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 Table of Contents  
Year : 2016  |  Volume : 2  |  Issue : 2  |  Page : 128-129

News from regulatory corner

Date of Web Publication20-Dec-2016

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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2455-3972.196230

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How to cite this article:
. News from regulatory corner. Indian J Drugs Dermatol 2016;2:128-9

How to cite this URL:
. News from regulatory corner. Indian J Drugs Dermatol [serial online] 2016 [cited 2021 Apr 14];2:128-9. Available from: https://www.ijdd.in/text.asp?2016/2/2/128/196230

  European medicines agency approves emtricitabine/tenofovirdisoproxil for preexposure prophylaxis in the European Union Top

July 22, 2016 - European Medicines Agency recommends granting marketing authorization to Truvada ® (emtricitabine/tenofovirdisoproxil) for preexposure prophylaxis (PrEP) in the European Union (EU). PrEP is a method to prevent transmission between serodiscordant couples. Truvada ® is to be taken by HIV-negative partner when trying to achieve conception. [1]

  Migalastat has been approved for Fabry's disease Top

April 04, 2016 - Migalastat has been approved for Fabry's disease. Fabry's disease is associated with the deficiency of alpha-galactosidase A enzyme which breaks down globotriaosylceramide-3). Due to the deficiency of the enzyme, this lipid accumulates in the body. The present treatment is enzyme replacement therapy through intravenous infusion. This oral medication may form a more convenient treatment for patients. This drug acts as a pharmacological chaperone which binds to the enzyme, transports it to its site of action, and activates it. However, it is active only in specific mutations on the disease, not in all types. [2]

  Warfarin can lead to calciphylaxis Top

July 12, 2016 - An EU-wide review found that warfarin may lead to calciphylaxis (calcific uremic arteriolopathy) even in patients with normal renal function. It is a life-threatening condition commonly seen in patients with end-stage renal disease. Patient information leaflet will now be updated warning patients and physicians about the development of painful skin rash. [3]

  References Top

1. European Medicines Agency - News and Events - First medicine for HIV Pre-exposure Prophylaxis Recommended for Approval in the EU. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002578.jsp&mid=WC0b01ac058004d5c1. [Last cited on 2016 Nov 10].

2. European Medicines Agency - News and Events - First oral Treatment for Fabry Disease Recommended for Approval in the EU. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002502.jsp&mid=WC0b01ac058004d5c1. [Last cited on 2016 Nov 10].

3. Warfarin: Reports of Calciphylaxis Drug Safety Update - GOV.UK. Available from: https://www.gov.uk/drug-safety-update/warfarin-reports-of-calciphylaxis. [Last cited on 2016 Nov 11].

  Fluconozole can result in miscarriages Top

The United States of America - The Food and Drug Administration (FDA) is evaluating the results of a Danish study that point to a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan ® and generics), an antifungal medicine used to treat yeast infections. The agency is also reviewing additional data. Guidelines issued by the US Centers for Disease Control and Prevention recommend only topical-not oral-antifungal products in pregnant women, even in case of persisting or recurring infections that necessitate prolonged treatment. The current FDA product information states that data available from human studies suggest no increased risk in pregnant women exposed to a single 150 mg dose of oral fluconazole. However, high doses (400-800 mg/day) taken repeatedly have resulted in reports of abnormalities at birth. In the Danish study, most of the oral fluconazole use appeared to be one or two doses of 150 mg. Until the review is complete, the FDA advises cautious prescribing of oral fluconazole in pregnancy. The prescribing information for fluconazole-containing medicines in the EU cautions against use during pregnancy. This is based on reports of multiple congenital abnormalities (including brachycephalia, ears dysplasia, giant anterior fontanelle, femoral bowing, and radio-humeral synostosis) in infants whose mothers received long-term treatment with high doses of fluconazole for fungal infections (Source: http://www.who.int/medicines/publications/druginformation/WHO_DI_30-2_SafetyNews.pdf?ua=1).

  International operation pangea ix highlights dangers of buying medicines online Top

Operation Pangea IX highlights the dangers of buying medicines online (Lyon, France) - Regulatory authorities of 103 countries participated in the International Operation Pangea IX, which took place from May 30 to June 07, 2016, as part of the Ninth Annual International Internet Week of Action. Coordinated by INTERPOL, Operation Pangea is an annual global cooperative effort aiming to combat the unlawful sale and distribution of illegal prescription of medicines and medical devices on the Internet. This year's operation was the largest of its kind so far. It led to the seizure of 170,340 shipments containing a total of 12.2 million potentially dangerous illicit medicines worth more than 53 million US$, as well as the suspension of 4932 websites selling illicit pharmaceuticals. ►INTERPOL News, June 09, 2016 (Source: WHO Drug Information Vol. 30, No. 2, 2016).

(This is compiled by editorial team for the purpose of information only and the content may change or may have changed until the time of publishing).


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