January 4, 2016 – The U.S. Food and Drug Administration (FDA) warned about Noxafil (posaconazole) and several serious adverse side-effects that have been reported, including one fatality when incorrect dosages were taken. Noxafil is used for the prevention of invasive Aspergillus and Candida infections among patients whose immune systems are impaired.
Noxafil is available as an injected medication, an oral suspension and delayed-release tablets. The suspension and tablets cannot be interchanged at the same dosages or dosing schedules because they release medication differently. Substituting either form for another form, even when using the same strength, can cause serious side effects if the dosage is too high and can fail to prevent infection and if doses are too low.
The FDA required statements cautioning about the lack of interchangeability on each product’s labeling. They also recommend that prescribers specifically indicate the dosage form, strength and schedule on prescriptions. Dispensers are advised to verify the form, strength, dose and frequency for any Noxafil prescription that is not clear.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.