Safety alert issued by FDA regarding Avandia and Actos

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Safety alert issued by FDA regarding Avandia and Actos

Postby dlcnurse » Tue May 22, 2007 9:50 pm

Recently, two studies done on the drug Rosiglitazone, also called Avandia, a drug used to treat diabetes type II, have presented disturbing data about increased risk for adverse cardiovascular events in persons taking Avandia.
The FDA has issued a safety alert advising persons taking Avandia who have underlying cardiovascular disease to talk to their doctors.

Those interested in reading about the studies can find the results and conclusions of those studies in the New England Journal of Medicine.

http://content.nejm.org/cgi/content/full/NEJMoa072761

and

http://content.nejm.org/cgi/content/full/NEJMe078099&
Last edited by dlcnurse on Thu Aug 18, 2011 3:19 am, edited 1 time in total.
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Actos linked to same risks as Avandia

Postby dlcnurse » Wed Jul 18, 2007 11:11 pm

Not in the forefront of the news and the articles and risks in regards to Avandia But because Actos is of the same type of diabetes medication as Avandia, it also has been linked to the risk of increased heart disease.

Actos was never really studied in its effects until the studies regarding Avandia were published. What most people aren't aware of is that Actos has always had it on its label in regards to "heart failure".

One of the biggest side effects of Actos is the potential for liver damage. So persons taking Actos should have their liver enzymes checked regularly.

For anyone wishing to check to see if their medication has any safety alerts, you can check them at http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm or if you do not see the medication you are looking for, type the name of it in the search box located in the upper left corner.
Last edited by dlcnurse on Thu Aug 18, 2011 3:23 am, edited 1 time in total.
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Drug company spin doctors are not real doctors

Postby NoPocketCash » Sat Aug 04, 2007 12:20 am

If an older proven med is better... why allow a dangerous drug to remain as a top selling medication for diabetics?

The Annals of Internal Medicine (established by the American College of Physicians in 1927) just published a federally funded (Health and Human Services) report on Monday (July 16, 2007) comparing all diabetes medications.

The results do not surprise me.

The newest medications, Avandia and Actos, for which in May, 2007 the FDA requested their most extreme "black box" warning were shown to be less effective than older, cheaper, safer drugs.

216 controlled trials and cohort studies and 2 systematic reviews that addressed benefits and harms of oral diabetes drug classes available in the United States were identified and analyzed.

Besides being just as effective as newer drugs with blood sugar control, Metformin (Glucophage) had another positive effect.

Metformin decreased LDL cholesterol levels by about 0.26 mmol/L (10 mg/dL), whereas other oral agents had no obvious effects on LDL cholesterol levels. Most agents other than metformin increased body weight by 1 to 5 kg. Sulfonylureas and repaglinide were associated with greater risk for hypoglycemia, thiazolidinediones with greater risk for heart failure, and metformin with greater risk for gastrointestinal problems compared with other oral agents. Lactic acidosis was no more common in metformin recipients without comorbid conditions than in recipients of other oral diabetes agents.


Conclusions: Compared with newer, more expensive agents (thiazolidinediones, {alpha}-glucosidase inhibitors, and meglitinides), older agents (second-generation sulfonylureas and metformin) have similar or superior effects on glycemic control, lipids, and other intermediate end points.

http://www.annals.org/cgi/content/full/ ... type=HWCIT

Basically this extremely extensive government sponsored study published by a very respected journal says that Metformin (Glucophage) is better and safer.

This is an important study that diabetics should review with their doctor (especially if they take medication for cardiovascular problems which the FDA "black box" warnings of Avandia and Actos is all about).
Last edited by dlcnurse on Thu Aug 18, 2011 3:18 am, edited 2 times in total.
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FDA uses strongest Black Box Warning on Thiazolidinediones

Postby dlcnurse » Wed Aug 15, 2007 10:44 pm

The FDA issued a Black Box warning for All of these drugs: Avandia, Actos, Avandaryl, and Avandamet. You can read it here:

http://www.fda.gov/bbs/topics/news/2007/new01683.html
Last edited by dlcnurse on Thu Aug 18, 2011 3:16 am, edited 1 time in total.
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A New Safety Warning for Actos-Actosplusmet, Duetact

Postby dlcnurse » Sat Jun 21, 2008 2:53 am

A new study done is showing a increase in fractures among women recieving long-term therapy with pioglitazone and its combination medications (Actos Plus Met, and Duetact).

The majority of these fractures have involved the forearm, hand, wrist, foot, ankle, or leg. Takeda Pharmaceuticals has issued a warning letter to physicians to consider this fact when prescribing this medication long term.
If you are someone who has taken this medication long term, you should bring it up with your own doctor and take steps to ensure that this doesn't happen to you.
Last edited by dlcnurse on Thu Aug 18, 2011 3:15 am, edited 1 time in total.
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