The following post from the FDA appeared today about complaints that generic long-acting methylphenidates (brand name-Concerta) may not work equally well.
“In the case of the ADHD drug — certain generic versions of methylphenidate hydrochloride (Concerta, Janssen Pharmaceuticals) — the issue is a possible lack of therapeutic effect, which may be linked to product quality issues, according to the FDA.
A drug’s appearance on the list, which grows quarter by quarter, does not mean the FDA has concluded that the drug actually poses the health risk reported through FAERS. Instead, the agency is studying whether there is indeed a causal link. If it establishes one, the FDA then would consider a regulatory response such as gathering more information to better describe the risk, changing the drug’s label, or mandating a risk evaluation and mitigation strategy.”
If you have followed my blogs, I wrote about this in January 2014, as patients were mentioning that “my medicine isn’t working any more.” So, what to do?
Turns out that Watson Pharmaceutical makes generic Concerta with the original OROS technology that delivers methylphenidate in a very specific fashion. Mallinkrodt Pharmaceutical makes the generic Concerta without the OROS technology. The reason the FDA originally approved this generic was that it shown to be “bioequivalent” on a pharmacokinetic chart. How can you tell the difference? The OROS pill is barrel shaped, Mallinkrodt is a “flatten oblong” pill. IF you receive your medication from mail order, this will help you identify what pill you’re getting. If in doubt, call the mail order pharmacy and ask specifically about brand of generic.
What to do? I have been advising my patients on generic Concerta who are complaining about diminish effect to change to the Watson brand. This change may not be needed if the Mallinkrodt brand works for you. If not, the your doctor needs to write Watson brand specifically on your prescription.
But where to find it? As of this posting, Walgreen’s dispenses the Watson brand and Target and CVS dispense the Mallinkrodt brand. This is because they have different medication distributors. Who would have know?
So, what to do? If your medication is working, the brand of generic Concerta doesn’t matter. If your generic Concerta was working and has “lost its effect”, check the manufacture. If you were changed to Mallinkrodt, and you were better with the “barrel” shape pill, go back to Watson brand. Don’t simply conclude that generic Concerta doesn’t work. Unfortunately that is likely to happen to new patients started on generic Concerta who get the Mallinkrodt brand.
Anticipating over 300 attendees, the 13th Annual ADHD Conference for parents, teachers, professionals and adults with ADHD on Saturday, February 22, 2014 from 8:00am to 1:00pm will feature several expert speakers. West Chester University is just outside Philadelphia. Below is the program of speakers and topics.
Marie Paxon, program coordinator, invited me to present on the science of diagnosis and treatment of ADHD in adolescents and adults. If you reside in the area, please consider attending because it is a great way to learn a great deal about ADHD quickly and network with people with ADHD and those who offer guidance and treatment. See you there.
ADHD and the Brain: Knowledge Matters Speakers
Marilyn B. Benoit, M.D. is a child and adolescent psychiatrist. She is senior vice president of Clinical and Professional Affairs and chief clinical officer at Devereux. She is a past president of the American Academy of Child and Adolescent Psychiatry. Dr. Benoit has served on the faculties of Howard and George Washington Universities and is a clinical associate professor of psychiatry at Georgetown University Medical Center, from which she received the Vicennial Silver Medal of Honor for 20 years of distinguished service.
David W. Goodman, M.D. is assistant professor of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. He is also director of the Adult Attention Deficit Disorder Center of Maryland in Lutherville and medical director of Suburban Psychiatric Associates, LLC. Dr. Goodman is the author of The Black Book of ADHD.
Marjorie Johnson, LCSW, PCC is a licensed clinical social worker and certified coach who provides leadership and career coaching, training, and counseling. She specializes in helping students and professionals with ADHD. Ms. Johnson serves on Chester County/Main Line CHADD’s Professional Advisory Board and is a professional member of ADDA (Attention Deficit Disorder Association.). She is past president of the International Coaching Federation-Philadelphia chapter and was named the 2011 Small Business Person of the Year by the Exton Chamber of Commerce (PA).
Jesse D. Matthews, Psy.D. is a licensed psychologist and has worked with individuals with ADHD for a number of years. He is in private practice at The Center for Psychological Services in Paoli and Ardmore and also works at Holcomb Behavioral Health Systems, a community mental health organization. He evaluates adolescents for substance abuse at the Chester County Youth Center in West Chester and does substance abuse evaluations and treatment in an outpatient program in Kennett Square. Dr. Matthews is an adjunct professor at Immaculata University. Previously, Dr. Matthews worked for six years as a counselor at Hill Top Preparatory School, and he facilitated the Chester County/Main Line CHADD teen ADHD support group for two years.
Joan M. Polka, Ph.D. is a psychologist in the Counseling Center at West Chester University assigned full time to the Act 101 portion of the Academic Development Program (a developmental education opportunity for underprepared first-time college students). She is also co-chair of Chester County/Main Line CHADD’s Adult Program and was the 2011 CHADD Educator of the Year.
Martin Patwell, Ed.D. is director of the Office of Special Services for Students with Disabilities at West Chester University. He has also been the director of evaluation clinic at Landmark School. He has presented “Trends and Issues in Disabilities in Higher Education” at Jiangxi University, Nanchung, China. He is also a consultant to The College Board, Inc.
Preeti Singh, M.S. is the associate director of the Twardowski Career Development Center at West Chester University.
Sharon Watson, M.S. is assistant director of West Chester University’s Office of Services for Students with Disabilities. She has over 20 years of experience working with students with learning differences, mental health, and physical disabilities.
