Where are oral and dental adverse drug effects in product information?

Oral adverse drug reactions are common and are associated with some of our most frequently used medicines. It is important to identify and manage oral adverse drug effects promptly as they not only negatively impact dental health, but also adversely affect medication adherence, clinical outcomes and patient quality of life. This study assessed the location of oral drug-induced adverse effects in the registered drug company product information (PI) of the top 100 most commonly used drugs in Australia as dispensed on the Pharmaceutical Benefits Scheme in 2018.

Publicly available data on dispensed medicines were accessed from the Australian Commonwealth Department of Health, to determine the top 100 medicines. The drug company PI for each of these drugs was manually searched to find their oral adverse effects. The number, type and location of the oral adverse drug reactions (ADRs) were recorded.

Oral ADRs were commonly found varying in nature and severity. However, they were difficult to find as there is no dedicated section for oral/dental adverse effects in the PI and the section they are in is inconsistently applied.

We recommend that regulatory authorities such as the Therapeutic Goods Administration in Australia create an additional section for oral/dental adverse effects so they are easier to find, which may assist health professionals detect recognise and report adverse drug effects manifesting in the oral cavity.