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More than 5,000 bottles of Invokamet, a popular diabetes drug that combines Invokana and metformin, are being recalled because they may be incorrectly labeled with prescription information for the blood thinner Xarelto.
The FDA announced the Invokamet recall in last week’s enforcement report, indicating that the action was initiated on October 19.
Patients who receive bottles with the incorrect prescribing information may miss vital warnings about side effects of Invokamet, indications and dosages. However, the FDA rated the recall as class III, indicating that it does not believe serious injury or death is likely.
The Invokamet recall affects 5,346 bottles of 60-count tablets. The bottles have a lot number of 16GG581X, and an expiration date of 09/17.
The recall comes amid growing concern over both Invokamet and Xarelto.
Invokana (canagliflozin) is a controversial diabetes treatment that was introduced by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in March 2013, and was quickly adopted by the medical community amid aggressive marketing that suggested it was superior to other diabetes treatments. The drug maker introduced Invokamet the following year.
As more and more individuals have been switched to the new drugs, a steady stream of serious side effects have emerged, including a risk of diabetic ketoacidosis, heart attack, kidney failure and other health problems from Invokamet and Invokana.
Johnson & Johnson now faces Invokana lawsuits and Invokanamet lawsuits pending in courts nationwide, alleging that the drug maker failed to adequately research the medication and withheld important safety warnings in an effort to avoid loss of drug sales.
In addition, thousands of reports involving uncontrollable Xarelto bleeding problems have plagued the new drug, and there are currently more than 7,000 Xarelto injury lawsuits filed nationwide, alleging that the Bayer Healthcare and Janssen Pharmaceuticals sold an unreasonably dangerous and defective anticoagulant, without warning about the risk of severe and uncontrollable bleeding linked to the medication.