Hedex withdrawn from Kenya
A LEADING drugs manufacturer has withdrawn its painkillers from the market over claims of serious health risks to consumers.
A LEADING drugs manufacturer has withdrawn its painkillers from the market over claims of serious health risks to consumers.
While the efficacy of the painkiller, Hedex Extra was not in doubt, one of its active components was found to have a potentially toxic substance.
Glaxo SmithKline (GSK) says Hedex Extra is formulated to provide extra relief from headaches, including migraines. It also offers relief from backache, rheumatism, muscle pain, nerve pains, toothache and period pains.
Dr William Mwatu, GSK’s medical and regulatory affairs director for East Africa, said Hedex Extra was withdrawn from the market because it was producing a by-product, salicylic acid, in much higher concentrations than is medically permitted.
“We received complaints from Mombasa that Hedex was smelling as if it had expired,†said Mwatu. It was established that the smell was due to salicylic acid.
With a year to go before expiry of the drug, the levels of salicylic acid had hit 4%, the maximum limit. That level is only expected after two years of shelf-life, said Mwatu.
Salicylic acid, although causes severe irritation in the mouth and throat. It also upsets the stomach.
Mwatu said although the problem was only reported in Mombasa, GSK decided on a country-wide withdrawal.
The company is now reformulating Hedex, with plans of re-launching it soon.
While the efficacy of the painkiller, Hedex Extra was not in doubt, one of its active components was found to have a potentially toxic substance.
Glaxo SmithKline (GSK) says Hedex Extra is formulated to provide extra relief from headaches, including migraines. It also offers relief from backache, rheumatism, muscle pain, nerve pains, toothache and period pains.
Dr William Mwatu, GSK’s medical and regulatory affairs director for East Africa, said Hedex Extra was withdrawn from the market because it was producing a by-product, salicylic acid, in much higher concentrations than is medically permitted.
“We received complaints from Mombasa that Hedex was smelling as if it had expired,†said Mwatu. It was established that the smell was due to salicylic acid.
With a year to go before expiry of the drug, the levels of salicylic acid had hit 4%, the maximum limit. That level is only expected after two years of shelf-life, said Mwatu.
Salicylic acid, although causes severe irritation in the mouth and throat. It also upsets the stomach.
Mwatu said although the problem was only reported in Mombasa, GSK decided on a country-wide withdrawal.
The company is now reformulating Hedex, with plans of re-launching it soon.