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Confessions from an insider
Published in Peter C. Gøtzsche, Richard Smith, Drummond Rennie, Deadly Medicines and Organised Crime, 2019
Peter C. Gøtzsche, Richard Smith, Drummond Rennie
The NSAID area is a horror story filled with extravagant claims, bending of the rules, regulatory inaction, and complacency with what the industry wants even though statements from industry scientists were often logically inconsistent or plainly wrong.22 Several drugs that were so kindly treated by the FDA were later withdrawn from the market because of their toxicity despite claims to the contrary, e.g. ‘Excellent gastrointestinal tolerance’ (benoxaprofen), ‘superior tolerance’ (indoprofen), ‘proven gastrointestinal safety’ (rofecoxib), ‘hurts the pain not the patient’ (ketorolac) and ‘least possible side effect profile’ (tolmetin).24 Sheer nonsense, as a least possible side-effect profile can only occur if you don’t take a drug at all. Other withdrawn drugs are, for example, zomepirac, suprofen and valdecoxib.22,26
Classifications
Published in Fazal-I-Akbar Danish, Ahmed Ehsan Rabbani, Pharmacology in 7 Days for Medical Students, 2018
Fazal-I-Akbar Danish, Ahmed Ehsan Rabbani
Drugs with analgesic and moderate anti-inflammatory effectsPropionic acid derivativesIbuprofenKetoprofenFenoprofenFlurbiprofenCarprofenIndoprofenNaproxenOxaprozinFenamic acid derivativesMefenamic acidMeclofenamic acidFlufenamic acidTolfenamic acid
Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review
Published in Expert Opinion on Drug Safety, 2018
Igho J. Onakpoya, Carl J. Heneghan, Jeffrey K. Aronson
Greater transparency in the reporting of harms by drug sponsors should be encouraged. This would facilitate more robust assessment of the benefit-to-harm balance of new medicinal products and also minimize the risk of exposure of the public to products with harmful properties. The swift and voluntary worldwide withdrawal of indoprofen by the manufacturer following evidence of an increased risk of cancers is a commendable example. Regulatory authorities could delay the granting of marketing licenses of new products until the drug sponsors demonstrated convincing evidence that the product had a favorable benefit-to-harm profile. In addition, rapid evidence synthesis of harms associated with newly approved products could be conducted when serious adverse reactions are suspected. Research aimed at strengthening the methods of conducting such reviews should also be a priority for regulators, drug manufacturers, and health-care organizations. Indeed, a checklist for reporting of harms in clinical trials of analgesics has been proposed [32].
Spinal Muscular Atrophy and Common Therapeutic Advances
Published in Fetal and Pediatric Pathology, 2019
Saeed Bozorg Qomi, Amir Asghari, Arash Salmaninejad, Majid Mojarrad
Increasing translation activity of SMN2 can be a promising strategy to increase the cellular SMN protein level. Indoprofen can enhance mRNA translation of SMN2 gene [46]. Furthermore, aminoglycosides can pass the translation machinery through the first stop codon created after the removal of exon 7, leading to the generation of a longer and more stable protein [46]. For example, BBrm02 is a Read-through drug which is being developed by BioBlast Pharma Company (Tel Aviv, Israel) and its mechanism is based on the above strategy [71].