ChEMBL withdrawn_flag true; not an FDA-approved drug product
The note concerns a different formulation, related agent, efficacy, or an insufficiently specified source. Excluded from definitive safety and setback totals pending review.Sources (3)
- ChEMBL (EMBL-EBI) CHEMBL752 withdrawn_flag true, first_approval null
- ClinicalTrials.gov (NIH/NLM) NCT00179010
- DrugBank DB00131 (adenosine phosphate)
Systemic heparin carries HIT risk; nebulised route not an approved formulation
The note concerns a different formulation, related agent, efficacy, or an insufficiently specified source. Excluded from definitive safety and setback totals pending review.Sources (3)
- ChEMBL (EMBL-EBI) CHEMBL1201513 max_phase 4
- ClinicalTrials.gov (NIH/NLM) NCT05886998
- Nebulised heparin inhalation-injury meta-analysis (Burns & Trauma 2020, PMC7271764)
ChEMBL withdrawn flag set (formulation-specific); no major safety withdrawal for the flavonoid itself
The note concerns a different formulation, related agent, efficacy, or an insufficiently specified source. Excluded from definitive safety and setback totals pending review.Sources (2)
- ChEMBL CHEMBL231884 (DIOSMIN, nutraceutical, withdrawn flag)
- ClinicalTrials.gov NCT07369635, NCT03413618
ChEMBL withdrawn_flag set; bleeding risk (antiplatelet interaction). No rigorous FDA drug approval.
The note concerns a different formulation, related agent, efficacy, or an insufficiently specified source. Excluded from definitive safety and setback totals pending review.Sources (2)
- ChEMBL (EMBL-EBI)
- ClinicalTrials.gov (NIH/NLM)
Esketamine (Spravato) carries FDA boxed warning: sedation, dissociation, abuse/misuse potential
The note concerns a different formulation, related agent, efficacy, or an insufficiently specified source. Excluded from definitive safety and setback totals pending review.Sources (3)
- ChEMBL (EMBL-EBI) CHEMBL742, max_phase 4, first_approval 1970
- ClinicalTrials.gov NCT04933149 (brachial plexus injury), NCT02655692 (PTSD)
- FDA Spravato label - boxed warning
5 FDA warnings; CKD +20-50%; fractures +30%; $590M settlements
The note concerns a different formulation, related agent, efficacy, or an insufficiently specified source. Excluded from definitive safety and setback totals pending review.Sources (0)
No primary citation attached yet.
US FDA repeatedly declined approval (cardiovascular concerns incl. increased MI after cardiac bypass at high doses)
The note concerns a different formulation, related agent, efficacy, or an insufficiently specified source. Excluded from definitive safety and setback totals pending review.Sources (3)
- ChEMBL (EMBL-EBI) CHEMBL1206690 max_phase 4, approved 2002
- EMA Dynastat EPAR product information
- Medscape/PharmaTimes: FDA rejection of parecoxib (Dynastat)
FDA Nonprescription Drugs Advisory Committee (Sept 2023) concluded oral phenylephrine is ineffective as a decongestant; FDA proposed removing oral OTC phenylephrine (2024)
The note concerns a different formulation, related agent, efficacy, or an insufficiently specified source. Excluded from definitive safety and setback totals pending review.Sources (3)
- ChEMBL (EMBL-EBI) CHEMBL1215 max_phase 4, approved 1952
- FDA NDAC Sept 2023 (oral phenylephrine ineffective as decongestant)
- ClinicalTrials.gov (NIH/NLM) NCT06770426