Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication – Low Magnesium Levels Can Be Associated With Long-Term Use
Prescription PPIs include:
- Nexium (esomeprazole magnesium)
- Dexilant (dexlansoprazole)
- Prilosec (omeprazole)
- Zegerid (omeprazole and sodium bicarbonate)
- Prevacid (lansoprazole)
- Protonix (pantoprazole sodium)
- AcipHex (rabeprazole sodium)
- Vimovo (a prescription combination drug product that contains a PPI (esomeprazole magnesium and naproxen)
FDA NEWS RELEASE
May 27, 2011
The U.S. Food and Drug Administration (FDA) approved a sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed.
Fecal incontinence is the involuntary loss of bowel control. It can have different causes including nerve damage, weakened anal sphincter associated with aging, or rectum muscle damage. According to the National Institutes of Health, there are more than 5.5 million Americans with fecal incontinence.
The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area. By growing the surrounding tissue, the opening of the anus narrows and the patient may be able to better control those muscles.
“Fecal incontinence is difficult to treat,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This approval provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies.”
The FDA based its approval on results from a clinical study of 206 patients. In the primary study, most patients received two treatments, consisting of four injections each, for a total of eight injections. After six months, more than half of the patients injected with Solesta experienced a 50 percent reduction in the number of fecal incontinence episodes. However, one-third of patients who received no Solesta in the study also experienced a similar reduction. Overall, a greater proportion of patients treated with Solesta experienced improvements, indicating the gel provides benefit.
Solesta is approved for use in patients ages 18 and up. It should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products.
The most common side effects associated with Solesta include injection area pain and bleeding. Infection and inflammation of anal tissue are more serious risks, but are less common.
Solesta is manufactured by Oceana Therapeutics Inc. of Edison, N.J.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: www.fda.gov – May 2011
Short Interesting Facts About Us, the Human Body & More…
Did You Know That…
The pancreas has a tremendous reserve capacity for the production of some enzymes.
More than 95 percent of the function of the pancreas must be lost before the pancreas fails and symptoms of bloating and poor digestion occur. That’s amazing!!
Celiac Disease News
Restless legs syndrome (RLS) was found to be frequently associated with celiac disease, researchers reported in the June 2010 issue of Digestive Diseases and Sciences. These findings could lead doctors to screen for celiac disease in patients with RLS and diagnose and treat them for a disease they otherwise would have missed.
“Screening for celiac disease in patients with idiopathic RLS may have importance because celiac disease is a commonly overlooked silent disease,” stated Leonard B. Weinstock, M.D., Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO, and colleagues. “Thus, celiac disease may be an underlying correctable factor for some patients diagnosed with idiopathic RLS.”
Pronounced – POL-ee-SISS-tik KID-nee dih-ZEEZ
Polycystic kidney disease (PKD) is an inherited disorder characterized by many grapelike clusters of fluid-filled cysts that make both kidneys larger over time. These cysts take over and destroy working kidney tissue.
Polycystic kidney disease may cause chronic kidney disease and kidney failure, also called end-stage renal disease (ESRD). About one-half of people with the most common type of PKD progress to kidney failure.
- Choose whole fruits more often than fruit juice. Fresh, frozen, or canned, it doesn’t matter, they all count.
- Try to eat two vegetables with your evening meal.
- Keep a bowl of veggies washed and prepared in your refrigerator. Cucumbers, celery, or carrots are a good choice for a quick snack.
- Make a meal around dried beans or peas (also called legumes) instead of meat.
There is soluble fiber and insoluble fiber. Both soluble fiber and insoluble fiber has important health benefits. Eat a variety of foods to get enough of both soluble fiber and insoluble fiber.
Soluble fiber dissolves easily in water and takes on a soft, gel like texture in the intestines. Soluble fiber is not broken down until it reaches the large intestine where digestion causes gas (flatulence). It is found in such foods as oat bran, beans, peas, and most fruits.
When your digestive system is working well, the average transit time for food, from mouth to bowel movement, is anywhere from 12 to 24 hours.
Many people have a transit time that is too long, 48 to 96 hours, because they don’t eat enough high fiber food, drink enough water, or get enough exercise.
But how do you really know how long your transit time is? Here’s a way to find out:
- Swallow 1 gram of activated charcoal tablets (from your drugstore) or eat a couple of small beets, noting the exact time you do this.
- When you see darkened stool (charcoal will turn it black; beets will turn it deep red), figure out how many hours have passed. That is your transit time.
What are Kidneys?
Your kidneys are a pair of vital organs that perform many functions to keep your blood clean and chemically balanced.
Your kidneys are bean-shaped organs, each about the size of a fist.
Your kidneys are located near the middle of your back, just below your rib cage, one on each side of your spine.
Safer Alternatives to Laxatives
If you are eating 25 to 35 grams of fiber every day and drinking six to eight glasses of water, you shouldn’t need laxatives!!!
Inevitably though, there will be times when nature needs a little help. But reaching for a laxative may not be a good idea, even ones that say they have natural ingredients like senna or cascara. Though these laxatives are natural, they are not gentle. And using them for more than a week or so can make you dependent on them for normal bowel function, just as pharmaceutical laxatives can.
The habits listed below can also help prevent colon cancer: