Four months into a previously stable relationship with the ADHD drug Concerta (also known as methylphenidate hydrochloride or extended-release Ritalin) the side-effects suddenly got really, really bad.
My jaw started clenching up, unprompted. My heart rate skyrocketed. The appetite I had been fighting to maintain essentially disappeared. Eating less made it harder to focus and stabilize my anxiety.
To make matters worse, the drugs effects started wearing off sooner. The same dose that had, up to that point, reliably ushered in at least 10 productive, anxiety-free hours now left me feeling jittery and completely drained after only six.
As far as I knew, there had been no changes in my medication, so I assumed the shift was my fault and tried adjusting accordingly. When nothing helped, I stopped taking the pills regularly to mitigate the physical toll.
A yelling match with my boss combined with some gentle chiding from my therapist convinced me to try again. As a Schedule II drug, Concerta requires a doctor visit every 90 days for refills. While visiting to renew my prescription I asked about testing a higher dosage next time if symptoms didn’t get better.
But then, things got better. It was like the early days all over again — my appetite came back, my mood improved, the jitters dissipated, and I felt productive and focused from 9:00 a.m. to 9:00 p.m. I started to question if what I had experienced had even been the drug’s fault in the first place. Maybe I had been under more stress than usual, or I really hadn’t given my body enough opportunity to get used to the new chemistry.
At my next visit, my doctor had a different explanation.
Like many in the US healthcare system, my insurance doesn’t cover name-brand drugs. Instead, my prescriptions are filled with generic versions of Concerta, manufactured to meet Federal Drug Administration (FDA) benchmarks for same-ness or “bioequivalence" with the original.
According to the FDA, however, the generic drug that had been used to fill my prescription when my problems started, manufactured by a company called Mallinckrodt Pharmaceuticals, failed to meet new bioequivalence benchmarks. It was subsequently removed from the Agency’s Orange Book, a repository of approved drug substitutions, in 2015. The FDA filed a notice to withdraw approval for the generic in October 2016.
The generic pill with fewer side-effects and better results was manufactured by the same company that makes the brand-name version, Janssen Pharmaceutica, which partially explains why it performed so much better than Mallinckrodt’s version.
My doctor warned me to check my prescriptions before leaving the pharmacy for the foreseeable future. Mallinckrodt can still technically sell their drug until the FDA’s process forces them to pull it, and once you leave the drug store with the problematic pills, they legally cannot exchange them.
In spite of his warning, I forgot to double-check the bottle when I picked up my very next refill. A week later when I went to open the bottle, my heart sank. Inside rested 30 Mallinckrodt tablets. Thirty days of tough choices — forego medication and struggle in class, or take the medication and struggle everywhere else.
I was livid. How is it possible for a drug to continue to be legally sold as a generic substitute two years after the FDA has confirmed the drug doesn’t do what it claims? If FDA testing confirmed the drug wasn’t good, why had it approved the drug for use in the first place? Why does my pharmacy sell the lesser pills if others are available on the market?
Read my next article in two weeks as I attempt to find some answers.
Reach columnist Sarah Corn at firstname.lastname@example.org. Twitter: @ThatSarahCorn