Do Not Use! Dexmethylphenidate (FOCALIN) - a Methylphenidate (RITALIN) Copy

Dexmethylphenidate (FOCALIN), approved by the Food and Drug Administration (FDA) in November 2001 for attention-deficit/hyperactivity disorder (ADHD), joins a growing list of Do Not Use drugs, so called because they primarily result in economic harm to both individuals and the health care system. These drugs exist solely to extend a manufacturer’s brand name monopoly position in a lucrative market but offer nothing better than the drugs they replace. Besides Focalin, recent examples of such “new” drugs include esomeprazole (NEXIUM; see the November 2001 issue of Worst Pills, Best Pills News) and desloratadine (CLARINEX; see the March 2002 issue of Worst Pills, Best Pills News).

Dexmethylphenidate is identical to one-half of the chemical mixture that makes up the 40 year old drug methylphenidate (RITALIN)—a type of compound known as an optical isomer of the older drug. Both drugs are produced by Novartis Pharmaceuticals of New Jersey.

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 that accompanied loss of weight, fluctuations in blood pressure and heart rate, abdominal pain, nausea, and headaches. There was one case of convulsion reported, in addition to possible onsets of psychotic and other behavioral disturbances.

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

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 improvement is more than merely cosmetic. Unfortunately, this strategy works, not only with patients but with many health professionals as well. Novartis tried to claim that “the duration of activity was statistically significantly longer” than with methylphenidate. But the FDA medical officer who reviewed Novartis’ data disagreed: “This statement is misleading for several reasons.”

A number of possible drug interactions with methylphenidate apply with dexmethylphenidate. Both drugs, because they increase blood pressure, decrease the effectiveness of high blood pressure drugs. Studies have shown that methylphenidate may inhibit the breakdown of anticoagulants (blood thinners) such as warfarin (COUMADIN). Also, the breakdown of anticonvulsants such as phenobarbital (LUMINAL, SOLFOTON), phenytoin (DILANTIN), and primidone (MYSOLINE) may be inhibited. Also, tricyclic antidepressants—amitriptyline (ELAVIL) and imipramine (TOFRANIL) are examples—and selective serotonin re-uptake inhibitor (SSRI) antidepressants such as fluoxetine (PROZAC) and paroxetine (PAXIL) are inhibited in their breakdown.

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.

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

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

We agree with the conclusion of the editors of the highly respected Medical Letter on Drugs and Therapeutics in their May 13, 2002 review of dexmethylphenidate:

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.

Even if you use methylphenidate, we would add the following precautions, excerpted from the 1999 edition of Worst Pills, Best Pills’ discussion of the limited use of methylphenidate (RITALIN):

There is no doubt that although this drug can be effective in helping children (or adults) who actually have a diagnosis of attention deficit disorder (ADD), it is greatly overused and misused. Many children diagnosed with this condition actually have problems which are caused or worsened by inadequate teachers in the schools they attend or by problems with their parents. Similarly, many adults may have interpersonal problems which need to be dealt with by psychotherapy. Until causes of what might appear to be ADD are searched for and ruled out in a systematic way, it is not appropriate to use RITALIN or similar drugs.

Methylphenidate should not be used in children under six, since safety and efficacy in this age group have not been established. Little information is available on the long term safety and effectiveness of this drug in children. Suppression of growth has been reported with the long term use of stimulants in children.

What Can You Do

There is no medical reason that you or a family member should be taking dexmethylphenidate rather than methylphenidate.