Health regulators in Europe warn about Invokana side effect risks

by John Chapman

Health regulators in Europe are calling for stronger warnings about the risk of lower limb amputation and similar side effects associated with the Type 2 diabetes drug Invokana. Janssen Pharmaceuticals, the manufacturer of Invokana, is facing dozens of lawsuits in the U.S. filed by patients who suffered complications from using the diabetes drug.

In February 2017, the European Medicines Agency (EMA) warned that patients taking Invokana may face an increased risk of lower limb amputation. The EMA launched an investigation of Invokana and other diabetes drugs known as SGLT2 inhibitors following a pair of clinical trials in which found that patients taking these drugs experienced an increase in lower limb amputations. The EMA called for the manufacturers of Invokana and other SGLT2 inhibitors to add a warning label to these products concerning the potential increase risk of limb amputations associated with these drugs.

Following the EMA’s warning about Invokana, the Medicines and Healthcare products Regulatory Agency (MHRA) – the agency that regulates drugs and medical devices in the U.K. – announced that it would add a warning about the increased risk of lower limb amputations to Invokana. The warning will advise doctors who prescribe Invokana to monitor their patients for signs of lower limb problems. The warning also advises patients to engage in routine preventive foot care and hydration in order to reduce their risk of lower limb amputations.

The Food and Drug Administration has also warned about the risk of side effects from Invokana. In May 2015, the FDA warned that patients taking the diabetes drug could face an increased risk of diabetic ketoacidosis, a potentially life-threatening condition that can occur when a patient’s blood becomes too acidic. The FDA also recently warned that Invokana users may face an increased risk of kidney failure or kidney damage caused by the diabetes drug.

Lawsuits Filed on Behalf of Invokana Users

Janssen Pharmaceuticals is facing at least 126 lawsuits in the U.S. filed on behalf of patients who suffered complications after taking Invokana to treat Type 2 diabetes. These lawsuits allege that patients taking Invokana have developed kidney failure, ketoacidosis, and other side effects caused by the drug.

In December 2016, dozens of lawsuits filed against Janssen involving Invokana were consolidated in New Jersey in a Multi-District Litigation (MDL). The MDL will consolidate all Invokana lawsuits filed in New Jersey or transferred to its jurisdiction in the future “to provide for the fair and equitable sharing among plaintiffs, and their counsel, of the burden of services performed and expenses incurred by attorneys acting for the common benefit of all plaintiffs in this complex litigation.”

Invokana Patients May Qualify to File a Lawsuit

If you or a loved one have been diagnosed with kidney failure, kidney damage, diabetic ketoacidosis, or other complications that may be caused by Invokana, you may be eligible to file a lawsuit and seek compensation for your injuries. The first step in taking legal action is to speak with an experienced team of pharmaceutical litigation attorneys who can advise you regarding your legal rights and walk you through the first steps in filing a case.

The lawyers at Heygood, Orr & Pearson have filed numerous lawsuits involving dangerous drugs and other pharmaceutical liability matters on behalf of our clients. Heygood, Orr & Pearson has handled more cases involving the fentanyl pain patch than all other law firms in the country combined, and have filed numerous lawsuits on behalf of patients who were injured after taking Yasmin, Actos, Avandia, Zofran, and other prescriptions drugs.

The attorneys at Heygood, Orr & Pearson have tried hundreds of cases to verdict and have achieved settlements in hundreds more on behalf of our clients. At Heygood, Orr & Pearson, we believe that when pharmaceutical companies manufacture dangerous drugs or medical devices, they should be held responsible for the injuries caused by these products in a court of law.

For more information about the Invokana litigation and to receive a free consultation to learn whether you may qualify to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following this link to our free case evaluation form and answering a few brief questions to get started.