MHRA raises concerns with switching between long-acting J&J, Novartis and Takeda drugs

The U.K. drug regulator has told healthcare professionals to exercise caution when considering switching between long-acting attention-deficit/hyperactivity disorder (ADHD) therapies from companies including Johnson & Johnson, Novartis and Takeda. 

Multiple companies sell long-acting formulations of methylphenidate in the U.K. Branded products such as J&J’s Concerta XL, Novartis’ Ritalin XL and Takeda’s Equasym XL compete with generics for a share of the market, giving physicians the option of switching patients between similar formulations of the same active ingredient. 

Building on a recent European procedure, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has identified differences between the formulations, leading it to issue advice to healthcare professionals about how to approach switching. 

“Caution should be used if long-acting formulations of methylphenidate are to be used interchangeably due to the differences between formulations in dosing frequency, administration with food, amount and timing of the modified-release component, and overall clinical effect,” the MHRA wrote.

All the formulations release methylphenidate in two phases, with the immediate-release component ensuring a fast onset of action and the modified-release component potentially avoiding the need for the patient to take a second dose later in the day. However, the specific release profiles are different, as are the proportions of the immediate- and modified-release components. 

There are benefits to the differences. The diversity of the formulations allows physicians to target the release of methylphenidate at periods of the day that are particularly relevant to specific patients. But the differences also create challenges when switching. 

Because of the differences, the dose may need to be adjusted when switching formulations to avoid under- or overdosing the patient. The MHRA warns that switching can be associated with adverse events, adding frequent switching should be avoided.