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lower limb amputations 5 articles

Amputation warning to be added to type 2 diabetes drugs sold in Europe

Europe’s Committee for Medicinal Products for Human Use (CHMP) announced it is endorsing the European Medicine Agency (EMA) Pharmacovigiliance risk Assessment Committee (PRAC) recommendations to add new warnings to the labels to a class of type 2 diabetes drugs called SGLT2 inhibitors alerting users to an increased risk for lower limb amputations, mostly affecting the toes. The recommendations will be sent to the European Commission for a final legally binding decision that will stand for all drugs in the class sold throughout the European Union. The EMA issued a statement stating, “Patients taking these medicines are reminded to check their ... Read More

FDA mum about whether amputation warning will be added to Invokana, Invokamet

The Food and Drug Administration (FDA) has not tipped its hand on whether it will require updating of the safety labels of the type 2 diabetes drugs Invokana and Invokamet to include new warnings of lower limb amputations following an announcement earlier this week that European drug authorities were ordering the updates on labels of Invokana and Invokamet as well as others in the same class. Invokana and Invokamet (marketed as Vokanamet in Europe) are in a class of type 2 diabetes medications known as sodium-glucose go-transporter 2 (SGLT2) inhibitors. Other drugs in this class include Forxiga and Jardiance. Both ... Read More

NICE recommends diabetes drugs despite serious risks

The National Institute for Health and Care Excellence (NICE) is recommending the use of one of three drugs in a newer class of type 2 diabetes treatments if standard treatment is not suitable. The news comes on the heels of an announcement by the European drug regulator that it was conducting a safety review of one of the medications due to an increased risk of lower limb amputations and new warnings by the U.S. drug regulator for an increased risk of a serious condition called ketoacidosis. NICE is part of the UK’s Department of Health serving both the English National ... Read More

Invokana plagued by new side effects since its FDA approval

It’s been three years since the Food and Drug Administration (FDA) approved Johnson & Johnson’s Janssen Pharmaceutical’s drug Invokana (canagliflozin) as a treatment for type 2 diabetes. Since then, the FDA and other drug regulators have issued numerous warnings over new Invokana side effects that have emerged outside initial clinical trials. Invokana was the first drug approved in the United States in a class known as sodium glucose cotransporter 2 (SGLT2) inhibitors. Prescriptions for the drug have since soared, generating hundreds of millions in revenue. In May 2015, the FDA issued a Safety Communication warning that Invokana and two other ... Read More

Diabetes drug Invokana linked to increased toe amputation risk

Johnson & Johnson’s Janssen Pharmaceuticals’ type 2 diabetes drug Invokana has taken some hits since March 2013 when it was approved for marketing in the U.S. by the Food and Drug Administration (FDA). Last May, the agency warned that the medication had been linked to cases of ketoacidosis, a serious condition in which too much acid builds up in the blood. Four months later, the FDA issued new warnings for Invokana over bone fracture risk and decreased bone density. Now, European regulators reviewing data from a large ongoing clinical trial say they found evidence that patients taking Invokana were more ... Read More