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Dr Maycock's draft letter stated that there was always the problem of non-B hepatitis which he said American authorities thought accounted for 90% of transfusion associated hepatitis and which opened a "new vista of complications."

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In the draft product licence application for Kryobulin on the manufacture and composition it stated that any donor who had a pathological transaminase level or positive Australia antigen test was excluded from the donor program but despite this the risk of transmission of homologous serum hepatitis could only be diminished not eliminated.

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Under the heading "side effects" Kryobulin's draft product licence application stated that despite the precautions taken in the selection of donors, the risk of transmission of homologous serum hepatitis could not entirely be excluded when administering human coagulation factors.

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Immuno in a draft application for its product license stated that their product was prepared from the pooled plasma of healthy donors, and that donors were tested at each donation for their GPT level and the absence of AU/SH/HA antigens.

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Dr Dane stated in a letter that they did not consider the warning about homologous serum hepatitis on the leaflet of Kryobulin to be adequate, particularly when the product had been shown to contain HBsAg.

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Norman Berry stated that he was surprised at Dr Dane's letter about the warning label because they had submitted the warning phrase on the labels to the Committee on Safety of Medicines as part of their product licence application and it had been accepted.

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In a letter to Mr Berry Dr Dane stated that their comments on the warning on Kryobulin leaflets was a personal observation, and that they were aware that their views and those of several of their colleagues did not coincide with those of the Committee on Safety of Medicines.

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A memo from J A Holgate shows that the DHSS considered Dr Dane's comments about the warning labels on Kyrobulin and stated he hoped they could disprove and show they would never release a batch known to be positive and rely on the warning label.

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The warning label on Kryobulin by Immuno Ltd stated that despite the precautions taken in the selection and testing of donors and donations, the risk of transmitting hepatitis could not be entirely excluded.

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Abbott Laboratories Ltd information pages for Antihemophilic Factor (Human) included the warning that "This product is prepared from units of human plasma which have been tested and found nonreactive for Hepatitis Associated Antigen. However, it is recognized that presently available methods are not sensitive enough to detect all units of potential infectious plasma and the risk of transmitting hepatitis is still present."

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The initial product label for Profilate by Alpha/Abbott Laboratories included a warning which stated that "Patients with mild deficiencies who consequently have not received multiple transfusions of blood, or blood products, are at greatest risk. Under such circumstances, the benefits of Profilate administration must be weighed carefully against the risk of viral hepatitis"

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Alpha/Abbott Laboratories data sheet and warning label for Profilate later included the statement that present methods of testing plasma were not sensitive enough to detect all units of infective plasma and that whenever possible single donor products were preferable.

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Abbott Laboratories data sheet for Profilate repeated the warning on the 1976 label that the benefits of administration must be weighed against the risk of viral hepatitis.

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Alpha's application for the renewal of its license of heat treated profilate contained the warning that viral hepatitis may be transmitted by the product.

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A study by Kasper and Kipnis reviewed the incidence of clinical hepatitis in people with haemophilia and concluded that older children and adults who had little exposure to blood products were at a high risk of developing hepatitis after the introduction of clotting factor concentrates.

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Hyland Laboratories product information leaflet for Hemofil contained the warning that although the lot had been reconstituted for use and found non reactive for HBsAg using RIA techniques the product should continue to be considered to carry a risk with respect to hepatitis.

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Cutter laboratories included a warning on Koate label which stated that "Koate concentrate is a purified dried fraction of pooled plasma obtained from many paid donors. The presence of hepatitis virus should be assumed and the hazard of administering Koate concentrate should be weighed against the medical consequence of withholding it."

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The warning label on Armour's Factorate package insert stated that radioimmunoassay testing for Hepatitis B surface antigen had been done, however that since no completely reliable laboratory test was yet available to detect all potentially infectious plasma donations, the risk of transmitting viral hepatitis was still present.

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The wording of the warning label on Armour's Factorate was done in a roundabout way; unlike the more direct approach of some other manufacturers such as Cutter, Armour's said that "Despite careful selection of donors, it may contain causative agents of viral hepatitis."

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The warning label on Armour's Factorate package continued to state that the risk of transmitting viral hepatitis to patients was still present, and personnel administering this should exercise caution.

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