17.06.2014
|
Sutent® 25 mg and 50 mg hard capsules: BfArM issues warning regarding counterfeits of the medicinal product from Romania
Active substance: sunitinib
The Federal Institute for Medicinal Products and Medical Devices (BfArM) is circulating a warning against counterfeits of the 25 mg and 50 mg strengths of the cancer drug Sutent® produced by Pfizer. The counterfeits that are parallel imported can be identified based on visible differences in hard capsules and foil sealing of the plastic bottle.
|
15.11.2018
|
Suicidal tendencies possibly linked to depression associated with use of hormonal contraception
Active substance: hormonal contraceptives
As a result of a signal procedure on the risk of suicidal tendencies in connection with the use of hormonal contraceptives, a new warning is to be included in the Summary of Product Characteristics and Patient Information Leaflet.
|
27.03.2015
|
Sofosbuvir: Arrhythmias as a possible interaction with other direct-acting antiviral agents (DAA) for the treatment of hepatitis C in combination with agents that could cause bradycardia (e.g. amiodarone)
Active substance: sofosbuvir
Signs of potential arrhythmias, especially the possibly life-threatening slowing of the heart rate (bradycardia), have become known especially due to case reports from France.
|
18.12.2009
|
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.
|
25.06.2015
|
Saxagliptin: EMA investigates irregularities in large cardiovascular study (SAVOR)
Active substance: Saxagliptin
On its website, the French supervisory authority (ANSM) has reported a possibly increased mortality due to infections during the course of a study performed with the active substance saxagliptin (SAVOR: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus Study) to investigate effects on the cardiovascular system.
|
16.07.2010
|
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).
|
23.07.2010
|
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.
|
20.11.2018
|
Risk information for Colchicum-Dispert® and Colchysat®Bürger by the company Bürger
Active substance: Colchicin
Based on reports of overdosage leading to death, the dosing recommendations and warnings have been updated.
|
05.06.2014
|
Rienso® (ferumoxytol): Risk of serious hypersensitivity reactions
Active substance: ferumoxytol
The EMA is in the process of evaluating all worldwide data available on serious hypersensitivity reactions in connection with administration of the medicinal product Rienso (ferumoxytol) which, however, is currently not being marketed in Germany.
|
06.10.2020
|
Remdesivir (Veklury®): PRAC checks signal for kidney damage
Active substance: remdesivir
PRAC has begun reviewing a safety signal for acute renal damage in some COVID-19 patients treated with Veklury® (Remdesivir).
|
20.12.2016
|
Recall of the medicinal product Tranexamsäure Carino 100 mg/ml, 5 ml ampoules, 5x5 ml solution for injection, PZN 10816978 batch designation: 013024 due to mix-up with Urapidil-25 mg-Carino ampoules
Active substance: tranexamic acid
The Federal Institute for Drugs and Medical Devices (BfArM) calls attention to the recall of batch 013024 of the medicinal product Tranexamsäure Carino 100 mg/ml by the company Carinopharm GmbH.
|
17.09.2019
|
Ranitidine: Recall of ranitidine containing drugs
Active substance: Ranitidin
The Federal Institute for Drugs and Medical Devices (BfArM) informs that in the European Union there is a recall of drugs containing the active substance ranitidine produced by the active substance manufacturer Saraca Laboratories Limited.
|
24.04.2015
|
Pulmozyme: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany
Active substance: dornase alfa
The BfArM has received information that counterfeits of the medicinal product Pulmozyme 2500 U/2.5 ml (nebuliser solution) are possibly on the market in Germany.
|
28.01.2016
|
Protopic® – Herpes-simplex eye infections
Active substance: Tacrolimus (topische Anwendung)
The BfArM points out that herpes simplex infections of the eye have been included as a new adverse reaction in the product information of Protopic®.
|
22.07.2011
|
Pioglitazone: The European Medicines Agency recommends new contraindications and warnings for medicinal products containing pioglitazone due to a slightly increased risk of bladder cancer
Active substance: pioglitazone
In its July meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency finalised the benefit-risk assessment for medicinal products containing pioglitazone. This confirms a slightly increased occurrence of bladder cancer due to pioglitazone. As a risk-minimising measure it recommends that physicians should only administer pioglitazone to patients if it is proven that they will benefit from this therapy. This decision should consider the risk profile of the patients in terms of the occurrence of bladder cancer.
|