Thu 25 Jun 2026
All official websites of government entities in the Kingdom of Saudi Arabia end with.gov.sa.
All official websites of government entities in the Kingdom of Saudi Arabia end with.gov.sa.
2024-02-21
In agreement with European Regulatory Authorities, GlaxoSmithKline (GSK) is informing you of recent safety data concerning rosiglitazone-containing products, i.e., Avandia® (rosiglitazone maleate) Tablets, Avandamet® (rosiglitazone maleate and metformin hydrochloride) Tablets, and Avaglim® (rosiglitazone maleate and glimepiride) Tablets. The information could be summarized as follows:
• Clinical trial data (ADOPT) show that female patients treated with rosiglitazone experienced significantly more fractures in feet, hands and upper arms (humerus) than female patients who received either metformin or glyburide.
• The mechanism for the observed increase in fractures is uncertain. Further evaluation of these findings is ongoing.
• The risk of fracture should be considered in the care of patients, in particular female patients treated with rosiglitazone.
Source: Medicines and Health Care Products Regulatory Agency
Warning date
Last update date: 26/02/2024 at 12:48 AM Saudi Arabia time
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