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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Published June 20, 2006