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Does Synvisc (hylan G-F 20) cause side effects?
Osteoarthritis is a type of arthritis in which the joints of the body degenerate and become painful and stiff. Osteoarthritis is the most common form of arthritis. Joints contain a fluid, called synovial fluid, which acts as a lubricant and shock absorber.
Patients with osteoarthritis have synovial fluid that is thinner than normal, and, therefore, it is less effective as a lubricant and shock-absorber. Synvisc is an elastic fluid that is made from a substance called hyaluronan, that is found in normal joint fluid.
Hyaluronan is the key substance in joint fluid that provides the shock-absorbing quality to the fluid, and it is essential for the proper functioning of joints. When Synvisc is injected into the knee of a patient with osteoarthritis, the drug helps to restore the shock-absorbing effect of the fluid within the knee. This can reduce pain, resulting in a more active lifestyle.
Common side effects of Synvisc include
- joint pain,
- joint stiffness,
- joint swelling,
- flu-like symptoms,
- back pain,
- injection site reactions (pain, stiffness, redness),
- skin rash,
- facial flushing, and
- facial swelling.
Serious side effects of Synvisc include
- severe pain or
- swelling around the knee after injection.
What are the important side effects of Synvisc (hylan G-F 20)?
About 1 in 14 persons experience pain or swelling in the injected knee, and one third of those who do, need to have fluid removed from the knee.
Common side effects include:
Other side effects include:
Synvisc (hylan G-F 20) side effects list for healthcare professionals
Potential Adverse Effects Of The Device On Health
Reported Device-Related Adverse Events
The most commonly reported adverse events associated with Synvisc (hylan g-f 20) are the following:
- Pain in the injected knee
- Swelling in the injected knee
- Joint effusion
Potential Adverse Events
The following adverse events are among those that may occur in association with intra-articular injections, including Synvisc (hylan g-f 20) :
- Joint stiffness
- Joint effusion
- Joint swelling
- Joint warmth
- Injection site pain
- Gait disturbance
A summary of adverse events identified in the clinical studies is provided in the Adverse Event section below.
Synvisc (hylan g-f 20) (3-injection regimen) post-marketing experience has identified the following systemic events to occur rarely with administration:
- muscle cramps,
- peripheral edema,
- respiratory difficulties,
- flushing and
- facial swelling.
There have been rare reports of thrombocytopenia coincident with Synvisc (hylan g-f 20) (3-injection regimen) injection.
Adverse Events Involving the Injected Joint
- Clinical Trials: A total of 511 patients (559 knees) received 1771 injections in seven clinical trials of Synvisc (hylan g-f 20).
- There were 39 reports in 37 patients (2.2% of injections, 7.2% of patients) of knee pain and/or swelling after these injections.
- Ten patients (10 knees) were treated with arthrocentesis and removal of joint effusion.
- Two additional patients (two knees) received treatment with intra-articular steroids.
- Two patients (two knees) received NSAIDs. One of these patients also received arthrocentesis.
- One patient was treated with arthroscopy. The remaining patients with adverse events localized to the knee received no treatment or only analgesics.
- A total of 157 patients have received 553 injections in the three clinical trials of repeated courses of Synvisc (hylan g-f 20) treatment.
- The reports in these trials describe a total of 48 reports of adverse events localized to the injected knee in 35 patients that occurred after injections that patients had received during their second course of treatment.
- These adverse events accounted for 6.3% of injections in 22.3% of patients as compared to 2.2% of injections in 7.2% of patients in a single course of Synvisc (hylan g-f 20) injections.
- In addition, reports of two retrospective studies during the post-marketing period have described adverse events localized to the injected knee that have occurred after 4.4% and 8.5% of injections that patients had received during one or more repeated courses of Synvisc (hylan g-f 20) treatment.
- Postmarket Experience: The most common adverse events reported have been pain, swelling and/or effusion in the injected knee.
- In some cases the effusion was considerable and caused pronounced pain.
- In some instances, patients have presented with knees that were tender, warm and red. It is important to rule out infection or crystalline arthropathies in such cases. Synovial fluid aspirates of varying volumes have revealed a range of cell counts, from very few to over 50,000 cells/mm³.
- Reported treatments included symptomatic therapy (e.g., rest, ice, heat, elevation, simple analgesics and NSAIDs) and/or arthrocentesis. Intra-articular corticosteroids have been used when infection was excluded. Rarely, arthroscopy has been performed.
- The occurrence of post-injection effusion may be associated with patient history of effusion, advanced stage of disease and/or the number of injections or treatment courses a patient receives.
- Reactions generally abate within a few days.
- Clinical benefit from the treatment may still occur after such reactions.
- The clinical trials described above included 38 patients who received a second course of Synvisc (hylan g-f 20) injections (132 injections).
- There were twelve reports in nine patients (9.1% of injections, 23.7% of patients) of knee pain and/or swelling after these injections.
