Xeljanz Lawsuits: potential risks for Xeljanz users, FDA claims
There have been developments regarding the potential risks of the drug, Xeljanz. Xeljanz and Xeljanz XR are marketed by Pfizer for the treatment of rheumatoid arthritis. It was initially approved by the FDA back in 2012.
The problem is, it was approved at doses of 5 mg/day. A lot of patients are now taking the drug at a higher dose of 10 mg/day. When Pfizer asked for approval at this higher dose, the FDA required they conduct a post-marketing study to test its safety.
At the higher dosage, the drug has been known to increase the risk of:
- Cardiovascular events such as pulmonary embolism
- Blood clots in the lungs
- Cancer and an increased risk of death
If you’re currently taking Xeljanz, either at 5 mg/day or 10mg daily of Xeljanz, contact a personal injury attorney right away. You should also talk to your doctor to make sure the medication hasn’t affected you already.
What Does Xeljanz Do?
Xeljanz, also known as tofacitinib, was designed to help people with the following conditions:
- Moderately to severely active rheumatoid arthritis
- Ulcerative colitis
- Psoriatic arthritis
It was approved by the Food and Drug Administration (FDA) in the United States in 2012 at the 5 mg/day dose. Since then, thousands of patients have been prescribed the drug for daily use.
Recently, Pfizer requested that the FDA approve Xeljanz at the higher daily dosage of 10 mg/day. The FDA wouldn’t issue this approval until Pfizer conducted a post-marketing trial study involved with the drug.
Xeljanz works by blocking the enzymes in our body that cause inflammation and damage to our joints. This helps to relieve the symptoms of rheumatoid arthritis.
Did Pfizer Know the Drug May Be Unsafe?
Back in 2013, Europe refused to approve Xeljanz for the treatment of active rheumatoid arthritis. When they conducted their studies of the drug, they found that the 5 mg daily dose of Xeljanz seemed pretty safe. However, they wouldn’t recommend that patients use it at a higher dose of 10 mg/day.
The Committee for Medicinal Products for Human Use in Europe found in their clinical trials that the drug posed certain risks and side effects including:
- Liver damage or renal impairment
- Risk of serious infections
- Gastro-intestinal perforations
- Blood clot or pulmonary embolism
They warned their patients not to use the drug at all given their findings. However, this was not communicated by Pfizer to its American customers.
What Signs to Look For?
If you or a family member are patients taking Xeljanz or Xeljanz XR, you should talk to your doctor about any risks. You also need to look out for the following signs and symptoms:
- Shortness of breath or difficulty breathing
- Sweating profusely
- Clammy skin
- Coughing up blood
- Experiencing chest or back pain
If you are experiencing any of these symptoms, get checked out immediately. You also need to contact one of the personal injury lawyers at McDonald Worley. We have decades of combined experience handling defective drugs cases. We’re also at the forefront of any potential litigation involving Xeljanz. We stay apprised of any developments and make sure we protect our clients.
It’s important that you don’t stop taking any medications until you’ve talked to your doctor.
Contact an Experienced Attorney at McDonald Worley for Your Free Consultation
When news comes out that a drug may have dangerous side effects, you may worry. You’re afraid that you could be sick or worse. You may worry that your loved ones are at risk of being harmed by the drug.
Even if you think that you’ve been injured by Xeljanz, you need to talk to your doctor before you stop taking any medication. You also need to call and speak with a personal injury lawyer at McDonald Worley and schedule a free case review.