Pharmacovigilance
By the time medicinal products are granted a marketing authorisation, knowledge about their safety is incomplete because the clinical trials investigating the safety profile and efficacy are usually performed with a relatively small number of subjects. Furthermore these subjects are selected with regard to special aspects and in general do not represent the average patient in medical practices. Therefore, rare or very rare adverse drug reactions, interactions or other hazards related to the use of a medicinal product cannot be observed during clinical trials. Especially the rarely occurring serious adverse reactions are very important for the overall assessment of a new medicinal product. New findings regarding the safety of a medicinal product may occur even long time after its authorisation and depend on new developments in medical science.
Therefore, the German Medicines Act (Arzneimittelgesetz, AMG) provides that information obtained during the use of a medicinal product be continuously and systematically collected and evaluated after the marketing authorisation is granted. This is done for all finished products on the market in Germany and is the most important duty of the Pharmacovigilance Division. This Division continuously informs about adverse drug reactions and interactions related to the use of medicinal products which have become known and ensures that patients, medical doctors and other interested parties are made aware of existing risks as well as of possibilities to decrease them. If, due to the risk assessment of a medicinal product, its marketing authorisation status needs to be adopted to the state of scientific knowledge, the Pharmacovigilance Division co-ordinates the measures necessary for risk prevention and informs patients, medical doctors and other interested parties accordingly.
Pharmacovigilance - News
Search results 1 to 20 from a total of 33 (2 pages).
| Date | Title | Link |
|---|---|---|
| 2013.05.02 |
Dear Doctor Letter (Rote-Hand-Brief) on Pletal® (cilostazol): New safety information As the result of a review of the benefits and risks of cilostazol and in collaboration with the European Medicines Agency, the indications for medicinal products containing cilostazol have been restricted. |
to article |
| 2013.05.02 |
Dear Doctor Letter (Rote-Hand-Brief) on Tavor® pro injectione 2 mg solution for injection (lorazepam): Recall Recall of Tavor® pro injectione 2 mg solution for injection due to possible contamination with glass splinters. |
to article |
| 2013.04.30 |
Increlex® 10 mg/ml solution for injection (mecasermin, recombinant human IGF-1): Temporary market shortage The company Ipsen Pharma GmbH is sending out information that the medicinal product Increlex® 10 mg/ml solution for injection will presumably be out of stock starting early August 2013. This shortage is due to manufacturing difficulties and the safety or efficacy of Increlex® already on the market is not affected. |
to article |
| 2013.04.23 |
Information Letter on CAELYX®: As of Monday 29 April 2013, supply with the medicinal product will return to normal Janssen-Cilag is sending out information that the supply with CAELYX® 2 mg/ml concentrate for solution for infusion is returning to regular availability and that the "CAELYX® Managed Access Programme" is being terminated. |
to article |
| 2013.04.08 |
Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Risk of second primary haematological malignancies The pharmaceutical manufacturer is sending out information on the risk of second primary haematological malignancies in patients treated with thalidomide. |
to article |
| 2013.04.08 |
Dear Doctor Letter (Rote-Hand-Brief) on INCIVO® (telaprevir): Occurrence of serious skin reactions The pharmaceutical manufacturer is sending out information on the occurrence of serious skin reactions associated with treatment with INCIVO®. |
to article |
| 2013.03.26 |
Dear Doctor Letter (Rote-Hand-Brief) on Mimpara® (cinacalcet): Occurrence of severe hypocalcaemia resulting in death Important safety-relevant information regarding a fatal case with severe hypocalcaemia in a clinical study in children and adolescents. |
to article |
| 2013.03.26 |
Information letter on NULOJIX® (belatacept): Increased occurrence of acute graft rejection The pharmaceutical manufacturer is sending out information on the increased occurrence of acute graft rejection under treatment with NULOJIX® (belatacept) associated with rapid corticosteroid taper in patients at high immunologic risk for acute rejection reactions. |
to article |
| 2013.03.25 |
