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Saturday, April 26, 2014

4/26/14 Health News: Myths About Food Safety That Can Cost Your Life ♦ Who's Protecting Whom From Deadly Toxin? ♦ Sniffing Out Infection: Smell Test Speedier Than Urinalysis

Shocking Myths About Food Safety That Can Cost Your Life
There are 48 million new cases of foodborne illnesses every year in the United States. What's going on? Why are there so many cases of food poisoning each year? One cause is that people believe 'myths' about food poisoning that in reality hold no value Continue Reading

Who's Protecting Whom From Deadly Toxin?
Questions are swirling around a science journal's decision last year to publish a description of a newly discovered botulinum toxin while omitting key genetic details that researchers would normally disclose. The unusual case highlights important unresolved issues in how to balance scientific openness with the worry that biological information could potentially be misused. Continue Reading

Sniffing Out Infection: Smell Test Speedier Than Urinalysis
An "electronic nose" can sniff the difference between healthy urine specimens and those infected with Escherichia coli, according to a pilot study. "The electronic nose can identify not just the organism but the particular strain of organism. It has a specificity of almost 100%, which is very encouraging," said Emmanuel Johnson, MD, from the Royal Liverpool and Broadgreen University Hospital NHS Trust in the United Kingdom.

"We started with E coli because 80% of urinary tract infections in the community and 50% in hospitals are from E coli, but the potential is limitless," Dr. Johnson told Medscape Medical News. The results of the pilot study were presented here at the European Association of Urology (EAU) 29th Annual Congress. Continue Reading

Beware of False or Misleading Claims for Treating Autism

April is National Autism Awareness Month, a fitting time to think about the growing need for concern and awareness about autism.
One thing that is important to know up front: There is no cure for autism. So, products or treatments claiming to “cure” autism do not work as claimed. The same is true of many products claiming to “treat” autism. Some may carry significant health risks.
According to the Centers for Disease Control (CDC), about 1in 68 children has been identified with an autism spectrum disorder (ASD). ASDs are reported to occur in all racial, ethnic and socioeconomic groups, and are almost five times more common among boys (1 in 54) than among girls (1 in 252).
The National Institutes of Health (NIH) describe autistic children as having difficulties with social interaction, displaying problems with verbal and nonverbal communication, exhibiting repetitive behaviors and having narrow, obsessive interests. These behaviors can range in impact from mild to disabling.
“Autism varies widely in severity and symptoms,” says Amy Taylor, M.D., M.H.S., a pediatrician at FDA. “Existing autism therapies and interventions are designed to remedy specific symptoms and can bring about improvement,” she adds.
In addition, FDA has approved medications that can help some people manage related symptoms of ASD. For example, the FDA has approved the use of antipsychotics such as risperidone and aripripazole to treat children 5 or 6 years of age and older who have severe tantrums or aggression and self-injurious behavior. Before using any behavioral intervention or drug therapy (prescription or over-the-counter), check with your health care professional.
The Association for Science in Autism Treatment (ASAT), a not-for-profit organization of parents and professionals committed to improving the education, treatment, and care of people with autism, says that since autism was first identified, there has been a long history of failed treatments and fads.
According to Gary Coody, R.Ph., FDA’s national health fraud coordinator, the agency has warned a number of companies that they are facing possible legal action if they continue to make false or misleading claims about products and therapies claiming to treat or cure autism. Some of these so-called therapies carry significant health risks and include:
  • “Chelation Therapies.” These products claim to cleanse the body of toxic chemicals and heavy metals by binding to them and “removing” them from circulation. They come in a number of forms, including sprays, suppositories, capsules, liquid drops and clay baths. FDA-approved chelating agents are approved for specific uses, such as the treatment of lead poisoning and iron overload, and are available by prescription only. FDA-approved prescription chelation therapy products should only be used under medical supervision. Chelating important minerals needed by the body can lead to serious and life-threatening outcomes.
  • Hyperbaric Oxygen Therapy. This involves breathing oxygen in a pressurized chamber and has been cleared by FDA for certain medical uses, such as treating decompression sickness suffered by divers. It has not been cleared for autism, among other conditions.
  • Miracle Mineral Solution. Also known as Miracle Mineral Supplement and MMS, this product becomes a potent chemical that‘s used as bleach when mixed according to package directions. FDA has received reports of consumers who say they experienced nausea, severe vomiting and life-threatening low blood pressure after drinking the MMS and citrus juice mixture.
  • Detoxifying Clay Baths. Added to bath water, these products claim to draw out chemical toxins, pollutants and heavy metals from the body, falsely offering “dramatic improvement” for autism symptoms.
  • CocoKefir probiotics products. Product claims include being a “major key” to recovery from autism, but they are not proven safe and effective for this advertised use.
Coody offers some quick tips to help you identify false or misleading claims.
  • Be suspicious of products that claim to treat a wide range of diseases.
  • Personal testimonials are no substitute for scientific evidence.
  • Few diseases or conditions can be treated quickly, so be suspicious of any therapy claimed as a “quick fix.”
  • So-called “miracle cures,” which claim scientific breakthroughs and secret ingredients, may be a hoax.
The bottom line is this—if it’s an unproven or little known treatment, talk to your healthcare professional before buying or using these products.