- Reports of two additional clinical trials in which patients received repeated courses of Synvisc (hylan g-f 20) treatment have appeared during the post-marketing period.
- One of these trials included 48 patients who received 210 injections during a second course of Synvisc (hylan g-f 20) treatment; the other contained 71 patients who received 211 injections during a second course of Synvisc (hylan g-f 20) treatment.
- Intra-articular infections did not occur in any of the clinical trials and have been reported only rarely during clinical use of Synvisc (hylan g-f 20) .
Other Adverse Events
- Clinical Trials: In three concurrently controlled clinical trials with a total of 112 patients who received Synvisc (hylan g-f 20) and 110 patients who received either saline or arthrocentesis, there were no statistically significant differences in the numbers or types of adverse events between the group of patients that received Synvisc (hylan g-f 20) and the group that received control treatments.
- Systemic adverse events each occurred in 10 (2.0%) of the Synvisc (hylan g-f 20) treated patients.
- There was one case each of rash (thorax and back) and itching of the skin following Synvisc (hylan g-f 20) injections in these studies.
- These symptoms did not recur when these patients received additional Synvisc (hylan g-f 20) injections.
- The remaining generalized adverse events reported were calf cramps, hemorrhoid problems, ankle edema, muscle pain, tonsillitis with nausea, tachyarrythmia, phlebitis with varicosities and low back sprain.
Other adverse events reported include:
- muscle cramps,
- peripheral edema,
- respiratory difficulties,
- flushing and
- facial swelling.
There have been rare reports of thrombocytopenia coincident with Synvisc (hylan g-f 20) injection. These medical events occurred under circumstances where causal relationship to Synvisc (hylan g-f 20) is uncertain. (Adverse events reported only in worldwide postmarketing experience, not seen in clinical trials, are considered more rare and are italicized.)
Synvisc (hylan G-F 20) is an injectable fluid that is used to treat osteoarthritis (OA) of the knee. Common side effects of Synvisc include joint pain, joint stiffness, joint swelling, headache, flu-like symptoms, back pain, injection site reactions (pain, stiffness, redness), skin rash, itching, facial flushing, and facial swelling. There are no known drug interactions with Synvisc. No adequate studies have been done in pregnant women with this Synvisc. The risks of Synvisc during breastfeeding are not known.
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Second Source article from Government
Osteoarthritis is a type of arthritis caused by inflammation, breakdown, and eventual loss of cartilage in the joints. Also known as degenerative arthritis, osteoarthritis can be caused by aging, heredity, and injury from trauma or disease.
Osteoarthritis vs. Rheumatoid Arthritis
Osteoarthritis (OA) and rheumatoid arthritis (RA) are chronic joint disorders. RA is also an autoimmune disease. OA and RA symptoms and signs include joint pain, warmth, and tenderness. Over-the-counter pain relievers treat both diseases. There are several prescription medications that treat RA.
Osteoarthritis vs. Osteoporosis Differences and Similarities
Arthritis is defined as painful inflammation and joint stiffness. Osteoarthritis is a type of arthritis and the most common cause of chronic joint pain, affecting over 25 million Americans. Osteoarthritis is a type of arthritis that involves the entire joint. Osteoporosis is not a type of arthritis. It is a disease that mainly is caused by a loss of bone tissue that is not limited to the joint areas. It is possible for one person to have both osteoarthritis and osteoporosis. The differences in the signs and symptoms of osteoarthritis and osteoporosis include; pain, stiffness, and joint swelling, joint deformity, crackle sounds when the joint is moving, and walking with a limp. Osteoporosis is called the "silent disease" because it can progress for years without signs and symptoms before it is diagnosed, severe back pain, bone fractures, height loss, and difficulty or inability to walk. The differences in the causes of osteoarthritis and osteoporosis are that osteoarthritis usually is caused by wear and tear on the joints. Osteoporosis usually is caused by one or more underlying problems, for example, calcium and vitamin D deficiencies. Treatment for osteoarthritis and osteoporosis are not the same. There is no cure for osteoarthritis or osteoporosis.
What Is the Main Cause of Osteoarthritis?
Osteoarthritis (OA) is a chronic degenerative disease of the joints affecting middle-aged and elderly people. It involves the breakdown of cartilage and associated inflammatory changes in the adjacent bone. It is a leading cause of chronic disability, affecting 30 million people in the United States alone.
Arthritis in Knee: 4 Stages of Osteoarthritis
Painful joint swelling is called arthritis. Osteoarthritis is due to wear and tear of the joints over many years. Arthritis maye develop in any joint, including the fingers, hips and knees. Usually, patients with arthritis feel pain in their joints even after moderate movements. There are four stages of osteoarthritis of the knee.
Osteoarthritis and Treatment
Painful swelling of the joints due to wear and tear over many years is called osteoarthritis. Osteoarthritis may develop in any joint that includes the fingers, hips, and knees. There are many treatment options available to curb the complications of arthritis.
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.