On September 1, 2021, we saw new FDA Xeljanz warnings about the increased risks of heart attacks, strokes, cancer, blood clots, and deaths. These Xeljanz drug safety problems have been associated with all doses of Xeljanz (5 mg tablet and 10 mg tablet) and Xeljanz XR (11 mg tablet and 22 mg tablet). This September 2021 document, “FDA requires … [Read more...]
FDA Advisory Committee Meeting Could Review Risk/Benefit Profiles for All JAK Inhibitors
The FDA has delayed its decision for Abbvie’s applications to have Rinvoq approved for the additional indications of psoriatic arthritis and ankylosing spondylitis, apparently due to possible new JAK inhibitors heart side effects and cancer risks issues identified in connection with a Xeljanz safety signal. From this June 25, … [Read more...]
Possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in Future
Based on these several recent developments, we expect that there will be an FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in the months to come. The focus of such will likely be these adverse drug events and side effects related to the JAK inhibitors class of drugs: Heart AttacksMyocardial Infarction (MI)Strokes — Ischemic / … [Read more...]
Are Heart Problems and Cancers JAK Inhibitors Drug Class Safety Issues?
Since the February 2021 FDA alert about Xeljanz-associated heart problems and possible Xeljanz-related cancers was issued, we have been watching for any related drug safety developments concerning Olumiant and Rinvoq. The reason being there has been some concern that those adverse drug events and side effects risks may apply to those other two … [Read more...]
Some Information About Our Monthly Law Firm Newsletter
The Lamb Law Office Newsletter is a monthly communication from our law firm to help keep you up to date with some of the cases that we are working on for clients at the present time. In addition, we provide at least one information resource item per month, which you or someone you know might find helpful from time to time. Past … [Read more...]
Xeljanz Side Effects Include Blood Clots, Pulmonary Embolism, And Serious Infections
In the past, we have written about Xeljanz-related blood clots and Xeljanz pulmonary embolism risks, i.e., blood clots in the lung, which can lead to death in some cases. Recently, however, we saw there are some new clinical trial findings of serious infections linked to Xeljanz. In March 2020 the UK’s Medicines and Healthcare products … [Read more...]
Xeljanz Should Be Used With Caution In Patients At High Risk Of Blood Clots
There is a new Xeljanz drug safety warning about an increased risk of blood clots resulting in pulmonary embolism (PE) and deep vein thrombosis (DVT). From this PDF document, “Xeljanz to be used with caution for all patients at high risk of blood clots”, issued in October 2019 by the European Medicines Agency (EMA), we get these details: A review … [Read more...]
Xeljanz FDA Drug Safety Communication About Increased Risks of Blood Clots And Death
This Xeljanz FDA Drug Safety Communication was issued July 26, 2019: “FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)”. From that document we get the following information: The U.S. Food and Drug Administration has approved new … [Read more...]
Xeljanz Safety Concerns and New Precautions
You may have read our previous articles about Xeljanz and its risk of leading to Pulmonary Embolism or even death. In June, we posted "Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible" that provides information on the serious side effects found out through a post-marketing … [Read more...]
Serious Side Effects For Xeljanz 10 mg Dose Leads To European Drug Safety Regulatory Action
In May 2019 there was more drug safety regulatory action, this time from Europe, regarding the serious side effects associated with Xeljanz related blood clots. We get some details from this news report, “EMA Puts Temporary Restrictions on Tofacitinib Due to PE Risk”: The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment … [Read more...]