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Case Of The Month - Past Issues
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Risk Management Alerts
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Vioxx Withdrawal
On September 30, the FDA issued a Public Health Advisory regarding Merck's voluntary withdrawal of VIOXX (rofecoxib) from U.S. and worldwide markets.
According to the FDA advisory, Merck voluntarily withdrew the non-steroidal anti-inflammatory drug in response to significant patient safety concerns arising from data obtained in a recent clinical trial. The FDA states that new clinical trial data suggest that Vioxx is associated with "an increased risk of serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo."
Physicians can expect to receive calls from concerned patients regarding discontinuing use and transitioning to other medications. Good risk management practice would suggest physicians discuss patient responses to Vioxx and closely monitor the transition to alternative medications.
Additionally, CAP Risk Management encourages physicians to reinforce the content of the FDA advisory and to refrain from offering personal opinions regarding the timeliness or wisdom of Merck's actions. Voicing opinions may cause patients to become critical of their physician's role in prescribing Vioxx.
For more information visit:
www.fda.gov , or 888-INFO-FDA (888-463-6322)
(FDA website offers questions and answers regarding Vioxx withdrawal)
www.merck.com and www.vioxx.com, or 1-888-368-4699
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RE: HORMONE REPLACEMENT THERAPY (HRT)
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) announced this week that a major clinical trial of the risks and benefits of combined estrogen and progestin in healthy menopausal women was stopped due to an increased risk of invasive breast cancer. The study was a component of the Women's Health Initiative (WHI) and also found increases in coronary heart disease, stroke, and pulmonary embolism in study participants on the above medications. The results applied to all women on the above medications, irrespective of age, ethnicity, or prior disease status. The study's findings will be published in next weeks' issue of The Journal of the American Medical Association (JAMA) but are now available at their web site www.jama.ama-assn.org.
Additional resources and patient recommendations can be found on the following sites:
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Reprint of October 11, 2001 CMA ALERT
(Used with Permission)
CALIFORNIA MEDICAL ASSOCIATION (CMA) REVS UP TO ASSIST MEDICAL PREPAREDNESS EFFORTS, ADDRESS BIOTERRORISM FEARS
To underscore warnings from public health agencies, CMA asks physicians to warn patients about the dangers of stockpiling antibiotics or taking them as a precaution against potential bioterrorism. "It is unwise for individuals to stockpile their own supply of powerful antibiotics such as Cipro, and especially dangerous for patients to be self-medicating," says CMA CEO Jack Lewin, M.D.
In other actions related to building preparedness for disaster in California, CMA is working with county and specialty medical societies, hospitals, and medical staffs who want to better coordinate emergency responses. CMA also urges physicians to volunteer for emergency response efforts and embrace existing response protocols at their hospitals. These volunteer activities should be coordinated with existing local, state, and federal public health and emergency response agencies.
CMA leaders asked that CMA Alert provide information that could help physicians calm their patients' anxieties over the anthrax cases in Florida and avoid a run on Cipro or other antibiotics that could cause more harm than good if the nation's supply is used unwisely. CMA next week will post to its Web site patient-oriented fact sheets in English and Spanish about misuse of front-line antibiotics.
Your patients should know that:
- It is extraordinarily rare for people to contract anthrax and requires great sophistication for anyone to maliciously disseminate it wisely.
- Having a supply of Cipro on hand may also do no good if you do not know when to start taking it, when to stop, or what illness you might have.
- Indiscriminate antibiotic use needlessly diminishes existing supplies and increases the resistance of dangerous organisms to antibiotics.
- Cipro was not developed for use in children, who may experience serious side effects from it.
- Many agents could be used for a bioterrorist attack, and vaccines and medications to prevent or minimize morbidity or mortality are specific for each agent. Anticipating which medications to keep on hand is practically impossible. Currently, there are no supplies of smallpox and anthrax vaccines for public use. It is also conceivable that agents used for bioterrorist actions have been engineered for resistance to known therapies and preventive measures.
- CDC has stockpiled critical antibiotics and other vaccines, ready for local distribution to affected populations within hours.
- Your physicians are well trained to quickly adapt their diagnostic skills to identify emerging diseases. Please try not to play doctor yourself.
CMA also recommends that members explore the following Web sites related to bioterrorist agents and antibiotic resistance:
- CDC Bioterrorism, http://www.bt.cdc.gov
- California Health Dept., Communicable Disease Control, http://www.dhs.ca.gov/ps/dcdc/bt/index.htm
- Nuclear, Biological, and Chemical Diseases, http://www.nbc-med.org/ie40/Default.html (includes textbook of military medicine and management of biological casualties handbook)
- AMA's Disaster Preparedness & Medical Response, http://www.ama-assn.org/ama/pub/category/6206.html
- CMA Foundation AWARE Project: http://www..aware.md.
See related article:
CMA BIOTERRORISM ACTION UPDATE-ADVICE FOR PATIENTS, INFORMATION FOR PHYSICIANS
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NOTICE TO CAP ORTHOPEDIC SURGEONS
SulzerMedica (Sulzer Orthopedics, Inc.) is contacting Orthopedic
Surgeons about the voluntary recall of the Inter-Op(tm) shell. This
product is a component of a commonly used hip replacement prosthesis.
Letters are currently being sent by Sulzer Orthopedics seeking
permission to participate in the defense of claims made against
physicians in connection with claims arising out of any defect in
Inter-Op(tm) shells used in surgery.
Should you be sued in connection with your use of the Inter-Op(tm)
shell, SulzerMedica's participation may present many advantages.
Nevertheless, the proposed terms of the letter agreement may affect
rights you have under state law and under the MPT Agreement.
Before signing this agreement, please contact the CAP Hotline at
(800) 252-0555. We are available to respond to your inquiries and to
provide further information for you.
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