Synvisc® / Synvisc-One®
DCI : Hylane G-F 20
Acide hyaluronique réticulé pour gonarthrose. 1 ou 3 injections selon protocole. Effet 6 mois en moyenne.
Pharmacovigilance — Top effets indésirables
6 928 366 rapports FAERS- Inefficacité du traitement464 964 (13%)
- Utilisation hors AMM349 874 (10%)
- Nausées308 429 (9%)
- Fatigue297 884 (8%)
- Diarrhée268 738 (8%)
- Douleur267 726 (7%)
- Dyspnée266 472 (7%)
- Céphalées229 020 (6%)
- Décès200 280 (6%)
- VOMITING198 627 (6%)
- DIZZINESS194 479 (5%)
- Rash cutané182 037 (5%)
- Prurit178 083 (5%)
- Arthralgies169 819 (5%)
Source : OpenFDA / FAERS (FDA Adverse Event Reporting System). Termes MedDRA traduits FR. Les rapports incluent des attributions causales non confirmées.
⚠️ Rappels (recalls) FDA
D-1744-2015
Class IILack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
20150602 · Terminated
D-518-2014
Class IILabeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500
20130702 · Terminated
D-0165-2018
Class IILabeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
20171116 · Terminated
D-0081-2026
Class IILack of Assurance of Sterility
20250730 · Ongoing
D-0375-2019
Class IICGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
20190102 · Terminated
Avis HAS — Commission de la Transparence
Source HAS via Google News RSS · avis SMR/ASMR officiels.