International Journal of Risk & Safety in Medicine - Volume 22, issue 1

Authors: Hunfeld, Nicole G.M. | ten Berge, Rosita L. | LeBrun, Paul P.H. | Smith, Sierd J. | Melief, Piet H.G.J.

Article Type: Research Article

Abstract: This case report describes an episode of acute hepatotoxicity with liver injury after citalopram use in an 83-year old female. Drug intake was stopped immediately on admission. A biopsy of the liver showed extensive liver cell damage and inflammation consistent with drug-induced injury. After cessation of drug intake, the patient fully recovered within a couple of days. Recommencing of medication, with the exception of citalopram, did not cause liver abnormalities during one year of follow-up.

Keywords: Hepatotoxicity, citalopram, case report

DOI: 10.3233/JRS-2010-0486

Citation: International Journal of Risk & Safety in Medicine, vol. 22, no. 1, pp. 1-5, 2010

Authors: Healy, David | Mangin, Derelie | Mintzes, Barbara

Article Type: Research Article

Abstract: In recent years, a number of authors have advocated the merits of conducting randomised controlled trials (RCTs) of antidepressants in women with nervous disorders during the prenatal period. However, a critical review of the literature indicates RCTs are not justifiable. At a time when it has become clear that a significant proportion of the existing literature on the use of pharmaceutical agents is ghostwritten, ethicists and others making assertions that RCTs are needed risk becoming part of an apparatus that plays down the hazards of treatment and promotes the use of treatments that may be harmful.

Keywords: Antidepressants, birth defects, pregnancy, miscarriage, ghost-writing

DOI: 10.3233/JRS-2010-0487

Citation: International Journal of Risk & Safety in Medicine, vol. 22, no. 1, pp. 7-16, 2010

Authors: Burapadaja, Siriporn | Kawasaki, Naohito | Charumanee, Suporn

Article Type: Research Article

Abstract: Safety is one of the very important elements of medicines, especially in daily practice. It is expected that the medicines listed by the Thai Essential Medicine Lists (EML) and their market products registered by the Thai Food and Drug Administration (FDA) should be comparable with respect to practical safety. The objective was to investigate if there are differences in practical safety between anti-infective essential medicines and their products assigned by the two authorities in Thailand. Data were based on Thai EML, Thai FDA registration, and Thailand Index of Medical Specialities 2008. Results showed that Thai EML and Thai FDA divided …anti-infective items (n = 101) and their products into groups varying in practical safety. Two thirds of the items and their products were comparable with respect to practical safety, but one third of them were not. The products of the latter were defined as having a lower practical safety compared to their corresponding items. This study has demonstrated that there are differences in practical safety between several essential medicines and their products. Consistent practical safety is very necessary for safe use of anti-infective products. Thus, there should be deliberations between the two authorities to reconsider the practical safety of these items and their products. Show more

Keywords: Thailand, essential medicines, anti-infective medicines, safety practices

DOI: 10.3233/JRS-2010-0488

Citation: International Journal of Risk & Safety in Medicine, vol. 22, no. 1, pp. 17-25, 2010

Authors: Mody, Rustom | Varshney, Brajesh | Patankar, Dhananjay

Article Type: Research Article

Abstract: A second wave of blockbuster products will go off-patent between 2012–2016 in Europe and USA, triggering a rush for the approval of biosimilars or follow-on biologics. Biosimilars are approved through an abbreviated route which relies on a limited safety and efficacy data enabling biogeneric companies to develop these products at lower cost giving a price benefit to the payer. This advantage needs to be weighed against the potential risk that any variation could have with respect to safety and efficacy, especially from long-term use. The paper attempts to rationalize the current “risk” perceptions regarding biosimilars, which have been in existence …over a decade in the Indian market. The differences from the Reference product are substantial yet their safety record over a long use warrants a more “realistic” rather than “speculative” assessment, keeping cost-to-benefit as an important criteria and identify ways of mitigating potential risk that are perceived for biosimilar products. Show more

Keywords: Biosimilars, follow-on-biologics, EMEA, India, aggregates, PRCA, risk, cold-chain

DOI: 10.3233/JRS-2010-0489

Citation: International Journal of Risk & Safety in Medicine, vol. 22, no. 1, pp. 27-40, 2010

Authors: Lexchin, Joel

Article Type: Research Article

Abstract: The Food and Drugs Act theoretically gives Health Canada considerable authority in dealing with safety issues but there are also significant limitations in the legislation. Furthermore, the priorities of Health Canada are skewed in favour of rapid approval of new drugs at the expense of the postmarketing pharmacosurveillance system as judged by how much money and many personnel are allocated to each activity. Health Canada has explicitly rejected developing quantitative standards for evaluating its postmarketing pharmacosurveillance system. In addition to lacking standards in this area, it does not monitor whether or not its communications to professionals and the public have …had the desired effect in terms of changing the way that drugs are prescribed and used. Health Canada continues to treat safety information that companies submit as confidential business information. What safety information it does release is insufficient to allow an adequate independent assessment of a drug’s safety. Progressive licensing is a new regulatory model that would allow Health Canada to retain control over a drug throughout the product's entire lifecycle. In its initial incarnation progressive licensing would have actually further strengthened Health Canada’s reliance on the industry for information and would have worked to enhance regulatory secrecy. Show more

Keywords: Adverse drug reactions, drug regulation, drug safety, pharmaceutical industry, user fees

DOI: 10.3233/JRS-2010-0490

Citation: International Journal of Risk & Safety in Medicine, vol. 22, no. 1, pp. 41-53, 2010