This Day (Lagos)

Nigeria: Nafdac, Luth, Barewa Trade Blames

Lagos — The last is yet to be heard of My Pikin teething mixture, the allegedly contaminated drug, which reportedly killed 25 children between the ages of four months and three years at different locations in the country.

Barewa Pharmaceuticals Limited, manufacturers of the teething mixture, last night took issues with the National Agency for Food and Drug Administration and Control (NAFDAC) that its teething mixture was responsible for the alleged death of the children.

It called for a probe of the incident.

Also yesterday, the Lagos State University Teaching Hospital (LUTH), Idi-Araba said NAFDAC should be blamed for the deaths.

There was no activity of any sort at the company yesterday as its premises on No 1-5, Olugbo Close Shasa Road, Akowonjo, Lagos.

NAFDAC Director-General, Prof. Dora Akunyili, had at a news conference two days ago in Lagos alleged that 15 children died at LUTH, eight at the Ahmadu Bello University Teaching Hospital, Zaria, while two died at the University College Hospital, Ibadan as a result of the use of the mixture.

"Seven paediatric patients within the ages of one to three years were referred to the UCH from hospitals in Lagos. The seven toddlers had renal failure linked to administration of My Pikin," Akunyili said, pointing out that two out of the seven died.

But in a statement by Barewa Pharmaceuticals and signed by its Chairman, Mr. Kola Okunlola, the company said it was surprised by the allegations of NAFDAC in the face of facts by some of the teaching hospitals disclaiming the agency's reports.

The company said it not only has NAFDAC licence to produce the drug, it had also produced thousands of the drugs for more than two years without complaints from users or NAFDAC.

Barewa Pharmaceuticals said it has come out clean from routine inspections of its production facilities and products by relevant government agencies including NAFDAC and expressed surprise at its castigation in the media when NAFDAC is yet to conclude its investigation into alleged deaths of patients in the hospitals.

The company said: "As a responsible corporate citizen of Nigeria and one that is involved in the protection and promotion of good health, we are shocked at the claims of deaths of children in some of the nation's hospitals.

"We are, however, bothered that there are conflicting claims between NAFDAC and the teaching hospitals regarding the deaths and the cause of such deaths.

"For instance, the Chairman of the Medical Advisory Committee of the University of Ibadan Teaching Hospital has disputed claims that some children died in the hospital. We also note that the Chief Medical Director of the Lagos University Teaching Hospital has also disputed claims that the deaths recorded in the hospital were due to the consumption of a particular drug. As the CMD said only a conclusive laboratory test will reveal the cause of such deaths.

"As operators in the health sector committed to the promotion of good heath, we are shocked and sympathetic to the patients and their family. We are interested in the investigation of the cause of such deaths. This explains why we instructed our lawyers today (Wednesday) to address a letter to NAFDAC, requesting for a copy of the result of the tests.

"We hereby affirm our readiness to cooperate with NAFDAC and other relevant agencies to establish the truth in this case. We also wish to allay fears about the reliability of our products. We are a responsible corporate citizen of Nigeria and have operated in the past years in compliance with the best of international standards to promote good health in the country and beyond."

Last night, however, NAFDAC insisted its investigations had revealed that a batch of My Pikin produced in August was contaminated.

"We have the lab reports. The batch was contaminated," Akunyili told THISDAY on phone.

NAFDAC had earlier blamed LUTH for not informing the agency when the first few children died at the hospital as a result of My Pikin.

At a press briefing yesterday, Chairman Medical Adversary Committee of the hospital, Prof. James Renner, who stood in for the Chief Medical Director, Prof. Akin Osibogun, who was said to have gone to Abuja on official assignment, noted that before any drug is sold in Nigeria, such product must have gone through NAFDAC's approval.

He said if any product registered by the agency is found dangerous, then the agency must be blamed.

He said when the hospital experienced the death of the first six children over the same cause, it immediately alerted the Federal Ministry of Heath and the Lagos State Ministry of Health, informing both ministries that LUTH had a case of epidemic on its hands.

According to him, in a situation like that before an alarm could be raised, the hospital has to convince itself beyond reasonable doubt that the case at hand is genuinely that of epidemic.

Renner said the hospital in the first few days of recording the deaths of the children started putting certain theories together to get to the root of the deaths, noting that the management immediately sent sample of the paracetamol to its pharmacy department to try it on the rabbit to see how the animal will react to the drug.

"If it dies, it means the drug is the cause of the children," he said, adding that there was good reason for the hospital to think of some other reasons why the children were dying.

"For example," he said, "just recently, there was the case of teething powder, the gold milk from China before the My Pikin, and the hospital thinks it might be the gold milk that has found its way into the country."

According to Renner, 20 children were brought to the hospital out of which 15 died; two were referred to UCH Ibadan while one of the children was treated by LUTH.

One was discharged on medical advice but the hospital could not give account of the condition of the last child for now, he said.

NAFDAC said yesterday that all around the world, a development of this nature is usually reported to the regulatory agencies, not just the Ministry of Health, which reportedly did not notify NAFDAC about LUTH's report on the fatal medicine.


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