Things You Always Wanted to Know About the Benefits and Risks of Drugs
This website provides you with some useful information on the benefits and risks of drugs and how they are researched, developed, and continuously monitored and evaluated for safety.
Whatever the choice – make it an informed one!
Your doctor prescribed a drug. It should help treat or prevent an illness. But now, back home, you take the time to read the comprehensive package insert and doubts creep in … should I really take it? What about all these side effects mentioned? And two tablets a day really seems a lot, maybe one will do? Your friend swears by this medicine from the drug store, no question what she would advise! This website provides you with a lot of useful information on the benefits and risks of drugs and how drugs are researched, developed, and continuously monitored and evaluated for efficacy and tolerability. This way, Bayer wants to help you make an informed decision together with your doctor or pharmacist. When doing so, make sure the decision is based on facts, not rumors: your health is your most precious asset!
The benefits and risks of drugs are evaluated, confirmed, and double-checked
Drug development is a very complex job, which is strictly regulated. Before a new medicine hits the pharmacy shelves, scientists and physicians spend ten to twelve years comprehensively investigating the drug candidate, first in the lab and then in healthy volunteers and finally in thousands of patients who volunteer to participate in clinical studies. All the data – roughly 500,000 pages – are then submitted to the health authorities. Only when the experts at the regulatory authorities have carefully reviewed all the information and approved the drug, is it available for you, the patient.
Want to witness the journey in time lapse in an entertaining way?
For each approved drug the benefits have to outweigh the risks
On average, pharmaceutical companies spend more than EUR 1 billion from the time an idea for a new therapeutic approach and the first active ingredient candidates are discovered until the drug is available to patients. The largest sums go into clinical development where the efficacy and tolerability of the new drug candidate are comprehensively studied. However, the benefit and risk evaluation continues even after approval. Do you want to find out more?
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.
Test your knowledge in the quiz.
Are the following statements true or false?
These five tips will help you to put the information in the package insert into perspective
Package inserts can be a scary read. So scary that some people would rather live with their disease than risk any of those horrid side effects. These golden rules may help you to put the information into perspective.
Your doctor prescribed you the drug to treat a disease or prevent a condition from getting worse. These positive effects were observed in hundreds or thousands of patients.
After checking all the data, the health authorities decided that the drug’s benefits outweigh its risks in this patient population.
Side effects cannot be ruled out entirely. But it is far more likely that the drug will help you get better than expose you to the risk of serious side effects.
The dosage regimen – i.e. how much of the drug you should use, how often, and before, during or after a meal – has been determined in the course of clinical studies with hundreds or thousands of patients. The optimal dose balances the positive effects with potential side effects.
Changing the dosage on your own accord can not only diminish the benefits, but also increase the risk of unwanted side effects.
In these sections, the insert tells you in which cases you should not use this particular drug, e.g. if you are allergic to any of the ingredients, suffer from kidney or liver problems, use certain other medications, or if you are pregnant.
If any of the criteria listed in the package insert apply to you, you have an increased risk of experiencing negative drug effects.
In this case, you should consult your doctor or pharmacist first.
If milk gets sour, you will smell it and won’t drink it anymore. When a drug gets too old or has not been stored properly, it will very likely look unchanged. But it may have lost its efficacy or not be well tolerated anymore.
When you get a new drug, check the storage information on the package insert. And before you use a drug, make sure that it has not expired yet.
You should not use drugs after they have expired or if you are unsure if they have been stored properly. When in doubt, show the drug to your pharmacist for advice.
The package insert lists the side effects and also states how often each effect occurred. “Frequent” means 1 in 10 to 1 in 100 patients; “very rare” side effects affect fewer than 1 in 10,000 patients.
While under medication, be alert to the side effects listed in the package insert as well as to any other unusual reactions.
If you notice that your health and wellbeing seem to be affected while using a medicine, contact your doctor or pharmacist immediately for advice.
