Is this the end for ranitidine? NDMA presence continues to confound

Wagner, Jennifer A.; Dinh, Jean C.; Lightdale, Jennifer; Gold, Benjamin D.; Colombo, Jennifer

doi:10.1111/cts.12995

Cited by 10 publications

(9 citation statements)

References 4 publications

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“… 23 In April 2020, the FDA requested the complete withdrawal of ranitidine from the market on the grounds that when stored at high temperatures, NDMA levels may increase. 24 However, there is no long‐term epidemiological studies on the risk of cancer caused by long‐term exposure to NDMA from specific drugs. Some studies have shown that there was no increase in the risk of various cancers after taking ranitidine.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, a few studies that evaluated the cancer risk of ranitidine were flawed. 24 Therefore, more studies are needed on the safety of ranitidine. These circumstances were not known when we conducted the study in 2016, and the ranitidine was considered safe at that time.…”

Section: Discussionmentioning

confidence: 99%

“…Some studies have shown that there was no increase in the risk of various cancers after taking ranitidine. In addition, a few studies that evaluated the cancer risk of ranitidine were flawed 24 . Therefore, more studies are needed on the safety of ranitidine.…”

Section: Discussionmentioning

confidence: 99%

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The efficacy and safety of the short‐term combination therapy with ticagrelor and PPIs or H2RA in patients with acute STEMI who underwent emergency PCI

Wei

Zhuo

et al. 2021

Clinical Translational Sci

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Combination therapy with platelet inhibitors and acid‐suppressive agents is recommended for patients with acute ST‐segment elevation myocardial infarction (STEMI) who underwent percutaneous coronary intervention (PCI), but there remains a paucity of data to evaluate both the efficacy and safety of these combinations. In this prospective study, a total of 170 patients with acute STEMI who underwent PCI were divided into four groups: pantoprazole + ticagrelor, omeprazole + ticagrelor, ranitidine + ticagrelor, and ticagrelor only. The risk of PCI, antithrombotic efficacy, cardiac function, and main end points were evaluated and compared. No significant differences were found in infarction‐related artery perfusion indexes (thrombolysis in myocardial infarction [TIMI], corrected TIMI frame count), the incidence of stent thrombosis after PCI, platelet indicators (platelet count, mean platelet volume, and platelet distribution width), platelet activation (P‐selectin and glycoprotein IIb/IIIa levels), platelet aggregation (thrombelastography indicators, such as ADP% and MAADP), myocardial necrosis biomarker (creatine kinase isoenzyme‐MB and cardiac troponin I) levels, brain natriuretic peptide levels, the incidence of ischemic end point events, and the incidence of other tissue and organ bleeding events among the four groups. The incidence of gastrointestinal (GI) bleeding events in the proton pump‐inhibitor (PPI) group was significantly lower than that in the control group, whereas in the H2 receptor antagonist (H2RA) group it was not significantly different from the control group. The short‐term combination therapy with ticagrelor and PPIs or H2RA is safe and effective in patients with acute STEMI after PCI. In addition, the PPIs combined with ticagrelor could reduce the incidence of GI bleeding events without increasing the incidence of ischemic events.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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The efficacy and safety of the short‐term combination therapy with ticagrelor and PPIs or H2RA in patients with acute STEMI who underwent emergency PCI

Wei

Zhuo

et al. 2021

Clinical Translational Sci

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“…29 Since the initial discovery of nitrosoamine contamination, a ratcheting up of regulations on permissible levels of nitrosoamine impurities has taken place, leading to further recalls. [30][31][32] Thus, there are three distinct types of contamination we need to consider with the sartan drug class: AZBT, nitrosoamines and DMF solvent (Figure 1 and Table 1). and a 57% uptick in alternative ARB medications.…”

Section: What This Study Addsmentioning

confidence: 99%

“…More recently, the identification of the possible mutagen 5‐(4′‐(azidomethyl)‐[1,1′‐biphenyl]‐2‐yl)‐1 H ‐tetrazole (AZBT) (Figure 1) resulted in the recall of 31 batches of irbesartan‐containing products and two batches of losartan‐containing products by the MHRA (UK) in June 2021 29 . Since the initial discovery of nitrosoamine contamination, a ratcheting up of regulations on permissible levels of nitrosoamine impurities has taken place, leading to further recalls 30–32 . Thus, there are three distinct types of contamination we need to consider with the sartan drug class: AZBT, nitrosoamines and DMF solvent (Figure 1 and Table 1).…”

Section: Introductionmentioning

confidence: 99%

Angiotensin II receptor blockers (ARBs) and manufacturing contamination: A retrospective National Register Study into suspected associated adverse drug reactions

Salim

Jones

2022

Brit J Clinical Pharma

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The aim of this study was to determine if any suspected adverse drug reactions (ADRs) observed with the use of angiotensin II receptor blockers (ARBs) could be linked to either (a) their unique respective physicochemical and pharmacological profiles and (b) the recently disclosed suspected carcinogenic manufacturing contaminants found in certain sartan drug class batches. Methods:The pharmacology profiles of ARBs were data-mined from the Chemical Database of bioactive molecules with drug-like properties, European Molecular Biology Laboratory (ChEMBL). Suspected ADR data (from 01/2016-10/2022, inclusive) and prescribing rates of ARBs over a 5-year prescribing window (from 09/2016 to 08/2021, inclusive) were obtained via analysis of the United Kingdom Medicines and Healthcare products Regulatory Authority (MHRA) Yellow Card drug analysis profile and Open prescribing databases, respectively. Results:The overall suspected ADRs and fatalities per 100 000 prescriptions identified across the ARBs studied were found to be different between the sartan drug class members (chi-squared test, P < .05). There is a greater relative rate of reports for valsartan across all investigated organ classes of ADRs, than other ARBs, despite valsartan's more limited pharmacological profile and similar physicochemical properties to other sartans. The disparity in ADR reporting rates with valsartan vs other ARBs could be due to the dissimilarity in formulation excipients, patient factors and publicity surrounding batch contaminations, amongst others. Cancer-related ADRs and fatalities per 100 000 prescriptions identified across the ARBs studied are not statistically significant (chi-squared test, P > .05) based on the datasets used over the 5-year period. Conclusion:No connection between ARB pharmacology and their suspected ADRs could be found. No conclusion between sartan batch contaminations and increased suspected cancer-related ADRs was found.

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Best Practices in Treatment of Laryngopharyngeal Reflux Disease: A Multidisciplinary Modified Delphi Study

et al. 2022

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Is this the end for ranitidine? NDMA presence continues to confound

Cited by 10 publications

References 4 publications

The efficacy and safety of the short‐term combination therapy with ticagrelor and PPIs or H2RA in patients with acute STEMI who underwent emergency PCI

The efficacy and safety of the short‐term combination therapy with ticagrelor and PPIs or H2RA in patients with acute STEMI who underwent emergency PCI

Angiotensin II receptor blockers (ARBs) and manufacturing contamination: A retrospective National Register Study into suspected associated adverse drug reactions

Best Practices in Treatment of Laryngopharyngeal Reflux Disease: A Multidisciplinary Modified Delphi Study

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