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 25 (2 pages).
| Date | Title | Link |
|---|---|---|
| 2010.08.13 |
Angiotensin-receptor-antagonists: BfArM and EMA are assessing studies on the risk of cancer. In June 2010 “Lancet Oncology“ published the results of a meta-analysis (Sipahi et al., 2010), in which the authors observed a slightly increased risk for new cases of cancer under angiotensin-receptor-antagonist therapies. |
to article |
| 2010.08.12 |
Dear Doctor letter on Xyrem® (sodium oxybate): Risk of dosing errors Risk of dosing errors with Xyrem® (sodium oxybate) because gramme (g) and milliliter (ml) are easily confused. |
to article |
| 2010.08.09 |
Dear Doctor Letter (Rote-Hand-Brief) regarding Ketoprofen, topical formulations Important safety information about the risk of photosensivity reactions in association with topical uses of Ketoprofen. |
to article |
| 2010.07.26 |
Dear Doctor letter (Rote Hand Brief) on Cardioxane® (dexrazoxane): Secondary neoplasia in children Important safety information on Cardioxane® (dexrazoxane) and increased risk for secondary neoplasia in children. |
to article |
| 2010.07.23 |
Rosiglitazone: The BfArM and the EMA emphasise restrictions in indications In July 2010 the CHMP at the EMA initiated assessment of new study results on the antidiabetic, rosiglitazone. The BfArM, like the CHMP, is repeating the advice that the long-existing restrictions in rosiglitazone indications should be strictly observed by prescribing physicians. |
to article |
| 2010.07.21 |
Dear Doctor letter on Perfalgan® (paracetamol i.v.): Correction Correction of the letter on Perfalgan® (paracetamol i.v.) |
to article |
| 2010.07.16 |
Rosiglitazone: The EMA initiates assessment of new study results In July 2010 the CHMP at the EMA is assessing the recently published new study results on rosiglitazone (June 2010). |
to article |
| 2010.07.15 |
Dear Doctor letter on Invirase® (active substance: saquinavir): QT-prolongations Additional safety information on the arrhythmogenic risk due to QT and PR interval prolongations in association with Invirase (saquinavir). |
to article |
| 2010.07.14 |
Dear Doctor letter on Perfalgan® (paracetamol i.v.): Inadvertent overdose in newborn babies and infants Important information on the risk of inadvertently overdosed intravenous infusion of paracetamol 10 mg/ ml to newborn babies and infants. |
to article |
| 2010.07.09 |
Dear Doctor letters on temozolomide: Recall For precautionary reasons the pharmaceutical companies will recall certain batches of temozolomide. |
to article |
| 2010.06.17 |
Valproic acid/valproate: Interaction with carbapenems The product information texts on all valproic acid or products containing valproates should include warnings about clinically relevant interactions with carbapenems (decreased valproate plasma concentration) to come up to the latest findings. The intended measures are due to an EU recommendation. A hearing in writing under the graduated plan procedure (Stufenplan), stage II, will follow. |
to article |
| 2010.05.05 |
Bufexamac-containing products for topical use A two-year period for selling bufexamac-containing products cannot be granted according to BfArM’s Feststellungsbescheid (ascertainment decision). Prior to the BfArM order the authorisation holders had abandoned their marketing authorisations in Germany. |
to article |
| 2010.05.03 |
Information letter on Exelon® and Prometax® transdermal patches (active substance: rivastigmine): incorrect administration and medication error In association with the rivastigmine transdermal patches, Exelon® and Prometax®, cases of overdosage due to medication errors and incorrect administration have been reported. |
to article |
| 2010.04.29 |
Information letter on Exelon®/Prometax® transdermale Pflaster (active substance: rivastigmine): Improper use and faulty medication Cases of overdose have been reported due to faulty medication and improper use of the transdermal patches Exelon® and Prometax®. |
to article |
| 2010.04.27 |
Bufexamac products for topical use: Revocation of authorisations in the EU because of unfavourable benefit-risk ratio Assessment of medicinal products containing bufexamac for topical use in the authorised indications has revealed a negative overall benefit-risk ratio. Therefore the authorisations are revoked |
to article |
| 2010.04.23 |
PSURs: FAQ s and Submission Form – German and English Versions The BfArM has published modified FAQs relating to PSUR submission. |
to article |
| 2010.04.20 |
Dear Doctor letter (Rote-Hand-Brief) on Kepivance® (active substance: palifermin): Restriction of indication Indication for Kepivance® restricted to patients exposed to radiotherapy and chemotherapy for conditioning prior to autologous stem cell transplantation. |
to article |
| 2010.04.16 |
Dextromethorphane (DXM): Growing number of reports on misuse in 2009. Pharmacies are recommended to sell with caution. In 2009 the BfArM received a noticeably increased number of reports on (suspected) misuse of dextromethorphane products compared with previous years. |
to article |
| 2010.03.29 |
Yasmin® and venous thrombosis: Update of product information Data from two studies into the risk of venous thromboembolic incidents due to the use of combined oral contraceptives containing drospirenone, have been evaluated by the Pharmacovigilance Working Party of the European Medicines Agency EMA. |
to article |
| 2010.03.18 |
Tamoxifen: Interaction with SSRIs (selective serotonin reuptake inhibitors) A Canadian cohort study showed that the SSRI, paroxetin, may decrease the effect of tamoxifen in a hormone therapy of mamma carcinoma (BMJ 2010; 340:c693). Concomitant administration of tamoxifen and paroxetin was found to increase breast cancer mortality. |
to article |