4/26/14 Health News: Texas quarantine expanded for citrus disease ♦ Bird flu found on California quail farm ♦ BEARDED DRAGONS LINKED TO SALMONELLA OUTBREAK ♦ 1 in 20 Adult Outpatients Misdiagnosed

Texas quarantine expanded for citrus disease
The vast majority of Texas’ commercial citrus groves now reside in expanded quarantine areas aimed at slowing the spread of a disease decimating citrus around the world.The state Department of Agriculture expanded the citrus greening quarantine areas in South Texas on Monday to cover Hidalgo and Cameron counties. Only a small amount of commercial citrus grown in Willacy County remains outside the current quarantine. Continue Reading


Bird flu found on California quail farm; Russia bans import of state's poultry
Low-pathogenic avian influenza, a disease known as bird flu, has been detected on a California quail farm earlier this month, and Russia has announced a ban on California poultry imports due to the sickness outbreak in the state.Continue Reading


CDC: BEARDED DRAGONS LINKED TO SALMONELLA OUTBREAK
The U.S. Centers for Disease Control and Prevention (CDC) earlier this week announced the likely source of a Salmonella Cotham outbreak was bearded dragons children like for pets. The illnesses involved 132 people in 31 states, and most were children aged five and younger. The Wisconsin Department of Health Services first reported the outbreak last... Continue Reading


1 in 20 Adult Outpatients Misdiagnosed, Study Reports

At least 1 in 20 adult outpatients receives an incorrect diagnosis from their doctor, according to a new study. Sometimes the consequences are minor -- calling something an “allergy” when it’s really a cold, for instance. But in more than 6 million patients a year in the United States, such misdiagnosis could have major consequences, such as a dangerous delay in cancer treatment.Continue Reading
health 

Friday, April 25, 2014

Publix recalls Baby Bella Sliced Mushrooms.

Publix recalls Baby Bella Sliced Mushrooms.
Out of an abundance of caution, Publix Super Markets is issuing a voluntary recall for Publix Baby Bella Sliced Mushrooms that may contain pieces of glass. The Publix Baby Bella Sliced Mushrooms were distributed to all Publix retail locations in Florida, Georgia, South Carolina, Alabama, Tennessee and North Carolina. The product is sold in the produce department in an 8oz package:
  • UPC 4141502286
  • Lot Code: PHG 096
Publix was made aware of this product hazard after receiving one customer complaint. No injuries have been reported.
"As part of our commitment to food safety, potentially impacted product has been removed from all store shelves," said Maria Brous, Publix media and community relations director. "To date, there have been no reported cases of injury. Consumers who have purchased the product in question may return the product to their local store for a full refund. Publix customers with additional questions may call our Customer Care Department at 1-800-242-1227 or by visiting our website at www.publix.com.

4/25/14 Mad Cow Disease in Brazil ♦ EPA ASKED TO HALT PESTICIDE USE ON APPLES ♦ Boston Banning Deadliest Pathogens ♦ Pentagon Seeks More Funds to Counter Bio Weapons

BRAZIL INVESTIGATES SECOND POSSIBLE MAD COW CASE SINCE 2010
A second possible case of bovine spongiform encephalopathy (BSE), or Mad Cow disease, in Brazil is coming in for public scrutiny much sooner than the first, which was discovered in 2010. Brazil’s Ministry of Agriculture says it is investigating why an animal with symptoms of “nerve disease” collapsed at a slaughterhouse in the state of... Continue Reading

EPA ASKED TO HALT PESTICIDE USE ON APPLES UNTIL NEW SAFETY STUDIES ARE DONE
The Environmental Working Group (EWG) is calling on the U.S. Environmental Protection Agency (EPA) to halt use of a pesticide commonly applied to conventionally grown apples to limit storage damage until EPA has done further safety studies. EWG’s president, Ken Cook, wrote EPA on Thursday asking that the agency launch a new investigation to determine... Continue Reading

