Recalls & Alerts Published by NAFDAC

The attention of the Agency has been drawn to recent warning by the US Food and Drug Administration concerning some Medicines containing Pioglitazone (They include Actos, Actoplus Met, Actopus Met XR, Duetact, and Oseni) which increases the risk of bladder cancer in patients who have Type 2 diabetes as its often recommended for them.

Pioglitazone is a drug approved to improve blood sugar control, along with diet and exercise, in adults with type 2 diabetes. This Drug is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. It is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).

POSSIBLE RISK ASSOCIATED WITH THIS DRUG:

Patients with type 2 diabetes may experience the following symptoms after using Pioglitazone which may be due to bladder cancer and they are as follows;

Blood or a red color in the urine

New or worsening urge to urinate

Pain when urinating

DETAILS OF THE PRODUCT:

Product names:              Actos

                                                Actoplus Met (containing Metformin, Pioglitazone)

                                                Actoplus Met XR (containing Metformin, Pioglitazone)

                                                Duetact (containing Glimepiride, Pioglitazone)

                                                Oseni (Alogliptin/pioglitazone )

Product Manufacturer: The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland.

Manufacturing Date:       Unknown

Expiry date:                   Unknown

Health care professionals are advised not to use pioglitazone in patients with active bladder cancer, and should carefully consider the benefits and risks before using Pioglitazone in patients with a history of bladder cancer.

Patients are advised to contact their health care professionals if they experience any signs or symptoms after starting Pioglitazone, as these may be due to bladder cancer:

The Agency also encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC........Safeguarding the health of the nation!!!

The Agency warns against sale and Distribution of Nancy’s Fancy Butterscotch Budino Gelato and Nancy’s Fancy Peanut Butter with Crunchy Peanuts Gelato as they were produced in a co-packing facility and has the potential of being contaminated with Listeria monocytogenes, an organism which can cause fatal infection in young children, frail or elderly people and others with weakened immune system.

PRODUCT DETAILS

Product Names:             Nancy’s Fancy Butterscotch Budino Gelato

                                    Nancy’s Fancy Peanut butter with crunchy peanuts gelato

Brand Names:               Butterscotch Budino flavor and Peanut Butter with Crunchy    Peanuts flavor

Manufacturer’s name:     ISB Food Group, LLC of Los Angeles, Califonia

Expiration date: 18th March 2017

NAFDAC implores importers to ensure that they do not import these products and members of the public who have already purchased these products to noy eat them but to throw them away or take them back to point of purchase

NAFDAC.........Safeguarding the health of Nation!!!

The attention of the Agency has been drawn to the recent warning by the Singapore`s Health Science Authority against consumption of longred oyster and lifespark 100% Natural pain Relief Supplement  over undeclared potent ingredients  of all lots (i.e. ingredients not specified on the label). The product longred Oyster-x contains Sildenafil which is used to treat male erectile dysfunction and may lead to decreased or loss of vision and hearing, low blood pressure, strokes and heart attacks and LifeSparks 100% Natural pain supplement on the other hand contains chlorpheniramine, diclofenac, paracetamol, piroxicam, sulphamethoxazole and dexamethasone, a potent steroid usually prescribed for inflammatory

condition;

Risk Associated:

  • Long term unsupervised use of an oral steroid can cause increase blood glucose levels leading to diabetes, high blood pressure, cataracts, 
  • Use of this product may pose a threat to consumers because the undeclared active (Sildenafil)ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrate

INFORMATION ON PRODUCTS

  • Manufacturer: Paul Harrison International Singapore.
  • Drug specification: 20 count bottles.

In view of this, the:

  • Patients taking these drugs should contact their health care professionals right away if they experience symptoms or any adverse effect related to the use of this product.
  • Healthcare professionals are implored to report adverse effect or side effects related to the use of these products to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC...... Safeguarding the health of the nation!!!

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