On December 21, 2017, Primus Pharmaceuticals, in osteoarthritis of knee symptoms to unwarranted pressure from the FDA, has voluntarily suspended promotion and sale of Limbrel, an important and in many cases the only medical option for people suffering from osteoarthritis, pending Primus receiving requested safety data held by the FDA and meeting with the FDA as requested. The FDA claims safety as the basis of its unilateral actions, but the incidence, severity and reversibility of these adverse events from 13 years of in-market experience are contrary to the aggressive and far-reaching conclusions taken by the FDA.
Limbrel’s medical food status appeared to have somehow moved to a final determination of unapproved new drug status without ever reviewing Primus’ extensive distinctive nutritional requirements analyses for OA that Primus offered to the FDA. Limbrel is representative of the type of innovation in nutrition and patient care Congress intended to stimulate when it enacted the statutory definition of a medical food in 1988. If the FDA and industry could work together and the FDA be open to innovation, medical foods provide a great opportunity to advance public health while reducing total costs of care. The FDA appears to disregard the major public health implications of Limbrel because it is the only prescription product that can be safely taken by big segments of the population with OA. Many OA sufferers cannot take NSAIDs and want to avoid opioids.
Established by expert opinion letters, not only is Limbrel significantly safer than alternative options for osteoarthritis, Limbrel is for many elderly patients the only hope for relief from osteoarthritis. FDA regulation, but the FDA to date has declined to share any of this information with Primus or consulting independent scientific and medical experts, even former senior FDA senior safety experts. Primus is doing all that it can to cooperate with the FDA, which to-date has been uncooperative and has operated under a veil of secrecy. Primus hopes that the FDA will provide the information that Primus has requested to permit independent expert analysis of the basis for FDA’s actions, and to meet with FDA in the near future to make the continued distribution of Limbrel to those patients in need possible.
Limbrel is not an NSAID, nor a COX-2 selective inhibitor. This site is intended for U. ARTHRITIS is inflammation of the joint, and osteoarthritis of the knee can cause severe pain and affect quality of life. Don’t overdo these three positions.