I just received a Warning Letter from SYDNEY WOLFE, M.D., EDITOR OF “BEST PILLS-WORST PILLS”
HERE IT IS…
“This is an urgent alert for patients with gastroesophageal (acid) reflux disease and others who are using any of the following listed drugs, with total U.S. prescriptions of 120 million in 2009.
Public Citizen, the publisher of WorstPills.org, told the U.S. Food and Drug Administration (FDA) today that many drugs widely prescribed to reduce stomach acid can cause dependence, are dangerous and should carry the strongest possible warning label, a black box warning.
These medications, known as proton pump inhibitors or PPIs, include:
- Esomeprazole (brand name: NEXIUM)
- Dexlansoprazole (DEXILANT)
- Omeprazole (PRILOSEC and PRILOSEC OTC)
- Omeprazole and sodium bicarbonate (ZEGERID and ZEGERID OTC)
- Lansoprazole (PREVACID and PREVACID 24-HR)
- Pantoprazole (PROTONIX)
- Rabeprazole (ACIPHEX)
- Naproxen and esomeprazole (VIMOVO)
The FDA has approved these drugs to treat gastroesophageal reflux disease, gastric ulcers, erosive esophagitis and stomach bleeding associated with using anti-inflammatories, but there is ample evidence that these medications may do more harm than good for millions of other patients.
After reading the attached 30 page explanation
of the dangerous effects of these drugs, I feel obligated
to inform all my patients and all my readers to stop using
HERE ARE THE HIGHLIGHTS:
August 23, 2011
Margaret A. Hamburg, M.D.
Commissioner Food and Drug Administration
Department of Health and Human Services WO 2200
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Dear Dr. Hamburg:
Public Citizen, a research-based advocacy group representing more than 225,000 members and supporters nationwide, hereby petitions the Food and Drug Administration (FDA), pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Â§ 352, and 21 C.F.R. Â§Â§ 10.30 and 201.56, to immediately add black box warnings and other safety information concerning several
severe risks to the product labels of all proton pump inhibitors (PPIs) presently on the market in the United States (U.S.) (Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, Vimovo, Prilosec OTC, Zegerid OTC, Prevacid 24-Hr, and all generic counterparts).
In addition, the serious nature of so many of these adverse reactions also mandates the requirement for FDA-approved patient Medication Guides, none of which exist now, for all of these drugs.
For the past 20 years, PPIs have become increasingly popular, partly because of their ability to relieve acid-related symptoms, and are now one of the most widely used classes of drugs in the U.S., with 119 million prescriptions dispensed in 2009.
1. Some of the approved uses for prescription PPIs are treatment of gastroesophageal reflux disease (GERD), gastric ulcers and erosive esophagitis, and upper-gastrointestinal (GI) bleeding prophylaxis with nonsteroidal anti-inflammatory drug (NSAID) use.
However, PPIs are often prescribed outside of their approved uses, for purposes such as stress ulcer prophylaxis in noncritical hospitalized patients
2 and long-term treatment of conditions such as GERD past the approved time frame.
3 It has been estimated that up to two-thirds of all people on PPIs do not have a verified indication for the drug.4 In addition, even in many people with presumed GERD on PPI therapy, less intense acid-suppressive therapies are effective in relieving symptoms,5 and in other cases, the medical problem does not even involve acid reflux.6
Compounding the problem of massive inappropriate use, recent evidence has documented several serious new safety problems with long-term PPI use.
For some of these risks, current FDA-approved PPI labels do not mention the adverse effect at all,
including the potential for developing dependence on the drugs, which results in rebound hypersecretion of stomach acid 2
and recurrence of symptoms after stopping
We petition the FDA to require the inclusion of black box warnings identifying the following risks for all prescription PPIs (and equivalent, prominent warnings for over-the-counter [OTC] PPIs):
- Rebound acid hypersecretion risk: This is a form of dependence on PPIs that can be seen after as little as four weeks of use. Patients and providers need to be made aware of the possibility of dependence on PPIs and alerted not to take or prescribe PPIs beyond indicated uses and time frames. (Currently, this serious adverse effect is entirely missing from all PPI labels.)
- Fracture risk: Long-term and multiple daily-dose PPI therapy has been associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Due to its potential severity, this adverse effect also needs to be placed in a black box warning on all prescription PPIs and in an equivalent, prominent warning on OTC PPIs, in addition to its current place in the â€•Highlightsâ€– section of the prescription label.
