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Zanamivir is only approved for use with the Diskhaler device that is provided in the package with the flu medicine. Relenza is not designed or intended to be administered by nebulization....
According to the FDA, there is a risk that the lactose sugar used in the formulation of this flu medicine can interfere with the proper functional of mechanical ventilator equipment. The reported death occurred outside of the United States, and the patient was a pregnant woman on a ventilator who received the nebulized flu medicine solution for 3 days.
[Posted 10/09/2009] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation.
The effects of two pharmacologically distinct histamine H2 receptor antagonists were studied in combination with ibuprofen (I) and diphenhydramine (D) in a porcine model of septic ARDS. Cimetidine (C) is reported as having direct oxygen radical scavenging abilities and is an inhibitor of cytochrome P-450, whereas ranitidine (R) acts solely by H2 receptor blockade.
Indigestion, or dyspepsia, affects at least 20% to 40% of the general population, and most victims take something to reduce acidity - an acid-suppressing drug. Acid suppressants are of two types: H2-receptor blockers, like Tagamet® (cimetidine), Pepcid® (famotidine) and Zantac® (ranitidine), or a proton-pump inhibitor, like Prilosec® (omeprazole) and Nexium® (esomeprazole). It's now emerged that these drugs, apart from the benefit they have on the indigestion symptoms, may have an unexpected side effect - an increased risk of the patient acquiring pneumonia.
[Posted 11/13/2009] FDA and Genzyme notified healthcare professionals about the potential for foreign particle contamination of several products that are used to treat rare, serious, and life-threatening diseases. The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process and could potentially cause serious adverse events in patients....
Potential adverse events from IM administration of a contaminated product could include local pain, swelling and inflammation. Potential adverse reactions from IV administration of a product contaminated with foreign particles could be more serious, including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions....
The Agency is acutely aware of the critical need for patients to have continued access to these important products. In reaching its decision to allow these products to continue to be marketed, FDA has carefully considered the potential for serious adverse events, the likelihood that the recommendations in this notice will significantly reduce the risk of administration of contaminated products, and the lack of FDA-approved therapeutic alternatives for these products. The FDA is actively investigating the nature of the contamination and seeking immediate implementation of corrective actions to mitigate the situation.
FDA approved Tamiflu (oseltamivir phosphate), an oral anti-viral drug for the treatment of uncomplicated influenza in patients one year and older whose flu symptoms have not lasted more than two days. This product is approved to treat Type A and B influenza; however, the majority of patients included in the studies were infected with type A, the most common in the U.S. Efficacy of Tamiflu in the treatment of influenza in subjects with chronic cardiac disease and/or respiratory disease has not been established.
Tamiflu is also approved for the prevention of influenza in adults and children aged one year and older. Efficacy of Tamiflu for the prevention of influenza has not been established in immunocompromised patients.
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (DHHS) determined that a public health emergency exists involving Swine Influenza A (now called 2009-H1N1 flu) that affects or has significant potential to affect national security. Pursuant to section 564(b) of the Act (21 U.S.C. § 360bbb-3(b)), and on the basis of such determination, the Secretary of DHHS then declared an emergency justifying the authorization of the emergency use of certain oseltamivir phosphate products subject to the terms of any authorization issued under section 564(a) of the Act (21 U.S.C. § 360bbb-3(a)). The Secretary's determination of emergency has been renewed. The Secretary's April 26, 2009 declaration of emergency justifying an EUA remains in effect.
The authorized oseltamivir phosphate products are as follows:
Tamiflu (oseltamivir phosphate) (30 mg, 45 mg, and 75 mg) capsules
Tamiflu (oseltamivir phosphate) oral suspension
Oseltamivir phosphate products are approved and indicated for the treatment of uncomplicated acute illness due to influenza infections in patients 1 year and older who have been symptomatic
2 FDA is authorizing the emergency use of Tamiflu (oseltamivir phosphate) (30 mg, 45 mg, and 75 mg) capsules and oral suspension for treatment and prophylaxis of influenza as described in the scope section of this letter (Section II). For ease of reference, this letter of authorization will use the terms “certain oseltamivir phosphate product(s)” and “authorized oseltamivir phosphate product(s).”
3 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
for no more than 2 days. Oseltamivir phosphate products are also approved and indicated for the prophylaxis of influenza in patients 1 year and older.4
1. The above oseltamivir phosphate products are authorized for use in patients less than 1 year old. Such products are also authorized for use at later time points (i.e., patients who are symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization (i.e., patients who do not have “uncomplicated acute illness” per se).
2. The above oseltamivir phosphate products labeled consistent with the manufacturer’s label are authorized to be distributed under this EUA. Such products are authorized to be distributed or dispensed without the requisite prescription label information under section 503(b)(2) of the Act (e.g., name and address of dispenser, serial number, date of prescription or of its filling, name of prescriber, name of patient, if stated on prescription, directions for use and cautionary statements, if contained in the prescription), except for product described in paragraph 3c. below that is held by entities that are not public health authorities.
3a. The above oseltamivir phosphate products may include products that are deployed from the SNS and that have passed testing under the federal government’s Shelf Life Extension Program (SLEP) for use beyond their expiration dates.
Although authorized oseltamivir phosphate products should be held in accordance with CGMP holding requirements, including appropriate product storage conditions7, I am waiving CGMP requirements with respect to the holding of authorized oseltamivir phosphate products by CDC
Only CDC may request changes to the authorized Fact Sheet for Health Care Providers and authorized Fact Sheet for Patients and Parents/Caretakers. Such requests will be made by contacting FDA concerning FDA review and approval.
However, the appropriate public health authorities will ensure that authorized oseltamivir phosphate products are distributed, dispensed, and/or administered to patients less than 1 year old only under the supervision of a licensed healthcare provider.