Tamiflu FDA Alerts
The FDA Alerts below may be specifically about Tamiflu or relate to a group or class of drugs which include Tamiflu.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Tamiflu
Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)
Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012).
ISSUE: Labeling changes are being made to Tamiflu oral suspension to reduce the possibility of prescribing and dosing confusion that can lead to medication errors. The changes to the product label include:
- A change in the concentration of Tamiflu from 12 mg/mL to 6 mg/mL. The lower concentration of Tamiflu is less likely to become frothy when shaken, which helps to ensure an accurate measurement. A change in the measurements of the oral dosing device from milligrams (mg = weight) to milliliters (mL = volume).
- A change in the dosing table for Tamiflu to include a column for the volume (mL) based on the new 6 mg/mL concentration. Revised container labels and carton packaging. Revised compounding instructions for pharmacies to prepare a 6 mg/mL oral suspension from Tamiflu capsules in an emergency situation only if the commercially manufactured Tamiflu for oral suspension is unavailable.
BACKGROUND: Tamiflu is in a class of medications called neuraminidase inhibitors. These drugs work by stopping the spread of the influenza (flu) virus in the body. Genentech, the manufacturer of Tamiflu for oral suspension, plans to begin distribution of the new 6 mg/mL product in July 2011. The company has instituted a voluntary Take Back Program for wholesale buyers, distributors and pharmacies to remove the 12 mg/mL product from the marketplace. The 12 mg/mL product will remain in the marketplace and in state or national stockpiles until current supplies expire.
RECOMMENDATION: It is important for healthcare professionals to be aware that a patient may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012). Steps should be taken to avoid the potential for a medication error due to confusion between the two concentrations. Prescribers should include the new concentration (6 mg/mL) and dose in milliliters on all prescriptions for Tamiflu for oral suspension.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[07/11/2011 – Drug Safety Communication - FDA]
[12/11/09 - Tamiflu Information Page - FDA]
Tamiflu: Counterfeit Product Sold on Internet
Fraudulent product is dangerous to patients allergic to penicillin
Issue: FDA notified consumers and healthcare professionals about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin. Patients who are allergic to penicillin products are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse.
Background: The FDA bought the fraudulent "Generic Tamiflu" without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations. Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements.
Recommendation: The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by visiting the OCI website (http://www.fda.gov/OCI).
Consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178
[06/17/2010 - News Release - FDA]
Tamiflu (oseltamivir) for Oral Suspension
[UPDATED 10/16/2009] FDA News Release: FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet.
[UPDATED 10/05/2009] New information added to web site.
[UPDATED 09/25/2009] New links added to provide information on emergency use in infants less than 1 year of age and directions to pharmacists on emergency compounding of oral suspension from capsules.
[Posted 09/24/2009] FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser. Health care providers should write doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.
[10/15/2009 - News Release - FDA]
[10/02/2009 - Information for Healthcare Professionals - Authorization of Use of Expired Tamiflu for Oral Suspension - FDA]
[10/02/2009 - Treatment of Influenza During Pregnancy - FDA]
[09/25/2009 - Emergency Compounding of an Oral Suspension from Tamiflu 75 mg Capsules (Final Concentration 15 mg/mL) - FDA]
[09/25/2009 - Emergency Use of Tamiflu in Infants Less than 1 Year of Age - FDA]
[09/24/2009 - Public Health Alert - FDA]
[09/23/2009 - Information for Pharmacists - CDC]
Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors
[UPDATED 09/25/2009] New links added to provide information on emergency use in infants less than 1 year of age and directions to pharmacists on emergency compounding of oral suspension from capsules.
[Posted 09/24/2009] FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser. Health care providers should write doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.
[09/25/2009 - Emergency Compounding of an Oral Suspension from Tamiflu 75 mg Capsules (Final Concentration 15 mg/mL) - FDA]
[09/25/2009 - Emergency Use of Tamiflu in Infants Less than 1 Year of Age - FDA]
[09/24/2009 - Public Health Alert - FDA]
[09/23/2009 - Information for Pharmacists - CDC]
Tamiflu for Oral Suspension: Potential Medication Errors
FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser. Health care providers should write doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.
[09/24/2009 - Public Health Alert - FDA]
[09/23/2009 - Dear Healthcare Professional letter - Roche]
[09/23/2009 - Information for Pharmacists - CDC]
Tamiflu (oseltamivir phosphate) - Mar 3, 2008
[Posted 03/04/2008] Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza. These symptoms, as described in post marketing reports mostly from Japan, include delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated.[February, 2008 - Dear Healthcare Professional Letter - Roche]
Tamiflu (oseltamivir phosphate) - Jan 4, 2007
Indication: Treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days.[Posted 01/04/2007] Roche notified healthcare professionals of a correction to a Dear Healthcare professional letter issued on November 13, 2006. The original letter referenced changes to the PRECAUTIONS Section of prescribing information for Tamiflu about post marketing reports of self-injury and delirium with the use of Tamiflu in patients with influenza. The prescribing information that accompanied the letter contained an incorrect dosing chart for the Standard Dosage of Tamiflu Oral Suspension for prophylaxis of influenza in pediatric patients. The chart incorrectly specified twice daily instead of once daily dosing under "Recommended Dose" for 10 days. Healthcare professionals should discard the incorrect version of the package insert included in the November 13, 2006 mailing and refer to the new dosing chart included in the December 26, 2006 letter.
[December 26, 2006 - Letter - Roche]
Tamiflu (oseltamivir phosphate) - Nov 13, 2006
[Posted 11/13/2006] Roche and FDA notified healthcare professionals of revisions to the PRECAUTIONS/Neuropsychiatric Events and Patient Information sections of the prescribing information for Tamiflu, indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days and for the prophylaxis of influenza in patients 1 year and older.There have been postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior. A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior.[November 13, 2006 - Letter - Roche]
[November 13, 2006 - Prescribing Information - Roche]
Tamiflu (oseltamivir phosphate) Capsules and for Oral Suspension
Roche Laboratories and FDA notified healthcare professionals of new preclinical safety data that have implications for the use of Tamiflu in very young children. Preclinical findings in juvenile rats have raised concerns regarding the use of Tamiflu in infants less than 1 year of age. A single dose of 1000 mg/kg oseltamivir phosphate (about 250 times the recommended dose in children) in 7-day-old rats resulted in deaths associated with levels of oseltamivir phosphate in the brain approximately 1500 times those seen in adult animals. It is likely that these high exposures are related to an immature blood-brain barrier. The clinical significance of these preclinical data to human infants is uncertain. Given the uncertainty in predicting the exposures in infants with immature blood-brain barriers, it is recommended that Tamiflu not be administered to children younger than 1 year.[December 2003 Letter - Roche Pharmaceuticals]
[October 2001 Package Insert - Roche Pharmaceuticals]
