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Our pharmacists want to make sure you have the most
current information on the news regarding the diabetes drug Avandia in the media.
Here is an FDA statement on the matter posted today (2/22/2010)
This is the key information for Avandia patients:
FDA recommends that patients currently using rosiglitazone:
- Not stop taking their
medication without talking with their healthcare professional.
- Discuss any questions or concerns they have about rosiglitazone with
their healthcare professional.
- Read the Medication Guide that comes with each rosiglitazone
prescription to better understand the risks and benefits of their
medication.
- Report any side effects with rosiglitazone to FDA's MedWatch program
using the information at the bottom of the page.
If any patient cannot find the Medication Guide that came
with your prescription, we would happily provide you with another copy, please
don't hesitate to ask; click here
for our contact info.
Full article from
FDA page below
FDA Drug Safety Communication: Ongoing
review of Avandia (rosiglitazone) and cardiovascular safety
Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
[02-22-2010] The U.S. Food and Drug Administration (FDA) is
reviewing data, submitted in August 2009, from a large, long-term clinical study
on possible risks with the diabetes drug, Avandia* (rosiglitazone). The clinical
study, called the Rosiglitazone Evaluated for
Cardiovascular Outcomes and Regulation
of Glycemia in Diabetes or RECORD study was designed to
evaluate the cardiovascular safety of rosiglitazone, a medication used to treat
type 2 diabetes mellitus.
In addition to the RECORD study, a number of observational studies of the
cardiovascular safety of rosiglitazone have been published. FDA has been
reviewing these on an ongoing basis.
FDA is now reviewing the primary data from the completed RECORD study,
conducting follow-up audits, and reviewing additional studies. This work is
ongoing and no new conclusions or recommendations about the use of rosiglitazone
in the treatment of type 2 diabetes have been made at this time.
Once FDA completes its review of the data from the RECORD study, the agency
will present the totality of new and existing cardiovascular safety data on
rosiglitazone at a joint public meeting of the Endocrinologic and Metabolic
Drugs and Drug Safety and Risk Management Advisory Committees in July 2010. At
that meeting, the Advisory Committee will provide an updated assessment of the
risks and benefits of rosiglitazone in the treatment of type 2 diabetes.
When prescribing rosiglitazone, healthcare professionals should follow the
recommendations in the drug label. Patients should continue taking rosiglitazone
unless told by their healthcare professional to stop. Patients who are concerned
about the possible risks associated with using rosiglitazone should talk to
their healthcare professional.
FDA previously communicated to the public about the possible association
between rosiglitazone and increased cardiovascular risk in a
2007 safety alert. The agency also sought advice from external experts at
the
July 30th 2007 joint meeting of the FDA Endocrinologic and
Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. The
RECORD study data represent the only new information from a completed
randomized, controlled clinical trial of rosiglitazone received by FDA since the
2007 announcements.
The RECORD study was designed to evaluate the cardiovascular safety of
rosiglitazone, which is consistent with FDA's December 2008
Guidance for Industry recommending that manufacturers of new treatments for
diabetes carefully design their clinical trials to include an evaluation of
cardiovascular safety. The RECORD study will be evaluated in the context of this
recent Guidance.
* Rosiglitazone is sold as a single-ingredient product under the brand
name Avandia. It is also available in combination with other diabetes
medications, metformin under the brand name Avandamet or glimepiride under the
brand name Avandaryl.
FDA recommends that patients currently using rosiglitazone:
- Not stop taking their medication without talking with their healthcare
professional.
- Discuss any questions or concerns they have about rosiglitazone with their
healthcare professional.
- Read the Medication Guide that comes with each rosiglitazone
prescription to better understand the risks and benefits of their medication.
- Report any side effects with rosiglitazone to FDA's MedWatch program using
the information at the bottom of the page.
FDA recommends that healthcare professionals:
- Follow the recommendations in the drug label when prescribing
rosiglitazone. This includes a Boxed Warning stating that:
- Use of rosiglitazone in patients with established NYHA Class III or IV
heart failure is contraindicated. Further, rosiglitazone is not recommended
in patients with symptomatic heart failure.
- Rosiglitazone causes or exacerbates congestive heart failure in some
patients. Healthcare professionals should monitor for the signs and symptoms
of heart failure (including excessive, rapid weight gain, difficulty
breathing, and/or swelling) after starting treatment and after dose
increases of rosiglitazone. If heart failure signs and symptoms occur, the
heart failure should be managed appropriately and discontinuation or dose
reduction of rosiglitazone must be considered.
- Available data on rosiglitazone and risk of myocardial ischemia are
inconclusive. A meta-analysis of 42 clinical studies (mean duration 6
months; 14,237 total patients), most of which compared rosiglitazone to
placebo, found an association between rosiglitazone use and an increased
risk of myocardial ischemic events such as angina or heart attack. Three
other studies (mean duration 41 months; 14,067 total patients), comparing
rosiglitazone to other oral diabetes medications or placebo, have not
confirmed or excluded this risk. The recently completed RECORD study,
currently being reviewed by FDA, is one of these three studies.
- Discuss with patients the risks of rosiglitazone treatment, taking into
account the clinical utility of rosiglitazone, the risks/benefits of other
antidiabetic medications, and the risks associated with poorly controlled
blood glucose.
- Discuss with patients the importance of adhering to their diabetes
medication regimen.
- Report any adverse events associated with the use of rosiglitazone to
FDA's MedWatch program using the information at the bottom of the page.
Part of a post-approval commitment between the European Medicines Agency (EMA)
and the manufacturer, the RECORD study compared cardiovascular safety outcomes
in 2,220 patients with type 2 diabetes taking rosiglitazone plus other diabetes
medications (metformin or a sulfonylurea) to 2,227 patients taking metformin and
a sulfonylurea.
Patients in the study were followed on average 5.5 years and were monitored
for the occurrence of the primary endpoint (cardiovascular death and
cardiovascular hospitalizations). There were several secondary endpoints
including the composite endpoint for major cardiovascular events (cardiovascular
death, heart attack or stroke). All CV endpoints were determined by a team of
cardiologists who were unaware of which patients were receiving rosiglitazone.
The study reported no difference in the primary endpoint in the rosiglitazone
group [hazard ratio = 0.99 (95% Confidence Interval of 0.85 to 1.16)] compared
to combined use of metformin and a sulfonylurea. In addition, there was no
significant treatment difference in any of the secondary composite endpoints
except an increase in heart failure, which is a well-known side effect of drugs
in this class, including Actos (pioglitazone). The increase in risk of heart
failure is consistent with the warnings contained in the current drug label. The
RECORD study findings were published in the June 2009 issue of Lancet1.
FDA will present a summary of any new observational studies of rosiglitazone
safety at the upcoming Advisory Committee meeting in July 2010.
References:
1. Home PD, Pocock, SJ, Beck-Neilsen H, et al. Rosiglitazone evaluated for
cardiovascular outcomes in oral agent combination therapy for type 2 diabetes
(RECORD): a multicentre, randomized, open-label trial. Lancet 2009;
373: 2125–35.
Labeling and Regulatory History from Drugs@FDA