Stating that many effects utilized in treatment are side effects for healthy people, Prof. Dr. Tayfun Uzbay, Head of the Department of Medical Pharmacology, said, “Sometimes a side effect of a drug can also be useful in our treatment.” Uzbay, stating that birth control pills are known to cause depression with continuous use, warned, “Additionally, women using these types of pills should definitely not smoke and should be warned about weight control and hypertension.”
Prof. Dr. Tayfun Uzbay, Head of the Internal Medical Sciences Department and Head of the Department of Medical Pharmacology at Üsküdar Üniversitesi Faculty of Medicine, evaluated the issue of drug side effects.
The Ministry of Health issues drug licenses
Prof. Dr. Tayfun Uzbay stated that a drug that cures any disease or any symptom of a disease must be licensed before it can be prescribed, saying, “The license is granted by the Ministry of Health for the drug to be used in treatment. This means that until a license is obtained, any drug candidate is not in ‘drug’ status. Before reaching the licensing stage, a drug candidate (an active substance or molecule) must be tested using various scientific methods. This process is step-by-step.”
During the preclinical stage, the success of the drug is evaluated
Uzbay noted that initially, in the preclinical stage, it is examined whether the drug candidate exhibits the predicted effect in cell cultures, various isolated organs, and tissues, and continued as follows:
“For example, a drug with smooth muscle relaxant properties can be effective against hypertension. Subsequently, the effects of the drug candidate are observed in living experimental animals using in vivo methods. Diseases and their symptoms are induced in experimental animals, and the drug's effect on them is evaluated. During this process, if the effective drug candidate does not show any harmful or toxic effects, it successfully completes the preclinical stage. An unusual adverse effect encountered during this time or ineffectiveness against disease symptoms leads to the elimination of the drug candidate.”
Effects are observed on healthy volunteers
Explaining that the drug candidate, which has passed the preclinical period, enters clinical trial tests, Uzbay said, “Here, first, its effects on healthy volunteers are examined. We call this Phase 1. If the molecule does not cause any serious problems in healthy volunteers during Phase 1, its usefulness is investigated by using it in a limited number of relevant patients in the process we call Phase 2. If the drug sufficiently improves disease symptoms, its effects are tested in a wider population, which we call Phase 3. If, at the end of Phase 3, the drug has provided sufficient clinical effect, meaning it has satisfactorily treated the patient or a targeted symptom of the disease, and more importantly, if there are no serious side effects or toxic effects that would necessitate not using it in the monitored population, it receives a license for widespread use.”
Benefit from treatment is compared with potential harm from side effects
Prof. Dr. Tayfun Uzbay stated that some side effects observed from Phase 1 to Phase 3 can emerge and are noted, adding the following:
“The severity, transience, and frequency of these side effects are extremely important. Also, the degree of benefit to be gained from treatment and its contribution to the patient are compared with the potential harm the side effect may cause to the patient. If side effects are temporary, tolerable, low in frequency, and do not significantly impair patient comfort, the drug is permitted, provided they are stated in the package leaflet. One of the most important conditions here is that the benefit the drug will provide in treatment must be much higher when compared to its side effects.
For example, a drug that completely eliminates a life-threatening condition for the patient will not be avoided due to side effects like headache, sedation, dizziness, or drowsiness. Tolerance to most of these symptoms develops over time, but patient survival is a very valuable outcome. However, this does not mean that the drug is now completely safe and will not be monitored.
Under what circumstances is a drug's license suspended?
Every new drug is monitored by a system we call pharmacovigilance, a process known as Phase IV. Sometimes the frequency of some side effects of drugs is very low and only becomes apparent when used in a very large population during Phase IV. In this case, if the emerging side effect is very serious, the drug's license is suspended or revoked, and it is withdrawn from treatment. If different but tolerable side effects not included in the package leaflet are observed, these are added to the leaflet, and the drug continues to be used in treatment.”
If the used drug aggravates the symptoms of the existing disease, it can be considered a side effect
Prof. Dr. Uzbay also drew attention to drug side effects, stating, “Sometimes a drug's side effect can also be useful in our treatment. In fact, many effects we utilize in treatment are side effects for healthy people. For example, a drug that dilates blood vessels can cause a drop in blood pressure in a healthy person. This is a necessary effect for a hypertension patient. When given to a patient with high blood pressure, it normalizes their blood pressure. While drugs that can cause constipation in healthy people are effective in stopping diarrhea and preventing water loss, drugs that cause diarrhea in healthy people can be used to treat constipation. Interestingly, some drugs produce their effects only in patients, not in healthy individuals. If the used drug aggravates the symptoms of the existing disease instead of alleviating them, it can be considered a side effect.”
If side effects occur, it is essential to consult a physician
Uzbay also explained that this is a more common situation in cases such as drug interactions or drug-food interactions during polypharmacy, saying, “In this situation, it is essential to communicate with the prescribing physician. For example, if severe headache, vomiting, persistent stomach pain, diarrhea, etc., occur after medication, it is imperative to consult a physician before taking the next dose. Instead of establishing the causal link between side effects and disease symptoms ourselves, it is much more appropriate to seek support from specialists.”
Should the package leaflet be read or not?
Uzbay, stating that reading the package leaflet can create prejudice against the drug, said the following:
“Users mostly read the section related to side effects and, getting stuck there, stop taking their medication. However, most of the side effects they see there are rare and disappear over time. On the other hand, when prescribing the drug, the physician must have evaluated the weight of the benefit the patient will receive. In my opinion, the most important section to pay attention to in the package leaflet, especially if multiple drugs are being used, is the interaction with other medications. If there is a serious drug interaction, it is essential to communicate with the prescribing physician. However, the physician should have asked you if you are using other medications before prescribing the drug and made an evaluation accordingly.
If food interactions are involved, you should avoid the foods mentioned in the package leaflet while using the drug. Some drugs interact with tea and coffee. This type of information is also found in the package leaflet. The package leaflet also contains drug-specific temporary, non-dangerous features that may cause panic in the user. For example, some drugs can color urine red. The patient may panic, thinking they have bleeding. It is important to have this knowledge, and such information is included in the package leaflet.”
Birth control pills should not be used without a prescription
Prof. Dr. Tayfun Uzbay noted that birth control pills are drugs that change hormone balances and secretions, thus capable of making significant changes in biochemical systems dependent on sex hormones, and stated the following:
“Their use without a prescription and indiscriminately is not correct. They have different mechanisms of action, and the same mechanism of action may not work for every woman, or it could even be harmful. A gynecologist should decide what kind of birth control method or pill a woman should use after evaluating her. In some special cases, consultation with an endocrinologist is also required.
Birth control pills can cause depression
It has long been known that continuous use of these drugs can negatively affect the monoamine system in some women, leading to depression. Such an effect does not appear in every woman, but it is observed in some. If a woman using them enters a state of reluctance, loss of energy, pessimism, and a constant feeling of weariness, she must inform her physician. Unfortunately, obstetricians and gynecologists sometimes do not evaluate the situation as depression and may insist on continued use.”
Women using these pills should absolutely not smoke
Uzbay also noted that the depressive side effects of these drugs should be discussed more in relevant medical congresses and more data should be presented to physicians on this matter, “adding, 'Additionally, women using these types of pills should definitely not smoke and should be warned about weight control and hypertension. If blood pressure tends to increase or has increased, and weight gain is an issue, the drug should be stopped or changed, and if problems persist with the changed drug, non-medicinal birth control methods should be used.'” He concluded his remarks.