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Myths and facts about the benefits and risks of drugs
Every drug has benefits and risks, and both must be carefully evaluated to define the benefit-risk profile of that drug. But don’t let rumors and half-truths confuse you.
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Each drug can cause wanted and also unwanted effects. This is why new drugs are thoroughly tested. The health authorities only give their approval if the medicine is well tolerated and its benefits clearly outweigh its risks in the tested patient population.
Drug development is a highly regulated process and may take around 10 to 12 years. During this time, scientists select the most suitable molecules and optimize their structure for maximum benefit and tolerability. The best candidate is finally tested in clinical programs with many patients who volunteer for the clinical studies. All the data are reviewed by the international and national health authorities. Only when they g.ve their approval, can the new drug be made available to patients and offered in pharmacies.
Infact, the side effects of the drug, interaction with other drugs or other risk factors that have been observed by physicians during the clinical studies must be included in the package insert. Before a drug can be sold, the package and package insert along with the drug itself must be reviewed and approved by the health authorities. The package insert is continually updated to include any adverse events which may have occurred in clinical practice over the years.
It is not the drug manufacturers, but the regulatory authorities who define how a package insert has to look – not only the content required, but also the format, including legibility, readability, and type size. That’s why for each and every drug the package insert looks more or less the same in one country. We know the package insert is not always an easy read, but it’s important to understand which adverse events are already known. If you have any questions, please ask your doctor or pharmacist.
Finding the optimal dose is part of the comprehensive and strictly regulated drug development process. The package insert lists the recommended dose which has been determined and confirmed in extensive clinical studies. While an experienced doctor may adapt the dose to a patient’s individual needs, you should never do so yourself as this can weaken the positive effects of the drug and increase side effects.
All pharmaceutical companies are subject to very strict regulations and international standards which have to be followed. These are defined and controlled by the international and national health authorities. Unless a manufacturer follows these high standards and delivers a complete documentation of all activities, and unless the data show beyond any doubt that the new drug is well tolerated and delivers a clear benefit for patients, the company will not obtain approval.
Depending on the type of drug, the medication may lose its efficacy and may not be safe to use when it gets too old. Both can cause health risks. Efficacy and tolerability are only guaranteed up to the displayed expiry date. Therefore, drugs should not be used after they have expired.