Limbrel^® FDA Alert

PATIENTS SUFFER DUE TO FORCED RECALL
Primus Continues to Seek FDA Cooperation to Restore Patient Access
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• Primus shall make its best efforts to restore access to Limbrel for those patients who have a medical necessity. These specific plans are in development and will hopefully be determined in consultation with the FDA. Everyone at Primus deeply regrets the difficulties this recall and FDA issue has caused patients and prescribers of Limbrel.

• Due to sustained pressure from the FDA, Primus announced a voluntary product recall on January 26, 2018. This announcement was made via press release, even though Primus does not agree that a recall was appropriate. The FDA said they would only meet to discuss patient access after Limbrel was recalled.

• On January 18, 2018, the FDA’s Ombudsman confirmed there was nothing else she could do to get FDA to reconsider its position. Primus contacted this office of the FDA which is responsible for facilitating communication and issue resolution earlier in January after it seemed numerous past requests to collaborate and meet were being categorically denied.

• Independent product safety and regulatory consulting firm Exponent reviewed all of Limbrel’s adverse events and the FDA’s Limbrel adverse events analysis called a Health Hazard Evaluation or HHE (view HHE). Exponent’s expert team comprised of former senior FDA scientists and specialist physicians did not agree with key components of the FDA's analysis, and demonstrated how the FDA’s faulty analysis led to the incorrect conclusion that Limbrel has potentially life-threatening adverse effects. These concerns are summarized in Exponent’s January 16, 2018 report. Primus shared this report with the FDA and requested numerous times to have an objective discussion between Exponent’s experts and the FDA’s scientists and physicians. The FDA declined.

• In December 2017 and January 2018, numerous physician and patient reported cases of successful management of osteoarthritis (OA) with Limbrel were forwarded to the FDA to demonstrate the unique public health role and safety of Limbrel. The FDA appeared to disregard that Limbrel was the only prescription product that could be safely taken by segments of the population with OA who failed traditional therapies, like NSAIDs, and who wanted to avoid opioids. The physician and patient letters showed that Limbrel was, for many elderly at-risk and comorbid patients, the only hope for a safe way to manage their OA.

• On December 21, 2017, Primus, in response to pressure from the FDA, voluntarily suspended all Limbrel promotion and shipments, including physician samples. This blocked access to Limbrel - an important and in many cases the only medical option for people suffering from osteoarthritis - pending Primus receiving and evaluating requested safety data that the FDA had in its possession but would not provide to Primus prior to asking Primus to recall.

• Primus’ letter to the FDA; setting forth this step was taken in response to repeated press releases, without any opportunity for Primus to comment, stating that Limbrel caused potentially life-threatening adverse effects and a letter from the FDA and a threatening enforcement action if Primus did not recall Limbrel, which Primus received on December 19, 2017 (read the FDA letter).

• The FDA claimed 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 stand in stark contrast to the actions taken by the FDA. The FDA’s actions were also contrary to many past positive interactions between the FDA and Primus over the years about Limbrel and medical foods in general, as well as Primus helping the FDA with some of its past initiatives.

• From early November through mid-January, Primus fully cooperated with the FDA, during its 11 home-office inspections and many follow-up conference calls and email requests. Limbrel’s contract manufacturing facility was inspected by the FDA approximately one month before its Limbrel investigation, and this inspection resulted in no compliance issues. This facility was inspected again because of the Limbrel investigation, which also resulted in no compliance issues.

• Through a Freedom of Information Act (FOIA) request for the Adverse Event (AE) reports on which the FDA based its actions, Primus eventually received a collection of the AE reports from the FDA. Upon analysis it was apparent that either the database that the FDA sent was incomplete and represented 114 of the 194 reports the FDA claimed in its negative Limbrel Safety Alerts and Updates, or that the FDA had misstated the number of reports. 34 of these AE reports were duplicative (for a net receipt of 80 of the 194). Of note, the 194 reports were for all types of cases and was supposed to include the 30 cases of concern regarding elevated liver enzymes and acute hypersensitivity pneumonitis.

• Recognized scientific and medical experts wrote opinion letters to the FDA supporting the urgency of continued access to Limbrel. These letters are underpinned with clinical trials and real-world clinical experience, and supported with scientific and medical literature. These established that the adverse events the FDA publicized were reversible and not life threatening, based on the established safety record of Limbrel and the medical literature on the AEs in question. Further, all patients on Limbrel are monitored by prescribers and the AEs in question are fully described in the Limbrel package insert.

• Without ever reviewing Primus’ extensive regulatory compliance dossier on Limbrel in support of the legal status of the product as a medical food, the FDA on December 5, 2017 via a press release reached a “preliminary determination” that Limbrel should not be a medical food. Subsequently, this somehow moved to a final determination of "unapproved new drug" status again without ever reviewing Primus’ extensive distinctive nutritional requirements analyses for OA. Primus offered to share this information multiple times. The FDA never accepted. Primus maintained that Limbrel complies with the regulatory and legal requirements of a Medical Food.

• On November 8, 2017 the FDA made its first inspection of Primus at the home-office asking about Limbrel adverse events and demanded the proprietary product formulation. Primus provided the adverse events reports, product samples and the formulations despite the obvious sensitivity about sharing confidential information.

• Limbrel is representative of the type of innovation in clinical nutrition and patient care Congress intended to stimulate when it enacted the statutory definition of a medical food in the Orphan Drug Act (1988). If the FDA and industry could work together and the FDA would be open to innovation, medical foods could provide a great opportunity to advance public health while reducing total costs of care.

Or mail a letter that Primus will forward to the FDA:
Primus Pharmaceuticals, 7373 N. Scottsdale Road, Suite B-200, Scottsdale, AZ 85253

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Limbrel Refund Policy

1. Refunds will be granted for unopened bottles accompanied by a sales receipt

2. Patient must return the bottle to Primus via USPS certified mail for tracking purposes to:
   Primus Pharmaceuticals, 7373 N. Scottsdale Road, Suite B-200, Scottsdale, AZ 85253

3. Refund checks are mailed via US mail once per week

4. Please allow up to 4 weeks for processing