FDA Reports – Increased Risk of Pulmonary Embolism and Death Observed in Tofacitinib Post Marketing Study

On February 25, 2019, the Food and Drug Administration (FDA) announced that data from an ongoing post marketing study found an increased risk of pulmonary embolism (PE) and death in rheumatoid arthritis patients treated with a 10 mg twice daily dose of tofacitinib (marketed as Xeljanz, Xeljanz XR). The FDA has not approved the 10 mg twice daily dose of tofacitinib for rheumatoid arthritis (RA); however, this dose is approved in the treatment of patients with ulcerative colitis.

Tofacitinib (Xeljanz, Xeljanz XR) Post Marketing Study Requirement

At the time of drug approval, the FDA required manufacturer, Pfizer, to conduct a clinical trial in patients with RA to evaluate the risk of heart-related events, cancer, and opportunistic infections with two different doses of tofacitinib, 10 mg twice daily and 5 mg twice daily, in combination with methotrexate, compared to another drug called a tumor necrosis factor (TNF) inhibitor.

According to the FDA, during a recent trial analysis, an external data safety monitoring committee found an increased occurrence of pulmonary embolism (blood clots in the lungs) and death in patients treated with tofacitinib 10 mg twice daily when compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor. Study patients who were on the high dose, 10 mg twice daily, are being transitioned to the lower and currently approved dose of 5 mg twice daily. The clinical trail is expected to be completed by the end of 2019. The FDA reports that it will work with Pfizer to evaluate available safety information and that the public will be updated based on the ongoing review.

Patients and health care professionals can report Xeljanz side effect and medication side effects to the FDA MedWatch program at MedWatch.

FDA Information for Health Care Professionals

Health care professionals are advised to follow the recommendations in the tofacitinib prescribing information for the specific condition being treated. Patients should be monitored for the signs and symptoms of pulmonary embolism, and advised to seek medical attention immediately if they experience these signs and/or symptoms.

FDA Information for Patients

The FDA cautioned patients as follows:

“Patients should not stop or change your dose of tofacitinib without first talking to your health care professional, as doing so may worsen your condition. Patients taking tofacitinib should seek medical attention immediately if you experience symptoms of a blood clot in your lungs or other unusual symptoms such as:

• Sudden shortness of breath or difficulty breathing
• Chest pain or pain in your back
• Coughing up blood
• Excessive sweating
• Clammy or bluish colored skin”

Xeljanz Lawsuit Information

If you or a loved one was injured by a Xeljanz side effect, including pulmonary embolism or a fatality, and you would like more information regarding your legal rights, please call our firm toll free at 877-934-6274 for a free legal case evaluation. Please see Xeljanz Lawsuit to learn more about our legal services.

FDA Safety Letter Regarding PE and Extracorporeal Photopheresis (ECP) Treatment – On February 5, 2018, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals that it is evaluating recent reports of venous thromboembolism (VTE), including pulmonary embolism (PE), in patients treated with autologous immune cell therapy with the CELLEX Photopheresis System by Therakos, Inc. According to the FDA Alert, these events typically occurred during, or shortly after treatment sessions.

The FDA reported that since 2012, it has received seven reports of patients experiencing PE during or soon after treatment (average of 1.2 days). The agency provided the following information regarding the seven reports of PE.

“Two of these reports were associated with the death of the patient, although the link between the PE and death cannot be made with certainty. Of the seven PE events, four occurred in patients known to be undergoing treatment for GVHD, including the two patients who died. In addition to PE, the FDA has received two reports noting the diagnosis of a deep vein thrombosis (DVT) in an extremity of a patient during, or soon after, an ECP session. Both of these occurred in patients undergoing treatment for GVHD. Although allogeneic transplant patients who develop GVHD are known to be at increased risk for VTE, the timing of the events in these reports suggests that ECP therapy may increase that risk.”

The following recommendations to healthcare professionals were included in the FDA Healthcare Letter:

• Alert patients, and clinical staff and technicians involved in ECP procedures, to the signs and symptoms of PE and DVT that can develop during or after a procedure.
• Refer to device labeling regarding considerations for anticoagulation use with this system and use clinical judgment in adjusting an individual patient’s heparin dosage.
• Report VTE events related to ECP procedures that come to your attention.

Pulmonary Embolism and Blood Clot Lawsuit Information

The Weinberg Law Firm is currently assisting those injured by PE and Blood Clots related to medical negligence and drug side effects. If you would like more information, please see Blood Clot Lawsuit or call our firm toll free at 877-934-6274.

