July 2001 - Health Notes

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Health Notes

Texas D.O. Online
July 2001

MedWatch News

Wyeth-Ayerst Pharmaceuticals notified health care professionals of two safety-related changes to the Cordarone IV (amiodarone HCl) prescribing information, describing potentially fatal or developmental side effects associated with use of this product in neonatal and infant pediatric patients. Wyeth-Ayerst Pharmaceuticals is aware that Cordarone IV is used off-label to treat arrhythmias in pediatric patients. The safety and efficacy of amiodarone IV in the pediatric population have not been established; therefore, its use in pediatric patients is not recommended. See the MedWatch Safety Summary and Dear Health Professional letter at:
http://www.fda.gov/medwatch/safety/2001/safety01.htm#cordar

· Genentech, Inc. recently became aware of the existence in the U.S. of a counterfeit drug product labeled as Nutropin AQ® 10 mg vials in 6-pack boxes. The Genentech web page referenced below includes detailed descriptions, along with comparison photos of the authentic and the counterfeited product. http://www.gene.com/gene/products/nutropin_aq/product_update.html

· Serono, Inc. and the U.S. Food and Drug Administration are informing distributors, pharmacies, physicians and patients of the existence of a new counterfeit lot of Serono's Serostim® 6 mg [somatropin (rDNA origin) for injection]. The counterfeit material, which is made to resemble Serostim®, bears lot number MNH605A. Any product labeled as Serostim® and carrying this lot number should be considered to be counterfeit. To see the Serono, Inc. press release and the "Dear Health Professional" letter, direct your browser to: http://www.fda.gov/medwatch/SAFETY/2001/safety01.htm#serost

· FDA is issuing a public health advisory concerning Sporanox and Lamisil, systemic drug therapies to treat onychomycosis (fungal nail infections). Healthcare professionals are notified of the possible association of serious cardiac and hepatic adverse events with the administration of these therapies. New labeling for both Sporanox and Lamisil recommends that healthcare providers obtain nail specimens for laboratory testing prior to prescribing the medications for onychomycosis to confirm the diagnosis. FDA's concerns do not apply to the over-the-counter versions of Lamisil, which are topical creams. For additional information, including links to the FDA Talk Paper, FDA Public Health Advisory, FDA Q's and A's, and the revised Sporanox and Lamisil labels, go to the MedWatch Safety Summary entry for Sporanox and Lamisil at http://www.fda.gov/medwatch/safety/2001/safety01.htm#sporan

· Pharmacia Corporation announced a recall in the United States of its 500 count bottles of DELTASONE Tablets (prednisone tablets, USP), 10 mg, Lot number 29DRB. The recall is based on one report from a pharmacist that a bottle labeled as DELTASONE Tablets, 10 mg, actually contained DELTASONE Tablets, 5 mg. While this may have been the only mislabeled bottle, other mislabeled bottles may have been distributed. No other lots or countries are affected by this recall. Read the Pharmacia News Release at http://www.fda.gov/medwatch/safety/2001/deltason.htm

· Bayer Corporation has notified healthcare professionals of changes in the prescribing information for Baycol, providing more specific guidance on initiating therapy and dose adjustment in order to reduce the risk of myopathy and rhabdomyolysis. See the MedWatch summary at www.fda.gov/medwatch/safety/2001/safety01.htm#baycol.

New Medications/Devices Approved by the FDA

· FDA Approves Implanted "Stomach Band" for Severe Obesity -- A device implanted by laparoscopic ("keyhole") surgery that can help severely obese people lose weight by limiting food consumption and creating an earlier feeling of fullness has received FDA approval. http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01087.html

· Catheter Device Could Benefit Thousands of Heart Patients -- FDA has cleared for marketing a new type of catheter for coronary bypass patients that can help prevent blood clots and other debris from traveling into the bloodstream and causing heart attacks and other serious problems. http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01086.html

· FDA OKs Combo Vaccine for Hepatitis A and B -- With Twinrix, a new vaccine that combines two existing ones, people at high risk for Hepatitis A and B can be immunized against both diseases at the same time.
http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01084.html

· Human Research Trials Site Debuts -- FDA has created a new Website with information about protection of human subjects in clinical trials. http://www.fda.gov/oc/ohrt/default.htm

· New Drug Treats Rare Form of Leukemia--FDA has approved Gleevec, a promising oral treatment for patients with chronic myeloid leukemia, a rare, life-threatening cancer. http://www.fda.gov/bbs/topics/NEWS/2001/NEW00759.html

