oseltamivir FDA Alerts
The FDA Alert(s) below may be specifically about oseltamivir or relate to a group or class of drugs which include oseltamivir.
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. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for oseltamivir
Tamiflu: Counterfeit Product Sold on Internet
Jun 17, 2010
Audience: Consumers, Pharmacists
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]
More oseltamivir Resources
- Oseltamivir Consumer Information
- Oseltamivir Capsules Consumer Information
- Oseltamivir Suspension Consumer Information
- Oseltamivir Advanced Consumer Information
- Oseltamivir Phosphate AHFS DI Monograph
- Oseltamavir Capsules Prescribing Information
- Oseltamivir Prescribing Information
- Oseltamivir Oral Suspension Prescribing Information
- Oseltamivir A-Z Drug Facts