To save money, many people with ADHD take generic medications. Is this a good idea? That depends.
Physicians—and pharmacists—tend to assure patients that generics are “exactly the same” as brand. Only cheaper. The official term is bioequivalence to the brand-name version.
Unfortunately, that is not always case—sometimes dangerously so. With ADHD medications, in particular, the most effective dosing tends to be precise.
For example, 36 mg. With generics, the effective ingredient has 20% wiggle room, up or down. That means you could get significantly more than 46 mg. Or significantly less.
Here at the ADHD Roller Coaster, this has been an ongoing concern. I first reported on this topic in 2009 (yes, I’ve been here a while!).: Consumer Reports on Autos? Yes. On ADHD Medications? No!
Most recently, I am helping readers to stay current with the ongoing search for Concerta’s authorized generic—or at least finding ways to get brand more economically.
I’ve edited this post, in 2022, to provide a little history on this topic.
Ignore Consumer Reports On Rx
A Consumer Reports press release was the catalyst: Parents: Don’t rush Children to Adderall, Concerta, Strattera.”
I found it shocking. The magazine known for its reviews of cars and appliances was now issuing medical advice. Even more shocking: CR actually warned consumers away from brand-name medications for ADHD.
Yes, you read that correctly.
Their rationale? Brand-name medications are too costly and unnecessary. But more importantly: Your child can get “hooked” on these brand medications? (But not the generics of them? Can you believe how ridiculous that is?)
My blog post countered the nonsense, detailing the potential risks of using generic medications for treating ADHD.
With other readers, I left comments at the Consumer Reports post. Unfortunately, as is increasingly the case, readers comments have since been deleted.
“A Gnawing Concern”
Later in 2009, The New York Times article (“Not All Drugs Are the Same After All”) backs up the points I made in that post. Some snippets:
- “There is a gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterpart.”
- “Some specialists, particularly cardiologists and neurologists, are concerned about generic formulations of drugs in which a slight variation could have a serious effect on a patient’s health.”
Hundreds of consumers posted messages about problems with the generic drug Budeprion XL 300 on Joe Graedon’s People’s Pharmacy Web site. In other generic versions, it is called bupropion, the generic name for Wellbutrin. He then worked with an independent laboratory, ConsumerLab.com, to test the drug.
The lab found that Budeprion XL 300 released the active drug at a different rate than the brand name Wellbutrin XL 300. Mr. Graedon and the lab conjecture that the different dissolution rates might be to blame for the reported side effects and lower effectiveness of Budeprion.
Kudos to Joe Graedon of The People’s Pharmacy for listening to his readers (despite his own longstanding support of generics) and reconsidering the issue!
Most Recently: Generic Concerta
About 6 years later, this Wellbutrin XL incident inspired me to launch a MedWatch complaint with the FDA, this time about the inferior Concerta generics trickling onto the scene. Two companies, Kudco and Mallinckrodt, exploited loopholes in novel delivery-system drugs.
That is, drugs whose delivery system—how the medication gets from the pill into your bloodstream—makes all the difference in how it works. That is, without Concerta’s sophisticated osmotic-release system, it’s active ingredient (methylphenidate) operates like simpler delivery system,
ADHD Roller Coaster readers and others followed through and filed their MedWatch complaints. In 2014, we won! (Victory! Concerta Generics downgraded.)
The battle waged on a bit more. Mallinckrodt refused to accept the downgraded status—and threatened to sue the FDA.
For some time after, some consumers were still forced to accept them as generics. That is, these pharmacies weren’t playing by the rules. You can read the history in this post, where I also detail the difference between “true” and “authorized” generics: Consumer Q&A On Generic Concerta.
Update October 2019
The Trump administration named a venture capitalist as FDA chief, Scott Gottlieb, MD. During his short stint, he pushed through dozens of generics.
The upshot: Gottlieb scorned FDA scientists’ concerns that some generic makers were exploiting loopholes in FDA guidelines. These loopholes allowed drugs with bare-bones formulation to claim bioequivalence for drugs with sophisticated delivery systems. That included Concerta with its proprietary osmotic pump, Alza’s OROS.
Ongoing Concerta Issues
You can follow about the ongoing status of Concerta generics (and the authorized generic) here: Authorized Concerta Update, 6/19.
I welcome your comments on generic medications and ADHD.