Are You Programmed to Enjoy Exercise?
It’s possible that some of us are born not to run. According to an eye-opening new genetics study of lab rats, published in The Journal of Physiology, the motivation to exercise — or not — may be at least partly inherited. Continue Reading
Boston Considers Banning Deadliest Pathogens From new Biolab
Boston is set this week to debate whether to ban a new, downtown biodefense laboratory from studying some of the world's deadliest disease agents. A city council hearing is expected to consider a proposed city wide prohibition on so-called "Biosafety Level 4" research, which can involve diseases for which there are no known cures. Continue Reading
Pentagon Seeks More Funds to Counter Bio Weapons
The Pentagon wants to spend more money on a secret program to track weapons of mass destruction because of new information showing an increased need to locate chemical and biological weapons, military budget plans show. Continue Reading


Thursday, April 24, 2014

Australia: Saltwater Barramundi Portions Were Recalled Due to Contamination



Barramundi.JPGOcean Chef Saltwater Barramundi Portions 1kg with a Best before date of October 15 2015 were recall is due to a possible foreign object contamination
The product was sold nationally by Woolworths
Consumers should not eat this product and should contact Pacific West Foods for a full refund of product with the noted Best Before date.
For further information please contact:
Pacific West Foods Australia Pty Ltd
02 9630 0188 or
email: pwest@accsoft.com.au

Indoor Firing Ranges Cause Elevated Blood Lead Levels

People using or working around indoor firing ranges are being exposed to lead which can cause harmful health effects. Range owners and patrons should follow available guidance to reduce the exposures. Indoor firing ranges are a source of lead exposure to employees, their families, and range customers.
From 2002–2012, 1,987 employees of law enforcement and amusement/ recreation industries had elevated blood lead levels (BLL), defined as >10 micrograms of lead per deciliter of blood, as reported by the Adult Blood Lead Epidemiology Surveillance Program.
Other workplace investigations in Washington and California have also documented elevated BLLs among firing range employees and found the potential for “take-home” and community exposure to lead. The Occupational Safety and Health Administration’s lead standard is based on lead toxicity information that is now over 30 years old. Current medical information clearly demonstrates harmful effects at levels well below those allowed in the workplace.

Pork Baby Back Ribs Recalled

Skilcor Food Products, an importer of record in Brampton, Ontario, is recalling approximately 36 pounds of fully cooked pork baby back ribs in honey garlic barbecue sauce, because they were not presented at the border for USDA FSIS inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.
FSIS issues a Public Health Alert for an imported product when the country of origin recalls the product. FSIS issues a recall for an imported product when the product is not presented for inspection at the U.S. border.
The following product is subject to recall:
  • 18 pound cases containing 1.5 pound packages of  “Cobblestone Farms Fully Cooked Pork Baby Back Ribs in Honey Garlic Barbecue Sauce” bearing package code “Sell By 2015-AL-08” and case code “15201”
The product bears the Canadian mark of inspection with establishment number “624.” The product was distributed to a retailer in New York..
The problem was discovered when FSIS import staff reviewed records and discovered that the independent third party carrier did not present product for USDA inspection at the U.S. – Canadian border.
FSIS and the company have received no reports of illness due to consumption of these products. Anyone concerned about illness should contact a healthcare provider.
A failure-to-present (FTP) occurs when importers fail to present a shipment to FSIS for import inspection prior to the product entering U.S. commerce. Failure-to-present will result in the recall of the product.
Presently, FSIS analysts compare Custom and Border Protection Automated Commerce Environment summary data to shipments received in the FSIS Public Health Information System to identify shipments that may not have been presented for inspection at the border. As part of this process, this only occurs after the product has entered U.S. commerce.
FSIS is working on solutions to prevent future failure-to-present episodes from occurring, including outreach to industry, foreign food safety agencies and importers.
Consumers and media with questions about the recall should contact Don Bernier at (905) 501-0111.

