Dagi Kimani
7 August 2007
Nairobi — The Swiss company has withdrawn Viracept, its second line Aids medicine due ti a potentially cancer-causing substance. The global recall of the Aids medicine, Viracept, has sparked the biggest prescription drug return in East Africa, with medicines worth more than $2 million being returned to Nairobi-based Roche Products, the regional distributor.
In total, more than 26,200 packs each of 270 tablets of the drug had been put out of circulation by last week in Kenya, Uganda, Tanzania and Ethiopia.
According to preliminary arrangements, the medicines were to be destroyed in Nairobi on July 31 following authorisation from Kenya's regulatory Pharmacy and Poisons Board (PPB).
Viracept, which is scientifically known as nelfinavir is a second-line Aids medicine which is used by HIV-positive patients whose disease has become resistant to first-line medicines.
Roche withdrew the medicine early last month after discovering that some batches had been contaminated with a potentially cancer-causing substance during a flawed manufacturing process at its factory in Switzerland.
Patients taking the drug had also complained that some tablets had a foul smell. Roche, which had revenues of $35 billion last year, said it would cover the "reasonable costs" of the recall.
Martina Rupp, a spokeswoman for Roche, had confirmed that the suspect drug had been shipped to over 35 countries, and that contamination had been "observed in batches of Viracept that had been released to countries since March 2007."
According to Ms Rupp, the contaminant in question was a substance called ethyl mesilate, which is created in the manufacturing process.
At high doses, ethyl mesilate has been shown to cause cancer in animals, and at lower levels it has caused genetic mutations. It is said to be particularly harmful to children and pregnant women.
An estimated 2,000 HIV-positive people in Kenya, Tanzania and Uganda were taking the medicine before its withdrawal. HIV/Aids experts say that those not on free treatment programmes will now have to pay for alternative medicines.
Globally, Roche estimates that about 45,000 patients were affected by the recall. The recall, however, did not affect North America, where Viracept is manufactured independently.
Following the global recall we promptly contacted the health authorities in the EAC countries and Ethiopia in writing on June 6 and advised them that Roche has decided to withdraw all batches of Viracept, including those already with patients, Roche products regional manager Dr Antony Wanyoike, told The EastAfrican.
A second letter, dated June 8, was circulated to all patient contact points advising that the medicine not be dispensed.
HIV/Aids specialists were also advised to contact their patients individually to tell them not to take Viracept. The doctors were asked to put patients on another second-line drug in the same class of anti-retroviral protease inhibitors such as Abbott Laboratory's Kaletra. Kaletra is, however, substantially more expensive than Viracept.
According to Dr Wanyoike, the recall affected all Viracept 250mg tablets, as well as the oral powder preparation meant for children. The daily dosage of the drug is three tablets of the 250mg tablets thrice a day.
In Kenya, 8,000 packs, most of which were intact with 270 tablets each, of the drug had been returned to Roche Products by last week. The largest batches were returned by the Mission for Essential Drugs and the Kisumu-based Centres for Disease Control research project, which is treating hundreds of HIV-positive people there.
Each pack is valued at about $73, meaning that the Kenyan recall alone had seen drugs worth $584,000 returned to Roche.
Individual patients also returned several opened packs to their doctors, which were also forwarded to Roche products.
In Uganda, a total of 574 full packs and 851 loose packs were returned by last Thursday. The total number of tablets returned through the packs were equivalent to 848 full packs, Dr Njoroge said.
Most of the drugs returned in Uganda had been purchased by MSF-France and Medical Access for use in their free treatment programmes. Other batches of Viracept were returned by Uganda care, Best Medical Clinic, Mildew Clinic and the Mulago Hospital Aids clinic.
In Tanzania, at least 352 packs had been returned to distributors and embargoed by Thursday last week, including from Muchs-Harvard research programme and from the country's mother-to-child prevention programme. In Ethiopia, a total of 17,000 packs of Viracept had been returned to Roche's distributors by Friday.
"The recall has gone well," said Dr Wanyoike. "We were alive to the extreme sensitivity of the issue, and that's why we moved with speed and circumspection."
Before its withdrawal, Viracept had been sold in 49 countries since 2004, according to the World Health Organisation, with over 12 million units were sold in 2006 and two million in 2007 before the recall.
Roche announced in February 2003 that it would make the drug available to poor countries following pressure from Aids activists.
Following the global recall of Viracept, the European Medicines Agency late last month announced a trade suspension which will prevent the Roche drug being produced or prescribed in the Union in the foreseeable future.
The WHO also suspended the drug from its list of pre-qualified products.
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