Although the Number of Americans Newly Infected with the HIV Virus has Stabilized At an Estimated 40,000 annually, Difficulties Persist in Reducing the Overall HIV Infection Rate Among Black Americans

According to the federal Centers for Disease Control and Prevention, blacks, who represent roughly 12 percent of the population, are now estimated to account for more than half of the new infections, representing one in every 50 black men. Among adult females, who account for 30 percent of new infections, black women account for an estimated 64 percent of new HIV cases. (Wall Street Journal, 5-30-2001)

Placebo Treatments Have Little or No Effect, Concluded a Study Published in the New England Journal of Medicine

Analysis of the findings of 114 studies from around the world involving dozens of conditions ranging from colds and seasickness to Alzheimer's disease and schizophrenia, found that in most studies the placebo group fared about the same as the group getting no treatment. Exceptions included studies of pain treatments and others in which patients reported how much symptoms bothered them, rather than having an objective measure such as blood pressure. The study's authors made the bold conclusion that high levels of placebo effect which have been repeatedly reported are the result of flawed research methodology. (New England Journal of Medicine, 5-24-2001; Associated Press, 5-24-2001)

Thirty-nine Percent of Physicians Do Not Follow Cancer Screening Guidelines Calling for Patients to Receive Follow-up Testing After a Positive Result on a Fecal Occult Blood Test (FOBT)

A study reported recently at the Digestive Diseases Week meeting in Atlanta, Georgia, of 544 people who had positive results on an FOBT found that 49 percent of the patients did not have a colonoscopy or a combination of flexible sigmoidoscopy and barium enema, only 10 percent of whom refused to have follow-up testing. In some cases, doctors who decided not to proceed with further testing concluded that the positive results were due to medications a patient was taking or to another medical condition, while some physicians were concerned about recommending tests to patients with other medical illnesses. (Yahoo News, 5-22-2001)

Quick Cholesterol Test Could Be the Best

A Canadian company is developing a three-minute test for predicting a patient’s risk of heart disease by measuring cholesterol levels in their skin. The test could be a big improvement over current cholesterol tests, which require fasting, drawing blood and waiting days for results.

To perform the test, a doctor places two drops of a chemical solution on the palm of the patient’s hand and waits for three minutes. Then the doctor reads the results with a highly sensitive color reader. The cholesterol level is determined by the shade of blue the solution becomes after contacting the patient's skin.

The manufacturer expects the test to be available in the U. S. late in 2001 or early in 2002.

“Initially the test is designed to be used in a doctors’ offices and pharmacies,” said Dr. Brent Norton, President and CEO of International Medical Innovations, Inc., the company that makes the test. “We’re also developing a home version that we hope to make available within two years.” (Texas Innovator, 6-2001)

Mortality Declines for Several Leading Causes of Death in 1999

Mortality for several leading causes of death declined in 1999, according to preliminary figures from HHS’ Centers for Disease Control and Prevention, released June 26 by HHS Secretary Tommy G. Thompson.

The report shows age-adjusted death rates continued to fall for heart disease and cancer, the two leading causes of death in the U. S. that account for more than half of all deaths in the country each year. In addition, suicide, homicide and firearm mortality dropped an estimated 6 percent between 1998 and 1999.

At the same time, there were increases for other leading causes of death, including septicemia (6.6 percent); hypertension (5 percent); chronic lower respiratory diseases (4 percent); and diabetes (3.3 percent0.

These estimates are featured in a new CDC report, “Deaths: Preliminary Data for 1999,” an analysis of over 99 percent of the death certificates recorded in the U. S. for 1999. The report can be found online at the CDC Web site: http://www.cdc.gov/nchs.

Medicare to Cover Surgical Procedure for Incontinence

HHS Secretary Tommy G. Thompson announced on June 29 that the Centers for Medicare & Medicaid Services (CMS) will expand Medicare coverage to include a surgical treatment known as sacral nerve stimulation for urinary incontinence and other voiding difficulties.

Urinary incontinence affects approximately 13 million adults in the United States, with nearly half of nursing home residents having some degree of incontinence. It is twice as prevalent in women as it is in men, and costs more than $15 billion per year, including both direct treatment of the disease and nursing home costs.

Under this treatment, an electrical pulse generator about the size of a pacemaker is implanted in the abdominal wall of a patient, with a wire leading to the sacral nerves, which help control bladder contractions. Electrical impulses are transmitted from the generator to the sacral nerves through the implanted wire. These impulses control the troublesome contractions of the bladder muscle, giving the patient the ability to regulate the frequent and uncontrollable contractions that cause incontinence.