- Infection risk: An increased likelihood of serious infections, such as C. difficile-caused diarrhea and community-acquired pneumonia has been seen with both short- and long-term PPI use. Pneumonia risk is currently entirely missing from all PPI labels, while information on C. difficile infections – although attributed to all PPIs in the label – is only present on three (Nexium, Prilosec, and Vimovo). Given the potentially fatal nature of these two conditions, particularly in elderly and other vulnerable populations, information about both conditions needs to be placed in a black box warning.
- Magnesium deficiency risk: Information on the risk of severe magnesium deficiency with long-term PPI use needs to be placed as a black box warning due to its potentially fatal course. This adverse effect is particularly concerning, given the possibility of concomitant use with many medications that prolong the QTc interval on an electrocardiogram, which in the presence of low magnesium would increase the likelihood of life-threatening heart rhythm disruptions, or arrhythmias. (The FDA has recently placed this information in the â€•Highlightsâ€– section of all prescription – but not OTC – PPI labels but has decided not to insert a black box warning.)
In addition to the black box warnings, we petition the FDA to require the following label changes for all PPIs:
- Drug-drug interactions: Taking PPIs may reduce the effectiveness of the heart-protective drug clopidogrel, leading to an increased rate of serious cardiovascular adverse events,
Appropriate risk information on a potential interaction with at least two other medications used to treat serious conditions – methotrexate and mycophenolate mofetil – needs to be listed in the label.
- Vitamin B12 deficiency:
The available evidence on the potential for vitamin B12 deficiency with long-term PPI use needs to be placed in the appropriate section of the label. Although the label states that this can occur with â€•any acid-suppressing medication,â€– the warning has only been placed on the label for one PPI (Dexilant).
- Acute interstitial nephritis:
Information regarding the potential for drug-induced acute interstitial nephritis, seen in at least 60 case reports, should be included in the appropriate section. There is currently no detailed risk information on any PPI for this adverse effect.
- GERD-treatment length consistency: All PPIs approved for the treatment of GERD should have specific recommendations for length of treatment in the â€•Indicationsâ€– section of the label.
Finally, we urge the FDA to:
- Require the distribution of FDA-approved Medication Guides for patients – containing these adverse effect warnings and describing alternatives to PPI use for all patients – to be dispensed when prescriptions are filled.
- Ask the sponsors of all PPI medications to send a â€•Dear Doctorâ€– letter alerting physicians to these adverse effects and to include information on appropriate prescribing of PPIs in inpatient and outpatient settings.
It is critical that these potentially dangerous adverse effects be made known to the public since they pose a serious threat to the general well-being of PPI users. The added risk information, and provider and patient awareness of appropriate PPI use, should help to limit the massive amount of needless overprescribing.
DR PINNA SAYS…
There is a 30 page explanation of the patho-physiology
of these drugs and what bad effects they produce.
1. THEY PRODUCE DEPENDENCE AND INCREASE
THE SECRETION OF ACID.
2. THEY CAUSE INCREASED FRACTURES.
3. THEY DECREASE MAGNESIUM LEVELS LEADING
TO NEUROLOGICAL AND HEART DISORDERS.
4. THEY INCREASE THE RISK FOR DEADLY INFECTIONS.
5. FOR PATIENTS TAKING THE BLOOD THINNER
“CLOPIDOGREL” THE DRUG BECOMES INACTIVE AND THEY
RISK A HEART ATTACK!
6. THEY REDUCE B12 LEVELS.
7. THEY CAN CAUSE KIDNEY FAILURE!
FOR ALL THESE REASONS, I RECOMMEND
THAT YOU STOP RIGHT NOW OR SEE YOUR
HEALTH CARE PROVIDER.
I, PERSONALLY, WAS TAKING “OMEPRAZOLE”
AND I HAVE STOPPED INSTANTLY!
THE SCIENTISTS WITH THE COMPANIES THAT
PRODUCE THESE PILLS KNOW THESE HORRIBLE DANGERS, BUT, BECAUSE OF THE
INCREDIBLE PROFIT PRODUCE BY THEIR SALE THEY, THE COMPANIES NOT ONLY CONTINUE TO
MARKET THESE DANGEROUS DRUGS, BUT ARE TRYING TO MAKE MORE OF THEM
AVAILABLE TO THE WORLD PUBLIC AS “OVER THE COUNTER” DRUGS, SOLD
WITHOUT A PRESCRIPTION!
THESE MEN, BOTH SCIENTISTS AND COMPANY DIRECTORS, NEED TO BE PUNISHED
SEVERELY WITH MINIMUM JAIL SENTENCES!
BUT, IN THE U.S.A. AND EUROPE, THAT WILL NEVER HAPPEN.
THE POWER GROUPS RUN THE WEST.
YOUR ONLY HOPE IS TO PROTECT YOURSELF BY NOT BUYING THESE POISONS!