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(Cas) AEMPS: Actualización de la información sobre retirada de lotes de Omeprazol Farma-Química Sur S.L. que contenían minoxidil y seguimiento clínico de los niños expuestos

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Tras los análisis llevados a cabo por la AEMPS, se han identificado dos lotes que contenían minoxidil en lugar de omeprazol [...]

2019-09-19T20:17:37+00:0019.09.2019|Pharmacovigilance|

(Cas) AEMPS: Revisión de los medicamentos que contienen ranitidina por la presencia de nitrosaminas

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La AEMPS informa del inicio de dos procedimientos europeos en relación a la presencia de nitrosaminas en medicamentos de uso humano. [...]

2019-09-18T20:37:14+00:0018.09.2019|Pharmacovigilance|

EMA to review ranitidine medicines following detection of NDMA

At the request of the European Commission, EMA is to start a review of ranitidine medicines after tests showed that some of these products contained an impurity called N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies. It is present in some [...]

2019-09-16T20:30:15+00:0016.09.2019|Pharmacovigilance|

FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a [...]

2019-09-13T21:35:34+00:0013.09.2019|Pharmacovigilance|

(Cas) AEMPS: Ondansetrón: riesgo de defectos de cierre orofaciales (labio leporino, paladar hendido) tras su uso durante el primer trimestre del embarazo

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Existe un ligero aumento del riesgo de defectos de cierre orofaciales en hijos de madres expuestas a ondansetrón durante el primer [...]

2019-09-13T20:13:02+00:0013.09.2019|Pharmacovigilance|

ANSM: Lucentis® (ranibizumab): recommandations en cas de difficulté pour actionner le piston des seringues pré-remplies

Information destinée aux ophtalmologistes et aux pharmaciens Suite à des difficultés à actionner le piston de certaines seringues pré-remplies de Lucentis, il est recommandé aux professionnels de santé de: Vérifier systématiquement que le piston de la seringue pré-remplie puisse être poussé facilement lors de l’ajustement de la dose Ne pas commencer l’injection si le piston [...]

2019-09-13T20:08:07+00:0013.09.2019|Pharmacovigilance|

FDA Statement on improving adverse event reporting of compounded drugs to protect patients

Compounded drugs can serve an important medical need for certain patients, however, they also present risksExternal Link Disclaimer to patients since they are not evaluated by the FDA for safety, effectiveness and quality. The FDA’s compounding program aims to help protect patients from poor-quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have [...]

2019-09-12T21:50:02+00:0012.09.2019|Pharmacovigilance, Regulatory Affairs|

Infarmed: Nova edição do Boletim de Farmacovigilância, Volume 23, nº 7, julho de 2019

Já está disponível a nova edição do Boletim de Farmacovigilância, Volume 23, n.º 7 de julho de 2019. Publicação com informação sobre efeitos adversos de medicamentos autorizados, quer a nível nacional quer europeu. Encontra-se também, nesta publicação, informação detalhada sobre os Alertas de Segurança emitidos pelo Infarmed. Posted on the Infarmed website on 4 September 2019

2019-09-11T12:50:09+00:0011.09.2019|Pharmacovigilance|

ANSM: Nutrition parentérale: les produits doivent être protégés de la lumière pour réduire les risques d’effets indésirables graves chez les nouveau-nés prématurés

Durant leur administration à des nouveau-nés et à des enfants de moins de 2 ans, les produits de nutrition parentérale contenant des acides aminés et/ou des lipides doivent être protégés de la lumière (conditionnements et dispositifs d’administration). L’utilisation de produits de nutrition parentérale contenant des acides aminés et/ou des lipides exposés à la lumière, particulièrement [...]

2019-09-11T11:11:52+00:0011.09.2019|Pharmacovigilance|

FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy

The U.S. Food and Drug Administration has warned Stemell, Inc. (Stemell), of San Juan Capistrano, California, and its president and Chief Executive Officer, Peyman Taeidi, Ph.D., for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, [...]