4/24/14 Health News: Florida Citrus Greening Decimates Crops ♦ Ban on junk food in schools ♦ 60% of China Underground Water.is poluted ♦ Touchscreens Are Contaminated With Pathogens

Florida Citrus Greening Decimates Crops
Florida’s citrus growers are fighting to keep their trees alive. Since 2005, when the deadly citrus greening disease was first discovered in Dade County, it has become the single largest threat to Florida’s entire $9 billion industry. Continue Reading
The Centre for Science and Environment Director-General, Sunita Narain, has demanded that all junk food be banned from unaided and private schools across the country. Food high in fat, sugar and salt (HFSS) should not be available in educational institutions and within 500 yards of them.Continue Reading
60% of China Underground Water.is poluted
Water quality measured in 203 cities across the country last year rated "very poor" or "relatively poor" in an annual survey released by the Ministry of Land and Resources, the official Xinhua news agency said late Tuesday. Continue Reading
Virtually All Touchscreens Are Contaminated With Pathogens

Virtually all smartphones and tablet computers used by healthcare workers are contaminated with at least 1 organism, research from a German hospital shows. "We might be transferring these pathogens to patients, increasing their risk for infection," said investigator Romy Wendler Continue Readings

Ground Annatto recalled Due to Salmonella


Ground Annato frontMiravalle Foods, Inc. of El Monte, CA, is conducting a voluntary recall on its 0.75 ounce packages of Miravalle brand Achiote Molido Ground Annatto spice because they have the potential to be contaminated with Salmonella
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The recalled packages of Ground Annatto 0.75 oz. were distributed in California, Utah, Idaho, Colorado, Nevada, Washington and Oregon, in retail stores.
The product comes in a 0.75 ounce, clear plastic package marked with lot # 0015 & #0018 on the top of the UPC number (712810005020).
The potential for contamination was noted after routine testing by FDA revealed the presence of Salmonella in some 0.75 ounce packages of "Ground Annatto."
Production of the product has been suspended while FDA, California Department of Public Health, and Miravalle Foods, Inc. continue their investigation as to the source of the problem.
Consumers who have purchased 0.75 ounce packages of Ground Annatto with Lot # 0015 & 0018 are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 626-575-7551, Monday through Friday 8AM to 4:30PM Pacific.

Arthritic Supplement is Recalled Because it Contains Ingredients that may Cause Death

Nano Well-being Health Inc. is voluntarily recalling lot L1P1-6100/Expiration date June 25, 2016 and lot L1P2-6000/Expiration date September 16, 2016 of Super Arthgold, 500 mg capsules to the consumer level. FDA laboratory analysis has found the product to contain chlorzoxazone, diclofenac and indomethacin, making it an unapproved new drug.
The product is used as a dietary supplement for joint pain and arthritis and is packaged in bottles of 120 capsules. The product was distributed nationwide to wholesalers.
Nano Well-being Health Inc. - Super Arthgold (label 1)Use of this product containing the undeclared drug ingredients listed above, has a reasonable probability of resulting in fatal adverse events in consumers and patients with underlying illnesses, including known allergy to the hidden ingredients, cardiac, gastrointestinal, hepatic, and renal conditions as well as patients who recently undergone cardiac bypass graft surgery. Consumers would be unaware that the product contains Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (and other ingredients), may inadvertently overdose by taking another NSAID concurrently, thus increasing the risk for NSAID associated adverse events, which include but are not limited to, myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines.
Nano Well-being Health Inc. is notifying its distributors and customers by letter and phone call and is arranging for replacement of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using and return to place of purchase.
Consumers with questions regarding this recall can contact Nano Well-being Health Inc. by phone at 1-714-515-4600 or e-mail address of at nanowellbeingh@gmail.com, Monday to Friday from 9:00 AM to 5 PM, Pacific Standard Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Adult Stem Cell Research Shows Promise

