DROPIZAL (opium brut)

Key points

Unfavourable opinion for reimbursement in the symptomatic treatment of severe diarrhoea in adults when the use of other anti-diarrhoeal treatments has not had a sufficient effect. 

Role in the care pathway? 

The clinical situations responsible for diarrhoea are very numerous and varied. To relieve recurrent functional bowel disorders in which diarrhoea is the predominant symptom, loperamide (IMODIUM) is prescribed to slow intestinal transit; it has no effect on abdominal pain.

In the event of severe acute diarrhoea, anti-diarrhoeal agents are symptomatic treatments which reduce stool frequency. They do not dispense with the need for dietary measures and rehydration if required. No anti-diarrhoeal agents have a demonstrated effect on preventing dehydration. Acute diarrhoea with dehydration (case of patients in care homes for the elderly) should not be treated with an anti-diarrhoeal but by rehydration. In rare circumstances, such as profuse diarrhoea on returning from a country with a high risk of “traveller’s diarrhoea”, and pending the results of bacteriological (Salmonella) and parasitological (amoebiasis) analyses, anti-diarrhoeal treatment may be useful, relieving diarrhoea and abdominal pain, but restriction of prescription to gastroenterologists will make prescription difficult in this context (expert opinion).

In the event of chronic diarrhoea, it is essential to determine the cause in order to be able to initiate specific aetiological treatment. The mechanisms for chronic diarrhoea may be multiple, or be unknown or imprecise, as is the case in drug-induced diarrhoea (more than 700 medicines implicated and a total of 7% of medicinal product adverse effects).

Loperamide, which is the most assessed anti-diarrhoeal agent, is an opiate derivative with the main effect of slowing transit.  In patients not responding to loperamide, in whom quality of life is severely impaired due to numerous and abundant stools, the need is not covered.

Role of the medicinal product in the care pathway

Considering:

- the absence of clinical data supporting the efficacy and safety of DROPIZAL (opium tincture) particularly compared to well-managed anti-diarrhoeal treatment,

- the potential risk of misuse, particularly in the event of long-term prescription renewal, and

- the risk of interactions with other medicinal products (addition of adverse effects, in particular respiratory depression) in patients already treated with morphine-based analgesia (morphine, codeine, etc.),

the Transparency Committee deems that DROPIZAL (opium tincture) has no role in the treatment of adults with severe diarrhoea not responding to other anti-diarrhoeals (in particular loperamide).