US Pharm . 2006;6:82. 

Electronic Health Records: 10-Year Plan
The FDA announced that within the next decade it anticipates the establishment of electronic health records for most Americans. By adopting the Systematized Nomenclature of Medicine (SNOMED) as the standard computerized medical vocabulary system to electronically code important terms in the Highlights section of prescription drug labeling, the FDA hopes this will enable health care professionals to access and share critical health and treatment information easily and efficiently.

"Once we have implemented a national e-health record, health professionals will have quick, reliable, and secure access to patient information that can be cross-referenced with critical treatment information, including information in the Highlights section of drug labeling," said Dr. Andrew C. von Eschenbach, Acting Commissioner of the FDA.

Eye Infections Associated with Contact Lens Solutions
The FDA reports several confirmed cases of Fusarium keratitis related to the use of various contact lens–cleaning solutions. It is continuing to monitor the situation and is working with the CDC to investigate the Fusarium keratitis infections to determine what action needs to be taken. The FDA will continue to update the public on its findings. The FDA and CDC are urgently advising consumers to consult their doctor immediately if they experience redness, pain, tearing, increased light sensitivity, blurry vision, discharge, or swelling. The CDC released further clarification on the multistate outbreak of Fusarium keratitis that may be associated with contact lens use. For more information, visit: www.cdc.gov/od/oc/media/pressrel/r060505.htm.

Higher-Dose Diovan HCT Approved
The FDA gave the green light for Novartis to begin manufacturing two new, higher doses of Diovan HCT (valsartan/hydrochlorothiazide): 320/12.5 and 320/25 mg. The approval will afford physicians more flexibility in managing their patients' high blood pressure. The company plans to have the product available this month.

Generic Pravastatin Approved
The first generic of Bristol-Myers Squibb's Pravachol (pravastatin sodium tablets) has been FDA approved, representing the FDA's continuing effort to increase availability of generic drugs.

"This approval is another example of our agency's endeavor to counter rising health care costs by approving safe and effective generic alternatives as soon as the law permits," said Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs.

Pravastatin is indicated for the treatment of individuals with hyperlipidemia or who are at increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack and stroke. In 2005, Pravachol was the 22nd highest-selling brand-name drug in the U.S., with sales totaling approximately $1.3 billion.

Warning Issued on Oral Sodium Phosphate Products
The FDA notified health care professionals and consumers of reports of acute phosphate nephropathy, a type of acute renal failure associated with the use of oral sodium phosphates (OSPs) for bowel cleansing. According to the FDA, there have been 22 documented cases of acute phosphate nephropathy, including 21 patients who used an OSP solution and one patient who used OSP tablets. Individuals at increased risk include older persons, those with kidney disease or decreas­ ed intravascular volume, and those using medicines that affect renal perfusion or function.

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