Important Information on Generic Versions of Concerta

by Ruth Hughes, PhD

 

If you, or those under your care, are taking a generic version of Concerta (methylphenidate hydrochloride extended release tablets), be aware that the Food and Drug Administration has some concerns about their bioequivalency—their effectiveness. After receiving numerous complaints about the generic versions made by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd., the FDA has given both companies six months to demonstrate their products’ bioequivalency to Concerta or withdraw them from the market.

The FDA has not identified any serious safety concerns with these generic brands. They are not suggesting you make changes to your treatment (or your child’s treatment) unless you consult with your health care provider. The FDA has not expressed concerns regarding the generic brands (methylphenidate hydrochloride EX) manufactured by Actavis or Janssen.

So what does this mean for you? If someone in your family is currently taking a generic version of Concerta, CHADD recommends that you:

1.    Check with your pharmacist and find out what company is manufacturing your medication.
2.    Share the FDA alert with your pharmacist.
3.    Consult with your health care provider if you are concerned about the effectiveness of your medication, or have any other concerns about its use.
4.    If you and your health care provider determine that it would be best for you to change your prescription for name brand Concerta, be certain to ask if your insurance plan covers this cost.
5.    If it doesn’t, ask your health care provider to contact your insurance company and request an exception from any restrictions requiring generic medications for ADHD.

We will keep you informed on this issue.


Ruth Hughes, PhD, is the former CEO of CHADD. A clinical psychologist by training, she has an adult son with ADHD who is thriving. A former member of CHADD's national board of directors, she served as both Deputy CEO and Chief Program Officer before becoming CEO, and now serves as a special advisor.

Acetaminophen, Pregnancy, and ADHD

Guest blog by Max Wiznitzer, MD

Newly published in JAMA Pediatrics, this is a study of mothers’ use of acetaminophen during pregnancy and the subsequent development of ADHD-like behavioral problems in their children. The data were taken from the Danish National Birth Cohort, which recorded information for sixty percent of pregnant women during the years 1996-2002, during and six months after pregnancy. Later, information was obtained about the mothers’ and fathers’ behavioral problems during childhood and about their children’s behavior, presence of hyperkinetic disorder (a form of ADHD), and stimulant prescriptions. The group of children numbered more than 40,000. The study found an association (a relationship) between the mother’s use of acetaminophen during pregnancy and the presence of ADHD-like behaviors, the diagnosis of hyperkinetic disorder and the use of stimulant medication, especially if the acetaminophen was used for more than one trimester or at least once weekly for many weeks.

What is the significance of this study? It tells us that, in this Danish population, there is an association or connection between use of acetaminophen during pregnancy and ADHD features in the children. It does not tell us why this relationship exists—does one cause the other, is there another factor that affects both, or is this just a coincidental result? The large number of mothers in this study makes it likely that the results are real and not coincidental. However, while many reasons that could explain the relationship were examined, others were not, such as ADHD in the family or the reason for acetaminophen use.

What does this mean for the pregnant woman? Experts do not recommend changing the usual habit of using acetominophen for fever or significant discomfort during pregnancy. However, pregnant women should be aware of the reason for the acetaminophen use and, as for any other medication, strongly consider whether it is needed. If necessary, they should discuss any concerns with their obstetrician or family doctor. Lastly, they should realize that more research is needed to confirm or refute this finding and, if real, to determine the reason for the relationship between acetaminophen and ADHD-like behavior problems in the children.

Max Wiznitzer, MD, is the director of the Rainbow Autism Center at Rainbow Babies and Children's Hospital in Cleveland. He is also associate professor of pediatrics and neurology at the Case Western Reserve University School of Medicine. He is a member of CHADD’s professional advisory board.

The Myth That "ADHD Doesn't Exist"

guest post by Mary V. Solanto, PhD

Recently, there has been much attention paid to an article entitled “ADHD Doesn’t Exist” that appeared in a number of major U.S. publications, based on a book of the same name just published by Richard Saul, MD. Dr. Saul, who describes himself as a behavioral neurologist, makes his point by describing cases of children who came to him exhibiting signs suggestive of ADHD (difficulty concentrating, poor academic work etc), but who turned out upon closer examination to instead have a learning disorder, anxiety, impaired vision, or even bipolar disorder. His implication is that all children who are referred for attention or behavior problems will be found instead to have another condition that accounts for their symptoms. Abundant evidence indicates otherwise.

Any reputable, knowledgeable mental health practitioner will take care to rule out these alternative conditions as the exclusive or primary cause of a child’s attention or behavior problems before diagnosing ADHD. But after other possible disorders are ruled out, a significant number of children meet the formal criteria for ADHD, as described in the Diagnostic and Statistical Manual. These are: (1) symptoms of inattention and/or hyperactivity-impulsivity that are extreme for the child’s age; (2) that occur both at home and at school; (3) with clear evidence that the symptoms reduce the quality of the child’s social, academic, or occupational functioning; (4) that are chronic, starting before age 12 and lasting at least 6 months; and (5) are not explained by another disorder.

Evidence that ADHD is a real disorder—and specifically a brain disorder—comes from several major sources. Neuroimaging has demonstrated that children with ADHD show (a) structural size differences in relevant brain areas and (b) less activation of brain regions that control attention, impulses and motor activity, organization, and planning, and that many of these differences persist to adulthood as well. Finally, family studies indicate that the condition is highly heritable and point to a genetic predisposition in the great majority of cases.

The unfortunate impact of this and other publications that are not fact-based is that they add to the stigma of ADHD and hinder the diagnosis and treatment of thousands of people who do have ADHD, and whose lives would be significantly improved with treatment.

Mary V. Solanto, PhD, is associate professor of psychiatry and director of the ADHD Center in the Division of Child and Adolescent Psychiatry at Mount Sinai School of Medicine. She is a member of the advisory board of the Journal of Child Psychology and Psychiatry and of the editorial boards of the Journal of Attention Disorders and The ADHD Report. Dr. Solanto serves on the professional advisory boards of Children and Adults with ADHD (CHADD) and the American Professional Society of ADHD and Related Disorders (APSARD). She is the author of Cognitive-Behavioral Therapy for Adult ADHD: Targeting Executive Dysfunction (Guilford Press, 2011).