Saturday, 11 July 2026
Contraceptive safety update, Bulk billing rules under scrutiny, TGA alerts on sexual products
- 01
PRAC issues new safety information on contraceptives and Litfulo
The Pharmacovigilance Risk Assessment Committee (PRAC) has released new safety information regarding desogestrel- and etonogestrel-containing contraceptives, highlighting a small increased risk of meningioma with prolonged use. The committee has recommended a direct healthcare professional communication to inform clinicians about this risk, which is estimated to result in one additional meningioma for every 67,300 women using these contraceptives for over a year. Additionally, the use of these medicines is now contraindicated in women with a history of meningioma. PRAC also updated warnings for Litfulo, a treatment for alopecia areata, to reflect potential serious side effects similar to other Janus kinase inhibitors.
- 02
Concerns over assignment of benefit rules may impact GP bulk billing
Accountant David Dahm warns that the Department of Health, Disability and Ageing's approach to assignment of benefit rules could jeopardise the 90% GP bulk billing rate. He highlights the complexity of the system, particularly the new requirement for practices to store patient consent for each bulk billed episode, which presents multiple risks for practices. Dahm notes that errors in assignment of benefit could lead to audits and assumptions of widespread non-compliance. While the Department has committed to a risk-based approach and education for honest mistakes, many clinics may consider shifting to private billing to mitigate risks.
- 03
TGA warns of undeclared drugs in sexual enhancement products
The Therapeutic Goods Administration (TGA) has issued warnings regarding multiple sexual enhancement products, including Grakcu capsules, which contain undeclared prescription medicines. Laboratory testing revealed these products, marketed as natural supplements, contain sildenafil, tadalafil, and dapoxetine, posing serious health risks and potential drug interactions. The TGA's alerts highlight concerns about unapproved therapeutic goods sold online and in retail outlets. The regulator is collaborating with the Australian Border Force to prevent further importation of these products and has advised consumers to stop using them immediately.
- 04
AMA Calls for Comprehensive Measures in Telehealth Reforms
The Australian Medical Association (AMA) supports the government's plan to reform telehealth but emphasises that a national medicines record alone will not ensure patient safety. The Department of Health, Disability and Ageing aims to implement reforms to address doctor shopping, including a requirement for online telehealth providers to upload medicines-related information to My Health Record by the end of the year. The AMA argues that while this is a necessary step, it must be part of a broader strategy to improve clinical governance and communication among healthcare providers. The submission highlights concerns about the risks of fragmented care and the importance of visibility regarding high-risk medicines.
- 05
GSK's ADC ris-rez shows survival benefit in lung cancer trial
GSK announced that its antibody-drug conjugate risvutatug rezetecan, or ris-rez, improved survival in patients with advanced or relapsed small cell lung cancer in a late-stage study conducted in China. This marks the first time an ADC targeting the B7-H3 protein has demonstrated a clear survival advantage in a Phase 3 trial across any tumor type. The drug also showed consistent benefits in delaying tumor progression compared to standard chemotherapy. GSK plans to file for regulatory approval in China and is advancing global trials for ris-rez, which is part of a broader strategy to expand its oncology portfolio.
via BioPharma Dive
- 06
Study reveals unreliable datasets in AI clinical prediction models
A study published in BMC Medicine has found that clinical prediction models based on unreliable datasets are being used in practice. Two datasets from a popular online repository informed 125 models across 32 countries, yet lacked verifiable provenance. Three of these models were likely applied in clinical settings, with some incorporated into publicly accessible stroke risk calculators. The findings raise concerns about patient safety, as poor data quality can lead to inappropriate treatment decisions.
MDDR is a news digest for medical professionals. It is not medical advice and should not be relied on for clinical decision-making.