Pharmacists have been forced to recall batches of blood pressure tablets amid fears they contain a cancer-causing ingredient.
Apotex, the Canadian pharmaceutical corporation that produces the medication, is recalling APO Valsartan after discovering trace amounts of “substances that could potentially cause cancer”.
The recall was made in partnership with Australia’s Therapeutic Goods Administration (TGA) because the medication is commonly prescribed to patients around the country.
The valsartan-containing products are used to treat high blood pressure (hypertension) and other heart-related disorders, such as heart failure and heart attack.
Trace amounts of an impurity called N-nitrosodiisopropylamine (NDIPA) have been detected in the two active pharmaceutical ingredient batches used to manufacture APO Valsartan tablets currently in the Australian market. NDIPA belongs to the N-nitroso chemical class, known to contain mutagens and carcinogens — substances that could cause cancer.
However, the company has advised that it expects the health risk from use of these tablets is very low.
The products being recalled comprise: APO-Valsartan 40 mg / 80 mg / 160 mg / 320 mg tablets, APO-VALSARTAN valsartan 40 mg tablet blister pack (all batches), APO-VALSARTAN valsartan 80 mg tablet blister pack (all batches), APO-VALSARTAN valsartan 160 mg tablet blister pack (all batches) and APO-VALSARTAN valsartan 320 mg tablet blister pack (all batches).
The products were on sale nationally from July 9, 2018 to November 27, 2018.
Patients returning affected packs of APO Valsartan should be given a full refund and offered an alternative equivalent product by their pharmacist or referred to their doctor immediately.
Importantly, patients are being advised to consult a doctor or pharmacist before stopping or changing their medication, as it is riskier for patients to suddenly stop taking high blood pressure medication.
“We sincerely regret any inconvenience caused by this incident to both our customers and consumers, and thank all parties for their understanding, patience and support of Apotex’s ongoing commitment to ensuring public health and safety,” Apotex Managing Director Roger Millichamp said.
“We are notifying our distributors and customers about the recall in writing, placing advertisements in consumer print media, and calling for the immediate return of all APO-Valsartan products.”
APO Valsartan is also used to treat people after they have had a heart attack (myocardial infarction), to reduce the risk of further heart damage and reduce further heart problems.
The medicine was made available on the PBS (Pharmaceutical Benefits Scheme) on December 1, 2018.
For questions concerning the APO Valsartan product recall, please contact Apotex Customer Service on 1800 276 839 to coordinate a refund, or return it to the place of purchase.