UK regulators caution against switching between common ADHD meds
UK regulators have a message for ADHD patients and their providers: Take caution when switching between long-acting forms of common meds such as Novartis’ blockbuster Ritalin LA and Janssen’s Concerta XL.
The country’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning on Monday about changing long-acting formulations of methylphenidate, the active ingredient in Ritalin, Concerta and a host of other drugs used to treat ADHD.
Ritalin was first approved in the US back in 1955. However, Novartis recently divested the European rights to Ritalin LA capsules, which accounted for roughly 30% of total sales, to Germany-based InfectoPharm. MHRA also named Janssen’s Concerta XL, Takeda’s Equasym XL, Flynn Pharma’s Medikinet XL and generics in its statement.
Long-acting forms of methylphenidate consist of two components, one for immediate release and another designed for a slower, extended release. However, those proportions vary across products, meaning many methylphenidate drugs require unique dosing schedules and instructions, such as whether or not to take the med with food.
Patients may also experience differences in side effects or efficacy, MHRA noted.
“The response to methylphenidate varies greatly from patient to patient and therefore the doctor will need to increase or decrease a dose to find one that suits the patient (dose-finding phase),” MHRA wrote to clinicians. “Due to these differences, changing preparations means that the dose may have to be adjusted to avoid the potential for overdose or underdose.”
In addition to advising clinicians to watch those labels when switching drugs, MHRA cautioned against frequent changes altogether.
“Changes to medication should only be made in the context of individual review and should be communicated to patients, who should be advised to report any changes to their symptoms or development of side effects,” MHRA warned. “We will continue to monitor safety information and will seek to introduce this wording in other long-acting methylphenidate formulations as appropriate.”
A couple years ago, MHRA joined a consortium of drug regulators that was formed in an effort to better align regulatory and policy approaches for pharmaceuticals around the world. Last summer, the group unveiled plans to improve their work-sharing process and boost the number and variety of new drug applications assessed through 2024.