In order to be eligible for this procedure, a Medicare beneficiary with urge incontinence or the urgency-frequency syndrome must also have failed more conservative treatments, such as behavioral modifications, drug therapy or other surgical interventions.

The decision by CMS, formerly the Health Care Financing Administration, to expand coverage was made using Medicare's evidence-based coverage process. The scientific and clinical evidence reviewed by CMS regarding the clinical value of sacral nerve stimulation is sufficient to support coverage of this technology for Medicare beneficiaries nationwide.

More information can be found at www.hcfa.gov/covrage/8b3-htm.

NCEP Issues Major New Cholesterol Guidelines

The National Cholesterol Education Program (NCEP) on May 15 issued major new clinical practice guidelines on the prevention and management of high cholesterol in adults. The guidelines are the first major update from NCEP in nearly a decade. NCEP, which is coordinated by the National Heart, Lung, and Blood Institute (NHLBI), develops new guidelines as warranted by research advances. Earlier guidelines were issued in 1988 and 1993.

An executive summary of the new guidelines, the "Third Report of the NCEP Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults," also known as Adult Treatment Panel (ATP) III, appeared in the May 16, 2001, issue of the "Journal of the American Medical Association".

Key changes in the new guidelines are: more aggressive cholesterol-lowering treatment and better identification of
those at high risk for a heart attack; use of a lipoprotein profile as the first test for high cholesterol; a new level at which low HDL (high-density lipoprotein) becomes a major heart disease risk factor; a new set of "Therapeutic Lifestyle Changes," with more power to improve cholesterol levels; a sharper focus on a cluster of heart disease risk factors known as "the metabolic syndrome;" and increased attention to the treatment of high triglycerides.

The new guidelines are expected to substantially expand the number of Americans being treated for high cholesterol,
including raising the number on dietary treatment from about 52 million to about 65 million and increasing the number prescribed a cholesterol-lowering drug from about 13 million to about 36 million.

According to ATP III, Americans at high risk for a heart attack include those with heart disease or diabetes, and many of those with multiple heart disease risk factors. The guidelines state that diabetes poses as great a risk for having a heart attack in 10 years as heart disease itself-and the threat from multiple risk factors can be equally great. The guidelines recommend these persons be treated as intensively as heart disease patients with
lifestyle changes and medication.

To better identify risk, the guidelines include a tool that predicts a person's chance of having a heart attack within 10 years. Based on newly analyzed data from the landmark, NHLBI-supported Framingham Heart Study, the "risk assessment tool" translates clinical conditions and lifestyle factors into a single, easy-to-understand category of risk. The tool calculates risk separately for men and women based on age, total cholesterol, HDL (the "good" cholesterol), systolic blood pressure, treatment for high blood pressure, and cigarette smoking. ATP III recommends use of the tool for persons with two or more heart disease risk factors.

Other changes in the new guidelines include:

· Treating high cholesterol more aggressively for those with diabetes;

· A lipoprotein profile as the first test for high cholesterol;

· A new level at which low HDL becomes a major risk factor for heart disease;

· Intensified use of nutrition, physical activity, and weight control in the treatment of elevated blood cholesterol. ATP III combines these steps into a new “therapeutic lifestyle changes” (TLC) treatment plan.

· Identifying a “metabolic syndrome” of risk factors linked to insulin resistance, which often occur together and dramatically increase the risk for coronary events.

· More aggressive treatment for elevated triglycerides.

· Advising against the use of Hormone Replacement Therapy as an alternative to cholesterol-lowering drugs.

The following ATP III and cholesterol-related materials can be found on line http://www.nhlbi.nih.gov:

The guidelines' executive summary and "At A Glance" desk reference for physicians http://www.nhlbi.nih.gov/health/prof/heart/index.htm#chol; an interactive version of the guidelines for PalmOS(r) devices http://hin.nhlbi.nih.gov/atpiii/atp3palm.htm; a patient brochure, "High Blood Cholesterol-What You Need To Know;" a 10-year heart attack risk calculator http://www.nhlbi.nih.gov/health/public/heart/index.htm#chol; and a "Live Healthier, Live Longer" Web site for
patients and the public http://www.nhlbi.nih.gov/chd/index.htm. To get these items, go to the NHLBI home page at www.nhlbi.nih.gov and click on ATP III Cholesterol Guidelines under Highlights.