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We come back from the pharmacy with the medicine prescribed by the doctor, sit at home over coffee and start reading the leaflet. Our attention is drawn to numerous side effects, which makes us wonder whether it is worth taking this drug at all and whether it will be worse than our disease.
Research by marketing managers working in pharmaceutical companies producing drugs shows that the most carefully studied part of the leaflet (included in the package of the drug) by patients are the methods of use and possible side effects occurring during treatment.
Leaflet in the patient
A well-known rule resulting from the observation of patients’ behavior by doctors says that the more side effects the leaflet contains, the more patients are usually afraid of taking a given preparation, and the more sensitive (not to say hypochondriacs) immediately feel at least a few of those listed in ailments leaflet. Meanwhile, fear has its eyes as big as ever, because no one has ever proven that each of these side effects of a given drug must occur in all patients. So when we read in the leaflet that during the treatment there may occur, for example, drowsiness, dizziness, nausea, vomiting, anaphylactic shock or other symptoms, most often in practice either none of them will occur or one clearly marked side effect will appear , but usually in a mild form.
However, if we are allergic and react strongly to various substances, not necessarily components of drugs, then we should be especially careful when taking any medicine, because side effects can be strong and quickly increase over time (e.g. the mentioned anaphylactic shock).
As you can see, you need to read the leaflet that comes with the drug, but do not go to extremes – neither look for all the side effects, nor ignore the wording of the warnings and take the drug almost like a candy, just because, for example, it is available over the counter (i.e. in colloquial and most often incorrectly understood, certainly safe).
Very often does not mean almost always
Many patients reading the package leaflet find it difficult to determine the frequency of the risk of a side effect. Meanwhile, the rules are simple, although they are not always clearly presented in the leaflet by the manufacturer. Namely:
● if a side effect is very common, ie it affects more than one in 10 patients, then it is recorded as> 1/10 of patients;
● common side effects are those which occur less than 1/100 patients at the same time;
● uncommon side effects occur in less than one patient in a hundred, and more than one patient in a thousand ( 1/1000 patients);
● rare side effects occur in less than 1 / 1000 patients and more than 1 / 10 patients;
● finally, side effects are extremely rare in one in 10 patients, or in one patient in even more than 10 people tested.
This raises the question of why, then, drug manufacturers scare us on the leaflet with side effects that appear even in one person in the world? Because of a few reasons. First of all, they are obliged to do so by pharmaceutical law, both those issued in the form of European Union directives, as well as our Polish one resulting from the interpretation of the ordinances of the minister of health.
Second, by writing about all possible side effects, the manufacturer protects itself against the consequences of legal proceedings that would be brought against him by patients if the drug harmed them, and there was nothing on this in the patient information leaflet.
And finally, thirdly, the patient is informed about all possible side effects, which, although sometimes very rare, may happen to a person just starting therapy with a given pharmaceutical.
There are no miracle drugs
Many patients ask pharmacists and doctors if there is a drug or group of drugs that do not have any side effects. Unfortunately not. Each drug – including herbal or parapharmaceuticals – can cause side effects, which largely depends not only on the patient’s individual sensitivity, but also on the dose and route of administration.
We can generally assume that medications administered orally will be more likely to cause gastrointestinal side effects such as abdominal pain, diarrhea or nausea than identical medicinal substances in the form of injections (injections) or rectal suppositories, for example. This is due to a different method of absorption and metabolism of a drug administered intravenously or intramuscularly than the same drug administered orally.
In addition, the side effects that appear at the beginning of taking the drug may either decrease as the body gets used to its effects (so often the initial side effect of somnolence in patients taking antiallergic medications disappears or decreases over time), or disappear completely when the dose is adjusted. by your doctor after a few days of treatment (for example, reducing dizziness when adjusting the dose of medicines used to lower the blood pressure).
On the other hand, however, the opposite may also happen, i.e. due to the need to increase the dose of the drug (for example, an antibiotic, due to bacterial resistance that has built up over several years), there is an increase in side effects such as abdominal pain and nausea. In addition, the patient may then have the erroneous impression that the doctor has made a mistake because he wrote down too much, not described in the leaflet, dose of the drug. Meanwhile, bacterial resistance often grows faster than the rate at which the manufacturer updates the leaflet, who by law only needs to update the leaflet data at least every five years.
