18.12.2009
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Sibutramin: New Study Data under Evaluation
Active substance: sibutramin
The Committee for Human Medicinal Products (CHMP) at the European Medicines Agency (EMA) is currently concerned with a risk evaluation of sibutramin. The re-evaluation was prompted by the preliminary results of a large long-time study conducted in several countries (SCOUT study) with about 10,000 substantially overweight patients.
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18.03.2010
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Tamoxifen: Interaction with SSRIs (selective serotonin reuptake inhibitors)
Active substance: tamoxifen
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.
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29.03.2010
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Yasmin® and venous thrombosis: Update of product information
Active substance: drospirenone
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.
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16.04.2010
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Dextromethorphane (DXM): Growing number of reports on misuse in 2009. Pharmacies are recommended to sell with caution.
Active substance: dextromethorphane
In 2009 the BfArM received a noticeably increased number of reports on (suspected) misuse of dextromethorphane products compared with previous years.
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27.04.2010
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Bufexamac products for topical use: Revocation of authorisations in the EU because of unfavourable benefit-risk ratio
Active substance: bufexamac
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
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05.05.2010
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Bufexamac-containing products for topical use
Active substance: bufexamac
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.
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16.07.2010
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Rosiglitazone: The EMA initiates assessment of new study results
Active substance: rosiglitazone
In July 2010 the CHMP at the EMA is assessing the recently published new study results on rosiglitazone (June 2010).
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23.07.2010
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Rosiglitazone: The BfArM and the EMA emphasise restrictions in indications
Active substance: rosiglitazone
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.
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13.08.2010
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Angiotensin-receptor-antagonists: BfArM and EMA are assessing studies on the risk of cancer.
Active substance: angiotensin-receptor-antagonists
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.
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04.11.2010
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Tamoxifen: Interaction with CYP2D6 inhibitors
Active substance: tamoxifen
Concomitant administration of tamoxifen and strong inhibitors of the cytochrome P450 2D6 enzyme (CYP2D6) should be avoided, as a resulting reduced efficacy of tamoxifen cannot be excluded.
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22.11.2010
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Medicinal products containing isotretinoin for oral administration: Risk of severe skin reactions, adherence to contraceptive measures
Active substance: isotretinoin
The BfArM considers it necessary to add information on the risk of severe skin reactions to the product informations of medicinal products containing isotretinoin. This information was compiled by the Pharmacovigilance Working Party (PHVWP) of the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA).
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14.12.2010
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Thelin® (sitaxentan): intended withdrawal from the market
Active substance: sitaxentan
The pharmaceutical company Pfizer has informed the BfArM that it intends to withdraw Thelin® (sitaxentan) from the market.
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28.01.2011
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Dexrazoxane: Referral procedure for clarification of a potentially increased risk of secondary cancers
Active substance: dexrazoxane
In the course of a graduated plan procedure, stage II, the BfArM announces the initiation of a referral procedure in accordance with Article 31 of Directive 2001/83/EC.
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22.03.2011
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Topiramate: Data concerning the risk of malformations
Active substance: topiramate
Based on evaluations from pregnancy registries, the USA has now also revised the product informations of medicinal products containing topiramate and has included corresponding warnings already implemented in European marketing authorisations.
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05.04.2011
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EMA announcement on possible radioactivity of medicinal products manufactured in Japan
Active substance:
The BfArM calls attention to the public announcement made by the European Medicines Agency (EMA) in co-ordination with the European licensing authorities following the radiation leak from the Fukushima Daiichi nuclear power plant in Japan.
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