The Soiled FDA Gives Us a Spurious Warning
- For Everyone,�
==> BEGIN SUMMARY ==>
In June 2011, the FDA issued a "Warning", concerning Diflucan/fluconazole. I would like to point out that the FDA cites only a "FEW case reports", (which is intentionally, dishonestly vague), but let's�use the normal number of ~5, to equal the deceptive FDA's "FEW". So it's claimed, BUT NOT PROVEN, that supersized, long-term dosing with Diflucan/fluconazole MIGHT HAVE caused birth defects in literally ONLY about five infants, (IN THE TWENTY YEARS SINCE 1990!!!).�
Surprisingly, (in my opinion), those ~5 cases are PROBABLY valid, but the FDA's timing with this ultra-belated "Warning" appears to be aimed at making doctors afraid to prescribe Diflucan/fluconazole in ANY form, and especially in the form of the miracle-cure of even BENIGN, TOPICALLY-APPLIED (DMSO + fluconazole). The usual administrations of this cure, (EVEN WHEN THE SOAK-METHOD IS USED), entail doses of Diflucan/fluconazole being absorbed that do not even remotely approach the massive dosing of Diflucan/fluconazole cited by this "FDA Warning". For more specific information about dosages used with (DMSO + fluconazole), SEE:
But doctors can now be manipulated when this "FDA Warning", (using such scaremongering-words as "teratogenic" and "congenital anomalies"), affects the cost and/or the coverage of medical-malpractice insurance, concerning ANY-AND-ALL prescribing of Diflucan/fluconazole. IN OTHER WORDS, I CONSIDER THIS "FDA WARNING" TO BE A CONSPIRATORIAL SCARE-TACTIC BY GREEDER$ AND BIG-PHARMA, TO PREVENT PEOPLE FROM BEING CURED BY (DMSO + fluconazole). In one sense, this is a good sign, because it means that the word about this cure is spreading, thus forcing the Greeder$ to cook up this obviously-spurious "FDA Warning", to try to prevent this cure's widespread use.�
There is one other unrelated, very good sign, AT:
In 2003 when I began this [rosacea-cure] group, the (jacoblab.com) source of reliable DMSO was only supplying DMSO that was mixed with either 50%-water, or with 30%-water. In my opinion, those 50% and 70% forms of DMSO are not usable for creating this (DMSO + fluconazole) cure. But (jacoblab.com) at some point began supplying both 100%-DMSO and 90%-DMSO, which is truly a godsend, since DMSO was in a "gray area" in 2003 whereby almost all pharmacists refused to supply you with 100%-DMSO unless you had a prescription for it. In fact, the weasel-type pharmacists are probably still refusing to supply you with 100%-DMSO.�Price info for 100%-DMSO is at:
BTW, I'm a bit of a perfectionist, so I like my 100%-DMSO to be in glass containers, (rather than plastic), and lo-and-behold, (jacoblab.com) even supplies it in glass if you like, for a couple of bucks extra.�
<== END OF SUMMARY <==
Thalidomide was introduced in ~1958, and was taken off the market in 1961. So it took the FDA just 3 years to act in that case of the truly horrendous "teratogenic anomalies" of thalidomide. Diflucan/fluconazole received FDA approval in 1990, so why in hell's bells would the FDA take TWENTY YEARS before giving us this June 2011 "Warning" of "teratogenic anomalies" of Diflucan/fluconazole???!!!??? Why indeed!�
Worldwide, there were an estimated 10,000 to 20,000 babies maimed by thalidomide, and surprisingly, in recent years thalidomide is being touted as a useful drug for new purposes, AS AT:
Concerning Diflucan/fluconazole-induced birth-defects, the FDA says there have been ONLY "A FEW published case reports" IN TWENTY YEARS -- and this was ONLY when massive, (400 to 800mg/day), long-term, (daily, for 84 days), doses were administered. Of course, the FDA never honestly says, "12 weeks" or "daily, for 84 days". The FDA only coyly uses the term, "400-800 mg/day", and states the duration as "during most or all of the first trimester". The FDA also conveniently "forgets" to inform you that when this dosing regimen is followed, a "loading dose" on the first day is given which is at least double the daily dose. So someone who is to receive 800mg/day will receive 1,600mg OR MORE on the first day. Since there is absolutely NO PROOF that Diflucan/fluconazole caused even those FEW birth defects, it is only the fact that studies on rats with Diflucan/fluconazole ARE CLAIMED to have produced similar birth defects in the rats, that this "FDA Warning" has any credibility at all.�
WHAT'S WRONG WITH THIS PICTURE?
