§ Mr. Ashley
asked the Secretary of State for Social Services (1) if he was satisfied with the safety of the drug Zomax when it was given a product licence; and what new circumstances have arisen since then;
(2) if he will make a statement on the reasons for the withdrawal of the drug Zomax in the United Kingdom;
(3) how many adverse reactions and deaths have been reported from the drug Zomax; and what is his estimate of the actual totals, whether or not reported;
(4) if he intends to revoke the product licence of the drug Zomax, or allow it back on the market at a later date;
(5) why the notification to doctors of the withdrawal of the drug Zomax has been left to the drug company; and if he will take the necessary steps to ensure that all doctors are notified of the decision immediately;
(6) what discussions he has had with the United States medical authorities about the drug Zomax;
(7) whether he or the drug company concerned initiated discussions which led to the withdrawal of the drug Zomax.
§ Mr. Kenneth Clarke
The drug Zomax has been withdrawn in the United Kingdom by Ortho-Cilag Pharmaceutical Ltd. following the company's decision to withdraw the drug in the United States of America. In neither country was this withdrawal at the instigation of the drug regulatory authorities although officials in the two countries have since been in close touch on the matter. The company has said that the withdrawal is temporary, pending discussions about changes in prescribing information in the United States of America. The decision200W followed reports in the United States of America of five cases in which patients had suffered severe allergic reactions and had died.
The pattern of adverse reactions reported to be associated with Zomax in the United Kingdom is similar to other non-steroidal anti-inflammatory drugs. Prescribing information here includes warnings that allergic reactions may occur, particularly in patients known to be sensitive to aspirin or other non-steroidal anti-inflammatory drugs. The Committee on Safety of Medicines has received 512 reports of adverse effects associated with the drug, five of which were fatal. I must emphasise that these reports do not necessarily indicate a causal relationship between the drug and the suspected reaction. Twenty-two of the reports concerned suspected severe allergic reactions similar to those described in the United States, but none was fatal.
It is not possible to use reports to the committee to estimate the actual incidence of adverse reactions to a drug, because not all reactions are recognised or reported, and the degree of under-reporting is not known.
The licensing authority was satisfied that the benefits of Zomax outweighed the risk when the drug was given a product licence and, on the basis of the evidence currently available to us, that remains the case. The licensing authority is therefore not proposing at present to take any action to revoke or vary the product licence and I understand that the United States Food and Drug Administration takes a similar view.