Faulty Blood-Thinner Monitor

Announcement Regarding Faulty Blood-Thinner Monitor

Alere Inc. will be withdrawing from the market the blood-thinner monitor, Alere INRatio® and INRatio®2 PT/INR Monitoring System, because the device may potentially show inaccurate results.

OBTAIN A FREE MEDICAL DEVICE LAWSUIT EVALUATION

If you are a loved one has been seriously injured by a medical device, and you have a question concerning your legal rights, please submit our easy-to-use “Legal Case Evaluation Form” found on this page, or contact us toll free at 1-877-934-6274 for a free legal case evaluation.

Blood-Thinner Monitor

This product is used to measure levels of blood-thinning medicines in the user. Blood-thinning medications are used to slow blood clotting, preventing complications like blood clots forming on artificial valves, valve obstruction and blood clots traveling to the brain and causing stroke.

In association with the U.S. Food and Drug Administration (FDA), Alere is determining when product discontinuation should occur.

Recall of Faulty Blood-Thinner Monitor

According to the Press Release publicized by the FDA, in December 2014, Alere initiated a correction to inform users of the blood-thinner monitor that patients with certain medical conditions should not be tested with the system.

In the intervening time since this correction, Alere conducted research which they claimed had addressed the instances in which their blood-thinner monitor displayed inaccurate results due to faulty software.

The FDA, however, did not find this research to “adequately demonstrate the effectiveness of the software modification”. Due to this lack of evidence, Alere, at the recommendation of the FDA, removed the blood-thinner monitor from the market.

MEDICAL DEVICE LAWSUIT HELP

The personal injury lawyers at The Weinberg Law Firm is currently assisting individuals injured by medical devices, including vaginal mesh, power morcellators, IVC filters, and endoscopes/duodenoscopes as well as other devices. Mr. Weinberg also serves as local counsel for mesh lawsuits filed against manufacturers C.R. Bard and Johnson & Johnson consolidated in New Jersey Superior Court in Bergen County.

According to a November 23, 2015 U.S. Food and Drug Administration (FDA) Safety Communication, intravascular medical devices pose the risk of harming patients due to the possibility of lubricious coating separation. This means that the slippery coating on the device that is necessary to reduce friction between the device and blood vessels during an endovascular procedure may peel or flake off of the device, leaving coating fragments in the patient.

Possible injuries caused by lubricious coating separation from intravascular medical devices include:
• pulmonary embolism,
• pulmonary infarction,
• myocardial embolism,
• myocardial infarction,
• embolic stroke,
• tissue necrosis.

If the lubricious coating separation from intravascular medical devices leads to remaining coating fragments in patient, this could require surgical intervention to mitigate the consequences, adverse tissue reactions, and thrombosis.

Lubricious coating separation from intravascular medical devices can be the result of several factors, such as the practitioner technique, using the wrong device for the procedure, improper preconditioning of the device, improper storage conditions, and/or issues with device design or manufacturing processes.

CONTACT THE WEINBERG LAW FIRM FOR A FREE MEDICAL MALPRACTICE LAWSUIT CASE EVALUATION

If you or a family member has been injured as a result of medical malpractice, and you have a question regarding your legal rights, you can request a free medical malpractice lawsuit case evaluation from our firm by visiting our Medical Malpractice Lawsuit Help page. You can also call us toll free at 1-877-934-6274. Our phones are answered 24/7.

500 Reported Cases of Lubricious Coating Separation, 9 Reported Deaths

Since Jan. 1, 2014, there have been about 500 reported cases, according to the FDA, of lubricious coating separation from intravascular medical devices, including nine cases that resulted in death.

These nine lethal reports of lubricious coating separation from intravascular medical devices were specifically due to “embolization of coating particles from devices during heart and brain catheterization procedures contributing to clinical adverse events such as heart attack and bleeding inside the brain.”

Cases of lubricious coating separation has been found mostly in guidewires, but there have also been cases associated with sheaths, retrieval devices and embolization device delivery wires used in the vasculature.

OBTAIN A FREE MEDICAL DEVICE LAWSUIT EVALUATION

The FDA has yet to pinpoint a specific manufacturer or brand of these devices as more susceptible to lubricious coating separation than any other. The FDA has, however, stated that the cause of coating separation is “multifactorial, and can be associated with factors including device design, device manufacturing, and use.”

The Weinberg Law Firm is currently assisting individuals injured by medical devices. If you are a loved one has been seriously injured by a medical device, and you have a question concerning your legal rights, please visit our Medical Device Lawsuit page, or contact us toll free at 1-877-934-6274 for a free legal case evaluation.

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