- Sanofi Genzyme Synvisc-One supplements natural fluid in the knee to relieve osteoarthritis pain.
- Synvisc-One’s active ingredient is harvested from chicken combs.
- The company recalled 18,000 units of Synvisc-One after finding bacterial contamination.
Synvisc-One is a gel made from a natural chemical. It is harvested from chicken combs – the fleshy crest on the birds’ heads. The arthritis treatment mimics the cushioning properties of synovial fluid in the knee.
Synvisc-One is intended for people with severe osteoarthritis knee pain – but only after diet, exercise and over-the-counter pain remedies do not provide relief. The gel is pre-packaged in syringes for use. A doctor performs the injections, which can provide pain relief for up to six months.
Genzyme is a U.S.-based subsidiary of French drug manufacturer Sanofi SA. In December 2017, it recalled 18,000 syringes of Synvisc-One. More than 12,000 syringes had already been distributed in the U.S.
All of the recalled syringes came from a single lot: 7RSL021. Patients who suffered complications after contaminated Synvisc-One knee injections are suing the manufacturer.
What Is Synvisc-One Knee Injection?
Synvisc-One is one of several treatment options for osteoarthritis (OA) of the knee.
OA is the most common cause of pain and disability in the joint. Knee osteoarthritis can result from trauma or from wear and tear on the joint. It’s estimated that more than one in 10 Americans older than 25 have signs or symptoms of the condition.
Symptoms of Knee Osteoarthritis:
How Synvisc-One Knee Injections Work
Did You Know
A single Synvisc-One knee injection may provide pain relief for up to six months.
Doctors inject Synvisc-One directly into the knee. It’s made from hyaluronic acid (HA), the same chemical found in synovial fluid in the knee. The gel lubricates the knee and works as a shock-absorber.
Genzyme introduced its original Synvisc in 1997. The original drug required weekly injections for up to three consecutive weeks.
The U.S. Food and Drug Administration approved the newer Synvisc-One in 2009. It allows for a single injection that may provide pain relief for up to six months.
Treating Arthritis Pain with Synvisc-One
Synvisc-One is part of a class of drugs called hyaluronic acid derivatives (HADs). The FDA has approved these drugs to treat arthritis knee pain when other methods don’t work.
The FDA says patients should use hyaluronic acid derivatives only after trying alternatives.
Pain Relief Treatments for Knee Osteoarthritis:
American College of Rheumatology guidelines call for treating mildly symptomatic knee arthritis with diet and exercise. The guidelines suggest over-the-counter or certain prescription pain relievers for initial pain management.
In 2012, the American Academy of Orthopaedic Surgeons published new guidelines for treating osteoarthritis in the knee. It did not recommend using HADs for patients merely showing arthritis symptoms.
Synvisc-One Knee Injection Recall
In December 2017, Sanofi Genzyme discovered bacterial contamination in some Synvisc-One syringes. The company recalled a single lot of the arthritis treatment.
The lot contained 18,000 syringes, including 12,380 already distributed. All of the affected syringes where shipped to the U.S. market.
Recalled Synvisc-One Syringes
Lot Number: 7RSL021
Expiration Date: May 31, 2020
Distributed Between: Oct. 25, 2017 through Nov. 7, 2017
Reasons for Synvisc-One Recall: Contamination, Infection Risk
Sanofi Genzyme said it was investigating the “presence of microbial contamination.”
Days later, the company ordered the Synvisc-One recall. The recall notice told doctors to be “aware of the potential of a gram-negative infection.”
Gram-negative bacteria include E. coli, Salmonella and other hard to treat bacteria. Many have developed antibiotic resistance. They can lead to serious complications including pneumonia and bloodstream infections.
Synvic-One Knee Injection Side Effects
The Boston Globe reported that the recalled lot of Synvisc-One was associated with “an unexpected surge in ‘adverse events.’”
The FDA received reports from people experiencing severe pain and other complications following Synvisc-One treatments.
Reports show patients had to have excess fluid drained from their knees.
At least one patient’s lab test showed an elevated white blood cell count (WBC). A high WBC is a sign the body is fighting off an infection.