Worse than in the leaflet
Occasionally, patients complain that they have developed a rash, for example, while taking the medicine, when there was no information on this side effect in the package insert. However, studies of these cases show that almost 100% of the cause of such a side effect is another drug that the patient is taking at the same time, or it is the result of an interaction (reciprocal reaction) between drug A and drug B being taken by the patient.
The chance that we will discover a new side effect of a given drug in the course of therapy is almost zero, especially in the case of drugs that have been on the market for a long time (from several to several years). This is because, in addition to listing any side effects during drug testing in the period prior to its approval for general use, the pharmaceutical company (manufacturer or licensee) and prescribing physicians after registering the drug with the Registration Office have a statutory obligation to report any adverse reactions to the President of the Registration Office directly or through the company responsible for the distribution of the drug in a given country (Pharmaceutical Law Act, Art. 24 and Art. 61, and the Act on the Medical Profession, Art. 45a).
In addition, a company that has obtained an authorization to distribute a medicine must, for 5 years from the date of first registration, submit periodic reports on side effects of its medicinal products every six months during the first two years after authorization and every twelve months for the next three years. The chance that something will be omitted in them is therefore minimal.
Finally, the package leaflets of a given pharmaceutical have the same content in all countries where it is sold, and therefore also the side effects reported in country A are always recorded on all package leaflets in the other countries where it is distributed.
Both, the stomach hurts the same …
Side effects of several similar drugs are often common within a group. This is because they depend on the chemical structure of the drug, the dose used, and where the drug is absorbed and metabolized in the body.
For example, oral antibiotics often cause fungal superinfections in patients and disturbances in the production of the natural bacterial flora of the gastrointestinal tract (dysbacteriosis), manifested in the form of diarrhea and abdominal pain.
However, depending on where the drug is metabolized in the body and on the accumulation of drug substance in each organ, a particular antibiotic from a particular subgroup will have slightly different side effects. For example, direct side effects on the kidneys (nephrotoxicity) are common to aminoglycosides and polymyxins.
The most harmful to the liver are tetracycline antibiotics and novobiocin. Chloramphenicol and novobiocin are also toxic to the bone marrow, which cannot be said about other drugs in this group.
In turn, the group of penicillins and their derivatives is burdened with the greatest risk of causing sensitization and inducing anaphylactic shock, so in this case it is important to perform an allergic test before administering the full dose.
To read or not to read, that is the question …
Optimistic data on patients show that approximately 17% of patients read the information leaflets attached to drugs. However, in the pessimistic version of this research, readership does not exceed 5%. As a result, unaware patients taking a given drug do not even know what the side effects of its action may be. Worse – in the event of ailments, they will not associate them with the measure taken at all. For example, a person who takes a blood pressure lowering medication and has nausea may not even put these two facts together. Similarly, a patient taking preparations from the group of angiotensin converting enzyme inhibitors, if he has not read the leaflet, has no chance of combining the occurrence of dry persistent cough with taking a drug for hypertension.
Lack of knowledge of the side effects and dosing rules described in this leaflet may lead to an overdose, especially of painkillers often bought without a prescription and considered, mistakenly, to be safe. Meanwhile, in 2008, nearly 1,5 thousand clinics were delivered to the ten centers of clinical toxicology operating throughout the country. patients with severe poisoning with painkillers.
In the United States, it has been calculated that the costs of treating one patient amount to an average of PLN 3,1 thousand. USD, and this sum increases to 4,6 thousand. USD for the treatment of patients treated for complications related to the liver and biliary tract. Moreover, drug-related complications are estimated to be one of the top 10 causes of death in the US! In Germany, it has been calculated that the average length of hospital stay associated with an adverse drug reaction is approximately 11 days.
Therefore, we advise you to carefully read the leaflet attached to the package and use the drug in the dose prescribed by the doctor. In this way, we will avoid additional problems and costs related to the further treatment of our carelessness and its consequences.
Text: Rafał Jabłoński, MA in pharmacy
Source: Let’s live longer,