Safety signals for inflammatory disease, kept in one public record.
FAERS disproportionality for NSAIDs, corticosteroids, TNF and interleukin inhibitors, and JAK inhibitors, next to FDA notices, recalls, trial starts, and new publications. The snapshot is rebuilt weekly.
openFDA extract dated 2026-07-30. Snapshot generated Oct 15, 2026, 6:37 AM UTC.
Weekly briefing
One email after the Monday refresh.
New FDA safety alerts and recalls, drug-safety signals that are new or stronger, notable trials, and the top new PubMed papers. Past issues stay in the archive.
Known-signal sanity check
How recovery is definedEvans screen on this snapshot: Pulmonary Embolism, Deep Vein Thrombosis, Thrombosis, Tuberculosis, Pulmonary Tuberculosis, Gastrointestinal Haemorrhage, Gastric Ulcer, Melaena. ROR only, with PRR below 2: Myocardial Infarction (PRR 1.24); Cerebrovascular Accident (PRR 1.58). A ROR signal here is not the same as an Evans signal.
Latest FDA notices
FDA Drug Safety Communications
FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditionsjak_inhibitor
FDA Drug Safety Communications
Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)jak_inhibitor · ulcerative_colitis
FDA Drug Safety Communications
FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluidnsaid
Recent recalls
D-0827-2026
Class ITyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Fresenius Kabi USA, LLC · reported 20260902 · matched “tocilizumab”
D-0653-2026
Class IIIMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.
Lack of assurance of Sterility:
ACCORD BIOPHARMA INC · reported 20260708 · matched “ustekinumab”
D-0546-2026
Class IIcimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.
Lack of Assurance of Sterility
UCB Biosciences Inc. · reported 20260527 · matched “certolizumab pegol”
D-0523-2026
Class IINAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Chemical contamination; presence of lead and lithium above specification
Acella Pharmaceuticals, LLC · reported 20260513 · matched “naproxen”
D-0342-2026
Class IIDiclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
SUN PHARMACEUTICAL INDUSTRIES INC · reported 20260211 · matched “diclofenac”
D-0291-2026
Class IIIDiclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Failed PH Specifications
Cipla USA, Inc. · reported 20260128 · matched “diclofenac”