Code Red: FDA Approves Dangerous Blood Thinner
Again I have to wonder who the FDA is protecting...because it certainly isn't us.
Late Friday, the FDA announced that they were approving a new drug -- Effient, Eli Lilly's new blood thinner -- even though this drug comes with extremely dangerous and potentially deadly risks.
The drug is so dangerous that the FDA has technically approved it only for specific patients, people getting angioplasty. Here's the catch: In the study the approval was based on, patients taking Effient faced "a greater risk of significant, sometimes fatal bleeding" when compared to Plavix, a top-selling blood thinner. On top of that, patients who'd already had strokes faced a higher risk of suffering another stroke if they took Effient.
Are the risks worth it? Nope. Not at all. Because while Effient slightly reduced the risk of non-fatal heart attacks, the number of deaths was "similar" with both drugs. So Effient doesn't really work better, and it increases your risk of repeat stroke and fatal bleeding.
The only possible explanations for this approval: Insanity. Stupidity. Money. (I'm betting on the third.)
Bottom line: If you're heading for angioplasty, make sure the doctor doesn't use Effient.
--Michele
With all the problems connected to non-steroidal anti-inflammatory (NSAIDs) drugs, I'm not surprised to learn how much harm they can do in the womb early in a pregnancy.
Researchers tracked the health of more than 36,000 pregnant Quebec women to identify women who had taken prescription NSAIDs during their first trimester and had babies suffering from congenital problems during their first year.
Of the more than 1,000 women who took NSAIDs early in their pregnancies, almost 9 percent had children with problems versus 7 percent among the remainder of the study group. Even worse, the number of children with multiple congenital problems was higher among mothers who took NSAIDs (16 percent) versus those who didn't (14 percent).
A reminder: If you're searching for safer alternatives to treat your pain, stay away from non-prescription NSAIDs, and look toward more natural treatments.
Birth Defects Research Part B: Developmental and Reproductive Toxicology August 23, 2006
A few months ago, it was the risk of hallucinations being added to the warning labels of attention deficit hyperactivity disorder (ADHD) drugs. Earlier this week, the FDA asked GlaxoSmithKline to include a new warning on its ADHD stimulant Dexedrine for heart problems.
In addition to alerting users about psychological side effects (delusions and hallucinations) of Dexedrine, the warning cites incidents of sudden death in kids and heart problems among teenagers with structural cardiac abnormalities. Unfortunately, as before, it's not a black box advisory.
Considering all the other advisories for side effects since the ones issued in the spring for hallucinations -- suppressing a child's growth and elevated risks of psychosis, aggression and bipolar disorder -- some health officials are concerned people will avoid being treated for ADHD altogether. And could you blame them?
A safer, better option among many for treating ADHD without the side effects of a potentially toxic drug: Taking a high quality fish or krill oil daily.
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