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.

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.

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.

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.

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).

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“).

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.

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.

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.

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^®.