Drug used in X-ray, painkiller recalled over safety concerns

The Pharmacy and Poisons Board has flagged several batches of Iodixanol sold under the brand name Visipaque and commonly used in X-rays.

This is after preliminary investigations showed they were substandard and falsified.

Healthcare facilities in possession of the affected product batches have been urged to immediately quarantine the products and report to the PPB offices for further guidance and necessary action.

Iodixanol belongs to a group of drugs called radiopaque contrast agents used to allow blood vessels, organs and other non-bony tissues to be seen more clearly on a CT scan or other X-ray examination.

Iodixanol is used to help diagnose certain disorders of the brain, blood vessels, heart, kidneys and other internal organs.

The PPB in a statement on Wednesday said the authority had received reports regarding the quality defects and adverse events associated with suspected substandard and falsified batches of Visipaque (Iodixanol) 320 mg/mL vial.

Upon receiving the complaints, the board initiated investigations into the matter, with preliminary reports indicating the product had entered the Kenyan market illegally.

“The PPB initiated preliminary investigations which revealed that the affected product batches had infiltrated the market illegally having been imported and distributed through unauthorised and illegal supply chains,” PPB CEO Fred Siyoi said.

According to the pharmaceuticals regulator, the affected product batches number 15950809, 15944839, 15950792 and 15906177 manufactured by GE Healthcare Ireland, Cork Ireland.

Also affected are batches number 5389618, 15429745, 15444386, 15661498, 15904073, 15751274, 16044911, 16085815, 16100415, 16107210 and 16177061 manufactured by GE Healthcare Shanghai Co, ltd China.

“In an effort to safeguard public health and safety, healthcare facilities in possession of these affected product batches are urged to immediately quarantine the products and report to the PPB offices for further guidance and necessary action,” Siyoi said.

“Further, PPB strongly cautions the public against engaging in any form of trade, distribution, wholesale, retail, issuance, dispensing or use of this product due to the serious safety and health risks it poses.”

Siyoi warned that any person found handling or distributing these products will be subjected to legal action.

The drug is recommended for use for diagnostic purposes only while procedures that involve the use of radiopaque imaging agents should be carried out under the direction of highly qualified personnel due to the possibility of serious reactions.

Experts advise that patients should be well-hydrated prior to, and following, administration of any contrast medium, including Visipaque, to prevent from acute renal failure.

This applies especially to patients with multiple myeloma, diabetes mellitus, renal dysfunction and elderly patients.

Paracetamol

The board has also recalled certain batches of a popular painkiller over alleged quality concerns.

The PPB urged members of the public to return specified batches of paracetamol oral solution sold under the brand name Tamedol for failing to meet market requirements.

Siyoi said the authority had received multiple market complaints on the quality of several batches of the Tamedol oral solution 120mg/5ml, 60mls manufactured by Biopharma Ltd.

Tamedol is widely used for headaches, colds and influenza, backache, period pain, pain of osteoarthritis, muscle pain, toothache, and rheumatic pain.

Siyoi said that upon receiving the complaints, the PPB undertook investigations into the issues raised by the public.

“PPB upon investigations indeed confirmed that the product failed to meet the prescribed market authorisation requirements and has initiated the mandatory recall of the product by the manufacturer in line with section 3A(i) of the Pharmacy and Poisons Act (Cap.244),” Siyoi said.

“In light of the above findings, the PPB advises all pharmaceutical outlets, healthcare facilities, healthcare professionals, and members of the public to take immediate action.”

Those with the specified batch will be required to quarantine the product or return it to the specified points.

Quarantine means they either stop further distribution, sale issues, or use of Tamedol oral solution.

“The public are urged to return the product to their nearest healthcare facility while healthcare facilities are instructed to return the products to their respective suppliers.”

PPB has called on the public to remain vigilant at all times and promptly report any suspected cases of substandard medicines or adverse drug reactions to the nearest healthcare facility of the PPB

He said the authority has put in place robust measures to guarantee that medicines supplied to the Kenyan market adhere to the requisite standards of quality, safety, and efficacy.