Recalls & Alerts Published by NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) has been notified by the U.S Food and Drug Administration (FDA) of the safety concerns on the use of Avycaz (ceftazidime and avibactam). Avycaz is approved for intravenous administration to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen in patients with limited or no alternative treatment options.

The FDA is warning about risk of dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion on how the strength was displayed on the Avycaz vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients in “2 gram/0.5 gram” format.

The reports involving Avycaz dose errors were apparently caused by confusion over the strengths displayed on the vial and carton labels. In the incident reports, doctors reportedly misunderstood that the product was based on the sum of the two ingredients, resulting in incorrect dosages administration.

To prevent medication errors, labels have been revised to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.

Action required from Prescriber/Patients

  • Healthcare providers are urged to exercise caution when administering the intravenous drug Avycaz and take note of strength of constituents displayed on vials and labels to avoid medication errors.
  • Report adverse events or side effects related to the use of these products to NAFDAC PRASCOR system (send text to 20543 from all network providers) or via adverse event report forms or e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. .
  • Patients should be encouraged to do same.

NAFDAC….Safeguarding the health of the Nation

The attention of the Agency has been drawn to the voluntary recall of Auvi-Q (Epinephrine injection USP) by Sanofi US. Auvi-Q (Epinephrine injection USP) is an injection given to the outer thigh used to treat life-threatening allergic reaction (anaphylaxis). It is for immediate self (or caregiver) administration and does not take the place of emergency medical care. It is used with caution in patients with heart diseases or other heart related symptoms. It works by narrowing and opening up airways and prevents drop in blood pressure and makes breathing easier.

The recall is due to the discovery by Sanofi that all Auvi-Q 0.15mg and 0.3mg strengths of lot numbers 2299596 through 3037230 which expires March 2016 through December 2016 have inaccurate dosage delivery (delivers inadequate doses).

Possible Risks

Patient with serious allergic reaction (anaphylaxis) who is not given intended dose when needed due to faulty dose delivery can have worsened health consequences including death.

Recalled product details

•           Manufacturer: Sanofi US

•           Expiration: March 2016 through December 2016

•           Lot number: 2299596 through 3037230

Health care Provider’s action

•           Make patient aware of the  possible risk of under dosing

•           Notify the Agency immediately of any available batch for further necessary action

•           Report adverse events or side effects related to the use of these products to NAFDAC      PRASCOR (20543, toll free from all network) or via individual case safety report forms and also encourage patients to do the same.

NAFDAC…safeguarding the health of the nation

The attention of the Agency has been brought to the voluntary recall of Multivitamin capsules produced by Glades Drug in Pahokee, Florida. The recalled multivitamin capsule contains high amounts of Cholecalciferol.

Cholecalciferol (Vitamin D3) is useful in maintaining bone and teeth integrity hence it is administered in treatment of osteoporosis, osteomalacia, rheumatoid arthritis and tooth or gum disease. It is also given to prevent fractures and low calcium levels in people with kidney failure and used in the prevention and treatment of rickets – a disease which results from Vitamin D deficiency. Vitamin D is used in the management of high blood pressure and high cholesterol levels. It also boosts the immune system and aids the prevention of autoimmune diseases such as cancer.

Administration of high doses of the drug could lead to Vitamin D toxicity which may be severe and lead to life threatening outcomes if left untreated. Vitamin D toxicity which often occurs as a result of hypercalemia presents as confusion, increased urination, increased thirst, loss of appetite, vomiting and increased muscle weakness. Long term toxicity may cause kidney failure, increased calcium deposits in the blood and soft tissue, bone demineralization and pains.

Healthcare Provider/Patient’s action

NAFDAC… Safeguarding the health of the Nation!

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