[Adverse effects of glycolic irrigation solutions].
The aim of this study was to evaluate the frequency and the gravity of Trans Urethral Resection of the Prostate Syndrome or 'TURP Syndrome,' which occurs when irrigating fluids containing 1.5 per cent glycocolle are used. All the adverse effects that occurred with 5 products containing 1.5 per cent glycocolle which were notified to the pharmacovigilance structures in France were reviewed. The adverse effects notified comprised 24 cases of TURP Syndrome and 5 of renal failure. TURP Syndrome consisted of neurological signs (92 per cent); cardiovascular signs (54 per cent); visual disturbance (42 per cent) and digestive signs (25 per cent). Hyponatraemia occurred in all patients (mean 113 +/- 6 mmol.l-1) and 25 per cent of patients died. In 27 per cent of cases TURP Syndrome occurred when glycocolle was in contravention of AMM guidelines. The Drugs Agency has requested that modification be included in the Vidal pharmacopoeia (warnings and adverse reactions) and on glycocolle bags and that surgeons and anaesthetists be informed.
Centre Régional de Pharmacovigilance, CHRU Bretonneau, Hôpital Bretonneau, Tours, France.
M
M
Radal
A P
AP
Bera
C
C
Leisner
O
O
Haillot
E
E
Autret-Leca
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017558:Elective Surgical Procedures; D005260:Female; D006018:Glycols / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy; D011468:Prostatectomy / Q000009:adverse effects; D012189:Retrospective Studies; D012996:Solutions; D007507:Therapeutic Irrigation / Q000009:adverse effects
D006018:Glycols; D012996:Solutions
Effets indésirables des solutions d'irrigation glycocollées.