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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

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Generic drug name: dexmethylphenidate (dex meth il FEN i date)
Brand name(s): FOCALIN, FOCALIN XR
GENERIC: not available FAMILY: Central Nervous System Stimulators
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING:

DRUG ABUSE AND DEPENDENCE

Dexmethylphenidate should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.

Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked. Long-term follow-up may be required because of the patient’s basic personality disturbances.

Drug treatment is not suitable for all children with attention deficit hyperactivity disorder (ADHD). Drug treatment is not intended for use in patients who exhibit symptoms of the disorder that result primarily from environmental factors (school, home), learning disabilities, and/or other psychiatric disorders, including psychosis.

The FDA has extensively strengthened the warnings section of the professional product labels of stimulant ADHD drugs that contain methylphenidate to warn not only of sudden death and serious cardiovascular problems but also of psychiatric problems, stunted growth, seizures and visual disturbances.

Facts About This Drug [top]

Dexmethylphenidate was approved by the Food and Drug Administration (FDA) in November 2001 for the management of attention deficit/hyperactivity disorder (ADHD).

Dexmethylphenidate is identical to one-half of the chemical mixture that makes up the 60-year-old drug methylphenidate. This type of compound is known as an optical isomer of the older drug. Both drugs are produced by the same company, Novartis Pharmaceuticals of New Jersey, but methylphenidate is also available in generic form.

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Dexmethylphenidate was approved by the Food and Drug Administration (FDA) in November 2001 for the management of attention deficit/hyperactivity disorder (ADHD).

Dexmethylphenidate is identical to one-half of the chemical mixture that makes up the 60-year-old drug methylphenidate. This type of compound is known as an optical isomer of the older drug. Both drugs are produced by the same company, Novartis Pharmaceuticals of New Jersey, but methylphenidate is also available in generic form.

A common strategy of drug companies trying to sell what is essentially an old drug with a new name is simply to "spin" — that is, to suggest that the difference between the new and old drugs is more than merely cosmetic. Unfortunately, this strategy works not only with patients but also with many health professionals as well. Novartis tried to claim that "the duration of activity was statistically significantly longer" (that is, that dexmethylphenidate worked longer in the body) with dexmethylphenidate than with methylphenidate. But the FDA medical officer who reviewed Novartis’ data disagreed: "This statement is misleading for several reasons."[1]

In the May 13, 2002, issue of Medical Letter on Drugs and Therapeutics, the editors concluded: "There is no evidence that dexmethylphenidate (FOCALIN) offers an advantage over any other formulation of methylphenidate (RITALIN and others). Older drugs with better established dosages and longer safety records are preferred."[1]

Side effects

In studies that Novartis submitted to the FDA in support of the newer drug’s approval, several safety risks (similar to those of methylphenidate) were identified. They included loss of appetite accompanying weight loss, fluctuations in blood pressure and heart rate, abdominal pain, nausea, vomiting and headaches. There was one case of convulsions reported, in addition to possible onsets of psychotic and other behavioral disturbances.[1]

In one study there was an average increase of 20 millimeters of mercury in systolic blood pressure (the upper number) and 30 beats per minute in heart rate in 12 children who had received a 10-milligram (mg) dose of dexmethylphenidate.[1] This is a significant increase, even in children.

The FDA-approved Medication Guide for dexmethylphenidate lists many of the associated safety risks. The guide also includes more recently discovered information about psychiatric risks, such as new or worsened bipolar illness, and heart risks, including sudden death in patients who have heart problems or heart defects and stroke and heart attack in adults.[2]

A 2013 article published in Prescrire International reported cases of dystonia (in which muscles contract involuntarily) and trismus (commonly known as lockjaw) with methylphenidate use.[3]

In 2015, Health Canada, an agency similar to the FDA, updated the warning section of the labels of drugs used to treat ADHD on the risk of suicidal thoughts and behaviors. The advisory stated that Health Canada had received reports that included thoughts of suicide, suicide attempts and, in a very small number of cases, suicide.[4]

Interactions with other drugs

A number of drug interactions that are possible with methylphenidate also apply to dexmethylphenidate. Both drugs, because they increase blood pressure, decrease the effectiveness of high blood pressure drugs.

Serious adverse reactions have occurred when methylphenidate has been used in combination with clonidine (CATAPRES). The same may apply to dexmethylphenidate.[1]

Studies have shown that methylphenidate may inhibit the breakdown of the following drugs:

  • Anticoagulants (blood thinners) such as warfarin (COUMADIN).
  • Anticonvulsants such as phenobarbital (LUMINAL, SOLFOTON), phenytoin (DILANTIN) and primidone (MYSOLINE).
  • Tricyclic antidepressants (such as amitriptyline [ELAVIL] and imipramine [TOFRANIL]) and selective serotonin reuptake inhibitor (SSRI) antidepressants (such as fluoxetine [PROZAC] and paroxetine [PAXIL]).

For patients using these drugs, it may be necessary to adjust the dose and monitor drug concentration in the blood or, in the case of warfarin, the effect on blood clotting when starting or stopping methylphenidate or dexmethylphenidate.[1]

Dexmethylphenidate should not be used in combination with a group of antidepressants called monoamine oxidase (MAO) inhibitors or for at least 14 days after taking an MAO inhibitor because of the risk of an acute elevation in blood pressure. The MAO inhibitor drugs include furazolidone (FUROXONE), isocarboxazid (MARPLAN), phenelzine (NARDIL), procarbazine (MATULANE), selegiline (ELDEPRYL) and tranylcypromine (PARNATE).[1]

2013: The FDA issued an advisory that dexmethylphenidate therapy has been associated in post-marketing reports with peripheral vasculopathy (damage to blood vessels outside of the heart), including Raynaud’s phenomenon. These disorders typically affect fingers and toes.[5] Raynaud’s phenomenon is characterized by a pale to blue to red sequence of color changes of the fingers or toes, most commonly after exposure to cold. The fingers or toes also may feel numb or painful.

In 2013, the FDA also issued a safety alert warning that methylphenidate products may be associated with rare cases of priapism (prolonged and sometimes painful erections). The drug product label and Medication Guide for these products were revised.[6]

last reviewed May 31, 2021