France. Propacetamol (Pro-Dafalgan) is a precursor of paracetamol that is soluble in water and rapidly released, therefore it can be used for parenteral administration.
Pro-Dafalgan is available in vials of powder for dissolution with an ampoule of solvent. In 1995, several reports were published of nurses suffering from contact eczema after performing this procedure. Other cases were reported in 1996 and 1997.
In 1998, after receiving reports of some 40 cases of contact eczema and 3 cases of generalized reactions, the French Agency for Medicines and Laboratories decided that the labelling of Pro-Dafalgan should bear a caution that gloves should be worn and that detailed instructions for use should be included in the package insert. In addition, the agency stressed that this medicine should be replaced as quickly as possible with an oral analgesic. Propacetamol is contraindicated in patients with a history of contact eczema caused by this substance.
Reference: La Revue Prescrire 18 (187): 590 (1998).