- Clobutinol
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Clobutinol Systematic (IUPAC) name (RS)-1-(4-chlorophenyl)-4-dimethylamino-2,3-dimethyl-butan-2-ol Clinical data AHFS/Drugs.com International Drug Names Pregnancy cat. ? Legal status ? Identifiers CAS number 14860-49-2 ATC code R05DB03 PubChem CID 26937 ChemSpider 25085 UNII 1NY2IX043A KEGG D07716 Chemical data Formula C14H22ClNO Mol. mass 255.783 g/mol SMILES eMolecules & PubChem (what is this?) (verify) Clobutinol is a cough suppressant distributed by Boehringer-Ingelheim, Novartis's Hexal (Sandoz), Stada and possibly other companies.
Side effects and withdrawal
Studies in 2004 had indicated that clobutinol has the potential to prolong the QT interval.[1] Clobutinol was in 2007 determined to cause cardiac arrhythmia in some patients.[2]
Boehringer Ingelheim products containing clobutinol were voluntarily withdrawn from sale in Germany, and the rest of the world, on August 31, 2007.[3]
The approval for Germany and the EU was revoked in 2008.[4]
See also
References
- ^ Bellocq, C.; Wilders, R.; Schott, J. J.; Louérat-Oriou, B.; Boisseau, P.; Le Marec, H.; Escande, D.; Baró, I. (2004). "A Common Antitussive Drug, Clobutinol, Precipitates the Long QT Syndrome 2". Molecular Pharmacology 66 (5): 1093–1102. doi:10.1124/mol.104.001065. PMID 15280442.
- ^ "Clobutinol-haltige Arzneimittel: BfArM ordnet Widerruf der Zulassung an.". BfArM (German Federal Institute for Drugs and Medical Devices). 2007-08-31. http://www.bfarm.de/DE/BfArM/Presse/mitteil2007/pm20-2007.html. "Clobutinol: BfArM orders cancellation of approval"
- ^ "Boehringer Ingelheim voluntarily withdraws its clobutinol containing medications.". Boehringer Ingelheim. 2007-08-31. http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2007/31_august_2007.html.
- ^ "Cancellation of approval" (pdf). BfArM (German Federal Institute for Drugs and Medical Devices). 2008-06-06. http://www.bfarm.de/SharedDocs/1_Downloads/DE/Pharmakovigilanz/stufenplverf/globutinol_bescheid_080613.pdf?__blob=publicationFile. "Die Zulassungen für die o.g. Arzneimittel werden mit sofortiger Wirkung widerrufen."
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