Do drug warnings and market withdrawals have an impact on the number of calls to teratogen information services?

BACKGROUND: IMAGe provides information on risks and benefits of medication use during pregnancy and lactation. OBJECTIVE: The aim of this study was to determine the impact of Health Canada warnings on the number of calls received at IMAGe. METHODS: We analyzed calls received between January 2003 and March 2008. The impact of the following warning/withdrawal were studied: paroxetine and risk of cardiac malformations (09/29/2005), selective serotonin reuptake inhibitors (SSRIs) and risk of persistent pulmonary hypertension of the newborn (PPHN) (03/10/2006), and impact of rofecoxib market withdrawal (09/30/2004). Interrupted auto-regressive integrated -moving average (ARIMA) analyses were used to test the impact of each warning on the number of calls received to IMAGe. RESULTS: 61,505 calls were analyzed. The paroxetine warning had a temporary impact increasing the overall number of calls to IMAGe, and an abrupt permanent effect on the number of calls related to antidepressant exposures. The PPHN warning had no impact but we observed a significant increase in the number of calls following rofecoxib market withdrawal. CONCLUSION: Health Canada needs to consider the increase in the demand of information to IMAGe following warnings on the risk of medication use during pregnancy.

Outbreak of Salmonella Thompson in the Netherlands since July 2012.

An ongoing outbreak of salmonellosis due to Salmonella Thompson is affecting the Netherlands. Between 2 August and 19 October 2012, 866 cases were confirmed. Their median age was 44 years (range: 0-95 years), 63% were female and 36% were hospitalised. A matched case-control study suggested smoked salmon as the vehicle. Salmonella Thompson was confirmed in four of nine batches of smoked salmon from one producer. A recall of all concerned smoked salmon products was executed starting end of September.

A prospective study of infliximab withdrawal after 12 months of treatment in patients with Crohn's disease: how will NICE guidance affect patient care?

Infliximab is a biological agent that is licensed for the treatment of severe Crohn's disease. The annual cost of infliximab treatment is approximately pound 16,456 (excl VAT). In May 2010, the National Institute for Health and Clinical Excellence (NICE) recommended that patients should receive biological agents as a planned course of treatment only until treatment failure or until 12 months after the start of treatment, whichever is shorter. Patients should then have their disease reassessed to determine whether they still have active disease and whether ongoing therapy is still appropriate. We assessed the impact of the new NICE guidance on patient care by prospectively auditing patients who had been receiving infliximab for 12 months or more. The audit provided the opportunity for full disease reassessment and, for patients who were in clinical remission, the option to stop treatment. Disease was reassessed in 21 patients; a further 13 patients refused consent. Four patients were in deep clinical remission and discontinued infliximab. Implementation of the NICE recommendations on the use of infliximab in Crohn's disease is likely to be challenging in the face of significant resistance from patients who have an understandable fear of relapse. It might be more appropriate to discuss treatment withdrawal when high-quality evidence is available to support this management option.

Management of Blood Product Market Withdrawals - A Single Institution's Process and Experience.

OBJECTIVE: While lookback investigations follow specific Food and Drug Administration (FDA) requirements, the management of blood product market withdrawals from suppliers varies widely. Follow-up data are limited, prompting this analysis of the types and reasons for recipient notification and their outcomes. METHODS: A single institution retrospective review of market withdrawal and lookback files from 2012-2015 included product type, reason, FDA category, notification, and turnaround time. Descriptive statistics and chi-square analysis were performed. RESULTS: Over 4 years, 796/229,549 (0.35%) blood components were implicated in supplier notifications, including market withdrawals (84.3%) and lookbacks (15.7%). Seventy-nine cases resulted in patient notification. 97% of patient notifications were achieved within 3 months. Plasma with human leukocyte antigen antibodies was the most common reason for withdrawal (20.5%). Category 1 notifications were the most commonly reported by this transfusion service, apart from in 2015 when category 4 notifications were highest. Over four years, the proportion of notifications by category remained relatively stable. CONCLUSIONS: Market withdrawal investigations involve significant effort to review, document, and appropriately notify. Standardized management and centralized reporting of recipient notification of market withdrawals may improve this process.