Scientists sporting white coats and safety gloves are working in a bright Food and Drug Administration (FDA) lab on an incredible project.
They are part of FDA’s MSC Consortium, a large team of FDA scientists studying adult mesenchymal stem cells (MSCs)—cells that could eventually be used to repair, replace, restore or regenerate cells in the body, including those needed for heart and bone repair.
The scientists’ investigational work is unprecedented: Seven labs at FDA's Center for Biologics Evaluation and Research formed the consortium to fill in gaps in knowledge about how stem cells function.
“This research aims to facilitate development of this important class of innovative medical products,” explains Carolyn A. Wilson, Ph.D., associate director for research at the center. “It’s the first time we’ve done anything like this, and it’s proven to be a very useful approach. It’s worked so well because this is a huge, complicated project that requires expertise in many different technologies and methods.”
The research could ultimately be key to the advancement of personalized medicine, the practice in which medical treatment is tailored to the needs of an individual patient. “It’s not science fiction,” says Steven R. Bauer, Ph.D., chief of the Cellular and Tissue Therapy Branch in FDA’s Office of Cellular Tissue and Gene Therapies. “For me, regenerative medicine is the most exciting part of what we regulate in our office.”
So What Are Stem Cells?
There are two basic kinds of stem cells that are currently useful in the field of regenerative medicine: multipotent and pluripotent stem cells. Multipotent stem cells are generally taken from adults and can divide and develop into many different cell types. Pluripotent stem cells can develop into any type of cell in the body. Both types could divide to replenish cells damaged by injury, illness or normal wear. When stem cells divide, the new cells can either remain stem cells or develop into a new type of cell with a more specific function.
Two types of pluripotent stem cells exist: human embryonic stem cells and induced pluripotent stem cells, which are created by reprogramming adult cells that had already changed into a mature type of cell.
FDA’s MSC Consortium is not studying stem cells taken from embryos. “We’re looking at a particular kind of multipotent adult stem cell—the MSC—which is being used in a lot of regenerative medicine clinical trials,” adds Bauer.
The group is currently studying eight unique cell lines, each acquired from commercial sources and sourced to one of eight distinct, adult donors. (Males and females age 22 to 47 donated stem cells from bone marrow.)
The cells under study are multipotent: “They can differentiate (mature into) at least three cell types: bone, fat and cartilage, primarily,” Bauer explains. “They can also differentiate into nerve cells, liver cells and a kind of cell called ‘stroma’ that is in the bone marrow and supports blood forming cells. Then, for investigational clinical uses, they’ve been used for repairing hearts, repairing bone and repairing cartilage.”
Why Is FDA Studying These Cells?
In addition to differentiating into a variety of replacement cell types, MSCs can limit a patient’s immune response. So they can potentially be taken from one human donor and placed into a different recipient with less possibility of rejection.
But growing stem cells and making sure they are safe and effective is challenging, which is one reason why stem-cell based clinical trials have not yet resulted in a marketed product.
“The major challenge is that cells are much more complex than traditional products that FDA regulates. And they have the ability to respond to their environment,” Bauer explains. “Taking them out of the body and manufacturing them—that is, growing large numbers of them—or isolating them can change their biology. And it can change the way they behave if they are put back into the patient.”
For instance, if cells are manufactured in large quantities outside their natural environment, they may become ineffective or develop harmful characteristics. For example, they can produce tumors, severe immune reactions or growth of unwanted tissue. So FDA is trying to develop methods that would predict with more certainty how manufactured or isolated adult stem cells will behave in patients.
What's Being Done?
In the labs, cells are suspended in a nutrient liquid solution and grown in sterile containers called tissue culture flasks. Cells then multiply and go through three, five or seven generations of growth.
FDA scientists are using a variety of cutting-edge methods to characterize cells and then determine if any of these characteristics can predict the behavior of the cells in biological assays or in animal models. The next step will be to determine if any characteristics they measure will predict the safety or effectiveness of stem-cell based products in patients.
Specifically, scientists will continue studying whether factors such as different methods of growing the cells, donor age or gender affects the cells’ quality and performance. This research will ultimately provide new tools to the community of academic and private industry scientists who are interested in evaluating and developing stem cells into new clinical treatments.
“The consortium has shown that widely accepted ways to identify and characterize MSCs do not reveal some important biological differences between batches of these cells,” Bauer says. So the consortium seeks to demonstrate ways to better characterize MSCs that will be used in clinical trials. That’s important because, if investigators can improve the tools used to characterize MSCs used for clinical trials, the data generated from their studies could also improve because their MSC products will be more predictable, he adds.
And the improved predictability of their products will, in turn, allow FDA scientists to more easily evaluate the safety and effectiveness of new stem cell technologies—a key part of the regulatory science that is the foundation of FDA decisions.
Stem cells, like other medical products intended to treat, cure or prevent disease, require FDA approval before they can be marketed. “It is important for FDA to maintain a sound regulatory science research program to promote the development of safe and effective products in emerging areas that hold great promise,” Bauer says.
“My colleagues and I hope our scientific findings will be helpful in the field of regenerative medicine, including the ability to repair or even replace organs and tissues more safely and effectively than traditional means,” he adds. “Although there are many scientific hurdles to overcome before the use of stem cells reaches its full potential, I think this medicine will eventually have the capacity to do that.”

