Biotech giant Sanofi Genzyme has initiated a voluntary product recall for one lot ofSynvisc-One,a brand of hyaluronic acid. The lot, which was found to contain contamination, has been linked to an unexpected increase in side effects. In an urgent “product hold” letter, doctors, clinics and pharmacies who received syringes from that lot were instructed to immediately stop using the injections on patients until the company can investigate.
“The voluntary product recall of one (1) lot ofSynvisc One, lot 7RSL021, is due to an ongoing investigation which revealed the presence of microbial contamination,” said Sanofi spokesperson Heather Guzzi in an email. “Use of this voluntary recalled lot may result in a risk of infection.”
Guzzi said the recall was “initiated as a result of an unexpected increase in the number of labelled adverse events received from the U.S. market” and that “no other Synvisc-One or Synvisc lots are impacted by this recall.”
Hyaluronic acid injections, includingSynvisc-One, are approved by the Food and Drug Administration to help with pain from knee osteoarthritis (although they are sometimes used in other joints) in patients who haven’t been helped by more conservative treatments, such as nonsteroidal anti-inflammatory drugs (NSAIDs). Hyaluronic acid is naturally present in healthy joints, where it acts as a shock absorber and lubricant, allowing joints to move smoothly over each other. However, the acid appears to break down in people with osteoarthritis. Injecting it into a joint – also called viscosupplementation – may lessen pain and inflammation.
Guzzi said each lot ofSynvisc-Onecontains approximately 18,000 syringes, and about 12,380 from this lot were distributed across the United States. Although the product was linked to “an unexpected increase in the number of labelled adverse events,” she did not say which particular side effects prompted the recall. Common side effects listed on the package insert include pain, swelling, heat, redness, and fluid build-up in and around the knee.
Guzzi noted that the recall is at the physician and wholesale/pharmacy level, not at the consumer level, and that it’s “being initiated with the knowledge of the U.S. Food and Drug Administration.”
Author: Andrea Kane for the Arthritis Foundation
When will my dr know if the injections are included in this lot??
I have had lots of pain from this injection.
I was in crippling pain for 2 weeks from this lot. How was the lot compromised? Has any recourse been initiated?
I could not put any weight on my knee for two weeks. It has been over a month and I still can’t walk more than a short distance. Would like to know what can be done about the pain
我也是。我徒步行走了10天，膝盖肿得无法弯曲。想知道被什么污染了，他们不会说的!
I also had extreme pain from this injection which WAS in the recalled lot.
Failed to mention that I was injected with the SynviscOne that was recalled
I got the shot December 11th and my knee swelled up horribly pain was tremendous cannot bear any weight on it I have been getting these shots since 2012 will the doctor tell me the truth and let me know if the shot I received was one of them that is infected
我也有这些。我失业了两周。我根本走不动了。我得去看我的医生，让他给我注射强的松和止痛药。家里有一把椅子可以让我们上下床。有关于资源的消息吗?That was terrible pain
My knee swelled to over twice its size, was very tight and painful, making it difficult to walk, ice and ibuprofen / tylenol did nothing.
I been getting injections for about 3 years now,the last 2 trips to doctor left me with all side affects.what kind of effect ion did they give me?
I had the injection on 12/4/17 at 10:30 AM. By 7
I had Synvisc injection at the Durham, NC VA hospital, January 8th 2018, with very bad pain. This injection is the only one of many that has ever caused pain. It continues to be swollen, but the pain has diminished. How to I find out if I was infected?
即刻疼痛肿胀，不能行走。现在跛行明显，肿胀基本消失，但整条腿仍然僵硬。Saw infectious disease specialist who said I would need direct culture before getting even steroid infection .worried about risk of knee replacement now or long term systemic effect now that I know I had methylobacterium thiocyanatum injected into my knee
How do I find out the lot #
This could be why I was in so much pain.
I had this injection but with lot number ending in 18. I had terrible pain and my knees swelled so bad. I had to go to the ER. At the time, I could not walk. They had to send a wheelchair to get me into the ER. They drained 90 cc of fluid on the right knee and 60 cc on the left. I am still dealing with pain.
Had the injection Jan 19,2017. Have had. It. Before with good results, however, this time, I am. Fighting to try and walk without. Tripping. It’s very difficult for me to take steps. My. Pace. Is the slowest it has ever been. And. The pain and swelling. Is at its worst!, for the first time in a long time I feel like a real cripple
I do not know what to do, I try every pain. Pill that my doctor. Suggests, but nothing is cutting the stiffness and hurt.
I had this injection February 1, 2018. My knees are very swollen and I am in a lot of pain. Have to have assistance getting around.
I had the injection Dec. 26th 2017. My question is how do i know the lot# that was used in my injection? Is that something the attorney will get?
I’ve had severe pain since the injection amongst several other things. My pain is 10x more severe now than prior to. Now I’m told I need another knee surgery. I had surgery Sept. 1st 2017 with little to no relief so we decided on the Synvisc one injection instead of cortisone due to the fact Synvisc one lasts up to 1 yr of relief vs cortisone of 3 mo. So I saw him at 12 wks for my follow up and I told him my Pain and other things were worse. He decided to do the Synvisc one injection and I’ve had nothing but more extreme pain and things. So I saw him this wk only to be told I should now have a surgery that they drill holes in the bottom of your femur so that new bone grows and this supposedly takes a ‘ll the knee issues away. Well I’m not having any more surgeries now until I know what’s going on with this recall.
I had 3 injections in each knee every couple of weeks since the beginning of November. I am in so much pain I walk way worse than before and now even getting around with a cane is difficult. I frequently have to use a wheel chair and cannot even grocery shop anymore. I am just now realizing as i read these cases that maybe I was injected with bad shots as well ? The pain has been excruciating.
Synvisc One shots are given once in a knee every 6 months.
THIS IS REALLY SAD THIS IS HAPPENING. THE DRUG COMPANYS NEED TO WATCH AND DO QUALITY CONTROL.
我是在2017年9月注射的。但我也有同样的问题。去看急诊了我的膝盖承受不了重量。感觉自己要翻倒了。我的日期和拍品不匹配。But im am experiencing these things
我是在2017年11月注射的，不能走路。第二天，我的医生尽可能多地切除了细胞。直到2月，我的膝盖才开始看起来和感觉正常。我一直在用手给自己吃药上台阶。到简的时候，我的手已经有关节炎了。在11月到1月的这段时间里，我感到非常疲惫和沮丧，就像别人说的那样，我有生以来第一次感到自己瘸了，老了。
I just reported the even to Sanofi. Everyone should.