This "FDA Warning" states, (quite vaguely), that, "Available human data do not suggest an increased risk of congenital anomalies following a single maternal dose of 150 mg (of Diflucan/fluconazole)". The dose(s) that are claimed to POSSIBLY be "teratogenic" BEGIN at cases wherein a MINIMUM of 400mg per day, (FOR TWELVE WEEKS!!!), are administered orally or intravenously.�
So a single (oral or I.V.) dose of 150mg is OK,�
but (400mg a day for 84 days = 33,600mg) is POSSIBLY not OK.�
ALL the dosages between (150mg-for-one-day) and (400mg-daily-for-84-days equals 33,600mg) ARE NOT COMMENTED ON BY OUR ILL-USTRIOUS FDA!!!�
SO, CONCERNING ONLY WOMEN OF CHILD-BEARING AGE WHO ARE SEXUALLY ACTIVE:
For example, what about a one-day-dose of any dosage between 150mg and 800mg? -- the FDA is silent.�
What about a daily-dose-for-84-days of any dosage less than 400mg? -- the FDA is silent.�
What about any TOPICALLY-APPLIED, 84-daily-doses of (DMSO + fluconazole) that contain LESS THAN the (400mg-daily-dose-for-84-days = 33,600mg) cited? -- the FDA is silent.�
For that matter, what about a one-day-dose of INGESTED (DMSO + fluconazole) that contains 150mg, (or less), of fluconazole? -- the FDA says that's OK.�
AND THIS "FDA Warning" DOES NOT APPLY TO ANYONE OTHER THAN THOSE SPECIFIC WOMEN, IN ANY CASE.�
According to this misleading "FDA Warning", ONLY about five infants have been born, (DURING THE LAST TWENTY YEARS!!!), with some degree, (PERHAPS MINOR), of "a pattern" of eight types of deformity. This "pattern" is CLAIMED WITHOUT ANY PROOF to be a "potential hazard", (whatever the hell that means), which MIGHT BE CAUSED BY massive, long-term, prescribed dosages of Diflucan/fluconazole. Although the FDA subtly admits that NO actual PROOF exists that Diflucan/fluconazole CAUSED any "teratogenic anomalies", the FDA nonetheless issued this INCREDIBLY-BELATED "Warning" on the basis of SUSPICIONS alone. BTW, if, (I repeat, IF, IF, IF), the studies with rats are true, I agree with the FDA suspicions, although I challenge the FDA's plausible-deniability stance that FDA intentions are honest in this matter. My firm, well-founded belief is that the soiled FDA is once more being used to prevent people from being cured, so that Greeder$ and Big-Pharma can continue to make a killing, (pun intended), by "treating" or "controlling", (and thus permanently prolonging), horrendous di$ease$ that could have been otherwise cured by (DMSO + fluconazole).�
FOLLOWING ARE THE SCARE-TACTIC BIRTH-DEFECTS LISTED BY THE FDA. As per this duplicitous "FDA Warning", the features seen in those ~5 infants include one or more of the following eight defects, (possibly to only a MINOR, or even NEGLIGIBLE degree of severity):�
brachycephaly, (flat-head syndrome):�
abnormal facies, (abnormal face):�
abnormal calvarial, (skull), development:�
femoral bowing, (bent femoral leg-bones):�
thin ribs and long bones:�
(no URL, since it's self-explanatory),�
arthrogryposis, (curved bone-joints):�
congenital heart disease:�
AS OF 09DEC11, THE FOLLOWING "FDA WARNING" IS FOUND AT:
Diflucan (fluconazole) Prescribing Information June 2011
Diflucan (fluconazole) tablets, I.V, and oral suspensionDetailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - June 2011�
Use in Pregnancy
There are no adequate and well-controlled studies of Diflucan in pregnant women. Available human data do not suggest an increased risk of congenital anomalies following a single maternal dose of 150 mg. A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in-utero to high dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus.
Pregnancy: Teratogenic Effects
Pregnancy Category C
Single 150 mg tablet use for Vaginal Candidiasis: There are no adequate and well-controlled studies of Diflucan in pregnant women. Available human data do not suggest an increased risk of congenital anomalies following a single maternaldose of 150 mg.
Pregnancy Category D
All other indications: A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in-utero to high dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus. (See WARNINGS, Use in Pregnancy)
Human Data: Several published epidemiologic studies do not suggest an increased risk of congenital anomalies associated with low dose exposure to fluconazole in pregnancy (most subjects received a single oral dose of 150 mg). A few published case reports describe a distinctive and rare pattern of birth defects among infants whose mothers received high-dose (400-800 mg/day) fluconazole during most or all of the first trimester of pregnancy. The features seen in these infants include: brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease. These effects are similar to those seen in animal studies.
Animal Data: Fluconazole was administered orally to pregnant rabbits during organogenesis in two studies at doses of 5, 10, and 20 mg/kg and at 5, 25, and 75 mg/kg, respectively. Maternal weight gain was impaired at all dose levels (approximately 0.25 to 4 times the 400 mg clinical dose based on BSA), and abortions occurred at 75 mg/kg (approximately 4 times the 400 mg clinical dose based on BSA); no adverse fetal effects were observed.
In several studies in which pregnant rats received fluconazole orally during organogenesis, maternal weight gain was impaired and placental weights were increased at 25 mg/kg. There were no fetal effects at 5 or 10 mg/kg; increases in fetal anatomical variants (supernumerary ribs, renal pelvis dilation) and delays in ossification were observed at 25 and 50 mg/kg and higher doses. At doses ranging from 80 to 320 mg/kg (approximately 2 to 8 times the 400 mg clinical dose based on BSA), embryolethality in rats was increased and fetal abnormalities included wavy ribs, cleft palate, and abnormal cranio-facial ossification. These effects are consistent with the inhibition of estrogen synthesis in rats and may be a result of known effects of lowered estrogen on pregnancy, organogenesis, and parturition.
Caution should be exercised when Diflucan is administered to a nursing woman.
Page Last Updated: 08/04/2011
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