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FDA Warns of Acute Kidney Injuries
The FDA says doctors who prescribe the OSP products should instruct patients how to prepare for their procedures, and tell them to avoid dehydration by drinking sufficient clear liquids before, during and after bowel preparation.
June 07, 2009 /Surgery PR News/ -- FDA Warns of Acute Kidney Injuries
Article provided by Marcus & Mack, please visit us at http://www.marcusandmack.com
The United States Food and Drug Administration has issued new safety measures for oral sodium phosphate (OSP) products used for bowel cleaning before colon examinations (colonoscopies) and other procedures. These products are associated with a rare, but serious type of kidney injury known as acute phosphate nephropathy. A patient with acute phosphate nephropathy, which is also known as nephrocalcinosis, may need dialysis or a kidney transplant.
The FDA first warned of this problem in 2006. Since then, more cases of kidney injury related to prescription and over-the-counter OSP products have been reported. The federal agency is now requiring Salix Pharmaceuticals, Inc., maker of prescriptions Visicol and OsmoPrep, to put highlighted warnings about acute phosphate nephropathy on the product labels.
Warning Signs of Kidney Injury
The FDA says doctors who prescribe the OSP products should instruct patients how to prepare for their procedures, and tell them to avoid dehydration by drinking sufficient clear liquids before, during and after bowel preparation. Prescribers should also tell their patients to be alert for symptoms of acute kidney injury, including malaise, drowsiness, lethargy, decreased urine volume and swelling of the ankles, feet and legs.
Higher Risk Individuals
People who are at higher risk of kidney injury after taking OSP products include those over 55 years old, or those who have kidney disease, bowel obstruction/constipation, active colitis or are dehydrated. The higher risk group also includes people taking drugs affecting renal perfusion or function such as diuretics (fluid pills), ACE inhibitors (medications that lower blood pressure), angiotensin receptor blockers (used to treat high blood pressure, heart or kidney failure) and possibly nonsteroidal anti-inflammatory drugs (NSAIDs) similar to ibuprofen and other arthritis medications.
Additional Requirements for Salix
In addition to putting warnings on its products, North Carolina's Salix Pharmaceuticals, Inc. is also required to conduct a new clinical trial to study the risk of acute kidney injury to patients using its products. Salix must also now provide a Medication Guide for people who receive prescriptions for their products and implement a risk evaluation and mitigation strategy to ensure the benefits of their products outweigh the risks.
The Salix Medication Guide for Visicol states that "people who take medicines that contain sodium phosphate can have severe loss of body fluid, with severe changes in body salts in the blood, and abnormal heart rhythms."
People who have taken Visicol are urged to call their doctors if they have any symptoms of dehydration while taking the products. The symptoms include:
Vomiting
Dizziness
Urinating less often than normal
Headache
Over-the-Counter Recall
The FDA believes oral sodium phosphate products should be available by prescription only when they are to be used for bowel cleansing. Accordingly, C.B. Fleet Company has recalled the company's oral sodium phosphate products sold over the counter (Fleet Phospho-soda and Fleet EZ-PREP). The FDA advises healthcare providers not to instruct their patients to use over-the-counter products for bowel cleansing. Unico Holdings, Inc., a Florida company making store brand pharmaceutical products, has also recalled its oral sodium phosphate products sold over the counter for bowel cleansing.
If You Have Been Injured
Many people who have taken OSP products had no previous kidney problems. If you believe you have suffered kidney damage due to the use of any of these products, you should consult your health care professional immediately. In addition, you may wish to contact an attorney who can help determine if you have a claim against the maker of the product.
Article provided by Marcus & Mack, please visit us at http://www.marcusandmack.com
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