The MedWatch June 2012 Safety Labeling Changes posting includes 35 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” available via the link below provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm309380.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and/or WARNINGS sections:

  • Avodart (dutasteride)
  • Bepreve (bepotastine besilate) 1.5% ophthalmic
  • CellCept (mycophenolate mofetil)
  • CellCept (mycophenolate mofetil hydrochloride)
  • Estraderm (estradiol) transdermal
  • Helidac Therapy (bismuth subsalicylate, metronidazole and tetracycline hydrochloride)
  • Incivek (telaprevir)
  • Jalyn (dutasteride and tamsulosin HCL)
  • Methergine (methylergonovine maleate)
  • Myfortic (mycophenolic acid)
  • Noxafil (posaconazole)
  • Prezista (darunavir)
  • Prinivil (lisinopril) tablets and
  • Prinzide(lisinopril/hydrochlorothiazide)
  • Privigen Immune Globulin Intravenous (Human) 10%
  • Stelara (ustekinumab)
  • Strattera (atomoxetine hydrochloride)
  • Sustiva (efavirenz)
  • Vesicare (solifenacin succinate)
  • Zithromax (azithromycin)

Remember, only prescribe or consume the above if they are genuinely essential. All medication is dangerous and all do cause some harm. Always! What is your honest harm-benefit analysis? Is it honestly and soundly informed or are you someone’s fool? Think about it.

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Editor Emeritus on July 1st, 2012

The July 2012 edition of The Health Gazette Ezine will be published as scheduled on July 1st.

This month’s edition provides a brief consideration of the controversial concept of Type-C personality, the so-called cancer personality. Could it be that one may indeed be just too nice for one’s own good?

We repeat our announcement that subscription to the Ezine Edition is now closed. Most subscription forms have been removed and any remaining ones will be found and removed soon.

Current subscribers will find the ezine in their mailbox on publication. It will be posted in the subscribers’ archive around the same time.

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The MedWatch May 2012 Safety Labeling Changes posting includes 41 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” available via the link below provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm306941.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

  • Lotensin (benazepril)
  • Divigel (estradiol gel)
  • Focalin (dexmethylphenidate hydrochloride)
  • Focalin XR (dexmethylphenidate hydrochloride)
  • Gilenya (Fingolimod)
  • 2% Chlorhexidine Gluconate (CHG)
  • Aciphex (rabeprazole sodium)
  • Actoplus Met (pioglitazone hydrochloride plus metformin hydrochloride)
  • Aredia (pamidronate disodium)
  • Avagard Surgical and Healthcare Personnel Hand Antiseptic (chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w)
  • Biaxin Filmtabs (clarithromycin tablets, USP)
  • Biaxin Granules (clarithromycin for oral suspension, USP)
  • Biaxin XL Filmtabs (clarithromycin extended release tablets)
  • Catapres (clonidine hydrochloride)
  • Catapres-TTS (clonidine) Transdermal Therapeutic System
  • Chlorascrub Swabsticks
  • Dexilant (dexlansoprazole)
  • Folotyn (pralatrexate injection)
  • Hibiclens (4% w/v chlorhexidine gluconate)
  • Hibistat (0.5% chlorhexidine gluconate solution and 70% isopropyl alcohol w/w)
  • Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets
  • Prevacid (lansoprazole)
  • Protonix (pantoprazole sodium) For Injection
  • Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension
  • Protonix (pantoprazole sodium) Delayed-Release Tablets
  • Scrub-Stat 2% and Scrub-Stat 4% (chlorhexidine gluconate 2% and 4%)
  • Ultravist (brand of iopromide)
  • Ultravist (brand of iopromide) Injection Pharmacy Bulk Pack
  • Zarontin (ethosuximide)

Remember, whether prescriber or consumer, you are a participant in a post-marketing trial when it comes to FDA Approved drugs and other products. NEVER use these products unless you really must. You CANNOT rely upon the ethics of professionals, company directors and employees, government officials and bureaucrats where incomes, profits and careers are at stake. YOUR health and wellbeing is your RESPONSIBILITY. Start learning how to promote your own health and/or how to obtain useful further opinions.

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Editor Emeritus on June 12th, 2012

June 12, 2012 marks the second day of International Men’s Health Week, sponsored by Men’s Health Network. The purpose of Men’s Health Week is to increase awareness about preventable health problems among men and boys and to encourage early detection and treatment.

Vitamin D and men’s health

Vitamin D plays an important role in men’s health! Did you know that vitamin D boosts testosterone levels? Did you know that vitamin D helps in prostate cancer and heart disease?

Prostate cancer is the most common cause of death from cancer among men over the age of 75. And, prostate cancer has been one of the most researched topics in vitamin D! Researchers were initially interested in the two when they observed that sun exposure decreases the risk of prostate cancer.

But since then, research has come along much further. Just this past year, a team of doctors discovered that 4,000 IU/day helped men with low-risk prostate cancer, lowering their Gleason score and number of “positive cores.

Men are also at a higher risk for heart disease. Men ages 35-64 are about four times more likely than women to die from heart disease. Observational studies suggest low vitamin D levels are associated with an increased risk of developing heart disease. A recent study published last month suggests higher vitamin D levels can lower the risk of dying from heart disease.

Finally, vitamin D boosts testosterone levels! In a randomized controlled trial, 3,300 IU/day of vitamin D increased testosterone levels by 30-40%. In men, testosterone is important for reproduction tissues like the testis and prostate, and it’s also important for key masculine features like increased muscle, bone mass, and the growth of body hair.”

How can you help?

To help increase awareness about preventable men’s health problems, you can organize an event, or simply talk to the men in your life about the facts and importance of getting check up’s. Be sure to discuss vitamin D! To download print materials and to learn more about men’s health week, visit Men’s Health Network: http://www.menshealthnetwork.org/

Source: Vitamin D Council Newsletter

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Editor Emeritus on June 1st, 2012

The June 2012 edition of The Health Gazette Ezine will be published as scheduled on June 1st.

This month’s edition provides a brief critical review of the medical scientific evidence supporting the claim that salt causes hypertension and widespread cardiovascular disease. It seems salt is fine and current medical advice to dramatically reduce or avoid salt is completely unjustified in almost all cases. Only a very small percentage of the population actually has an issue with salt.

We also wish to announce that subscription to the Ezine Edition is now closed. Most subscription forms have been removed and any remaining ones will be found and removed soon.

Current subscribers will find the ezine in their mailbox on publication. It will be posted in the subscribers’ archive around the same time.

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