use was curbed due to heart concerns, although restrictions were later lifted, while pioglitazone was hit by concerns over a possible link to bladder cancer.
Using a mouse model of cerebral malaria, they show that when they give rosiglitazone
in addition to antimalarial drugs at the onset of cerebral malaria symptoms, mice are more likely to survive, and the survivors which had received rosiglitazone
did not show the brain abnormalities or cognitive defects seen in surviving mice that had only received antimalarial drugs.
Concurring with the recommendations of two expert advisory panels in June, the FDA is modifying the cardiovascular safety statement in the labels of rosiglitazone
products, changing the rosiglitazone
Risk Evaluation and Mitigation Strategy (REMS), and releasing the manufacturer from a requirement to conduct a postmarketing safety study, according to the announcement.
4 million commercially insured members who were exposed to a rosiglitazone
PA program beginning January 1, 2009.
Pioglitazone and rosiglitazone
work the same way when treating diabetes, so if the risk is only there with one, there's something different about that drug," said Jeff Johnson, scientist at the University of Alberta, in a statement.
Our study shows that increased fracture risk is associated with higher TZD dose, but no difference between rosiglitazone
and pioglitazone is apparent, suggesting a class effect of TZDs on fracture risk," senior author William Herman, also of the university, said in a prepared statement.
According to many reports since its first authorisation, rosiglitazone
has been recognised to be associated with fluid retention and increased risk of heart failure and its cardiovascular safety has always been kept under close review.
On Thursday, the EMA recommended that drugs containing rosiglitazone
be suspended from the European pharmaceutical market due to concern over the finding that it raises the risk of heart disease.
patients currently on rosiglitazone
and take appropriate action, according to
It decided to halt the sale of Glaxo's other diabetes drugs, Avandamet and Avaglim, since they too contained rosiglitazone
An investigation found the Commission on Human Medicines advised an expert committee of the Medicines and Healthcare products Regulatory Agency (MHRA) in July to withdraw the drug as the risks of rosiglitazone
outweigh its benefits.
The British Medical Journal discovered that the Commission on Human Medicines had advised regulators in July that rosiglitazone
, marketed as Avandia, should be banned amid fears it can increase the risk of heart attacks.