Clinical trials are important to ensure that medications are safe for consumers.
Information about the safety and efficacy of a new medicine that is undergoing evaluation is mainly obtained from clinical trials. Such trials are carried out in a relatively small population (several hundred to a few thousand people) and within specific groups (by age or health condition). Therefore, some side effects may not be known at the time of approval and may only become apparent when a medicine is used over a long period of time and in larger, diverse groups of people.

It is therefore important to have a robust post-market surveillance programme where the safety of medicines is continually monitored. One of the ways HSA identifies potential safety issues is by monitoring side effects reported by healthcare professionals and pharmaceutical companies.

What are side-effects?

Side effects are unwanted effects that occur after taking a medicine. In general, most side effects are mild and can be self-managed. However, some can be more serious and require medical attention.

Here are some examples of commonly taken medicines, and their associated side effects:

  • Fever and pain medicine (e.g. Ibuprofen, diclofenac, aspirin) can help to bring down a fever or reduce pain but may also cause gastric problems. This side effect can be minimised by taking the medicine with or after food.
  • Antibiotics (e.g. amoxicillin, erythromycin) treat the infection but may cause diarrhoea which usually resolves on its own.

Different people react differently to medicines, and side effects may vary from person to person. This would depend on factors such as:

  • Dose of the medicine
  • General health, age and gender
  • Concurrent treatments or consumption of other medicines or health products (including health supplements or traditional medicines)

What should I do?

Report to your healthcare professional

If you suspect that you are experiencing a side effect and are concerned about it, inform your healthcare professional e.g. doctor, dentist, pharmacist or nurse about the symptoms.

You should provide your personal particulars and the following information, where applicable:

  • Description of the side effect
  • Name of the suspected medicine
  • Dose and the duration of the period that you had taken the product
  • Batch number (found on the product packaging)
  • Other products that you had taken around the same time (medicines, vitamins and health supplements, traditional medicines)
  • Other health/medical conditions that you may have

Why should I report?

Your report matters!

Your healthcare professional would be in the best position to advise you on your condition and how to manage and prevent side effects. Your healthcare professional may also advise if you should continue with your current treatment.

What happens to your healthcare professional’s report?

Your healthcare professional’s report will help HSA to identify and investigate any potential safety issues arising from the use of the medicine e.g. previously unknown side effects or poor quality of a medicine. HSA studies these reports to determine if the benefits of the medicine continue to outweigh the risks and assess if any actions need to be taken.

HSA’s regulatory actions can include:

  • Communicating safety information to healthcare professionals and consumers, alerting them to side effects and the measures needed to manage or prevent these side effects;
  • Making changes to the label or product information of the medicine; and
  • Recalling the medicine from the market if the risks are deemed unacceptable and public health is affected

Every side effect report helps to make medicines safer for everyone.

Report to your healthcare professional because it matters!