PRIMUS PHARMACEUTICALS, INC. WATCH

What should I watch out for?

Primus Pharmaceuticals, Inc. is a manufacturer of prescription medical nutrition.  Medical food products are marketed as a cure for a particular medical disease with no severe, adverse events. Unfortunately, the United States Food and Drug Administration (“FDA”) noted Primus Pharmaceutical Inc.’s Limbrel is a misclassified medical food that cause serious injuries. The FDA pressured Primus Pharmaceuticals, Inc. to voluntarily recall Limbrel due to Limbrel’s dangerous link to drug-induced liver injury and hypersensitivity pneumonitis.

Tell me about Primus Pharmaceuticals, Inc.

Primus Pharmaceuticals, Inc. advertises itself as the first and only company specializing in prescription medical nutrition. Primus Pharmaceuticals, Inc. developed a line of nutrition products that are prescribed by doctors for the treatment of specific diseases. The prescription medical nutrition products are marketed as low-risk and fast-to-market products used in chronic diseases or recurring conditions involving metabolic issues.

Products of Primus Pharmaceuticals, Inc. are used to treat the following metabolic etiologies:

• Atopic dermatitis
• Chronic Venous Insufficiency (CVI)
• Methotrexate therapy
• Osteoarthritis
• Osteopenia
• Osteoporosis

Primus Pharmaceuticals, Inc. promotes its products to physicians specializing in:

• Rheumatology
• Pain management
• Orthopedics
• Dermatology
• Obstetrics/gynecology.

The company claims the products are safer, as effective and have less side effects than current prescription drugs on the market. Primus Pharmaceuticals, Inc. uses clinical trials on humans to test the effectiveness of each product.

In the company’s mission statement, Primus Pharmaceuticals, Inc. states the company holds itself accountable to the highest manufacturing practices and product purity standards to make sure they create consistent quality products every time. All products contain active ingredients concentrated and purified from natural sources.

Primus Pharmaceuticals, Inc. first began operations in 2001 and launched their first product in 2004. The company is privately owned and is capitalized by the founders and wealthy individuals, including pharmaceutical executives and doctors.

What are some of the products manufactured by Primus Pharmaceuticals, Inc.?

One recalled product made by Primus Pharmaceuticals, Inc. is Limbrel.  Limbrel is an arthritis capsule that is used to decrease pain and inflammation by managing the metabolic processes of osteoarthritis. Approved in 2004, Limbrel is classified as a medical food product, rather than a drug, for patients under physician supervision for the dietary management of osteoarthritis, a degenerative disease of the joints.

Medical food products differ from dietary supplements in that medical foods are designed as a treatment for a particular medical treatment instead of supplements for healthy people. Limbrel supposedly improves mobility in patients with osteoarthritis by “balancing multiple inflammatory pathways to relieve joint discomfort.”  Unlike prescription drugs, prescription medical foods generally do not cause severe adverse events or dangerous drug-on-drug interactions.

Primus Pharmaceuticals, Inc.’s Limbrel has been linked to many different side effects, including drug-induced liver injury and hypersensitivity pneumonitis. Symptoms of drug-induced liver injury include fatigue, nausea, jaundice and gastrointestinal discomfort.

Hypersensitivity pneumonitis is an immune system disease in the lungs. It occurs in some patients when substances they ingest trigger their immune systems to overreact, causing inflammation in the lungs. This makes it harder for the lungs to function properly. Over time, chronic inflammation can cause permanent lung scarring.

Limbrel can damage the liver and reduce normal liver function. Signs of a damaged liver include elevated blood levels, itching, a loss of appetite, nausea and fatigue.

In December 2017, the FDA had received 200 adverse event reports regarding Limbrel. The conditions ranged from mild to life-threatening. On December 18, 2017, the FDA sent Primus Pharmaceuticals, Inc. a letter formally requesting a recall of all non-expired lots of Limbrel products because of the risk of liver injury and other severe adverse events associated with Limbrel. The FDA recommended a class I recall of the drug, which is the most serious type of recall.  A class I recall is reserved for instances where there is a reasonable probability that the product will cause serious adverse health consequences or death.

In response to the FDA, Primus Pharmaceuticals, Inc. voluntarily suspended all Limbrel promotions and shipments. On January 26, 2018, Primus Pharmaceuticals, Inc. issued a press release announcing the voluntary recall of all Limbrel lots due to serious and reversible adverse events. The FDA noted that Limbrel was misbranded and does not meet the definition of medical food. The FDA also encouraged anyone currently taking Limbrel to contact their health care provider.

Besides Limbrel, other products made by Primus Pharmaceuticals, Inc. are:

• EpiCeram- treats atopic dermatitis
• Fosteum Plus- treats osteopenia and osteoporosis
• Rheumate- treats the metabolic effects of methotrexate therapy
• Vasculera (diosimplex)- treats chronic venous insufficiency (CVI)

 

Where is Primus Pharmaceuticals, Inc. headquartered?

The pharmaceutical company is headquartered in Scottsdale, Arizona. The specific address of the headquarters of Primus Pharmaceuticals, Inc. is:

7373 N. Scottsdale Road

Suite B-200

Scottsdale, Arizona 85253

 

Where does Primus Pharmaceuticals, Inc. manufacture its products?

The products are manufactured in the United States by third party manufacturers.

 

How much does Primus Pharmaceuticals, Inc. sell?

In regards to the Limbrel osteoarthritis capsule, Primus Pharmaceuticals notes it has been marketed as a medical food with over 2 million packages sold and sampled over fourteen years. Primus Pharmaceuticals estimated 450,000 Limbrel patients over those fourteen years.

 

Who is in charge at Primus Pharmaceuticals, Inc.?

The following people are in charge at Primus Pharmaceuticals, Inc.:

• President and Chief Executive Officer- James D. (J.D.) Weir
• Chief Financial Officer, Treasurer and Corporate Secretary- Michael J. (Mike) Martin
• Director of Human Resources and Administration- Kathleen E. (Kathy) Arendt
• Director of Sales and Marketing- Mary Ann Demarco
• Trade and Managed Markets- William (Bill) Edwards
• Director of Product Supply- Trevor Hall
• Director of Clinical Development- Robert M. (Bob) Levy, M.D.
• Director of Corporate Development and Corporate Controller- Frank J. Strocchio

 

Be on Watch.

Primus Pharmaceuticals manufactures several products, including Limbrel.  The company voluntarily, but reluctantly, recalled osteoarthritis capsule Limbrel from the market as a result of urging from the FDA that the product may be linked to different side effects. These Limbrel side effects include drug-induced liver injury and hypersensitivity pneumonitis.

If you or a loved one took Limbrel and experienced symptoms while taking Limbrel, you may qualify for financial compensation for medical expenses, loss of income, and injuries suffered.

Call us at (888) 458-6825 or send us an email inquiry to discuss your legal options.

The consultation is free and confidential.

 

 

Resources:

1. Primus Pharmaceuticals, Inc. website: https://www.primusrx.com/
2. Limbrel website: https://www.limbrel.com/
3. December 18, 2017 FDA Letter https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM589655.pdf
4. Information on signs of a damaged liver https://www.mayoclinic.org/diseases-conditions/liver-problems/symptoms-causes/syc-20374502