Written By: Shraddha Rupavate | Published : May 14, 2014 12:43 PM IST
Every drug or medicinal product is being tested for safety and efficacy before it is approved by the regulatory agencies and is made available in the pharmaceutical market. We all know that all medicines have their own side-effects that are manageable. Everyone needs to be aware of the side-effects of the medicines they are consuming and what to do in case they are affected by them.
What is a side-effect?
A side-effect is an unintentional effect of a drug at a normal dose. A side-effect can be called an adverse event when it includes worsening of the condition, recurrent illness or unwanted drug interactions with other medicines used in the clinical study. Sometimes, the side-effect can even turn into an serious adverse event when the drug elicits an unwanted effect at any given dose. An unwanted effect of the drug is obviously an emergency that needs immediate medical attention.
'An adverse event implies that the patient has suffered harmful drug effect like medicinal injury caused due to medical advice or treatment (iatrogenic),' says Dr Talat Halim, director of Emergency and Trauma Services at Fortis Memorial Research Institute, Gurgaon. Not many people know that side-effects actually cause a lot of deaths. Dr Halim shares some facts about side-effects and adverse events in India.
Which drugs are likely to cause an adverse drug reactions?
'All medicinal products can cause side-effects as well as adverse drug reactions. Some of the medicines like nystatin (antifungal agents) or B12 supplements (vitamin supplements) have mild or near zero (not zero) side-effects. But apart from these all formulations have noticeable and unnoticeable side effects,' says Dr Halim.
What immediate action should people take after an serious side-effect has occurred?
'If you experience an adverse reaction, stop taking the drug immediately and visit a doctor', says Dr Halim. But you should remember that discontinuing some drugs may not be safe hence it is best to consult a doctor first. Also, do not take any other medicine without the doctor's prescription.
Dr Halim explains 'In general, the doctor will tell you to stop taking the medicine only if:
In case your side-effect or adverse-event is not that serious; for example fatigue, general nausea or dizziness, you can continue to take the medication until you visit the doctor. You doctor may modify the dose if:
What treatment is required for a person who suffers a serious side-effect or an adverse event?
According to Dr Halim treatment or management for side-effects is based on the time-line of the adverse drug reaction (ADR). He explains the three types of ADRs based on time-line.
In both sub-acute and latent ADR, stoppage of drugs, stoppage of non-essential drug, change in dosage and time of administration is needed.
Dr Halim further explains management of ADRs depending on its severity:
Are there any long-term effects of adverse events on the body?
'Yes. Certain drugs cause lifelong disability, congenital anomalies. They can lead to:
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