Wednesday, April 23, 2014

Glaucoma Drug Helps Women with Blinding Disorder Linked to Obesity

Drug treatment and weight loss can restore lost vision,
An inexpensive glaucoma drug, when added to a weight loss plan, can improve vision for women with a disorder called idiopathic intracranial hypertension (IIH), according to a study funded by the National Institutes of Health.
An image of a normal and swollen optic nerve.
On the left is a normal optic nerve (light circle at center) and on the right is the optic nerve swelling seen in IIH. Courtesy of Dr. Michael Wall, University of Iowa.
IIH, also called pseudotumor cerebri, predominantly affects overweight women of reproductive age. An estimated 100,000 Americans have it, and the number is rising with the obesity epidemic. The most common symptoms are headaches and visual problems, including blind spots, poor side vision, double vision and temporary episodes of blindness. About 5-10 percent of women with IIH experience disabling vision loss.
“Our results show that acetazolamide can help preserve and actually restore vision for women with IIH, when combined with a moderate but comprehensive dietary and lifestyle modification plan,” said Michael Wall, M.D., a professor of neurology and ophthalmology at the University of Iowa in Iowa City.
Acetazolamide (Diamox) is best known as a glaucoma drug. It has been commonly prescribed for IIH, but without much evidence that it helps. The IIH Treatment Trial tested the benefits of acetazolamide plus a weight loss plan versus the weight loss plan with a placebo pill, over six months. Patients in both treatment groups had improved vision, but those receiving the drug had the greatest improvement. All patients were allowed to take headache medications throughout the trial, and both groups experienced a similar reduction in headache.
“The vision problems associated with this condition can be extremely debilitating, at significant cost to patients and the health care system. Yet there are no established treatment guidelines. We made it a priority to develop an evidence-based treatment for helping patients keep their vision,” said Eleanor Schron, Ph.D., director of clinical applications at NEI.
IIH is named for one of its key physical findings — an increased pressure within the fluid-filled spaces inside and around the brain. This in turn can cause swelling and damage to the optic nerves that connect the eyes to the brain. A 5-10 percent weight reduction appears to improve symptoms for many patients, but can be difficult to achieve and maintain. Acetazolamide is known to reduce fluid production in the brain, and is often used as an add-on therapy. In severe cases, surgical procedures may be used to relieve pressure on the optic nerve.
The dosing and results with acetazolamide vary. In high doses, the drug can produce side effects including fatigue, nausea, tingling hands and feet, and a metallic taste, usually triggered by carbonated drinks. British researchers completed a trial of the drug for IIH in 2011, but the results were inconclusive.
The NIH-funded trial involved 161 women and four men with IIH and mild vision loss, who were enrolled at 38 sites. At enrollment, their average body mass index (BMI) was about 40. A BMI of 30 or greater is considered obese. All participants were put on a weight loss plan to trim salt and about 500 to 1,000 calories from their food intake each day, with the goal to lose 6 percent of their starting weight. They were provided with a weight loss coach and some simple low-cost exercise equipment. This included a step counter and a resistance band, a piece of rubber tubing used for strength training. About half the participants were randomly assigned to receive acetazolamide. The drug was given at 1 gram daily for the first week and increased by a quarter gram each week, to reach the maximally tolerated dosage, or up to 4 grams daily. The other half of participants received a placebo in gradually increasing dosages.
After six months, both groups had improved scores on visual field tests, a measure of side or peripheral vision. Participants on acetazolamide improved by about twice as much as those on placebo. Compared to weight loss alone, the drug also helped reduce swelling of the optic nerve. The drug-weight loss combination also led to greater improvements in daily function and quality of life compared to weight loss alone, based on the NEI Visual Functioning Questionnaire.
In the placebo group, there were six treatment failures — defined as a substantial worsening of vision that required withdrawal from the trial. There was one treatment failure in the acetazolamide group.
Seven people on acetazolamide and one person on placebo stopped taking their assigned study medication because of perceived side effects. Three people on placebo were admitted to the hospital compared to six on the drug, two of whom developed kidney stones. All side effects were reversed by stopping the drug or reducing the dosage.
“This study provides a much-needed evidence base for using acetazolamide as an adjunct to weight loss for treating IIH,” said Dr. Wall. “The drug has been around since the 1950s, and prior studies have found varying degrees of efficacy. One strength of our study is that we slowly introduced patients to the highest tolerated dose, in an attempt to maximize efficacy while limiting its side effects.”
Another strength of the study was the weight loss program, he said. The New York Obesity Nutrition Research Center designed the program to achieve moderate, sustainable weight control with an emphasis on changing lifestyle, as opposed to just dieting.
The trial will follow participants for five years to gauge whether they’re able to maintain a healthy weight and control their symptoms over the long term.