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Posted on 19 February 2019 | By Zachary Brennan
In a warning to consumers on Tuesday, the Food and Drug Administration (FDA) said consumers should be wary of facilities offering plasma infusions from young human donors, saying the injected plasma would prevent memory loss.
The FDA has indicated that these facilities, located in several states, currently offer plasma infusions without proven clinical benefit, at a cost of up to several thousand dollars per infusion.
For example, a start-up called Ambrosia, which has clinics in New York and California, offers such treatments at $ 8,000 for one liter and $ 12,000 for two liters, although the scientists described the test as pay-to-participant fraud.
The FDA also notes that institutions claim that blood transfusions can not only prevent aging or memory loss, but also treat conditions such as dementia, Parkinson's disease, multiple sclerosis, Alzheimer's disease, heart disease or post-traumatic stress disorder.
"The dosage of these infusions, which may involve large volumes administered, is also not guided by evidence from adequate and well-controlled trials. In addition, plasma infusion can be badociated with infectious, allergic, respiratory and cardiovascular risks, among others, "the FDA said. "In some people, especially those with pre-existing heart disease, plasma infusion can cause overloading of the circulatory system, resulting in swelling of the body and difficult breathing."
In a note to health care providers, the agency also indicated that the circular of information on the use of human blood and human blood components published by the AABB, recognized by the FDA, lists the following indications for plasma administration:
- "Management of preoperative or haemorrhagic patients requiring replacement of multiple plasma coagulation factors (eg, liver disease, disseminated intravascular coagulation)
- Patients with mbadive transfusion and clinically significant coagulation deficits
- Patients treated with warfarin who are bleeding or who have to undergo an invasive procedure before vitamin K can reverse the effect of warfarin or who need only have a transient reversal of the drug. effect of warfarin
- Transfusion or plasma exchange in patients with thrombotic thrombocytopenic purpura
- Transfusion or plasma exchange with a selected deficiency in coagulation factors, conbad or acquired, for which no specific coagulation concentrate is available
- Management of patients with rare specific plasma protein deficiencies, when recombination products are not available. "
Important information about plasma infusions of young, for-profit donors
Categories: Regulatory News
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