It’s all about reading and interpreting statistics
Risk increased by 500%! Sounds dramatic, doesn’t it? But is it in every case? A risk describes the possibility of an unwanted event. It does not say that you will experience this. Figures can be misleading. To understand figures correctly, the context is important. And not every dramatic headline on medicines is fact-based and reliable.
It depends. The sentence relates the risks of two groups of people. It does not say how many men and women are actually affected.
If the sentence applies to three women and two men in a population of two million, the danger will be fairly small. But if it applies to 30 women and 20 men in a group of 100, the risk will indeed be higher.
The sentence says that 20 out of 100 people who use the drug experience the side effect. If you use the medicine, your risk is 1:5. In the world of risk assessment, this is a fairly high figure.
Nonetheless: in the vast majority of patients in this example – 80% – the side effect does not occur.
Stopping your medication on your own accord is never a good idea, however. If you have any concerns, you should talk to your doctor or pharmacist first before making any changes to your treatment.
Positive news can be just as misleading as negative news. This example does not provide any reliable information on the drug, its effects or even the survey itself.
262 people – this number could stand for 90% in a small survey of 300, or less than 6% if 5,000 participated in the survey.
Furthermore, a survey of personal opinions – especially when its methods and authors are unknown – cannot be a reliable source for assessing the benefits and risks of a drug.
The Harding Center for Risk Literacy lists helpful questions to enable you to put risks into perspective.
Before you change the drug regimen, talk to your doctor or pharmacist – and be on the safe side
Finding the optimal dose is part of the strictly regulated drug development process. The patient information states the recommended dose and regimen (e.g. “three times a day”) that has been approved by the health authorities. Based on his or her medical experience and assessment, your doctor may slightly vary the dose to adjust it to your individual condition.
Changing the dose yourself is not safe: it can weaken the drug effects that you need to get better. And it can even increase the risk of side effects. If you find it hard to use the drug as instructed, talk to your doctor or pharmacist: he or she knows what to do and, if needed, might also be able to switch you safely to a different treatment.
What to do if you experience a side effect
Side effects cannot be ruled out. If this happens, you should not hesitate to call or see your doctor or pharmacist immediately. Only he or she can advise you what to do, change your treatment or adjust the dose of your current treatment.
Your doctor is asked to report the side effect to the health authorities (e.g. the European Medicines Agency or the Food and Drug Administration in the USA) or to the manufacturer. The reports are then evaluated very carefully and the information might well end up in the patient leaflet which is continually updated to include any additional side effects that are observed in clinical practice over the years.
If you want to report a side effect or quality complaint, please contact your health care professional (e.g. treating physician or pharmacist), your local health authority, or contact us directly.
Counterfeit drugs are a severe health risk – here’s how to avoid them
Crafted by professional criminals, counterfeit drugs often look identical to the original product. But the health risk is immense. Fake tablets may contain no active substance, different – even toxic – ingredients, a wrong dose, or carry a manipulated expiry date. Most counterfeit drugs are sold by illegal online vendors.
The best way to protect yourself: only buy from trustworthy suppliers. If you are not sure if the drug you bought is original or fake, don’t use it under any circumstances, but report it to the health authorities in your country or to the manufacturer.
View the video to learn more about the risks of counterfeit drugs and how to avoid them.
More information is provided on this website by Bayer.
This checklist will help you keep the essentials in mind!
Good preparation is half the battle. If you make a note of your questions beforehand, you won’t miss your chance to ask for the info you need. And taking notes during the appointment with your doctor will help you remember the essentials later.
You can make a start now and fill in your notes in the checklist online and then print it. Or you can send it without notes to your e-mail address. The protection of your private data is important to us. Therefore, we will only transfer the checklist with blank lines via e-mail to allow note taking later.
Make a start now – with our interactive checklist!
Use the checklist below as a guide to help you prepare your appointment. We recommend writing out all the information that could be useful. Take it to your appointment to prompt discussion with your doctor.
What should I share with my doctor?
What should I find out?
Please use the print icon to save the checklist with your notes as a PDF document. You can send the checklist with blank lines only via e-mail to your e-mail address. Due to data protection, your notes will not be transferred via e-mail. Any information you provide will not be stored.