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Health Notes

MedWatch News

Healthcare professionals are notified of a voluntary recall of the unimplanted inventory of nine batches of zirconia ceramic femoral heads manufactured by a French manufacturer, and by U.S. manufacturers that have included these components in their hip prostheses. The component was recalled by its French manufacturer St. Gobain Desmarquest August 14 because it was fracturing at a higher rate than expected in some patients 13 to 27 months after being implanted. The U.S. companies that use the St. Gobain Desmarquest zirconia femoral heads are: Apex Surgical, LLC, Lakeville, Mass.; Biomet, Inc., Warsaw, Ind.; DePuy Orthopaedics, Inc., Warsaw, Ind.; Encore Orthopedics, Inc., Austin, Tex.; Osteoimplant Technology Inc. (OTI), Hunt Valley, Md.; Smith & Nephew, Inc., Memphis, Tenn.; Stryker Howmedica Osteonics, Allendale, N.J.; and Zimmer, Inc., Warsaw, Ind. Surgeons should not continue to implant artificial hips with zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest since early 1998. For more info, see the MedWatch 2001 Safety Information page at http://www.fda.gov/medwatch/safety/2001/safety01.htm#zircon

FDA announces a voluntary recall of Micronase lots 84DWB (1.25 mg, bottle of 100); 91DYR (2.5 mg, bottle of 100); 67FPP (5 mg, bottle of 100); and 42 different lots of Greenstone Brand Glyburide Tablets. Fungal organisms have been detected in some lots of MICRONASE and Greenstone Brand Glyburide Tablets, traced to a raw material used in the formulation. See the MedWatch 2001 Safety Alerts page summary for Glyburide for additional information on the recall: http://www.fda.gov/medwatch/SAFETY/2001/safety01.htm#glybur

FDA and Ortho-McNeil have strengthened the WARNINGS and PRECAUTIONS sections in the label of Topamax Tablets and Sprinkle Capsules, indicated as adjunctive therapy for adults and pediatric patients ages 2-16 years with seizure disorders. Cases of secondary angle closure glaucoma characterized by ocular pain, accute myopia, and increased intraocular pressure were reported in pediatric and adult populations. The primary treatment is discontinuation of Topamax. If left untreated, serious sequelae, including permanent vision loss, may occur. Patients taking Topamax should be told to seek immediate medical attention if they experience blurred vision or periorbital pain. To read the "Dear Healthcare Professional" letter, direct your web browser to the MedWatch 2001 Safety Information summary at: http://www.fda.gov/medwatch/safety/2001/safety01.htm#topama

News from the FDA

New Breast Cancer Treatment Combines Two Drugs -- FDA has approved a combination of the cancer drugs Xeloda (capecitabine) and Taxotere (docetaxel) for treating patients with metastatic breast cancer that has progressed after treatment with an anthracycline-containing therapy.
http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01101.html

Former Medical Device Maker Sentenced for Fraud -- A former official of Micro Interventional Systems received a 10- month jail sentence after pleading guilty to submitting fraudulent documents to the government related to marketing medical devices. http://www.usdoj.gov/opa/pr/2001/September/445civ.htm

Dietary Supplement T3 Recalled -- Global Enterprises is recalling T3, a dietary supplement containing tiratricol, a potent thyroid hormone that may cause serious health consequences, including heart attacks and strokes http://www.fda.gov/oc/po/firmrecalls/global9_01.html

Eight Companies Recalling Hip Implants -- Due to a fracturing problem with the ball portion in certain hip implant devices, eight U.S. makers of the devices are recalling their products. http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01102.html

New Test Detects HIV, Hep C Virus Sooner in Plasma Donors -- FDA has licensed the first nucleic acid test systems, expected to further ensure the safety of plasma-derived products by permitting earlier detection of HIV and the hepatitis C virus in donors. Plasma is used to make products such as clotting factors and immune globulins. http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01103.html

MRI Safety Page Debuts on FDA's Web site-- Following a recent incident in which a six-year-old boy was killed by an oxygen tank pulled into the scanner of a magnetic resonance imaging (MRI) diagnostic device, FDA has posted a Web page devoted to MRI safety. http://www.fda.gov/cdrh/safety/mrisafety.html

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Reminder: TDH Urges Those at High Risk from Flu Complications to Receive Vaccine First

Texas Department of Health officials urge that those at high risk from flu complications be vaccinated first and that public flu vaccination clinics be held no earlier than November. Although supplies of flu vaccine will be sufficient this year, national health officials anticipate that distribution of vaccine to clinics and health care providers will be spread out over several months.