2019-09-11T11:07:36+00:0011.09.2019|Pharmacovigilance, Regulatory Affairs|

ANSM: GILENYA® (fingolimod) – Nouvelle contre-indication chez la femme enceinte et en âge de procréer n’utilisant pas une contraception efficace

Information destinée aux neurologues, neuro-pédiatres, gynécologues, obstétriciens, médecins généralistes et pharmaciens En raison du risque de malformations congénitales chez le fœtus exposé au fingolimod (Gilenya ®), le fingolimod est à présent contre-indiqué chez: la femme enceinte, la femme en âge de procréer n’utilisant pas une contraception efficace. Les données rapportées chez l’homme après la commercialisation suggèrent que [...]

2019-09-10T21:14:13+00:0010.09.2019|Pharmacovigilance|

UK MHRA: HRT users to discuss risks and benefits at next appointment as new study highlights persistent risk of breast cancer

Women who are current or past users of hormone replacement therapy (HRT) to treat symptoms of the menopause are reminded to be vigilant for signs of breast cancer, even after stopping HRT. This is because a new study, published by The Lancet, has confirmed that women who use HRT for longer than 1 year have a [...]

2019-09-10T19:59:01+00:0010.09.2019|Pharmacovigilance|

UK MHRA: Drug Safety Update (August 2019)

Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping New data have confirmed that the risk of breast cancer is increased during use of all types of HRT, except vaginal estrogens, and have also shown that an excess risk of breast cancer persists [...]

2019-09-05T23:28:25+00:0005.09.2019|Pharmacovigilance|

WHO Pharmaceuticals Newsletter (No.4, 2019)

The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines and legal actions taken by regulatory authorities around the world. It also provides signals based on information derived from  (ICSRs) available in the WHO Global ICSR database, VigiBase®. This newsletter also includes update on pharmacovigilance strengthening activities in Ethiopia. Posted [...]

2019-09-05T23:12:39+00:0005.09.2019|Pharmacovigilance|

FDA Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications

Protecting patients is the FDA’s highest priority, and Americans can be confident in the quality of the products the agency approves. The recent Angiotensin II Receptor Blocker (ARB) recalls have deeply concerned patients, the medical community, the agency and international regulatory bodies. The FDA is aware many patients rely on ARB medicines, and we are [...]

2019-09-03T17:05:05+00:0003.09.2019|Pharmacovigilance|

FDA requests recall of sterile compounded drug products produced by Pacifico National Inc., dba AmEx Pharmacy, reminds patients and health care professionals to stop using due to potential risks

The U.S. Food and Drug Administration is reminding patients and health care professionals not to use drug products intended to be sterile made by Pacifico National Inc., an outsourcing facility doing business as AmEx Pharmacy, in Melbourne, Florida. The drugs—which include compounded ophthalmic products among other drug products — pose unnecessary risks due to significant quality and [...]

2019-09-03T16:55:03+00:0003.09.2019|Pharmacovigilance|

WHO Pharmaceuticals Newsletter (No.3, 2019)

The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines and legal actions taken by regulatory authorities around the world. It also provides signals based on information derived from Individual Case Safety Reports (ICSRs) available in the WHO Global ICSR database, VigiBase®. This newsletter also includes updates on Smart Safety [...]

2019-09-02T17:48:16+00:0002.09.2019|Pharmacovigilance|

EMA: New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases

EMA has recommended new measures to prevent serious and potentially fatal errors with the dosing of methotrexate for treating inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. The recommendations result from a review of reports that patients are using methotrexate incorrectly despite previous measures to prevent errors. For inflammatory conditions, methotrexate must be [...]

2019-09-02T17:39:55+00:0002.09.2019|Pharmacovigilance|

(Cas) AEMPS: Información sobre la retirada de lotes del principio activo omeprazol Farma-Química Sur S.L.

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) informa de las causas de retirada de varios lotes del principio activo [...]

2019-08-13T19:43:23+00:0013.08.2019|Pharmacovigilance|