Is your medicine making you feel worse?

Whenever you take a new medicine or use a new medical device – whether it be something as simple as a painkiller or band aid, to a complex device such as a pacemaker – you may be at potential risk for a negative side-effect, or an ‘adverse event’.

These unexpected and unwanted symptoms may be caused by the way a medicine or a device works with your body and are sometimes listed as side effects in the Consumer Medicines Information (CMI) leaflets for medicines. For medical devices, side effects are listed in the Instructions for Use (IFU) or Patient Information Leaflet. However, only a small percentage of people experience the negative effects of a certain medicine or device.

Negative effects may only occur after an extended period of use. Sometimes they may only affect particular groups of people such as the elderly or pregnant women. In such cases these negative effects may not be detected in clinical trials and only come to light once the medicine or device has been used by thousands of people over a prolonged period of time.

Following release to market, the supplier and the Therapeutic Goods Administration (TGA) undertakes ongoing post-market monitoring (post-market surveillance) on these products to see if any negative effects appear that were not identified in clinical trials or that were greater than anticipated, as no medicine or device can be thought of as being absolutely free-of-risk.

An instance of adverse effects from a medical device is “breast implant associated anaplastic large cell lymphoma” (BIA-ALCL), a rare form of blood cancer that occurs in people with breast implants. Between one in 2,500 and one in 25,000 people with breast implants are diagnosed with the condition. 95 per cent of cases occurred between three and 14 years after the insertion of the implant.

After gathering and analysing a large amount of evidence including adverse event reports of BIA-ALCL  which were sent to the TGA from consumers, health professionals and the medical device industry; the TGA has removed, provisionally, the approval for specific implants to be provided in Australia. The TGA is continuing to monitor the safety and performance of breast implants and encourages people who are considering getting them to be aware of and weigh up the benefits and risks before undergoing the procedure.

Adverse event reporting

Reports of adverse events are important to ensure that these potential harms are recorded, investigated, and trends can be analysed for emerging issues with types of devices. This is a key component of the TGA’s safety monitoring program.

Anyone can report an adverse event to the TGA. If you are experiencing something that you think you shouldn’t be, and you suspect that it may be related to the medicine or medical device you are using, you should immediately contact your doctor or pharmacist. You should also report the incident – even if you are not certain if the medicine or device was responsible for the adverse event. Health professionals aren’t required to report adverse events, so if you think you have experienced an adverse event you should report it to the TGA yourself. If both you and your health professional report the same adverse event the TGA will recognise these as duplicate reports, and will use the information from both reports.

Adverse events can be reported by filling in a form on the TGA website.

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Consumers Health Forum