FDA Updates Warning for Alogliptin and Saxagliptin
April 11, 2016 – Updating their 2014 warning, the FDA warns of increased risks of heart failure for those taking alogliptin or saxagliptin. Also known as dipeptidyl peptidase-4 (DPP-4) inhibitors, these treatments, taken orally, treat type 2 diabetes. These drugs have the following brand names: Oseni® (alogliptin/pioglitazone), Kombiglyze® XR (saxagliptin/metformin extended release), Kazano® (alogliptin/metformin), Nesina® (alogliptin), and Onglyza® (saxagliptin). An FDA report showed that of those who took alogliptin or saxagliptin, more had to be hospitalized for heart failure than patients who took a placebo tablet. Those with heart or kidney disease were most likely to be affected. The brand name drugs listed above will have updated warning labels immediately. The FDA recommends patients notify their doctors about fatigue, rapid weight gain, shortness of breath, and swelling in the feet, legs or stomach. These are all symptoms of heart failure. Prescribers are urged to observe potential signs of heart failure among their patients who take alogliptin or saxagliptin and consider prescribing a different antidiabetic medication if necessary.
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 1-800-332-0178
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.