Hydroxyethyl starch (HES): Start of an European safety review At the request of the BfArM, the European Medicines Agency (EMA) has initiated a review procedure regarding the basic evaluation of the benefit-risk balance of solutions for infusion containing hydroxyethyl starch (HES). |
to article |
| 2013.03.11 |
Dear Doctor Letter (Rote-Hand-Brief) on Fentanyl®-Janssen and Durogesic® SMAT (12, 25, 50, 75, 100 µg/h), transdermal patch (active substance: fentanyl): New warning New warning regarding medicinal products (and generics) containing fentanyl and the possible occurrence of serotonin syndrome if used concomitantly with serotonergic medicines. |
to article |
| 2013.02.25 |
Information Letter on NeuroBloc® (botulinum toxin type B): Risks related to "off-label“ use Serious adverse events were observed in connection with NeuroBloc® if used outside the licensed indication ("off-label“). |
to article |
| 2013.02.21 |
Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing tolperisone: Risk of hypersensitivity reactions The pharmaceutical manufacturers are sending out information on the restriction of the indication for medicinal products containing tolperisone and on the risk of hypersensitivity reactions. |
to article |
| 2013.02.21 |
Information letter on Optimark® products (gadolinium): New peel-off tracking label In order to enable a better understanding on the use of contrast agents containing gadolinium (Gd-based contrast agents) within the European Union, the European Commission has requested all manufacturers of contrast agents containing gadolinium to introduce peel-off tracking labels for these products. |
to article |
| 2013.02.14 |
Diane 35 and its generics: European safety review started In its February meeting (4 - 7 February 2013) the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has started a safety review of the medicinal product Diane 35 (which contains 2 mg cyproterone acetate and 35 µg ethinylestradiol) and its associated generics. |
to article |
| 2013.02.14 |
Combined hormonal contraceptives: European safety review started In its February meeting (4 - 7 February 2013) the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has started a safety review on combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin or norgestimate as the gestagen component. |
to article |
| 2013.02.06 |
Dear Doctor Letter (Rote-Hand-Brief) on Xagrid® (active substance: anagrelide hydrochloride): Serious cardiovascular adverse events The pharmaceutical manufacturer is sending out information on a connection between Xagrid® and serious cardiovascular adverse events even in patients without known heart disease. This letter includes a reminder that Xagrid® is only indicated in patients at risk and only as second-line therapy. |
to article |
| 2013.01.22 |
Dear Doctor Letter (Rote-Hand-Brief) on Tredaptive® (combination of niacin/laropiprant): Discontinuation of marketing The pharmaceutical manufacturer is sending out information that due to new data available from a clinical trial the marketing of the medicinal product Tredaptive® has been discontinued and that therefore treatment with this medicinal product is to be terminated. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had previously issued a recommendation of suspension for the marketing authorisations concerned. |
to article |
| 2013.01.09 |
Dear Doctor Letter (Rote-Hand-Brief) on Pradaxa® (dabigatran etexilate): New contraindication The pharmaceutical manufacturer is sending out information that the medicinal product Pradaxa® is now contraindicated in patients with artificial heart valves who require anticoagulant treatment. |
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| 2013.01.08 |
Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Recommendations revised in analogy to the recommendations for first use regarding cardiovascular monitoring in case of renewed treatment Revised recommendations on repeated cardiovascular monitoring in case of renewed treatment with Gilenya®. These recommendations apply for patients following interruption of treatment and for patients with bradyarrhythmia requiring therapy following initial treatment with Gilenya®. |
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| 2013.01.08 |
Dear Doctor Letter (Rote-Hand-Brief) on Angiox® (bivalirudin): Inappropriate "bolus-only" dosing for PCI Communication for healthcare professionals based on reports of IV bolus injections of Angiox® (bivalirudin) alone without immediately following IV infusions. The resulting sub-therapeutic plasma concentrations bear the risk of ineffective ischaemic protection during percutaneous coronary intervention (PCI). |
to article |