Dr Maycock in a draft letter stated that the warning on the Hemofil labels overstated the risks since August 1975 the concentrates were being made from RIA tested plasma. However, that until concentrate prepared from UK plasma was available the benefits attached to Hemofil outweighed the risk. Read more about Dr Maycock in a draft letter stated that the warning on the Hemofil labels overstated the risks since August 1975 the concentrates were being made from RIA tested plasma. However, that until concentrate prepared from UK plasma was available the benefits attached to Hemofil outweighed the risk.
Dr Waiter stated that the risks of Hemofil were being understated or even misrepresented by the manufacturer. Read more about Dr Waiter stated that the risks of Hemofil were being understated or even misrepresented by the manufacturer.
Dr Sheila Waiter stated that it was generally accepted that the benefits of Hemofil outweighed the risks of acquiring hepatitis B but that the statement that every lot of the product was probably contaminated with hepatitis B would be a surprise to clinicians especially as the practice of issuing warning labels was being discontinued by the manufacturer. Read more about Dr Sheila Waiter stated that it was generally accepted that the benefits of Hemofil outweighed the risks of acquiring hepatitis B but that the statement that every lot of the product was probably contaminated with hepatitis B would be a surprise to clinicians especially as the practice of issuing warning labels was being discontinued by the manufacturer.
Peter Jones in reporting on the outcome of a recent meeting of haemophilia centre directors stated that although the product Haemofil was connected to the outbreak of hepatitis at the time, that it was clear all concentrates carried the risk. Read more about Peter Jones in reporting on the outcome of a recent meeting of haemophilia centre directors stated that although the product Haemofil was connected to the outbreak of hepatitis at the time, that it was clear all concentrates carried the risk.
In the package leaflet of Hemofil it said that the risk of hepatitis was unknown; this was not as clearcut as the warning on Hemofil bottles which said the risk of transmitting hepatitis was present. Read more about In the package leaflet of Hemofil it said that the risk of hepatitis was unknown; this was not as clearcut as the warning on Hemofil bottles which said the risk of transmitting hepatitis was present.
In Travenol's licence application for Hemofil the appendix includes a warning that the concentrate should be used when its expected effect is needed in spite of the unknown hepatitis risk associated with its use and special consideration should be given to the use of the concentrate in newborns and infants where a higher morbidity and mortality may be associated with hepatitis. Read more about In Travenol's licence application for Hemofil the appendix includes a warning that the concentrate should be used when its expected effect is needed in spite of the unknown hepatitis risk associated with its use and special consideration should be given to the use of the concentrate in newborns and infants where a higher morbidity and mortality may be associated with hepatitis.
In a memo from Edward Cutter to Jack Ryan, Edward Cutter stated that it was advisable to include a warning about AIDs in literature about Factor IX and VIII products. Read more about In a memo from Edward Cutter to Jack Ryan, Edward Cutter stated that it was advisable to include a warning about AIDs in literature about Factor IX and VIII products.
A Koate product licence application discussed the addition of a warning about hepatitis. Read more about A Koate product licence application discussed the addition of a warning about hepatitis.
The UK subsidiary of Travenol/Baxter was supplied with literature alongside the company's products, and that literature was initially drafted in the US. It was was then reviewed by the UK Regulatory Department to ensure compliance the current product licence requirements. Read more about The UK subsidiary of Travenol/Baxter was supplied with literature alongside the company's products, and that literature was initially drafted in the US. It was was then reviewed by the UK Regulatory Department to ensure compliance the current product licence requirements.
Elias Greene sent a fax to Marie Tatt stating that any labelling applied to products in the United States must contain the warning, and that where unlabelled products are sent, the recipient may prepare their own labels. Read more about Elias Greene sent a fax to Marie Tatt stating that any labelling applied to products in the United States must contain the warning, and that where unlabelled products are sent, the recipient may prepare their own labels.