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Drugs that are less secure for patients, now flagged in a special way. Find out what it looks like

The European Union has introduced a new method of flagging drugs under severe monitoring. These drugs are now identified by a black downward triangle on the prospectus and by a short sentence explaining the significance of that triangle: “This medicinal product is subject to additional monitoring”.pastile

All drugs are carefully monitored after being issued on the EU market. However, drugs marked with a black triangle are more carefully monitored than the rest.

Generally speaking, this is because there is less information about these drugs than others. ”This doesn’t mean that the drug is not safe. It has been authorized, but it’s still being monitored. This can happen for newer drugs, like biological ones or for drugs that have recently been issued on the market”, explained Roxana Stroe, head of the Pharmacovigilance Service of the National Drug Agency, in a meeting with patient associations.


Report adverse reactions, including abuses or medication errors

The number of patients who report adverse reactions is extremely small, say NDA officials, who are trying to find solutions to get doctors as well as patients interested in reporting such events. ”The doctors get credits if they have such a report. They shouldn’t be afraid to report them anymore, as is the case with hospital infections”, said the vice-president of the NDA.

You need to report any adverse reactions you suspect in association with a drug that you are taking, especially if it’s flagged with a black triangle.

„Try to also report reactions caused by interactions between several drugs, like in the case of treatments given to chronic patients, but also in case of an overdose, administration error or off label administration”, Mrs. Stroe also said.

You can report adverse reactions by filling out a form at your doctor’s office or at the chemist’s, who should then send the notice to the NDA.

The patients can also call a special number within the National Drug Agency in order to report an adverse reaction: 0757117259.

The form for reporting adverse reactions can be downloaded using the following link:


Geta Roman Neacsu

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