The existing contraindications of hypersensitivity and hypocalcaemia will be added to as follows:
- Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia
- Inability to stand or sit upright for at least 60 minutes
The current Summary of Product Characteristics (SPC) advises that individuals with a history of prolonged oesophageal transit time should pay particular attention to the dosing instructions.
It is unlikely that any bisphosphonate would be used or tolerated in patients with these contraindications as they would be likely to experience gastrointestinal side effects such as dysphagia, oesophagitis and oesophageal or gastric ulcers. These recommended changes will simply provide clarification and clearer information for clinicians and patients.
Action: Clinicians should be aware of these recommended changes and ensure that ibrandonic acid is not being used in patients with these contraindications.