They have the same sections to facilitate the search for information for users: composition, indications, dosage (indicated dose), contraindications, precautions, side effects and interactions.
When a drug hits the market, its benefits and risks have previously been studied according to the results of clinical trials, so they have had to show that it has more benefits than harm.
However, since September 1, 2013, there are certain medicines that include an inverted black triangle in their package insert and technical data sheet. But keep in mind that it does not appear on the outer packaging or on the inner labeling.
Black triangle: more intensive monitoring
As explained by the (AEMPS), this badge is used in all leaflets of medicines that are marketed in all the countries of the European Union to “identify that they are subject to even more intensive monitoring than other drugs.”
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“Generally, this is because there is less information available on these medicines than on others, for example because it is a recently marketed medicine or because there is limited information on its long-term use.”
But does this indicate that it is less secure? From the AEMPS they clarify that no, it does not mean that the drug puts the lives of users at risk.
Therefore, in the leaflets of the following drugs they will always be marked with a black triangle:
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If it contains a new active substance that has been authorized for the first time in the European Union after January 1, 2011.
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If they are biological medicines, such as vaccines or drugs derived from plasma, and that have been authorized after January 1, 2011.
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With conditional marketing authorization, which means that the pharmaceutical company must provide more data, or due to exceptional circumstances.
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Or because more information needs to be provided about long-term use or about an adverse effect observed during clinical trials.
Why do you need additional follow-up?
Although the benefits and risks of drugs have been studied in clinical trials, it is true that they have been analyzed in a very small group of volunteers.
However, in real life it will be used by a larger and, above all, more diverse number of users who may suffer from other diseases, which can lead to other side effects that have not been previously reported.
Thus, with this label, it is intended that patients inform the health authorities of any adverse effect (also with drugs that do not have inverted black triangles). such as the family doctor, pharmacist or nurse.
With this, professionals are helped to assess whether the benefits of a certain medication outweigh its risks.
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“The black colored triangle makes it easy to quickly identify subjects for additional follow-up. Patients and healthcare professionals are strongly encouraged to report any suspected adverse effects with medicines bearing the black triangle, so that any new information can be analyzed efficiently.”