8:30 a.m. Welcome
Chester County/Main Line CHADD and West Chester University
West Chester University
Earl F. Sykes Student Union
110 West Rosedale Avenue
West Chester, PA 19383
8:45 –9:15 a.m.
ADHD Across the Lifespan
Marilyn Benoit, M.D.
Research has proven that ADHD does not end with childhood. Over the course of a lifetime, the scenarios change, but the struggles might not. What does ADHD look like at each stage of life and what is the impact? This fast-paced-but-thorough presentation will help attendees learn more about this complex disorder and will provide a summary of current treatment and management options. Don’t miss this valuable session to gain a better understanding of childhood, teen, and adult ADHD.
9:15 –10:30 a.m.
ADHD and the Brain – What You Need to Know About Treatment and Management
David W. Goodman, M.D.
Those with ADHD express frustration with the disorder’s symptoms: trouble focusing, procrastination, forgetfulness, and difficulty filtering out distractions. Some people have a slower processing speed and others struggle with impulsivity. To make things even more complex, many people with ADHD will have a co-occurring condition like learning disabilities, anxiety, depression, or autism. The good news is that treatment is available, and there are strategies to counteract these challenges. Dr. Goodman will provide an overview of medications and pro-social treatments for ADHD and discuss common co-occurring conditions in this valuable presentation. Children and adults report that they receive unhelpful advice like “try harder,” “start applying yourself,” and “pull yourself up by your bootstraps.” Attend this session to learn about evidence-based treatments for ADHD and how they make a difference.
10:45 –11:30 a.m.
ADHD and Social Interactions
Jesse Matthews, Psy.D.
Social interactions can consist of anything from a casual conversation with an acquaintance to daily communication with loved ones. This can present challenges for both children and adults with ADHD. Those with ADHD may feel isolated and disconnected from others. They may find that executive function challenges can cause them to misinterpret social cues, which are usually unspoken or vague. The invisible challenges of impulsivity, forgetfulness, and an inability to regulate emotions can have a negative effect on forming and maintaining friendships. Fortunately, new information and strategies are available through the field of social learning and social cognition. Attend this session to learn more about this exciting topic and how to apply it to everyday life.
• Facilitated activity: Mindfulness Meditation and ADHD
Marjorie Johnson, LCSW
Mindfulness meditation is a way to calm the mind and relax the body while increasing the ability to sustain attention and manage distractibility. Hear about compelling research and daily applications of mindfulness meditation. Practice it to experience the deep relaxation it generates.
11:45 a.m. –1:00 p.m.
Becoming Successful in College and Early Career
ADHD and Career Success
Preeti Singh
Career development is a life-long process, involving decision making, self-awareness, exploration, preparation, and experience. What tools are available to help students successfully navigate this territory? This brief presentation will provide an overview of resources and strategies.
WCU Student Panel
Sharon Watson, facilitator
Current students at West Chester University who have “been there, done that” tell it like it is. Their transitions, challenges, and routes to where they are today provide a look at what real students face in college.
• Facilitated activity: ADD and Loving It?!
This video blends humor, hope, and science to dispel the myths about adult ADHD. Comedian Patrick McKenna seeks a diagnosis for adult ADHD and learns the facts from an impressive array of experts. Funny, moving, and transformative, this fascinating documentary will hold you spellbound!
I have been invited as an expert on ADHD to participate in an interview on the Mid-day with Dan Rodricks show on WYPR on January 27 1-2pm. This is a live panel discussion that will include Dale Archer M.D., a psychiatrist and writer, to discuss the use of medication and treatment options for ADHD. The discussion is moderated by Dan Rodricks who is a distinguished journalist in Baltimore with a regular feature in the Baltimore Sun newspaper.
Dr. Archer wrote an article online for Forbes on January 6, 2014 on his perspective of ADHD and the overuse of medication and the over-marketing of ADHD. His article highlights and echoes the sentiments of Alan Schwatz in his New York Times article “The Selling of Attention Deficit Disorder” published December 15, 2013.
This one-hour program will give me the opportunity to highlight the national and international scientific literature and research on ADHD. I hope to highlight the well documented negative consequences over the course of one’s life with untreated ADHD as reflected in several international prospective studies following ADHD children into young adulthood.
This program promises to be a lively discussion and offers listeners the opportunity to call in with questions. I encourage you to mark your calendar. I believe the program can be accessed online. If you listen, please leave me your comments for feedback.
This morning the FDA’s MedWatch posted the following alert to physicians and patients concerning counterfeit Adderall 30 mg tabs from Teva Pharmaceuticals. These “Adderall” tablets don’t contain the four amphetamine salts as it should be. These tablets contain a combination of tramadol (pain medication) and acetominphen (tylenol). READ THE FOLLOWING ALERT AND ADVISE ANYONE OBTAINING THIS MEDICATION ONLINE.
ISSUE: FDA is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. FDA’s preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.
BACKGROUND: Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – a class of drugs for which special controls are required for dispensing by pharmacists. The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers. Authentic Adderall 30 mg tablets produced by Teva are round, orange/peach, and scored tablets with “dp” embossed on one side and “30″ on the other side of the tablet.
See the Press Release for pictures of the product.
RECOMMENDATION: Anyone who believes they have the counterfeit version of Teva’s Adderall 30 mg tablets should not take or should stop taking the product. Consumers should talk to their health care professional about their condition and options for treatment.
Scott Erye, the San Francisco Giant pitcher, has ADHD and was profiled in the article. Dr. Goodman provided background information to the author and was quoted.
