We previously wrote concerning increased heart attack and heart failure risks to those taking the prescription drug Avandia (Rosiglitazone). The drug, manufactured by GlaxoSmithKline (GSK), is prescribed to Type II (non-insulin dependent) diabetics. The FDA has taken under advisement the issue of whether or not to increase warnings and precautions of taking the drug or to completely remove the drug from the U.S. market.
A September 5, 2010 article by BBC Panorama disclosed that the drug was
recommended for withdrawal in the UK two months ago by an expert panel
of the UK Medicines and Healthcare products Regulatory Agency (MHRA),
the UK’s equivalent of the FDA. In July, clinicians at the Commission
on Human Medicines (CHM), the MHRA’s advisory body, recommended
unanimously that Avandia be withdrawn from the UK. This recommendation
was not made public. MHRA has sent letters to healthcare officials, suggesting
they should “consider alternative treatments where appropriate.”
Avandia has been prescribed to tens of thousand of patients in the UK
over the last ten years, earning GSK billions of pounds. The European
Medicines Agency, in a Europe- wide review of Avandia, will announce later
this month whether or restrict Avandia’s prescription or to withdraw
it completely. Meanwhile, GSK said its research proved the drug was “safe
and effective when it is prescribed appropriately,” and that “patient
safety is our first priority.”
Actos, a competitor drug to Avandia, is being widely prescribed in the
U.S., although some studies claim to show that Actos is no more safe for
Type II diabetics than Avandia.
The drug choice facing prescribing physicians and patients at this time
is a difficult one and appears to be little more than a roll of the dice.