Avandia (rosiglitazone)

[pharout]

Ok, aside from the reports of ischemic events and heart failure, new report this morning stating that this drug now causes decreases in bone density leading to osteoporosis. I haven't read yet and not sure if you have in UK, but looking like this med is probably not going to be the best to recommend. I know the former (ischemic events and HF) has not been shown to hold true with Actos (pioglitazone), but will be interesting to see if this newest report will prove to be true with Actos as well. I dread these reports on major news stations in the U.S. as it inevitably leads to subsequent premature phone calls to me by patients !!!!

[Zoggite]

I know what you mean...
I remember spanding ages explaining to quite a few patients that Dioxin and Digoxin weren't the same thing...
Doesn't it make you really mad when somebody who stinks of cigarette smoke asks you whether it's true that their atenolol can cause cancer?

[Titch]

Sure there has already been a report about pio and osteoporosis risk - too late at night to think about it/find it now but will look tomorrow.

[Titch]

Found it - increased fracture risk, so was on right lines.



Medicines Information Web Site
Trent and West Midlands regional Medicines Information services


News Story 13 March 2007

FDA Medwatch – pioglitazone and fracture risk

Takeda and the FDA have notified US healthcare professionals of recent safety data concerning products containing pioglitazone. According to an analysis carried out using the manufacturer's clinical trial database, there have been more reports of fracture in women taking pioglitazone than in those taking a comparator (either placebo or active). The majority of fractures observed in female patients taking pioglitazone were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). The fracture incidence calculated was 1.9 fractures per 1 00 patient-years in the pioglitazone-treated group and 1.1 fractures per 100 patient-years in the comparator-treated group. The observed excess risk of fractures for women in this data set on pioglitazone is therefore 0.8 fractures per 100 patient-years of use. There was no increased risk of fracture in men.

In a letter issued to healthcare professionals in the US, the manufacturer states that none of the studies in the database were designed to study the effect of pioglitazone on bone, and that multiple known risk factors for fractures cannot be excluded as confounding variables. There is no current explanation for these findings, and further evaluation is ongoing. Healthcare professionals are advised to consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products.

The FDA previously issued a similar safety warning concerning rosiglitazone, following results from the ADOPT study and another ongoing long-term study (see link above for NeLM news item). GSK has recently written to healthcare providers in the UK about this matter, advising them to consider the risk of fracture in the care of patients, in particular female patients treated with rosiglitazone. The company says that at present, its understanding of the clinical significance of the findings is incomplete, and the mechanism(s) for the observed increase in fractures is uncertain.

The letter from Takeda is available from FDA Medwatch here

[pharout]

Originally Posted by Titch

Found it - increased fracture risk, so was on right lines.



Medicines Information Web Site
Trent and West Midlands regional Medicines Information services


News Story 13 March 2007

FDA Medwatch – pioglitazone and fracture risk

Takeda and the FDA have notified US healthcare professionals of recent safety data concerning products containing pioglitazone. According to an analysis carried out using the manufacturer's clinical trial database, there have been more reports of fracture in women taking pioglitazone than in those taking a comparator (either placebo or active). The majority of fractures observed in female patients taking pioglitazone were in the distal upper limb (forearm, hand and wrist) or distal lower limb (foot, ankle, fibula and tibia). The fracture incidence calculated was 1.9 fractures per 1 00 patient-years in the pioglitazone-treated group and 1.1 fractures per 100 patient-years in the comparator-treated group. The observed excess risk of fractures for women in this data set on pioglitazone is therefore 0.8 fractures per 100 patient-years of use. There was no increased risk of fracture in men.

In a letter issued to healthcare professionals in the US, the manufacturer states that none of the studies in the database were designed to study the effect of pioglitazone on bone, and that multiple known risk factors for fractures cannot be excluded as confounding variables. There is no current explanation for these findings, and further evaluation is ongoing. Healthcare professionals are advised to consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone-containing products.

The FDA previously issued a similar safety warning concerning rosiglitazone, following results from the ADOPT study and another ongoing long-term study (see link above for NeLM news item). GSK has recently written to healthcare providers in the UK about this matter, advising them to consider the risk of fracture in the care of patients, in particular female patients treated with rosiglitazone. The company says that at present, its understanding of the clinical significance of the findings is incomplete, and the mechanism(s) for the observed increase in fractures is uncertain.

The letter from Takeda is available from FDA Medwatch here

Thanks Titch, I vaguely recall this report in the U.S. I don't think it was "robust" enough to actually change practice styles especially since the studies involved were not designed to look at these outcomes. However, it is certainly worth considering risk on an individual level when considering Actos.