Roche discontinued Endep amitriptyline hydrochloride concentrate liquid due to safety concerns and a lack of market demand, according to the U.S. Food and Drug Administration (FDA) [1]. The FDA noted that amitriptyline hydrochloride, particularly in concentrated liquid form, posed a risk of accidental overdose, especially in children [1].
What are the risks of amitriptyline hydrochloride concentrate?
The primary risk associated with amitriptyline hydrochloride concentrate is the potential for accidental ingestion leading to overdose. This is particularly concerning for pediatric patients, as even small amounts can be dangerous [1]. Symptoms of amitriptyline overdose can include drowsiness, confusion, hallucinations, and cardiac issues [1].
When was Endep discontinued?
Roche discontinued Endep amitriptyline hydrochloride concentrate liquid in the United States in 2004 [1].
What are the alternatives to Endep concentrate?
Following the discontinuation of Endep concentrate, other forms of amitriptyline hydrochloride became available, including tablets [2]. Additionally, a variety of other antidepressant medications exist for treating conditions like depression and neuropathic pain [3]. These alternatives offer different mechanisms of action and may have varying side effect profiles [3].
Who else makes amitriptyline hydrochloride?
While Roche discontinued its concentrate liquid formulation, amitriptyline hydrochloride in tablet form is available from multiple manufacturers, including generic drug companies [2]. This means the active ingredient is still accessible to patients who require it, albeit in a different dosage form.