Up to 5 million doses of flu vaccine should reach Texas health care providers this year. TDH will supply approximately 350,000 doses to TDH regional offices, local health departments and federally qualified health centers. Delays with about 44 percent of the doses are anticipated from vaccine manufacturers. Because new strains of flu appear each year, vaccines must be reformulated annually.

High-risk groups include people 65 and older; residents of nursing homes and other long-term care facilities; people with asthma or other chronic lung conditions; those with diabetes, kidney or heart problems or weakened immune systems; women who will be more than three months pregnant during flu season; and children and teen-agers on long-term aspirin therapy.

Nationally, there are about 20,000 deaths and more than 110,000 people hospitalized with flu-related complications each year. Flu season in Texas usually runs from October to March, with the majority of the cases in January and February.

Those at high risk also are advised to ask their health care provider if a pneumococcal vaccination is appropriate.

Life Expectancy Is About Six Years Shorter for Blacks than Whites

Homicide adds about seven months to the gap, the U.S. Centers for Disease Control and Prevention said in what it called the first report analyzing life expectancy by race and cause of death. Overall life expectancy is about 75 years for whites and 69 years for blacks, while heart disease and cancer were the leading causes of the difference between the two races, each adding more than a year to the racial gap. (Associated Press, 9-13-01)

Nearly 40 Million American Adults Are Obese, According to a Government Survey Reported in the Journal of the American Medical Association

The 2000 national obesity average of 19.8 percent is up from 12 percent in 1991, and 22 states had a rate of 20 percent or higher, while no state had a rate that high in 1991. The survey also noted that 56.4 percent of Americans were overweight, compared with 45 percent in 1991, contributing to a parallel rise in diabetes, with 15 million diagnosed adult cases last year, compared with 9 million in 1991. (Journal of the American Medical Association,
9-12-01; Associated Press, 9-13-01)

Humans Are Building Up Dangerous Levels of Resistance to Modern Antibiotics that Could Leave Them Vulnerable to Deadly Diseases, According to the U.N. World Health Organization (WHO)

The WHO said that farmers who use antibiotics to fatten livestock and poultry are aggravating the problem, because microbes on animals build up defenses against the drugs, then jump up the food chain and attack human immune systems. The WHO noted that tuberculosis strains in several countries had become resistant to two of the most effective drugs and that some antimalarial medicines had become practically useless as parasites adapted their defenses. (Philadelphia Inquirer, 9-12-01)

Gently Warming a Patient’s Skin Before an Operation Could Reduce the Risk of Surgical Wound Infection by More than 60 Percent, According to a Study Published in Lancet

A study of 416 surgery patients found that those who were treated with heat where the surgical cut was to be made saw a 64 percent reduction in the rate of infection compared to patients who received no heat treatment. Researchers noted that warming the body before cutting into it improves the distribution of oxygen, enabling the immune system to fight off bacteria that might gather around a wound, and also noted that the heating technique could be a valuable and simple alternative to giving antibiotics before surgery. (Associated Press, 9-13-01)

The U.S. Food and Drug Administration Is Taking More Time to Approve New Drugs Amid Evidence that They Can Do Little Else but Issue a Recall to Control Life-Threatening Side Effects Discovered After a Product Reaches Pharmacy Shelves

After a speed-up of drug approvals in the late 1990s, the median review time for first-of-their-kind drugs rose for the first time in seven years to 15.6 months last year from 11.6 months in 1999, while 13 all-new drugs having been approved so far this year, down from 22 in the same period last year. The rate of FDA recalls for safety flaws rose to 3.75 percent between 1996 and 2000, up from slightly more than one percent of all new drugs between 1971 and 1975. According to John Jenkins, director of the FDA's pulmonary, metabolic, and endocrinology drugs division, the ability of 'Dear Doctor' letters and labeling changes to manage drug risks by influencing physicians has been disappointing. (Bloomberg News, 9-9-01)

The Preponderance of Americans Who Donated Blood in Response to the Attacks on New York and Washington May Have Abruptly Ended the Nation’s Chronic Blood Supply Problems

After years of spot shortages that occasionally forced cancellation of nonemergency medical procedures, the American Red Cross took in more than 200,000 units of blood between Sept. 11 and Sept. 15, about twice its usual collection, while blood services across the nation saw donations double or triple. Other blood banks reported similarly dramatic increases and said they hope to keep new donors coming back several times a year for the rest of
their lives. The Red Cross, which collects half the nation's blood, is preparing to expand freezer capacity at most of its 36 regional blood banks, with frozen blood able to be stored for up to 10 years. (Washington Post, 9-18-01)

Peripheral Arterial Disease is Underdiagnosed and Undertreated Despite the Availability of a Simple Test for Detecting It – Comparing Blood Pressure in the Arms and Ankles, According to a Study Published in the Journal of the American Medical Association

