Pay attention to the black triangle in the package insert

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Black triangle indicates possible side effects

Since January 1, 2014, around 150 active substances have been marked with a black triangle in the package insert. This is intended to sensitize patients to possible side effects. However, the drugs concerned are not particularly unsafe and do not necessarily trigger severe side effects, as the drug commission of the German pharmacists (AMK) reports. However, little information is available on the drug.

The black triangle is used to raise patient awareness
Since the beginning of the year, the black triangle has identified around 150 active substances in medicines that can cause side effects. Most of these are preparations that have only recently been on the market or for which little information is available to date. However, the trade association expressly points out that the medication concerned is in no way particularly unsafe or that it generally triggers strong side effects. Patients who notice the black triangle pointing downwards on the package insert should be particularly careful. If side effects occur, these should be discussed immediately with the treating doctor or pharmacist.

In the event of side effects of medication with a black triangle, inform a doctor or pharmacist. The black triangle is supplemented by the note: "This medicinal product is subject to additional monitoring." A committee of the European regulatory authority EMA in London decides which active ingredients have to be labeled in this way, by more Gather information about the drug.

"Patients should not be surprised if their pharmacist asks if they tolerate a drug well or if they experience side effects," explains Professor Martin Schulz, AMK chairman. “It has nothing to do with the pharmacist questioning the tolerability of a drug. Rather, it serves the purpose that pharmacists want to gather more information on medicines that are not yet established, with the aim of making drug therapy even safer. ”(Ag)

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