When new safety information for medicines is identified, the Therapeutic Goods Administration (TGA) works with the sponsors to update Product Information (PI) to ensure that health professionals and consumers have access to this information. New safety information can be identified through the TGA's ongoing safety monitoring activities or uncovered and submitted by sponsors themselves. Please see below details of some medicines that have recently had safety related updates to their PI.
The TGA monitors the safety of medicines marketed in Australia using:
- reports of adverse events
- Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs)
- reviews of literature
- sharing of information with other regulatory agencies
- sharing of information with Australian state and territory health authorities.
Changes to the PI that result from TGA safety monitoring activities may:
- narrow indications
- add or modify specific sections, such as:
- contraindications
- warnings or precautions
- use in fertility, pregnancy and lactation
- use in special populations
- adverse effects.
It is important for prescribers and other health professionals to be aware of safety-related PI changes, as they may require you to take actions or do things differently, such as:
- counsel patients on identified risks
- undertake special monitoring or precautions
- in some instances select alternate medications.
Significant PI changes are often supported by distribution of a Dear Health Care Professional Letter on the issue, which are produced by the medicine's sponsor and sent directly to health professionals.
We will publish a Medicines Safety Update (MSU) article detailing recent safety-related PI updates each month, although this may not include all safety-related updates. We will continue to publish MSU articles for critical safety issues or topics of special interest.
The below medicines are generally innovator brands (generic brands may be included in some circumstances). Generic brands containing the same active ingredients as the medicines below are required to align with the safety information in the innovator's PI and will be updated accordingly.
To view the full PI for each listing, click on the name of the product in the 'Brand/trade name' column. A 'Summary table of changes' appears at the end of the PI. If the TGA has published any further risk communication, such as a safety alert or stand-alone MSU article, it will be linked to in the 'Safety issue' column.
| Active ingredients | Brand name Sponsor |
PI updates (sections updated and summary of key information) | Date of approval |
|---|---|---|---|
| ampicillin | Alphapharm Pty Ltd |
4.5 - Interactions with other medicines and other forms of interactions
4.8 - Adverse effects (undesirable effects)
4.9 - Overdose
|
30 May 2024 |
| anastrozole | Astrazeneca Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
|
17 May 2024 |
| azithromycin | Pfizer Australia Pty Ltd |
4.8 - Adverse effects (undesirable effects)
|
31 May 2024 |
| cefalexin monohydrate | Aspen Pharmacare Australia Pty Ltd |
4.8 - Adverse effects (undesirable effects)
|
10 May 2024 |
| conjugated estrogens | Pfizer Australia Pty Ltd |
4.5. Interactions with other medicines and other forms of interactions
|
15 May 2024 |
| diazoxide | Pfizer Australia Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
|
1 May 2024 |
| dulaglutide | Eli Lilly Australia Pty Ltd |
4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
|
22 May 2024 |
| durvalumab | Astrazeneca Pty Ltd |
4.8 - Adverse effects (undesirable effects)
|
23 May 2024 |
| eptinezumab | Lundbeck Australia Pty Ltd |
4.8 - Adverse effects (undesirable effects)
|
15 May 2024 |
| etanercept | Pfizer Australia Pty Ltd |
4.8 - Adverse Effects (undesirable effects)
|
13 May 2024 |
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle ▼ in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