Please seek the advice of a medical professional before making health care decisions.
Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.
- McGrath, A.F. (2013, October 11). A Comparison of Intra-Articular Hyaluronic Acid Competitors in the Treatment of Mild to Moderate Knee Osteoarthritis. Journal of Arthritis. Retrieved from https://www.omicsonline.org/open-access/A-Comparison-of-Intra-Articular-Hyaluronic-Acid-Competitors-2167-7921.1000108.php?aid=19431
- Arthritis Foundation. (2017, December 12). Synvisc-One Injections Recalled. Retrieved from http://blog.arthritis.org/news/synvisc-one-injections-recalled/
- Palmer, E. (2017, December 12). Sanofi Recalls Arthritis Injection That is tied to Microbial Contamination. FiercePharma. Retrieved from https://www.fiercepharma.com/manufacturing/sanofi-recalls-arthritis-injection-u-s-tied-to-microbial-contamination
- Saltzman, J. (2017, December 12). Sanofi Genzyme Issues Recall for Contaminated Arthritis Gel. Boston Globe. Retrieved from https://www.bostonglobe.com/business/2017/12/11/sanofi-genzyme-issues-recall-for-contaminated-arthritis-gel/ruFBNfmYSyJdMy9i7qwF8N/story.html
- American Academy of Orthopaedic Surgeons. (2013, May 18). Treatment of Osteoarthritis of the Knee; Evidence-Based Guideline 2nd Edition. https://www.aaos.org/cc_files/aaosorg/research/guidelines/treatmentofosteoarthritisofthekneeguideline.pdf
- Hochberg, M.C., et al. (2012, April). American College of Rheumatology 2012 Recommendations for Use of Nonpharmacological and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care & Research. Retrieved from https://www.usbji.org/sites/default/files/COAMI%20American%20College%20of%20Rheumatology%202012_0.pdf
- CVS Caremark. (n.d.). Hyaluronic Acid Derivative FEP Clinical Rationale. Retrieved from https://www.caremark.com/portal/asset/FEP_Rationale_HyaluronicAcid.pdf
- U.S. Centers for Disease Control and Prevention. (2011, January 17). Gram-Negative Bacteria Infections in Healthcare Settings. Retrieved from https://www.cdc.gov/hai/organisms/gram-negative-bacteria.html
- Sanofi Genzyme. (2009, February 26). FDA Approves Genzyme’s Synvisc-One for Osteoarthritis of the Knee. Retrieved from http://news.genzyme.com/press-release/fda-approves-genzymes-synvisc-one-osteoarthritis-knee
- Sanofi Biosurgery. (n.d.). Synvisc-One; A Different Way to Treat. Retrieved from http://www.synviscone.com/what-is-synvisc-one.aspx
- Sanofi. (2017, December 19). Voluntary Recall of Synvisc-One Lot 7RSL021. Retrieved from http://www.news.sanofi.us/Voluntary-Recall-of-Synvisc-One-Lot-7RSL021
- Sanofi Genzyme. (2017, December 11). Urgent: Voluntary Device Recall. American Academy of Physical Medicine and Rehabilitation. Retrieved from https://www.aapmr.org/docs/default-source/news-and-publications/synvisc-one-customer-recall-lot-7rsl021-notification---hospital-and-physician-(3).pdf?sfvrsn=0
- Palo Alto Medical Foundation. (n.d.). Treatment Options for Osteoarthritis in the Knee. Sutter Health. Retrieved from http://www.pamf.org/sports/king/osteoarthritis.html
- National Institutes of Health. (2016, March 8). Gram-Negative Bacteria. National Institute of Allergy and Infectious Diseases. Retrieved from https://www.niaid.nih.gov/research/gram-negative-bacteria
- Mayo Clinic. (2018, January 11). High White Blood Cell Count. Retrieved from https://www.mayoclinic.org/symptoms/high-white-blood-cell-count/basics/causes/sym-20050611
- U.S. Food and Drug Administration. (2018, December 20). MAUDE Adverse Event Report. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7142071&pc=MOZ
- U.S. Food and Drug Administration. (2018, January 19). MAUDE Adverse Event Report. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7209040&pc=MOZ