A study of nearly 7,000 high-risk patients in 350 primary care physician offices in 25 cities found that 29 percent had the artery disease, including 823 diagnosed during the study, and that only about half of the doctors treating the patients knew about the previous diagnosis in the more than 1,000 cases diagnosed before the study began, although the patients' charts included the information. Among patients in whom the disease had already been diagnosed when the study started, more than 40 percent had not been prescribed aspirin or other blood-thinning medications and 12 percent were not on drugs to control high blood pressure, although most should have been taking them, (Journal of the American Medical Association, Associated Press, 9-19-01)

Whooping Cough Is Making a Comeback

The Centers for Disease Control and Prevention counted 56,775 whooping-cough cases during the 1990s, a 51 percent increase from the 1980s, and had reports of more than 7,000 cases last year, while suspecting that there may be ten times that amount because of underdiagnosis in teens and young adults. Experts warn new parents to keep infants away from coughing adults as scientists study whether millions of Americans should get booster doses of whooping-cough vaccine. (Associated Press, 9-23-01)

Antibiotics Are Selling Fast Amid Fears of Future Terrorist Attacks Involving Anthrax

Pharmacists in New York have sold greater-than-normal amounts of antibiotics for treating anthrax, amid rising fear of biological warfare. An alert was sent by the Ohio Department of Health, in conjunction with the Ohio State Medical Board, the Ohio State Pharmacy Board, the Ohio State Medical Association, the Ohio Emergency Management Agency and the Infectious Disease Society of Ohio, to local health departments, infectious control practitioners, hospital emergency departments and CEOs statewide urging doctors not to prescribe preventive antibiotics for patients to stash away in case of a bioterrorism attack. Although anthrax and some other diseases of biological warfare can be treated with antibiotics if the drugs are administered early enough, health officials are warning against the potential risks from indiscriminate use of antibiotics, including possible side effects, drug interactions and the increase of drug-resistant bacteria. (Boston Globe, 9-26-01; Akron Beacon Journal, 9-26-01)

The American Heart Association and the American College of Cardiology Revised Its Prevention Guidelines for Heart Attack Survivors to Recommend Wider Use of Beta-Blockers and ACE-Inhibitors, Along with More Aggressive Control of Risk Factors

A major change in the guidelines, first announced by the AHA in July, recommends that women not be prescribed estrogen solely to prevent strokes and heart disease, because of growing evidence that the supplements might cause harm. The changes are based on clinical trials completed since original guidelines were published in 1995. The guidelines were published in the September 25th issue of Circulation. (Associated Press, 9-24-01)

The World Health Organization Is Warning Governments to Be on the Alert for Attacks Using Chemical and Biological Weapons

Dr. Gro Harlem Brundtland, WHO director general, said the world has the capacity and the experience to control serious disease outbreaks, but stressed that national contingency plans, especially in countries where infectious disease outbreaks are rare, should be strengthened. "During the last week we have upgraded our procedures for helping countries respond to suspected incidents of deliberate infection," she said in her speech at the 43rd Directing Council of the Pan-American Health Organization. Guidelines for containing the resulting disease outbreaks - whether caused by anthrax, haemorrhagic viruses, other pathogens, biological toxins or noxious chemicals - are available to the medical profession through the WHO web-site <http://www.who.int/emc/deliberate_epi.html>. Any infectious agents or toxic chemical could in theory be engineered for deliberate use as a weapon. Experts in this field believe that smallpox, anthrax, botulism and plague are the pathogens most likely to be used. (Pan-American Health Organization, 9-24-01)

A Year After the Abortion Pill RU-486 Won Government Approval, Only Six Percent of Gynecologists Say They Are Offering the Early-Abortion Option, According to a New Survey Released September 24

Forty percent of the 595 gynecologists surveyed by the nonprofit Kaiser Family Foundation said they didn't offer the abortion pill, also called mifepristone or Mifeprex, because they personally oppose abortion. Of those who don't offer Mifeprex for other reasons, 62% said their patients simply hadn't asked for it and half also cited concerns about protest or violence. Another Kaiser survey of 1,000 women found that 42% confused the abortion pill with the so-called morning-after pill. (Associated Press, 9-25-01)

Medicare Will Soon Begin Paying for Thousands of Americans Who Take the Blood Thinner Coumadin to Use an At-Home Test to Ensure the Drug Is Working Properly

Payments will initially be restricted for patients who have artificial heart valves and use Coumadin or its generic version, warfarin. The Centers for Medicare and Medicaid Services said it is not yet convinced that paying for other Medicare patients to get at-home testing is cost-effective. (Associated Press, 9-27-01)

© 2002 Texas Osteopathic Medical Association
Last updated 01/14/2004