Important Safety Information:

• ATryn® is not advisable to use in patients with known hypersensitivity to goat milk proteins. Allergic-type hypersensitivity reactions, including anaphylaxis may occur in some patients.  Use of drug must be discontinued at once if these reactions are reported.
  
  
•  The alteration of anticoagulant effect of drugs that use antithrombin as anticoagulating agent may be observed when ATryn® is added or withdrawn. To avoid insufficient or excessive anticoagulation, suitable coagulation tests for the anticoagulant should be performed.

6-4.6 Limitation of transgenic animals in pharming:

• Both the time and cost to develop a transgenic model with high production level of therapeutic protein is high.
  
  
• Highly skilled persons are required for handling transgenic animals.
  
  
• Environmental and social impact of using transgenic animals as biopharming tools is complex and uncertain.
  
  
• Regulatory processes associated with the commercialization of a given product require description of detailed procedures and for the enforcement of intellectual property rights.
  
  
• Other concerns surrounding these technologies include the environmental and ethical aspects of transgenesis. Environmental issues associated with genetically modified organisms that have caused the most public outcry, including food and ecosystem contamination or threats to biodiversity, are generally more problematic in transgenic plants than animals.

6-4.7 Safety Aspects of Biopharming:

FDA has developed several regulations and guidelines for safe production and commercialization of recombinant products using transgenic animals. A crucial criterion in animal derived products is prevention of transmission of pathogenic factors from animals to human. All transgenic application of livestock requires compliance to the standards of genetic security and reliability of method applied in genetic modification.