Since being approved by the FDA as diabetes drugs years ago, Invokana, Farxiga, and Jardiance -- as well as Invokamet, Xigduo, Glyxambi, Synjardy, Qtern, Steglatro, Steglujan, Segluromet, and other SGLT2 inhibitors -- have been associated with other side effects, or adverse drug reactions, such as … More
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Recent News & Case Reports
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 … More
Tasigna Lawsuits Update: New Jersey MCL and Federal Court MDL Consolidations
We are currently investigating Tasigna side effects cases as possible Tasigna drug injury lawsuits against Novartis for patients who have developed some serious medical conditions during their use of Tasigna. In early June 2021, the New Jersey Supreme Court consolidated Tasigna drug injury … More
Novartis Stops 3 Beovu Clinical Trials in May 2021, Wants a Beovu Label Change
In late May 2021, the latest study data concerning Beovu safety issues resulted in Novartis stopping three key clinical trials -- MERLIN, RAPTOR, and RAVEN -- as well as Novartis indicating there will be another Beovu label change. To see how Novartis is seeking to present the current status of … More
Ocaliva-related Liver Injury Warnings Will be Added to Ocaliva Drug Label
We now know more about the Ocaliva-related liver injury "safety signal" that the FDA has been investigating over the past year, and as a result of that Ocaliva FDA safety evaluation there will be an Ocaliva label change with new warnings. On May 26, 2021, this FDA Drug Safety Communication about … More
A 2021 Look at the Increased Risk of Elmiron-associated Pigmentary Maculopathy
We have reported previously on Elmiron-related eye damage, particularly that long-term use of the interstitial cystitis treatment drug Elmiron has been linked to maculopathy eye damage. In this post, we present a 2021 Elmiron medical journal article wherein it is estimated that around 20% of … More