Fenoverine

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Fenoverine is a non-anticholinergic synchronizer of smooth muscle motility[i]. It was developed as an NCE (new chemical entity) by a French Research Laboratory for the treatment of spasmodic syndromes of the intestinal (e.g., irritable bowel syndrome) and urogenital tract (e.g., dysmenorrhea).

Warnings
The adverse events reported in the clinical trials with fenoverine were mostly gastrointestinal upsets, such as nausea, vomiting, heartburn, epigastric pain, dry mouth, bad taste in mouth, constipation, and flatulence. A few other events, as skin rash, dizziness, fatigue and insomnia, were also reported. These events were self-limiting within an average duration of 2 days. There was no evidence of detectable effects on other organs or systems except GI or urogenital tract.

The adverse events reported during the post-marketing surveillance have been of the same nature but with much fewer incidences. However, occasional occurrence of rhabdomyolysis, which can be a serious event, has been associated with the administration of fenoverine. Out of the 74 cases reported in the whole world, 72 of them occurred in France.

Rhabdomyolysis is a potential adverse effect of many therapeutic classes, and commonly seen with cholesterol-lowering agents. It is known to be genetically determined in subjects with an inherited predisposition to malignant hyperthermia and myoglobinuria. A specific sub-population with these genetic predispositions has been identified in France, which accounted for at least 8 cases out of the 72 cases in France. All monitored cases occurred in elderly patients (>65 years), and/or in patients with severely impaired liver function (liver cancer, terminal cirrhosis). These patients were all under multiple treatments and almost all cases were given a very high dose of fenoverine. These conditions are known to facilitate the occurrence of any kind of adverse events, including rhabdomyolysis. As determined by the attending physicians and the health authorities, the only two lethal events were clearly attributed to the underlying conditions, not to the administration of fenoverine or other medications.

As stated in the prescribing information, fenoverine is contraindicated in patients with liver insufficiency due to hepatitis, cirrhosis, alcoholic or narcoticism; and in patients with renal failure. Cautions should be exercised in elderly patients (more than 60 years), in patients on multitherapy with drugs metabolised by hepatic route. Where these precautions have been strictly followed, there was not a single event of rhabdomyolysis. In general, the overall risk for rhabdomyolysis event associated with fenoverine is very limited (3 events per million cycles), and lower than that of currently marketed lipid-lowering agents.

Contrary to certain unsubstantiated reports, fenoverine has never been withdrawn from the market because of the possible association with rhabdomyolysis.