Category: FDA

Aftermarket Studies Since 1957 Reveal that Propoxyphene is Can be Deleterious to Heart Function

~ Pharmer

Since 1957 the FDA has been allowing people to turn themselves yellow, (from liver toxicity)  in order to take enough Darvocet (propoxyphene and acetaminophen) to achieve pain relief.

Propoxyphene is the mild narcotic analgesic, 100mg of which is USUALLY  accompanied by 650mg of acetaminophen.  People wanting a little buzz could quickly ruin their liver, by means of acetaminophen overdose.  Frequently physicians were writing orders for Darvocet which could bring a patient to toxic acetaminophen levels, if used at the maximum allowable frequency.

FDA has decided that propoxyphene has sufficient deleterious  effect on the electrical activity and rhythm  of the heart, at therapeutic doses, that it ought to be taken off the market, and that 90 day supply you got from the mail order should be tossed out immediately.  Darvon and Darvocet manufacturer,  Xanodyne Pharmaceuticals of Newport, KY, has voluntarily withdrawn the drug from the market.

Specifically, prolonged PR and QT intervals, and widening of the QRS complex are blamed on propoxyphene at therapeutic doses.  A great number  of other drugs have similar effects, but the issue is whether the mild pain relief from  propoxyphene is worth the trouble.   After 53 years or so of aftermarket testing,  Dr. Janet Woodcock and the FDA say no.

That’s one  SLOW government bureaucracy, giving you one more reminder of the speed of Obamacare delivery.

http://www.fda.gov/Drugs/DrugSafety/ucm234338.htm

FDA remembers the old days, when it used to do its job.

~ Pharmer

Dr. Gerard M. Nadal appropriately nails the non-functional FDA to the wall, noting it’s new Kelsey award, honoring a former FDA reviewer from back when the agency was worth something.

Frances O. Kelsey, now 96 years old, is the namesake and first recipient of the Kelsey award from the FDA for doing what she was supposed to do. She stopped distribution of Thalidomide, for morning sickness, in the USA, likely sparing countless kids the associated birth defect called phocomelia, severely shortened limbs.

Nadal notes that the present FDA commissioner, Margaret Hamburg has ushered in the new drug Ella, ulipristal acetate, without appropriate testing, and with next to zero study of its effects on the babies who survive its embryocidal effects. In addition, the FDA has misbranded this drug as a contraceptive, thus disrespecting female patients’ right of informed consent to treatment.

Is it because Meridia is associated with deaths of Men?

~ Pharmer

FDA mulls pulling diet pill linked to heart attack.

A study found that 11 percent of the diet pill,  Meridia,  users experienced heart attack or stroke compared with 10 percent of those using placebo.

So the FDA wants to yank it.

However…….. the pill, which is well known for association with these events, as well as with  diabetes and certain cancers……. only affects women, with the group showing the most marked  negative effects  being those under 30.  (More links below).   These things are  not of curiosity to the FDA, which has put Plan B over the counter.

The FDA is pulling billions of eggs off the shelves due to a low incidence of salmonella in undercooked products.  Again…… a small percentage of males, who eat undercooked eggs, are suffering severe diarrhea, and drastic action is needed.

We’re STILL waiting for the FDA to take its role in exacerbating drug shortage problems more seriously and do something about it.   Do not hold your breath.   The lawyer feeding frenzy from  the errors, caused by necessary  drug substitutions and in house compounding, would make any government bureaucrat  giddy.

Progestins and arterial disease

Metabolic effects of oral contraceptives

Pharmacodynamic effects of oral contraceptive steroids on biochemical markers for arterial thrombosis