> Pharmacovigilance

EMA: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity

Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India. EDQM has now suspended the manufacturer’s CEP (a certificate of compliance with European standards for quality testing), effectively prohibiting the use of its valsartan in EU medicines. In addition, national [...]

FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs

The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As part of this commitment, we require evidence from premarket clinical trials that the medicine will be both effective and safe for use when prescribed according to its labeling. However, it’s not unusual for the FDA to identify issues that [...]

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018

EMA’s human medicines committee (CHMP) recommended four medicines for approval, including a medicine for use in countries outside the European Union, at its November 2018 meeting. The CHMP adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. This is [...]

UK MHRA: Drug Safety Update (November 2018)

Hydrochlorothiazide: risk of non-melanoma skin cancer, particularly in long-term use Advise patients taking hydrochlorothiazide-containing products of the cumulative, dose-dependent risk of non-melanoma skin cancer, particularly in long-term use, and the need to regularly check for (and report) any suspicious skin lesions or moles. Systemic and inhaled fluoroquinolones: small increased risk of aortic aneurysm and dissection; [...]

2018-11-15T19:20:15+00:00 16.11.2018|Pharmacovigilance|

WHO Pharmaceuticals Newsletter (No.5, 2018)

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 a short report from [...]

2018-11-15T18:57:58+00:00 15.11.2018|Pharmacovigilance|

EMA gives guidance on safety monitoring of medicines used in children

EMA has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population. It offers a holistic view of paediatric pharmacovigilance and provides guidance on how to make best use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. In addition it advises [...]

2018-11-13T22:24:21+00:00 14.11.2018|Pharmacovigilance, Regulatory Affairs|

Infarmed: Metamizol e risco de agranulocitose

Na sequência de diversas notícias relativas à utilização de medicamentos contendo metamizol, o Infarmed informa: O metamizol é um medicamento utilizado para o tratamento da dor e febre há cerca de 40 anos. Em Portugal, os medicamentos comercializados contendo metamizol são Nolotil, Dolocalma e Metamizol Cinfa. A utilização de medicamentos contendo esta substância pode causar [...]

2018-11-13T21:34:48+00:00 14.11.2018|Pharmacovigilance|

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to [...]

ANSM: Risques liés à l’utilisation des préparations coliques

A la suite des résultats d’une enquête française de pharmacovigilance sur les préparations coliques, l’ANSM souhaite rappeler les risques liés à leur utilisation. Des troubles hydro-électrolytiques survenant parfois dans un contexte de mésusage peuvent être à l’origine de décompensation cardiaque, de troubles du rythme ou de troubles neurologiques. Des manifestations allergiques ont également été mises [...]

2018-11-12T22:49:20+00:00 13.11.2018|Pharmacovigilance|

EMA: Human medicines highlights – November 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. Information is selected based on recommendations from consulted patients, consumers and healthcare professionals, and does not necessarily cover all [...]

ANSM: Kétamine: risque d’atteintes uro-néphrologiques, endocriniennes et hépatiques graves lors d’utilisations prolongées et/ou à doses élevées

Information destinée aux anesthésistes réanimateurs, aux centres de prise en charge de la douleur, aux centres de prise en charge de brûlés, aux néphrologues, aux centres de transplantation hépatique, aux HAD et aux pharmaciens hospitaliers.  Dans des contextes d’utilisation prolongée et/ou répétée de kétamine (dont utilisation dans des indications hors-AMM) et en cas d’abus ou [...]

2018-11-11T12:53:15+00:00 12.11.2018|Pharmacovigilance|

(Cas) AEMPS: Boletín trimestral de la AEMPS sobre productos sanitarios y cosméticos Julio – Septiembre 2018

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.Recoge información sobre la evolución de la legislación de estos productos, los documentos técnicos y científicos publicados, las actuaciones de vigilancia y [...]

ANSM: Fluroquinolones par voie systémique ou inhalée: risque de survenue d’anévrisme et de dissection aortique

Information destinée aux médecins généralistes, cardiologues, médecins internistes, infectiologues, pneumologues, ORL, pédiatres, gastro-entérologues, dermatologues, gynécologues, néphrologues, urologues, réanimateurs, gériatres, radiologues, urgentistes, pharmaciens d’officine et pharmaciens hospitaliers  Les quinolones et les fluoroquinolones sont des antibiotiques administrés par voie systémique (forme injectable ou orale) ou par voie inhalée1, utilisés pour traiter des infections bactériennes au cours desquelles [...]

2018-11-08T22:55:33+00:00 09.11.2018|Pharmacovigilance|

ANSM: Risque de cancers de la peau associés aux médicaments contenant de l’hydrochlorothiazide

L’hydrochlorothiazide est un diurétique, largement utilisé dans le traitement de l’hypertension artérielle, des oedèmes d’origine cardiaque, hépatique ou rénale et de l’insuffisance  cardiaque chronique. Des études récentes ont montré un risque accru de cancer de la peau ou des lèvres (carcinome basocellulaire et carcinome épidermoïde) chez les patients exposés pendant de nombreuses années à des [...]

2018-11-08T22:51:27+00:00 09.11.2018|Pharmacovigilance|

(Cas) AEMPS: Metamizol y riesgo de agranulocitosis

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 la revisión de los casos de agranulocitosis notificados en el Sistema Español de Farmacovigilancia y el consumo de metamizol en [...]

2018-11-08T22:47:54+00:00 09.11.2018|Pharmacovigilance|

ANSM: Médicaments à base de lévothyroxine: Point de suivi de la diversification de l’offre thérapeutique

Les patients souffrant de troubles de la thyroïde et les professionnels de santé disposent depuis octobre 2017 d’une offre élargie de médicaments à base de lévothyroxine: Levothyrox comprimé sécable (Laboratoire Merck) L-Thyroxin Henning comprimé sécable (Laboratoire Sanofi) Thyrofix comprimé non sécable (Laboratoire Uni-Pharma) TCAPS capsule molle (Laboratoire Genévrier) L-Thyroxine Serb solution buvable en gouttes (Laboratoire [...]

2018-11-06T20:34:33+00:00 07.11.2018|Pharmacovigilance|

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner, warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Roche Diagnostics issued a voluntary [...]

2018-11-06T20:25:07+00:00 06.11.2018|Pharmacovigilance|

EMA: Meeting highlights from EMA’s safety committee (PRAC) 29-31 October 2018

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of signals, risk management plans, periodic safety update reports and post-authorisation safety studies. The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under [...]

2018-11-06T20:09:41+00:00 06.11.2018|Pharmacovigilance|

ANSM: Antipsychotiques: rappel des mesures de suivi cardio-métabolique

A la suite des résultats d’une enquête conduite sur la base des données de l’Assurance maladie, qui met en évidence un respect insuffisant de la surveillance biologique des patients traités par antipsychotiques, l’ANSM rappelle les recommandations de suivi cardio-métabolique émises en 2010. Un traitement par antipsychotiques peut être à l’origine d’une prise de poids et [...]

2018-11-04T18:47:55+00:00 05.11.2018|Pharmacovigilance|