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Drug News Nov Issue 25

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Drug News Nov Issue 25 D r u g N e w s 藥 物 情 報 Issue No. 25 : November 2011 This is a monthly digest of local and overseas drug safety news and information released in the previous month. For the latest news and information, please refer to public announcements or the website of the Drug Office of the Department of Health (http://www.drugoffice.gov.hk). Safety Update US: Updated information about drug Canada and FDA released similar alerts on the interaction of Zyvox (linezolid) and interaction between methylene blue and serotonin Methylene Blue with serotonergic reuptake inhibitors. At the same time, FDA also released alert on the interaction between linezolid psychiatric medications and serotonin reuptake inhibitors. The news had 20 October 2011 – The Food and Drug been reported in Issue No. 17 and 22 of Drug News Administration (FDA) provided additional respectively. In addition, the Department of Health information about the possible serotonin syndrome (DH) issued press statement on 18 February 2011 in patients taking serotonergic psychiatric and letters were also sent to healthcare professionals medications and linezolid/ methylene blue. It was in February 2011 and July 2011. found that not all serotonergic psychiatric drugs had The product certificate holders of the an equal capacity to cause serotonin syndrome with pharmaceutical products containing methylene blue, use of linezolid/ methylene blue. According to the linezolid and serotonergic psychiatric medications FDA's Adverse Event Reporting System (AERS), have been requested to update the sales pack and/or most cases of serotonin syndrome with linezolid or package insert of these products to include methylene blue occurred in patients taking specific information about the potential drug interactions. serotonergic psychiatric drugs, namely a selective DH will keep vigilance against this issue. serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI); and for EU: Safety review of Protelos and Osseor cases associated with methylene blue, also (strontium ranelate) clomipramine . It was still unclear whether linezolid or intravenous methylene blue administration in 20 October 2011 –The Committee for Medicinal patients receiving other psychiatric drugs with lesser Products for Human Use (CHMP) of the The degrees of serotonergic activity posed a comparable European Medicines Agency (EMA) was reviewing risk. Besides, cases associated with methylene blue data on the cardiovascular and cutaneous safety mostly occurred in the context of parathyroid concerns, taking into account existing risk- surgery which involved the intravenous minimisation measures to determine whether the administration of methylene blue as a visualizing cases of venous thromboembolism and drug rash agent with dose ranging from 1 mg/kg to 8 mg/kg. with eosinophilia and systemic symptoms would The risk in patients taking methylene blue by other have an impact on the benefit-risk profile and routes or at intravenous doses lower than 1 mg/kg conditions of use for Protelos and Osseor. At this remained unknown. juncture, there were no changes to the recommendations on the conditions for use of these In Hong Kong, Zyvox (linezolid) is registered by two drugs in Europe. Pfizer Corp. HK Ltd., and is a prescription medicine used for treatment of infections, including In Hong Kong, Protos Granules for Oral Suspension pneumonia and infections of skin. Methylene blue 2g containing strontium ranelate is registered by injection is registered by Sino-Asia Pharmaceutical Servier Hong Kong Ltd. and is a prescription Supplies Ltd. It is a non-poison used for treatment of medicine used for treatment of osteoporosis in methemoglobinemia. Earlier this year, both Health postmenopausal women and to reduce the risk of Drug Office, Page 1 Department of Health, Hong Kong SAR Safety Update fracture at spine & hips. As reported in Issue No. 23 was linked to clinical adverse events. However, the of Drug News, safety alert about serious skin recall was conducted as a precautionary measure reactions, namely Stevens-Johnson syndrome and because the defect could have led to slightly higher toxic epidermal necrolysis, with Protos had been levels of tacrolimus in the blood of patients taking released by the Health Sciences Authority (HSA) of the affected capsules. Singapore in August 2011. DH will keep vigilance In Hong Kong, Advagraf Prolonged-release Hard against this issue. Capsule 0.5mg is registered by Astellas Pharma EU: Positive benefit-risk balance of Hong Kong Company Ltd., and is a prescription angiotensin II receptor antagonists medicine used as an immunosuppressant for adult in remained preventing transplant rejection in kidney or liver allograft recipients and treatment