritus, rash, seborrhea
Gastrointestinal
Very common (10% or more): Abdominal pain, diarrhea, dyspepsia, gingival disorder, nausea, vomiting Common (1% to 10%): Constipation, dry mouth, eructation, fecal incontinence, flatulence, gastralgia, gastroenteritis, glossitis, periodontal abscess, hematemesis, stomatitis
Genitourinary
Common (1% to 10%): Amenorrhea, cystitis, dysmenorrhea, dysuria, enuresis, metrorrhagia, urinary incontinence, urinary frequency, vaginal hemorrhage, vaginitis
Hematologic
Very common (10% or more): Thrombocytopenia Common (1% to 10%): Anemia, hemorrhage
Hepatic
Common (1% to 10%): Increased liver enzymes (particularly early in treatment), liver injury, SGOT increased, SGPT increased
Local
Common (1% to 10%): Injection site pain, injection site reaction
Metabolic
Very common (10% or more): Anorexia Common (1% to 10%): Weight loss/gain, increased appetite, hyponatremia
Musculoskeletal
Common (1% to 10%): Arthralgia, arthrosis, leg cramps, myalgia, myasthenia, twitching
Nervous system
Very common (10% or more): Dizziness, headache, somnolence, tremor Common (1% to 10%): Abnormal gait, amnesia, catatonic reaction, convulsion, disturbance in attention, dysarthria, extrapyramidal disorder, hypertonia, hypokinesia, incoordination, increased reflexes, memory impairment, nystagmus, paraesthesia, speech disorder, stupor, tardive dyskinesia, taste perversion
Ocular
Very common (10% or more): Amblyopia/blurred vision, diplopia Common (1% to 10%): Abnormal vision, conjunctivitis, diplopia, dry eyes, eye pain
Other
Very common (10% or more): Asthenia Common (1% to 10%): Back pain, chills, deafness, ear disorder, ear pain, face edema, fever, malaise, otitis media, tinnitus, vertigo
(20min delay)