Search

Purpose: Statins represent an effective treatment for hyperlipidaemia. Immune-mediated necrotising myopathy (IMNM), a form of statin myopathy, has recently been described, and is characterized by elevated creatine kinase, presence of antibodies against HMG-CoA and no improvement after drug discontinuation, even with immunosuppressive treatment. Information on IMNM is mainly from case reports and small case series. Therefore, all reported cases of IMNM in VigiBase, the WHO global database of individual case safety reports (ICSRs) including the underlying reporting patterns, were analysed to characterize more detailed this adverse drug reaction., Methods: ICSRs of IMNM up to October 1, 2016 were extracted from VigiBase. Corresponding case narratives were requested from responsible national authorities to maximize the available data. The reports were analysed in terms of reporting criteria, co-reported terms, patient demographics, clinical data, administered medication, latency time, seriousness of the reaction and outcome., Results: One hundred one deduplicated ICSRs of IMNM were reported from 17 countries until October 2016. Approximately two thirds of the cases were from the year 2016. Slightly more males than females were affected (52 [57%] males vs 39 [42%] females). Median reported patient age was 68 years (range 16 - 87 years). Ninety-one cases (99%) were classified as serious. Median latency time was 26 months (range 1 - 288 months). Median creatine kinase value was 6860 U/L (range 576 - 35,000 U/L). In total, eight patients (9%) had recovered from IMNM. Atorvastatin was the most frequently reported statin in 80% of cases., Conclusions: The number of IMNM reports has increased in recent years. IMNM associated with statin treatment seems to occur worldwide. Most IMNM cases were reported with atorvastatin. No dose dependency of statin-associated IMNM pathogenesis was identified.

Purpose: Sayana® was introduced as the first depot medroxyprogesterone acetate-containing contraceptive that is administered via subcutaneous injection. Within 10 months, the Regional Pharmacovigilance Centre (RPVC) Zurich received several anonymous reports of serious local reactions after Sayana® administration. In this retrospective study, individual case safety reports (ICSRs) on local adverse drug reactions (ADRs) related to Sayana® were analysed from the WHO pharmacovigilance database., Methods: International, national and regional ICSRs during Sayana® administration up to 1 January 2016 were examined. Data on ADRs were retrieved from the WHO Global Database VigiBase™. Demographic data, drug administration information, duration of Sayana® treatment, latency time of the ADR, and its course, severity and outcomes were analysed., Results: Worldwide, 398 ICSRs after Sayana® use were registered in the database. We identified 20 reported terms that were potentially used to describe a persistent lipodystrophy. When only cases containing one or more of these 20 reported terms were selected, 323 (81.2%) international ICSRs remained for analysis. Of those, 91.6% (n = 296) were categorised as serious. The majority of the reactions (n = 193, 54.4%) did not recover. In the 67 Swiss ICSRs, 77 ADRs were reported using 10 different terms including severe or persistent local reactions like lipodystrophy, atrophy or fat necrosis. Thirty-two patients (47.7%) did not recover. All 11 regional cases reported to the RPVC Zurich were categorised as serious ADRs. For the majority of the patients (n = 7, 63.6%) the interval between the application of Sayana® and development of the lipodystrophy was between 2 and 4 months. Most of the reactions were irreversible (n = 9, 81.8%). One patient underwent plastic surgery for artificial infill of the dent., Conclusions: Persistent local injection site reactions such as lipodystrophy, fat tissue necrosis or atrophy occur frequently after subcutaneous Sayana® use. These adverse drug reactions were recently integrated in the Swiss product information. Physicians and patients should be informed and advised about these potentially irreversible effects.

The aim of pharmacovigilance is to continuously update and enhance our knowledge about the safety of medicines in order to improve patient care. The most important method of postmarketing drug surveillance is the spontaneous reporting system. As a rapid alert system it is able to detect unknown and rare as well as insufficiently described reactions and risks. A broad population, including all potential high-risk groups, can be surveilled over a long period of time. The attentiveness of health care professionals as well as the quality and quantity of the information provided are crucial for the success of this system. As no detailed data concerning the number of patients taking a particular medication are available and only a small percentage of adverse drug reactions is reported, it is impossible to draw conclusions about the incidence of adverse drug reactions or the relative risk, which is a big disadvantage. Since 2002 healthcare professionals and pharmaceutical companies are obliged to report adverse drug reactions in accordance with the Swiss Therapeutic Products Act. Six Regional Pharmacovigilance-Centres collect health care professionals' reports, analyze them, enter the data into the national database and forward the anonymized reports to the National Pharmacovigiance-Centre at Swissmedic. There, all reports are screened for signals and, if necessary, appropriate measures are initiated. All reports received by Swissmedic are forwarded to the WHO Collaborating Centre for International Drug Monitoring (Uppsala, Sweden} for inclusion in the international database.

During the year 2014, a total of 268 adverse reactions due to Swissmedic-authorized veterinary medicinal products were reported representing an increase of 7% compared to the previous year. Similar to previous years, most of the reactions reported were linked to the use of antiparasitic products (47.8%) or antiinfectives (9.3%). In 10.8% of the reports, reactions were described after the use of products acting on the hormonal system. The affected animal species were primarily dogs (182 reports), cats (58 reports), and cattle (16 reports). Additionally, 33 reports were provided within the frame of consultations with the toxicological information centre in Zurich (Tox Info Suisse). We present a short overview of the safety of COX-2 inhibitors and a series of reactions following the use of a parenteral buprenorphine solution. Finally, the vaccinovigilance program received 124 declarations following the application of various vaccines, but no detailed analysis of those reports is available.

197 adverse reactions of Swissmedic-authorized veterinary medicinal products were reported during the year 2012 (2011: 167). Species and drug classes remain unchanged over the years: most of the reports related to reactions following the use of antiparasitic products (37.6 %), antiinfectives (15.7 %) or non-steroidal antiinflammatory drugs (11.7 %) in companion animals (94 dogs and 53 cats) followed by cattle/calves (29). Additionally, 45 cases transmitted by the Swiss Toxicological Information Centre in Zürich were processed. We discuss a paradoxical reaction under the potential influence of acepromazine as well as a modified protocol for treating permethrin intoxication in cats. Finally, the vaccinovigilance program received 95 declarations following the application of various vaccines, mainly to dogs or cats.