of allograft 20 October 2011 – CHMP reviewed all available rejection that are resistant to treatment with other data in patients taking angiotensin II receptor immunosuppressants. The company confirmed that antagonists (ARBs) and concluded that the evidence the affected batches have not been distributed in did not support any increased risk of cancer in Hong Kong. patients using these medicines. The review was initiated as a meta-analysis which showed a small Canada, Australia, Singapore and US: increased risk of new cancers (particularly lung Risk of increased blood pressure and cancer) with ARBs compared with placebo and other heart rate associated with Strattera heart medicines (7.2% versus 6%). However, the (atomoxetine) CHMP found that the evidence from the meta- analysis was weak as there were several problems A recent analysis of combined data from Eli Lilly with the quality of the data and there was a sponsored controlled and uncontrolled clinical trials possibility of publication bias. The CHMP also indicated that in 8417 pediatric patients treated with reviewed data from other studies and the results did Strattera (atomoxetine), a selective norepinephrine not show an increased risk of cancer with ARBs. reuptake inhibitor, approximately 25% experienced an increase in blood pressure of 10 mmHg and 5-8% In Hong Kong, there are about 130 registered an increase of 20 mmHg while heart rate increased pharmaceutical products containing ARBs. They are by 10 bpm in 33% of patients and by 20 bpm in 12% prescription medicines used to treat hypertension. of patients. These increases had also been observed They may also be used in the management of heart in similar proportion of adult patients with Attention failure and diabetic nephropathy. FDA had also Deficit Hyperactivity Disorder (ADHD) which announced similar conclusion in June 2011 as could be a potential risk for some patients. reported in Issue No. 20 of Drug News. DH remains Following its release, safety alerts were issued by vigilant to any new findings about ARBs. Health Canada, TGA and HSA on 21 October, 2 EU: Precautionary recall of Advagraf 0.5 November and 8 November 2011 respectively. mg capsule batches (tacrolimus) Healthcare professionals were advised to observe the following recommendations: 20 October 2011 – EMA agreed to the immediate recall of some batches of 0.5 mg prolonged-release • Atomoxetine is contraindicated in patients with hard capsules of Advagraf (tacrolimus) from symptomatic cardiovascular diseases, moderate pharmacies and wholesalers across EU because an to severe hypertension or severe cardiovascular unexpected increase in release of active substance disorders whose condition would be expected from the capsules was detected during routine to deteriorate if they experienced increases in testing by the marketing-authorisation holder, blood pressure or in heart rate that could be Astellas. The company found that an average of 70% clinically important. of the tacrolimus in the capsules was released during • Atomoxetine should be used with caution in the first 1.5 hours of dissolution testing which was patients whose underlying medical conditions above the permitted range of 48% to 68%. The could be worsened by increases in blood available information did not suggest that the defect pressure or heart rate, such as patients with Drug Office, Page 2 Department of Health, Hong Kong SAR Safety Update hypertension, tachycardia, or cardiovascular or inquiries following an unpublished report about the cerebrovascular disease. detection of recombinant HPV L1-specific DNA sequences in 13 vials of Gardasil from different lots. • Atomoxetine should be used with caution in The Agency reassured that the presence of DNA patients with congenital or acquired long QT fragments was expected in Gardasil and not syndrome or a family history of QT evidence of contamination. FDA considered that prolongation. Gardasil continued to be safe and effective and its • Patients should be screened for pre-existing or benefits continued to outweigh its risks. The review underlying cardiovascular or cerebrovascular of all reports related to Gardasil vaccination in the conditions before initiation of treatment with Vaccine Adverse Event Reporting System showed atomoxetine and monitored during the course no evidence of unusual clinical patterns or high of treatment. reporting rates of adverse events, including autoimmune diseases. FDA would continue to • Heart rate and blood pressure should be monitor the safety of Gardasil. measured in all patients before atomoxetine is started, after the dose is increased, and In Hong Kong, Gardasil Vaccine Injection available periodically during treatment, particularly in pre-filled syringes and vials are registered by Merck Sharp & Dohme (Asia) Ltd. and are
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