Texas D.O. Online - September 2001

Contact Information

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toma@txosteo.org

Health Notes

Texas D.O. Online
November 2001

The FDA Will for the First Time Regulate Certain Types of Fertility Treatments

In a letter sent to fertility clinics July 6, the FDA has informed doctors that they must fill out an Investigational New Drug application-the same form that pharmaceutical companies fill out when they want to test a new drug on humans-if they want to do experimental fertility procedures that involve mixing male and female genetic material in a way other than the union of sperm and egg. The new oversight will apply to a technique in which fluids from a young woman's egg are injected into an infertile woman's egg before that older woman's egg is fertilized by her husband's sperm. The FDA wants to ensure that precautions are being taken to minimize risks from the resulting genetic blend, as children born
by the technique have been shown to contain genes from all three people. (Washington Post, 7-11-01)

Lung Cancer Patients Who Undergo Lung Surgery at a Teaching Hospital That Performs a High Volume of Procedures Have a Better Survival Rate and Suffer Fewer Complications, According to a Study Published in the New England Journal of Medicine

A study of 2,000 patients older than 65 years of age who had lung resection surgery at 76 hospitals nationwide from 1985 to 1996 found that patients who had surgery in a hospital with a high number of procedures--67 to 100 a year-had five-year a survival rate of 44 percent, while patients who had surgery in a hospital with fewer than nine procedures a year had a survival rate of only 33 percent, with an average five-year survival rate of 38 percent for all patients. Patients who had surgery at a low-volume hospital had a 44 percent chance of developing complications such as a punctured lung or pulmonary collapse, while those who had surgery at a high-volume hospital had only a 20 percent chance of
suffering complications. (New England Journal of Medicine, 7-19-01; Yahoo News, 7-19-01)

FDA News

· FDA Issues Guidance on Levothyroxine Sodium Products Compliance -- Manufacturers of unapproved hypothyroidism drugs will have to cease distribution of their products.
http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01089.html

· Antibiotic Resistance Page Debuts -- FDA has created a new Web page that brings together sources of information on the growing problem of disease-causing microbes that have become resistant to drug therapy. http://www.fda.gov/oc/opacom/hottopics/anti_resist.html

· FDA Approves Hepatitis C Drug Formerly Available in Combo Package – Rebetol (ribavirin), an antiviral drug for use with Intron A (interferon alfa-2b) as a treatment for chronic hepatitis C infection, is now approved as a "stand-alone," giving patients and health care providers flexibility in adopting individualized therapies. Rebetol and Intron A have been approved since 1998 as a combination package. http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01092.html

· FDA Clears Camera Pill to Photograph Small Intestine -- FDA has cleared for marketing a tiny camera in a capsule that, after it has been swallowed, snaps pictures as it glides through the small intestine.
http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01094.html

MedWatch News

· The FDA Center for Devices and Radiological Health (CDRH) issued a Public Health Advisory alerting healthcare professionals to the potential for patient injury when cryogenic vessels containing medical gas are misconnected to oxygen delivery systems. See the CDRH web page with the full text of the advisory at: http://www.fda.gov/cdrh/safety/medical-gas-misconnect.html

· Ultra Botanicals, Inc. of Los Angeles, CA, is recalling all lots of its 1ounce bottles of "MSM Eye Drops" and "MSM Eyes & Nasal Drops" due to potentially serious health risks associated with bacterial contamination. Samples analyzed by FDA were found to contain Pseudomonas mendocina and Klebsiella pneumoniae, bacteria that in some cases can cause sight-threatening injury. See the MedWatch 2001 Safety Alert summary at: http://www.fda.gov/medwatch/safety/2001/safety01.htm#msmeye

· FDA and Purdue Pharmaceuticals have strengthened the warnings and precautions sections in the labeling of OxyContin, a narcotic drug approved for the treatment of moderate to severe pain, because of continuing reports of abuse and diversion. The changes are intended to reinforce proper prescription practices and increase physician focus on the potential for abuse, misuse, and diversion. See the MedWatch 2001 Safety Summary for OxyContin at http://www.fda.gov/medwatch/safety/2001/safety01.htm#oxycon

· Pacific BioLogic Co. is recalling capsules containing the herb Akebia Trifoliata Caulis (Mu Tong) and the herb Asarum Sieboldii Herba cum Radix (Xi Xin); as these herbs may present a serious health hazard to consumers. These herbs contain aristolochic acid, a potent carcinogen and nephrotoxin found in certain plants and botanicals. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The use of aristolochic acid -containing products has been linked to increased risk of kidney cancer in people who have consumed it. For more info on specific products named in the recall and other Aristolochic Acid safety alerts, see the 2001 MedWatch Safety Information page at http://www.fda.gov/medwatch/safety/2001/safety01.htm#aristo

· Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction, from this cholesterol-lowering (lipid-lowering) product. To read the latest MedWatch 2001 safety summary for Baycol, including Bayer's "Dear Health Professional" letter and FDA's Talk Paper and Q&A web
pages, go to http://www.fda.gov/medwatch/safety/2001/safety01.htm#bayco2

2001-2002 Flu Vaccine Supply and Production

The Centers for Disease Control and Prevention note that this season, the total flu vaccine supply will be greater than in 2000-2001 and comparable to the supply in the 1999-2000 season. Some delays are projected, but they are not expected to be as great as last year’s delays. It’s anticipated that the total supply by the end of November should be adequate. Vaccine manufacturers project that 77.1 million doses of influenza vaccine will be distributed this season.

Because of vaccine delays, however, the Advisory Committee on Immunization Practices recommends the following for the 2001-02 influenza season:

· Providers should target vaccine available in September and October to persons at increased risk for influenza complications and to health care workers. The optimal time for vaccinating high-risk persons is October through November.

· Beginning in November, providers should offer vaccine to contacts of high-risk persons, healthy persons aged 50-64 years, and any other persons wanting to reduce their risk for influenza.

· Providers should continue vaccinating patients, especially those at high risk and in other target groups in December and should continue as long as there is influenza activity and vaccine is available.

As preparation for the 2001-02 influenza season proceeds, updates on vaccine supply and other information about vaccination will be available at http://www.cdc.gov/nip/flu