Unexpected Effects? The Reliability of Medications

A drug approval process does not always provide a complete list of potential side effects. Below, we will examine in detail why it is important to monitor the side effects of medications and how various factors can influence the effectiveness of drugs. To ensure the safe use of medications, it is essential to continuously inform both patients and healthcare professionals about potential risks and side effects.

Monitoring the Risks of Medications

The assessment of a drug’s risks does not end at the moment of approval. The strict conditions of clinical trials differ from reality, where a diverse range of patients with various conditions may begin treatment. This heterogeneity can lead to the emergence of new information regarding the safety of the drug. It is important to note that medications are not necessarily dangerous; during the approval process, it must already be demonstrated that the expected benefits outweigh the potential risks.

After a drug is marketed, continuous monitoring helps identify possible side effects and ensure safer use of the medication. The long-term effects of drug use must also be considered, and newly acquired information should be incorporated into medication treatment protocols. Based on this information, authorities may take action to restrict or modify the further marketing of drugs if necessary.

Expected and Unexpected Side Effects

The side effects of medications include both expected and unexpected effects. Expected side effects are known at the time of approval and are included in the drug’s prescribing information. These are communicated to users in the patient information leaflet in the form of warnings, so that they are aware of the risks. Unexpected side effects, on the other hand, represent new information and are not included in the official documentation.

Doctors and healthcare professionals play a key role in monitoring side effects. The National Institute of Pharmacy and Nutrition (OGYÉI) particularly focuses on the reporting of serious side effects, as their evaluation is prioritized. Serious side effects include those that pose a life-threatening risk, cause permanent health damage, or require hospitalization. Patients and their relatives are also important stakeholders, as they experience the effects of medications. Therefore, it is recommended that anyone who notices a side effect consult a healthcare provider.

The Impact of Diet on Drug Effects

Nutrition can significantly affect the effectiveness of medications. Certain foods can influence the absorption, effect, and even cause side effects of drugs. Interactions between foods and medications are not always documented, so patients need to be mindful of what they consume while taking medications.

The medical community and the pharmaceutical industry are continuously working to provide patients with the most comprehensive information about potential interactions between medications and foods. Knowledge of this information can help avoid side effects and maximize the effects of medications.

EU Side Effect Database and Reporting Process

In the European Union, a central side effect database operates, allowing for the tracking of serious side effects. The number of reported cases is continuously increasing, indicating that patients and healthcare professionals are becoming more aware of the importance of reporting side effects. Reports are forwarded by the OGYÉI to the EU database, which aids in improving drug safety.

During the side effect reporting process, it is important for reports to be as accurate and detailed as possible. This not only assists professionals in their work but also contributes to a more precise evaluation of the causal relationships between drugs and side effects. It can be helpful for patients to document their experiences and seek their doctor’s assistance in making reports.

Medications Under Enhanced Supervision

In the European Union, medications under enhanced supervision are marked with a black triangle. This designation indicates that experiences related to the use of the drug are still limited, so monitoring is stricter. The black triangle marking can be found in the patient information leaflet and the prescribing information, aimed at drawing the attention of patients.

Medications under enhanced supervision include those that contain new active substances, biological products, or those whose approval is subject to special conditions. For these drugs, regulatory authorities conduct more intensive monitoring to ensure safe use. The list of medications is continuously updated, and the enhanced supervision status can be modified at any time based on the authorities’ decisions.

To ensure the safe use of medications, it is essential for patients to be informed about potential risks and side effects. Detailed information and monitoring of side effects help safeguard patients’ health and contribute to the safe application of drugs.