FOI release

Additional information on post marketing surveillance reports for Aclasta

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00855

Received 1 August 2026

Published 17 September 2026

Request

Please could you provide a breakdown as below: * By age * By sex * What dose/preparation was the patient taking (Aclasta(tm) or Zometa(tm)) * How long the medication was taken for, and whether it was stopped * Whether the patient had any pre disposing cardiac conditions * What the cardiac side effects were, and whether they were reversible (spontaneously, or on stopping the drug) * Was zoledronic acid considered to be cause of the fatal outcome In addition, with regard to the table of reactions by organ class in the Yellow Card reporting summary, please could you provide the same data but solely for Aclasta(tm) since, not only do those patients treated with Zometa(tm) have cancer, but they are given a more intense dosage regimen. This would then allow me to determine whether I would want to seek further detail for any more of the reactions, as per what I have requested for the cardiac side effects above.

Response

See attached

Documents

• Annex 1 UK Spontaneous Suspected Adverse Drug Reaction reports for Zoledronic Acid and Cardiac disorder SOC.pdf (169.2 KB)
• Annex 2 All UK spontaneous suspected Adverse Drug Reaction (ADR) reports associated with Aclasta up to and including 1st September 2026.pdf (384.4 KB)
• FOI202600855 (redacted).pdf (1.3 MB)

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