Alarm as experts warn baby syrup can cause liver problems

 Panadol Baby and Infant Suspension by GSK   photo: courtesy

The recall of Panadol Baby and Infant Suspension by GlaxoSmithKline (GSK) weeks ago has triggered an alarm. Medical practitioners have warned that prolonged use of wrong dosage of syrups could have serious health implications. The Pharmaceutical Society of Kenya (PSK) President, Dr Paul Mwaniki, raised the red flag last month and revealed that the recalled drug was still in the market, despite complaints raised on dosage and calibrations of syringes packed for its administration.

Dr Mwaniki said that though there were no major issues with the Panadol suspension, the wrong dosage was subjecting babies to high levels of paracetamol that could cause liver complications in the long-term.

“If Panadol syrup is taken by a child continuously over a period of time, it will affect the liver,” Dr Mwaniki warned at a Mombasa workshop recently.

The revelation has caused panic and left many parents worried. Some told The Nairobian that they were confused and could neither identify the defective product nor recognise the health implications.

“We are getting contradictory information. In case of an overdose, what will happen, what are the symptoms? What should we do before it is late?” asked Susan Njeri, a city mother.

“As parents, we are concerned. Even if they are assuring us there will be no health implications, we shouldn’t gamble with our children’s lives. You can imagine how many parents have used this product. It was a common product,” says Lucy Gichuhi, an archivist with a communication organisation.

Chemists claim they withdrew the drug from the market after the alert was issued. “The distributors came for the defective batch. Though we are yet to receive any complaints from our customers, we are nonetheless concerned,” said a chemist on Harambee Avenue in Nairobi.

The Pharmacy and Poisons Board (PPB) says the recall has been initiated to remove all questionable batches manufactured before December 2014.

Board registrar, Dr Kipkerich Koskei, says that, “As the recall proceeds, we advise the public to use other registered brands of baby and infant paracetamol suspension available in the market.”

Paracetamol toxicity, which results from the excessive use or overdose of paracetamol, is one of the most common causes of poisoning worldwide. In some Western countries, it is the most common cause of acute liver failure. The discrepancies in the calibration on the syringes were found to subject children to an overdose of paracetamol of about two millimeters per intake of the syrup.

The discrepancy was discovered during a routine review by GSK but Koskei says there should be no panic as the risk of the anomaly has been reviewed and found to be very insignificant. When the British multinational pharmaceutical company announced the recall recently, it was reported that all the batches of the suspension sold in Kenya were suspicious in view of the discrepancies established.

GSK’s Communications Director Africa, Pat Senne, told The Nairobian that the company’s medical assessment determined the daily doses are unlikely to pose significant hazard in healthy children.

She however noted that, “There may be an increased safety risk in children with risk factors for hepatic (liver or renal) problems.”

By the time of recall, the company reported that the distributors had 1,650 batches of the medicine in their warehouses. By May 26, about 554 batches had been retracted, but it is still unclear how much of the drug is still with retailers and in households.

“All stocks from distributors and supermarkets have been recalled. Similarly, we have received most of the stocks from pharmacies. We have no reported cases which suggest accidental overdose or hepatic toxicity associated with the product,” Senne said.

But it is not just children who should be worried. Dozens of substandard medicines for adults could have been sneaked into the market by cartels as well, Dr Mwaniki cautions.

The PSK blames the increased incidents of uncertified drugs in the market on failure to crack the whip on responsible cartels.

“Such drugs, ranging from diabetic medicines, antibiotics, to those for treating high-blood pressure, are outlawed in home countries like India. Some have banned substances. How they make their way here is unclear. It is the work of cartels,” says Dr Mwaniki.

He cites the case of a consignment of sex-enhancing drugs, Vega 100mg tablets worth Sh44 million that were impounded and produced in court as evidence. The magistrate however ruled in favour of the importer and ordered the release of the consignment.

On May 3, Koskei said the drugs from Signature Pharmaceuticals in India were illegal and of questionable standards.

“The public, health workers and establishments, including chemists and pharmacies, are requested to be on the lookout for the presence of any or all the listed batches of the drugs and advised not to purchase or stock them,” Koskei warned in a public alert.

The Kenya Pharmaceutical Association Secretary General, Evans Maperu confirmed that defective medicine have found their way into the market.

“Once in a while it happens, but we work closely with the Pharmacy and Poisons Board to address the problem. When we are required to act, we will definitely act,” said Maperu.

For the last six years, the Kenya Bureau of Standards (Kebs) and Pharmacy and Poisons Board have banned several local and imported products. This include milk, noodles, eggs and animal feeds and inputs from China and other Asian countries.

About 40 brands of dry cell batteries, 10 brands of soaps, about 20 types of skin lightening lotions, and over 100 brands of skin lightening creams contaminated with mercury have been banned.