FDA Alerts Consumers to Potentially Life-Threatening Side Effects from Taking Limbrel
Parker Waichman LLP Cautions Limbrel Users to Watch for Potentially Lethal Side Effects
Parker Waichman LLP learned the Limbrel, manufactured by Primus Pharmaceuticals, Inc.; from Scottsdale, AZ is the subject of an urgent U.S. Food and Drug Administration (FDA) warning. The FDA warns that at least 30 people showed signs of elevated liver function and “acute hypersensitivity pneumonitis.” These medical conditions are life-threatening which manifest themselves without showing any symptoms at first. As a result of these conclusions, the FDA recommends that people who use Limbrel should stop immediately and consult their physician about what steps to take next. At this time, the FDA does not possess information whether Limbrel caused any serious injury or deaths. Despite the lack of knowledge currently, Limbrel users must vigilantly monitor their health for signs of symptoms associated with the side effects of Limbrel.
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What is Limbrel?
Doctors give Limbrel to patients who suffer from osteoarthritis. Limbrel interacts with the food the user consumes to manage “the metabolic process” for people with osteoarthritis. Primus Pharmaceuticals designed Limbrel so that patients can take the product “enterally.” Enterally means that users can take Limbrel through a medical device or feeding tube connected to their digestive system. However, Primus distributes the questioned medical product in capsule form.
The FDA formally requested a recall of four doses of Limbrel. The recalled doses are:
- Limbrel (flavocoxid) 250 mg Product Identity Number 68040-601-16,
- Limbrel (flavocoxid) 250 mg with 50 mg citrated zinc bisglycinate Product Identity Number 68040-605-16,
- Limbrel (flavocoxid) 500 mg Product Identity Number 68040-602-16, and
- Limbrel (flavocoxid) 500 mg with 50 mg citrated zinc bisglycinate Product Identity Number 68040-606-16.
The FDA defines Limbrel as a medical food. A medical food falls under the auspices of the “Orphan Drug Act of 1983.” Medical foods are a specific designation. Pharmaceutical companies develop and market medical foods subject to some of the regulations FDA imposes on drug manufacturers, but not all. For example, a physician does not need to prescribe a medical food for their patient. Notwithstanding the designation as a medical food, the FDA monitors medical foods to ensure the safety of the patients who use the medicinal product.
FDA Investigation into Limbrel
The FDA encourages patients and healthcare professionals to report adverse side effects from prescribed medications and medical foods. The FDA compiles complaints and inspects the complaints looking for trends among users. Over 200 people filed complaints concerning the adverse side effects they experienced when taking Limbrel. The FDA initiated a more in-depth investigation into those complaints. Two hundred is not a “trifling” amount of people affected by the Limbrel when the number of users is small compared to other prescription medications.
The FDA indicates that the agency continues to receive reports about harmful events associated with taking ‘Limbrel’. The FDA will evaluate those reports and include them in their findings during their investigation. Out of the original 200 reports, 30 of the reports contained sufficient information to study. On the basis of those 30 reports, the FDA reached the conclusion that Limbrel may be linked to elevated liver function and acute hypersensitivity pneumonitis.
The increase in reported incidents prompted the FDA to take action. Accordingly, the FDA referred the reports to a council that specializes in investigating claims of adverse events connected to a medicinal product. The council preliminarily found sufficient connection to require additional investigation. The FDA obtained samples of ‘Limbrel’ from Primus to analyze. The FDA will also examine the manufacturing process Primus uses to produce Limbrel. The FDA did not stop there. Next, the FDA contacted Primus Pharmaceuticals, Inc. on November 30, 2017, requesting that the company voluntarily recall Limbrel. Primus Pharmaceuticals refused to recall their products from the market.
Primus’ refusal to cooperate forced the FDA to make a stronger recommendation. On December 18, 2017, the FDA presented a formal request to Primus Pharmaceuticals, Inc. to recall all non-expired lots of Limbrel. Primus Pharmaceuticals relented to the FDA’s formal demand and initiated a recall. However, Primus maintains that its product is not harmful and voluntarily recalled Limbrel to “fully cooperate” with the FDA.
The Possible Adverse Medical Problems Linked to Limbrel
The FDA found that Limbrel could cause two very serious, potentially life-threatening medical conditions. First, the FDA linked ‘Limbrel’ to “drug-induced liver injury.” Drug-induced liver injury happens when synthetic substances like medicine, over-the-counter medications, alcohol, and street drugs infiltrate the liver and harm the organ, causing liver disease.
Liver disease does not manifest itself right away. Blood tests will show elevated liver functions based on an increase in the liver enzymes produced. An increase in enzymes in the liver will appear before the outward signs of drug-induced liver disease appear.
Symptoms of the drug-induced liver disease appear in various ways. Some people, but not all, may experience:
- jaundice (yellowing of the skin),
- weakness,
- fatigue,
- strange abdominal pain,
- appetite loss, and
- Cirrhosis of the liver which is a fatal disease.
Secondly, the FDA linked acute hypersensitivity pneumonitis to ‘Limbrel’. Acute hypersensitivity pneumonitis is a lung disease that causes inflammation. Typically, acute hypersensitivity pneumonitis affects workers who inhale contaminants. In the 1700s a physician observed that people working with grain developed breathing problems, which later scientists named acute hypersensitivity pneumonitis.
People who develop the breathing disorder can acquire it through one of three ways. One of the methods of generating acute hypersensitivity pneumonitis is from ingesting antigens, or toxins, like zinc. Zinc is a component in two ‘Limbrel’ doses.
Symptoms of acute hypersensitivity pneumonitis include:
- fever,
- chills,
- a headache,
- a cough,
- fatigue,
- weight loss,
- chronic bronchitis,
- shortness of breath, or
- difficulty breathing.
These symptoms might appear to be indicators of another medical problem like the flu or a respiratory infection. The possibility might help the actual problem evade detection and last until the patient is in severe respiratory distress.
Actions to take if you use Limbrel
The FDA recommends that you stop taking ‘Limbrel’ immediately. Next, you should consult your physician about having blood tests done. Fortunately, drug-induced liver problems and acute hypersensitivity pneumonitis are curable if medical intervention comes in time. If not, the person could die or suffer severe and long-lasting medical issues.
Also, Limbrel users should contact Primus Pharmaceuticals and make arrangements to return any unexpired doses of ‘Limbrel’. Expired doses should not be taken in any event and discarded according to the manufacturer’s recommendations for disposing of medications.
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