Animi-3, a prescription medication from PBM Pharmaceuticals, Inc., contains ingredients that may have a beneficial, protective effect in inflammatory diseases such as rheumatoid arthritis (RA).
The only Rx product of its kind, Animi-3 contains the omega-3 fatty acids DHA and EPA, and a combination of three important B vitamins -- prescription strength folic acid, plus vitamins B6 and B12. The omega-3 fatty acids in Animi-3 are exclusive, DHA dominant, and highly refined.
"FDA has asked Pfizer, Inc. to withdraw Bextra (valdecoxib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex. FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs."
Clinical evidence presented by leading researchers at Cornell University(2) suggests that a synergistic combination product such as Animi-3 can be a valuable addition to the physician's therapeutic regimen for inflammatory diseases such as RA. Researchers reported that omega-3 fatty acids have been shown to lower the risk of cardiovascular disease, dementia, and inflammatory disease. Also presented were findings that folic acid, vitamin B6 and vitamin B12 have been clinically documented to lower the levels of homocysteine in the blood -- an important risk factor in RA.
"In light of today's FDA announcement and concern over the safety of some current pain management drug therapies, Animi-3 is an alternative without these side effects that has helped patients with RA," said Jack Schramm, EVP of PBM Pharmaceuticals.