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Risk Information

Taking medicine can be associated with certain risks. All medicinal products are carefully monitored after having been placed on the EU market. If a medicinal product is marked with a black triangle this means that it is under even more intense surveillance than other medicinal products. This is generally the case if less information is available with regard to the medicinal product concerned than concerning other medicinal products, e.g. because it is new on the market or ther is only insufficient data with regard to its long-term use.

The BfArM provides online access to its database with reports of suspected adverse drug reactions. This database contains all suspected cases of adverse drug reactions from Germany reported to the BfArM since 1995 (excluding cases from clinical trials and cases that have already been published in scientific literature). The suspected cases refer to adverse reactions observed in patients which occurred after intake of a medicinal product and were reported to the BfArM as being suspected of having a causal relationship with that intake. In other words, this does not necessarily mean that there is in fact such a causal relationship with the medicinal product.

Together with other information, these reports are the basis for the ongoing monitoring and improvement of drug safety. Warning signs of new risks resulting from the suspected cases can lead to the BfArM taking safety measures, if required. Patients, physicians, and other interested parties then have to be made aware of these risks and possible measures for the reduction thereof. If the assessment of the drug risks shows that the licensing status of a medicinal product has to be adapted to the scientific state of the art, the BfArM coordinates the necessary measures for risk prevention. Such changes are then communicated to physicians, patients and other interested parties.

The BfArM also publishes data on shortages in the supply of medicinal products in cases assumed to be of especial interest to healthcare professionals.