15 Jul 1999 – FDA approves prescription-drug Actos (pioglitazone hydrochloride) to help improve blog sugar (glucose) control in adults with type-2 diabetes.
14 Aug 2007 – FDA issues alert highlighting important safety information about Actos and other pioglitazone-containing medicines to strengthen the warning on heart failure risk. FDA now requires a new boxed warning and additional updated warnings, precautions and contraindications that Actos may “cause or exacerbate heart failure, particularly in certain patient populations.”
17 Sep 2010 – FDA issues safety announcement highlighting an ongoing safety review of Actos (pioglitazone) and potential increased risk of bladder cancer after two years exposure.
16 Mar 2011 – European Commission requests European Medicines Agency (EMA) to conduct a formal review of Actos and other pioglitazone-containing medicines to “investigate the signal of a possible increased risk of bladder cancer with pioglitazone.”
31 Mar 2011 – Actos manufacturer Takeda Pharmaceuticals reports that Actos had global sales of $4.84 billion in the previous year, accounting for 27% of Takeda’s entire revenue.
9 Jun 2011 – France’s drug safety authority, French Medicines Agency (Afssaps), suspends the use of Actos, ordering doctors to stop prescribing the drugs but advising patients to continue using them until they could consult with their doctors.
15 Jun 2011 – FDA issues safety announcement updating ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer, reducing the exposure time from two years (2010 warning) to “more than one year” in this notice and announcing new changes that must be made to product labeling and the patient medication guides.
21 Oct 2011 – EMA announces Actos remains a valid treatment option “for certain patients with type 2 diabetes, but only when certain other treatments (metformin) have not been suitable or have failed to work adequately”. The agency also announced that all “new warnings and contraindications recommended in July 2011 remain in place” and anyone prescribing Actos should “carefully select patients and monitor their response to treatment.”
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