The US Food and Drug Administration (FDA) last week added health warnings to the labels of several popular drugs used to treat type-2 diabetes, after reports showed patients may be at risk of high blood acid levels and severe urinary tract infections.
The official label warnings follow a consumer warning issued by the FDA in May when the agency first learned of the ketoacidosis risks.
The changes will affect three diabetes drugs sold in the United States: Invokana, Jardiance and Farxiga. Together, they account for more than 4,000,000 prescriptions each year.
These drugs are part of a new class known as SGLT2 inhibitors. They work by blocking the protein sodium-glucose co-transporter 2 to inhibit the kidneys from absorbing glucose. Reports show they may also reduce body weight and blood pressure.
Prior to May 2015, the FDA received 73 reports of patients developing ketoacidosis while taking Invokana, Jardiance or Farxiga through its Adverse Events Reporting System. The agency also was notified of around 20 cases of patients developing serious kidney infections that had spread from urinary tract infections while taking the drugs.
Both conditions can require hospitalization and even result in death in extreme cases.
The FDA warns that patients should stop taking Invokana, Jardiance or Farxiga and seek immediate medical help if they notice symptoms of ketoacidosis. These include nausea, vomiting, abdominal pain, fatigue, and difficulty breathing.
The agency will also require the makers of these drugs, Bristol-Meyers Squibb, AstraZeneca, Janssen and Boehringer Ingelheim, to perform new studies of patient data for 5 years in order to gauge the risks of ketoacidosis more accurately.
Due to the failure of SGLT2 makers to warn patients of these risks earlier, thousands may have been injured or hospitalized. Lawyers have already begun initiating lawsuits for those affected and will ask that cases be combined into a special federal multidistrict court (MDL).
For more information on the risks of SGLT2 diabetes drugs, or to speak with a lawyer about your case, contact DrugNews today.
Brown, T. FDA Adds Warnings to SGLT2 Inhibitors. MedScape. (December 4, 2015). Retrieved from www.medscape.com
FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. (December 4, 2015). Retrieved from www.fda.gov
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