Replies to post #115897 on Amarin Corp Plc (AMRN)

[Biobillionair]

Red Yeast producers that advertise treating cholesterol have received FDA action letters. The process of red yeast production is gras and fall within food supplements status, think brewing yeast. The process for concentrating fish oil in either ethyl ester or Trig form involving a synthetic process is not covered under gras.

Red Yeast production does not violate laws as long as it’s labeled appropriately.

Ethyl ester fish oil violates gras laws & labeling laws.

You can’t compare the two situations, not all red yeast contains the Lovastatin molecule, you are placing your patients at risk. That’s bad. IMO, you could be legally liable for misleading CV patients...

BB

[sts66]

To this day when I have patients who hate the evil chemicals of pharmaceuticals and refuse statins I will suggest that they instead use red yeast extract.

Glad you're not my doctor! Some red yeast rice products may contain a compound identical to lovastatin and another dangerous contaminant:

Safety

The same types of side effects that can occur in patients taking lovastatin as a drug can also occur in patients who take red yeast rice products that contain monacolin K. Potential side effects include myopathy (muscle symptoms such as pain and weakness), rhabdomyolysis (a condition in which muscle fibers break down, releasing substances into the bloodstream that can harm the kidneys), and liver toxicity. Each of these three side effects has been reported in people who were taking red yeast rice.

Red yeast rice supplements should not be used while pregnant or breastfeeding.

Lovastatin can interact with a variety of drugs to increase the risk of rhabdomyolysis; these drugs include other cholesterol-lowering agents, certain antibiotics, the antidepressant nefazodone, drugs used to treat fungal infections, and drugs used to treat HIV infection. Red yeast rice containing monacolin K could interact with drugs in the same way.

If the process of culturing red yeast rice is not carefully controlled, a substance called citrinin can form. Citrinin has been shown to cause kidney failure in experimental animals and genetic damage in human cells. In a 2011 analysis of red yeast rice products sold as dietary supplements, 4 of 11 products were found to contain this contaminant.