In preparation of the adoption of the Codex Alimentarius supplements are under daily attacks
fter tens of millions of doses of Hydroxycut were taken by consumers, one person died. This, along with reports of a few dozen liver-related side effects, caused the FDA to push for an industry-wide recall of virtually all Hydroxycut products. The thinking behind the warning? The risk of side effects is very low, but the FDA doesn’t believe consumers should be exposed to such risks.
Not from a dietary supplement, anyway. When it’s from a vaccine or a pharmaceutical, such risks are deemed “acceptable” by the FDA. Remember the outcry over the COX-2 inhibitor drug Vioxx and the testimony by Dr. David Graham of the FDA who calculated the drug killed over 60,000 Americans? That drug was voted “safe” by an FDA panel even after its own manufacturer voluntarily recalled it from the market!
When it comes to pharmaceuticals, you see, killing 60,000 Americans is no big deal. But when a dietary supplement is linked to a single death, that’s more than enough for the FDA to spring into action with its spin machine to destroy the credibility of the dietary supplement in question.
The same thing happened with ephedra (ma huang), a perfectly safe Traditional Chinese Medicine that’s been safely used for over 5,000 years in China. It’s an important ingredient in all sorts of Chinese Medicine formulas, including anti-viral formulas that cave save lives during a pandemic. But thanks to the FDA, ephedra is now illegal to sell or prescribe in the United States, and anyone prescribing it to patients can be arrested and threatened with being shut down and put out of business. (From an article by Mike Adams from NaturalNews).
he latest QuarterWatch report (May 7, 2009) by the Institute for Safe Medication Practices (ISMP) found the following disturbing trends during the third Quarter of 2008:
* During the third quarter of 2008 the FDA received 24,872 serious adverse drug event reports identifying 854 different drugs. For the third quarter of 2008 reported serious, disabling adverse drug events were 30.5% higher than the same quarter one year ago.
The cases described 2778 patient deaths, 1162 cases of disability and 20,932 cases of other kinds of serious injury. Reported patient deaths in the third quarter were 41% higher than the same quarter in the previous year.
*More than 1,000 patient deaths have been reported in connection with the recall of the heart drug digoxin, but a year later no testing has been performed to determine how many are directly linked to defective tablets.”
*More than 100 cases of serious injuries were reported in connection with a muscle relaxant (Lioresal Intrathecal) that is delivered to the spinal fluid through an implanted pump.”
Bear in mind that the adverse drug events reported to the FDA is miniscule–estimated at between 1% and 10% of the actual adverse events related to FDA-approved, marketed prescription drugs. That should, but has not, prompted the FDA to take timely action when a significant number of
serious adverse effects are reported about a particular drug.
1000 DIGOXIN DEATHS:
he ISMP report shows that even as more than 1000 patient deaths have now
been reported in connection with the recall of 800 million Digoxin tablets manufactured by the Actavis Group, one year after the announcement of the recall, no testing of returned tablets has been performed to establish how many of these deaths resulted from a manufacturing defect, and how many might have resulted from other safety problems.
The tablets were recalled because of the possibility that the strength of tablets was greater than labeled and might provide a potentially lethal overdose to patients taking the drug to aid failing hearts.
Furthermore, a new recall of digoxin tablets in March 2009 from another manufacturer-Caraco Pharmaceutical Laboratories-underlines weaknesses in the U.S. system for insuring quality control in the manufacture of generic drugs.
This problem has received little public or official notice in part because the FDA does not require that the size of the product recall be disclosed. And the size can vary from a few thousand tablets to nearly a billion.
As a consequence of FDA’s failure to warn about the scope of the recall, doctors don’t have a clue, and patients who had filled prescriptions prior to the recall are being killed by defective pills.
Varenicline (CHANTIX, CHAMPIX) CASE REPORTS LINKED TO SUICIDE AND VIOLENCE:
his drug, prescribed to help people stop smoking, continued to ACCOUNT FOR
MORE REPORTS OF SERIOUS PSYCHIATRIC SIDE EFFECTS than any other prescription drug.
Since Chantix approval, QuarterWatch identified 30 possible cases reporting
physical ASSAULT, 148 cases mentioning homicidal thoughts and 331 cases of behavior described as aggression. The FDA has failed to require prominent warnings about the assaultive behavior triggered by Chantix.
Conclusions:
“It is increasingly clear that the nation is experiencing serious problems in insuring that generic drugs are manufactured with adequate quality control. In the first quarter of 2008, there were large urgent recalls of most of the nation’s supply of one form of the drug heparin 2 and of millions of fentanyl patches from several drug manufacturers. In the second quarter, about 50% of the nation’s unexpired supply of digoxin
was recalled because of potential over strength tablets, and an additional digoxin recallwas announcedin March 2009.
In the third and fourth quarters of 2008, additional urgent recalls were announced for morphine sulfate, propafenone, and isosorbide-all drugs where over or under strength tablets could have significant health consequences.
In addition, two New Jersey plants of the Actavis Group were closed because of manufacturing problems, and all products manufactured there recalled. In December 2008 KV Pharmaceuticals’ plants were closed to resolve quality control problems.
This problem has received little public or official notice in part because the FDA does not require that the size of the product recall be disclosed. It can vary from a few thousand tablets to nearly a billion. For example, neither Caraco Pharmaceutical Laboratories nor the FDA would reveal how many digoxin tablets were involved in its March 31, 2009 recall notice.
The FDA’s current system for inspecting plants, dealing with violations and managing product recall notices requires systematic independent review.
See, full ISMP QuaterWatch report at:
http://www.ismp.org/QuarterWatch/2008Q1.pdf
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