Villepinte, 2 july 2008 - ...What is Nephrogenic Systemic Fibrosis (NSF)?NSF was first recognized in 1997 in 15 dialyzed patients and described in 2000 (1). This rare and highly debilitating disorder is characterized by extensive thickening and hardening of the skin associated with skin-colored to erythematous papules that coalesce into erythematous to brawny plaques with an “peau d’orange” appearance. Nodules are sometimes also described. Joint contractures may develop, with patients progressively becoming wheelchair-dependent. Patients often complain of pruritus, causalgia and sharp pains (2). The distal extremities are the most common area of involvement (with a distribution from ankles to mid-thighs and from wrists to midupper arms), followed by the trunk. The lesions are typically symmetrical. It is worth noting that the face and neck are virtually never involved (3)....
...Guerbet Pharmacovigilance Data
Guerbet markets meglumine gadoterate (Dotarem), a macrocyclic, ionic gadolinium chelate associated with a high thermodynamic and kinetic stability (15-19). So far more than eleven million patients have been exposed to Dotarem worldwide. With respect to NSF, Guerbet has recorded, to date, nine reports of patients who developed NSF after administration of gadolinium chelates.
There is no NSF case reported with Dotarem when it was injected alone.
These nine reports recorded by Guerbet and the Health Autorities are called “confounded cases”. The causal relationship to Dotarem is doubtful for the following reasons: linear gadolinium chelates were previously injected, the date of the onset of the disease and the chronology of injections...
... About the Group
Guerbet is the only pharmaceutical group fully dedicated to medical imaging. It has the most comprehensive range of x-ray and MRI contrast media available worldwide. These products assist medical professionals (radiologists, cardiologists, oncologists, etc.) in better diagnosing and treating their patients (cardiovascular, cancer, inflammatory and degenerative diseases)... [PDF] Guerbet's Press Release - PDF Communiqué de Presse Guerbet -
