FDA Approved Inhaled Diabetes Treatment
June 30, 2014 – The Food and Drug Administration (FDA) approved Afrezza manufactured by the Mannkind Corporation. Afrezza is an inhaled diabetes therapy which has been approved for Type 1 and Type 2 diabetes.
Because the medication is inhaled, it gives patients a new convenient option for insulin treatment. The packaging will contain a warning for this medication as it can cause acute bronchospasms in asthma and chronic lung disease patients. Studies will be conducted to evaluate Afrezza’s safety in children and to gauge any potential for lung cancer and heart risks.
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 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.