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Biotech / Medical : GUMM - Eliminate the Common Cold -- Ignore unavailable to you. Want to Upgrade?

To: Bo Didley who wrote (3411)	12/5/2000 7:14:54 AM
From: george eberting	Read Replies (1) \| Respond to of 5582

The FDA apparently has just issued a new health advisory with strong recommendations adverse to certain drugs used to reduce flu symptoms. This follows a previous warning issued last January. I was not able to find the latest advisory on the FDA site, but the January warning is provided below. Two thoughts. a. Zicam is offered as a treatment for the common cold, not influenza. b. Has Zicam been sold off the past couple of days because of "guilt by association", (even if they aren't truly associated at all)? PUBLIC HEALTH ADVISORY SUBJECT: SAFE AND APPROPRIATE USE OF INFLUENZA DRUGS 12 January 2000 Dear Health Care Professional: Diagnostic and therapeutic decisions for patients with symptoms of influenza involve many factors, including consideration of whether to prescribe one of the four drugs currently approved for treatment of influenza. Two of these drugs, amantadine (Symmetrel® and others) and rimantadine (Flumadine®), have been available for many years in the United States. The recent approval of, and promotional activities for, two additional drugs, zanamivir (Relenza®) and oseltamivir (Tamiflu®), have increased attention to, and interest in, the role of specific anti-viral therapy in this disease. Given that influenza is now occurring in many areas of the country, FDA is issuing this public health advisory to health care professionals to remind prescribers of important clinical decisions that need to be made when considering use of anti-viral drugs for treatment of patients with signs and symptoms of influenza. The following three considerations are important primarily for two reasons. First, they are important in identifying patients who are appropriate candidates for anti-viral therapy. Secondly, they are important in recognizing patients who may be at risk for serious adverse outcomes from other non-influenza diagnoses or from adverse events potentially related to anti-influenza therapy. 1.Vaccination remains the primary method of preventing and controlling influenza. 2.Always consider the possibility of primary or concomitant bacterial infection when making treatment decisions for patients with suspected influenza. When initiation of anti-viral therapy alone is considered on a presumptive basis, ongoing clinical assessment and diagnostic evaluation of the patient continues to be important. FDA has received several reports of patients with serious bacterial infections who initially had influenza-like symptoms and whose bacterial infections progressed during treatment with antiviral drugs alone. Prescribers should be aware that patients with severe influenza-like illness, especially patients with chronic medical conditions or complicated manifestations of acute illness, might have significant bacterial infections instead of, or in addition to, viral illness. These anti-viral products have no activity against bacterial infections. Appropriate anti-bacterial therapy should be initiated whenever bacterial infection is suspected. 3.Use special caution if prescribing Relenza® to patients with underlying asthma or chronic obstructive pulmonary disease (COPD). FDA has received several reports of deterioration of respiratory function following inhalation of Relenza® in patients with underlying asthma or COPD. Causal relationships with drug therapy are extremely difficult to evaluate in the setting of complex medical processes, but the possibility can not be excluded that an acute decline in respiratory function may contribute to a fatal outcome in patients with a complicated pre-existing medical history and pulmonary compromise. The Relenza® package insert contains important precautionary information regarding risks of bronchospasm in patients with underlying airway disease and regarding the lack of proven efficacy in such persons. If a decision is made to prescribe Relenza® for a patient with underlying airway disease, this should be done with careful consideration of the potential risks and benefits. In such patients, Relenza® should be used under conditions of careful monitoring, proper observation and appropriate supportive care, including the availability of short-acting bronchodilators. The evidence for use of anti-viral drugs to treat influenza is based principally on studies in patients with uncomplicated influenza. There is not clear evidence for safety and efficacy in persons with underlying respiratory or cardiac diseases, or in persons with complications of an acute influenza episode (for example, viral or bacterial pneumonia). Such patients may require extensive supportive and adjunctive care. Anti-viral therapy has not been shown to reduce the need for such care and monitoring. All health care professionals are encouraged to report any serious adverse event associated with the use of anti-viral drugs for influenza to the FDA’s MedWatch program at 1-800-FDA-1088 (fax 1-800-FDA-0178), or to the respective pharmaceutical manufacturers: Flumadine® (rimantadine), Forest Pharmaceuticals, Inc., 1-800-678-1605 Relenza® (zanamivir), GlaxoWellcome, Inc. 1-800-825-5249 Symmetrel® (amantadine; also available in generic forms), Endo Pharmaceuticals, Inc., 1-800-462-3636 Tamiflu® (oseltamivir), Roche Laboratories, Inc., 1-800-526-6367 Sincerely yours, Murray M. Lumpkin, M.D. Deputy Center Director (Review Management) Center for Drug Evaluation and Research Food and Drug Administration

To: Bo Didley who wrote (3411)	12/6/2000 1:51:13 PM
From: Bob Trocchi	Read Replies (1) \| Respond to of 5582

Bo... >>Everyone go talk to your local pharmacists at any store.<< Unless you go to a CVS store. I have yet to find a CVS store who carries ZICAM in either the suburban Boston or Nashville City stores. Hmmm.. I wonder why. Does anyone know of a CVS store anywhere who carries Zicam? NOte.. CVS has the largest number of retail outlets of any drug chain. I am not long or short but do enjoy this thread. I really feel I goofed some time back by not shorting but live and learn. Cheers Bob T.