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Pioglitazone — Regulatory History

5 clinically reviewed articles, written and peer-reviewed by the HealthRX.com Medical Team.

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2025-07-10latest review

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Pioglitazone — Regulatory History library

Showing 5 of 5 clinical reviews.

Safety2025-07-10

Actos (Pioglitazone) EMA vs FDA Approach: Label Differences, Safety Signals, and Post-Market Surveillance

A detailed comparison of how the FDA and EMA have regulated pioglitazone (Actos), including label differences, bladder cancer warnings, cardiovascular data, and post-market safety decisions.

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Safety2026-05-25

Actos (Pioglitazone) FAERS Safety Signals: Post-Market Surveillance Data

A clinical review of pioglitazone (Actos) FDA Adverse Event Reporting System signals, including bladder cancer risk, heart failure, fractures, and macular edema, with regulatory timeline and current label warnings.

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Safety2026-05-26

Actos (Pioglitazone) FDA Approval History: Timeline, Label Changes, and Safety Updates

Complete FDA approval history of pioglitazone (Actos), including original 1999 approval, black box warnings, bladder cancer reviews, and current prescribing label status.

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Safety2026-05-27

Actos (Pioglitazone) Label Updates 2020 to 2026: FDA Safety Changes, Warnings, and Clinical Context

A detailed review of every FDA label change for pioglitazone (Actos) from 2020 through 2026, including updated bladder cancer language, heart failure warnings, bone fracture data, and NASH-related off-label use considerations.

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Clinical Reviews2026-05-25

Actos (Pioglitazone) Pipeline, FDA History, and Next-Generation TZD Research

A clinical review of pioglitazone's FDA approval history, current label, post-market safety surveillance, and the next-generation thiazolidinedione pipeline including MSDC-0602K and seladelpar.

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