Council meeting times to change
District still far behind federal education standards
Local woman battling homelessness earns national honor
Metal finishing companies fined by EPA
City getting prettied up with Public Works projects
Hispanic, Latino leadership group plans 10-city tour
Where to get help paying for costly cancer drugs
Group to explore why Black babies are still dying
Funders forum targets nonprofits in need of tips on securing grants
Ridley-Thomas celebrates revamp of Southland transit hub
Benjamin
Todd Jealous:
Why we are marching on October 2
Earl
Ofari Hutchinson:
Bishop Eddie Long: Victim, hypocrite or both?
FDA
to strictly limit diabetes drug deemed too unsafe for most
In Europe, Avandia banned altogether based on heart-attack risks
By Matthew Perrone
WASHINGTON—European
regulators ordered the diabetes drug Avandia off the market and the
U.S. Food and Drug Administration placed stringent restrictions on
its use in the United States, saying heart attack risks associated
with the former blockbuster are too great a safety concern to continue
its use for most people.
In simultaneous news briefings last Thursday, the European Medicines
Agency and the U.S. Food and Drug Administration announced their long-awaited
decisions on the fate of British-based GlaxoSmithKline's controversial
drug. The European regulator said it would stop authorizing marketing of
Avandia, which will be banned from sales within the next few months.
The FDA said new patients will be able to get a prescription for
Avandia, but only if they can't control their blood sugar with other medications.
Doctors will have to document that their patients are eligible to receive
the drug and have been briefed on its risks. The FDA expects the restricted
plan “will limit use of Avandia significantly.”
The two decisions will virtually eliminate use of the drug around
the world, said Dr. Steve Nissen of the Cleveland Clinic.
“To prescribe this drug in the U.S., you now have to certify that
the patient has tried every other diabetes drug, and there are no
patients who only respond to Avandia,” said Nissen, who published
the first paper linking Avandia to heart risks.
While there are more than a dozen diabetes drugs on the market, only
Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia.
U.S sales of Actos have risen steadily — hitting $3.4 billion last
year — as Avandia's reputation has soured. Global sales of Avandia
have fallen from a peak of $3.2 billion in 2006 to $1.2 billion last year.
In the U.S., more than 2.6 million patients filled prescriptions
for Avandia last year, and some experts worry that those currently taking
the drug may continue using it despite the risk of heart attack.
Anyone already taking Avandia will need to sign a waiver saying that
they understand the drug's risks. But Dr. Harlan Krumholz of Yale University
says patients may not understand that they are still at risk even if they
feel good.
“Asking a patient, ‘Are you doing well on this medication?’ isn't
an adequate assessment of whether the drug is increasing their risk.
It's a silent risk. They don't feel the risk,” Krumholz said.
The safety of Avandia, the brand name for rosiglitazone, has been
the top drug safety controversy facing the FDA in recent years. The FDA's
critics have framed the Avandia decision as a key test of the agency's
Obama-appointed leadership, who vowed to bolster the agency's regulatory
stance after a series of drug safety problems under the previous administration.
...
...For
the rest of this story, subscribe to the Compton Bulletin
print edition by CLICKING THIS BUTTON:
ADVERTISE | CLASSIFIEDS | ABOUT US | CONTACT US | SUBSCRIBE | HOME
This site and its contents ©2010 thecomptonbulletin.com