Inadequate information on the labels of US drug products sold in the Third World have put many lives at risk, concludes a US government study
US-BASED pharmaceutical companies provide incomplete -- and even misleading -- information on the labels of products they market in developing countries, an official study by the office of technology assessment (OTA) states.
The study, based on the labelling of 241 products sold in 1988-90 in Kenya, Panama, Brazil and Thailand by 18 US firms, indicates almost two-thirds of the labels lacked information on how to use the drug safely.
The OTA study found warnings and precautions frequently understated and information on clinical pharmacology or adverse reactions lacking in 20 per cent of the labels.
Congressional leaders branded the study findings "a shocking indictment of industry abuses" and Representative Henry Waxman, who commissioned the study seven years ago, demanded prompt remedial action by the US government, stating: "The OTA report demonstrates that citizens in developing countries, which are without sophisticated drug regulatory agencies, are at risk."
The OTA study suggests the US government should either endorse a voluntary international code of conduct for labelling or ensure drugs sold in the Third World by US companies display government-approved labels.
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