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Ritalin LA (Methylphenidate Hydrochloride Extended Release) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The clinical program for Ritalin LA (methylphenidate hydrochloride) extended-release capsules consisted of 6 studies: 2 controlled clinical studies conducted in children with ADHD aged 6-12 years and 4 clinical pharmacology studies conducted in healthy adult volunteers. These studies included a total of 256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The subjects received Ritalin LA in doses of 10-40 mg per day. Safety of Ritalin LA was assessed by evaluating frequency and nature of adverse events, routine laboratory tests, vital signs, and body weight.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, MedDRA terminology has been used to classify reported adverse events. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Events in a Double-Blind, Placebo-Controlled, Clinical Trial with Ritalin LA

Treatment-Emergent Adverse Events

A placebo-controlled, double-blind, parallel-group study was conducted to evaluate the efficacy and safety of Ritalin LA in children with ADHD aged 6-12 years. All subjects received Ritalin LA for up to 4 weeks, and had their dose optimally adjusted, prior to entering the double-blind phase of the trial. In the 2-week, double-blind treatment phase of this study, patients received either placebo or Ritalin LA at their individually-titrated dose (range 10 mg-40 mg).

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Adverse events with an incidence >5% during the initial 4-week, single-blind Ritalin LA titration period of this study were headache, insomnia, upper abdominal pain, appetite decreased, and anorexia.

Treatment-emergent adverse events with an incidence >2% among Ritalin LA-treated subjects, during the 2-week, double-blind phase of the clinical study, were as follows:

Preferred term Ritalin LA 
N=65  
N (%)
Placebo
N=71  
N (%)
Anorexia 2 (3.1) 0 (0.0)
Insomnia 2 (3.1) 0 (0.0)

Adverse Events Associated with Discontinuation of Treatment

In the 2-week, double-blind treatment phase of a placebo-controlled parallel-group study in children with ADHD, only 1 Ritalin LA-treated subject (1/65, 1.5%) discontinued due to an adverse event (depression).

In the single-blind titration period of this study, subjects received Ritalin LA for up to 4 weeks. During this period a total of 6 subjects (6/161, 3.7%) discontinued due to adverse events. The adverse events leading to discontinuation were anger (in 2 patients), hypomania, anxiety, depressed mood, fatigue, migraine and lethargy.

Adverse Events with Other Methylphenidate HCl Dosage Forms

Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed below may also occur.

Other reactions include:

Cardiac: angina, arrhythmia, palpitations, pulse increased or decreased, tachycardia

Gastrointestinal: abdominal pain, nausea

Immune: hypersensitivity reactions including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura.

Metabolism/Nutrition: anorexia, weight loss during prolonged therapy

Nervous System: dizziness, drowsiness, dyskinesia, headache, rare reports of Tourette’s syndrome, toxic psychosis

Vascular: blood pressure increased or decreased; cerebrovascular vasculitis; cerebral occlusions; cerebral hemorrhages and cerebrovascular accidents

Although a definite causal relationship has not been established, the following have been reported in patients taking methylphenidate:

Blood/ L ymphatic: leukopenia and/or anemia

Hepatobiliary: abnormal liver function, ranging from transaminase elevation to hepatic coma

Psychiatric: transient depressed mood, aggressive behavior, libido changes

Skin/Subcutaneous: scalp hair loss

Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a 10-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.



REPORTS OF SUSPECTED RITALIN LA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Ritalin LA. The information is not vetted and should not be considered as verified clinical evidence.

Possible Ritalin LA side effects / adverse reactions in 40 year old male

Reported by a physician from Germany on 2011-10-04

Patient: 40 year old male

Reactions: Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Ritalin LA



Possible Ritalin LA side effects / adverse reactions in 19 year old female

Reported by a physician from Germany on 2011-10-18

Patient: 19 year old female weighing 70.0 kg (154.0 pounds)

Reactions: Pain in Extremity, Arthralgia, Systemic Lupus Erythematosus, Musculoskeletal Stiffness, Deep Vein Thrombosis

Suspect drug(s):
Ritalin LA



Possible Ritalin LA side effects / adverse reactions in 10 year old male

Reported by a consumer/non-health professional from Brazil on 2011-10-31

Patient: 10 year old male

Reactions: Dysphagia, Cardiac Murmur, Heart Rate Increased, Mitral Valve Stenosis

Suspect drug(s):
Ritalin
    Dosage: 10 mg

Ritalin LA
    Dosage: 30 mg, unk



See index of all Ritalin LA side effect reports >>

Drug label data at the top of this Page last updated: 2013-12-20

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