New Diabetes Drug Now Comes with Warning from FDA
New diabetes drugs that have been highly touted for their ability to manage even stubborn cases of type 2 diabetes now come with a warning from the FDA. The new class of drugs, which are manufactured by pharmaceutical giants Johnson & Johnson, Eli Lily and AstraZeneca, have been associated with dangerously high levels of blood acid in some patients.
The national product liability lawyers at The Sanders Firm are currently offering free case reviews to people who believe they were harmed by Invokana, Farxiga, Jardiance, or other type 2 diabetes medications and were never properly warned about the risks they were facing. We have over 45 years of experience going after the big pharmaceutical companies and winning multi-million dollar verdicts and settlements for our clients in drug injury cases. Don’t delay, since statutes of limitations set a deadline for the time you have to file.
FDA issues warning about ketoacidosis
The FDA issued a warning last month regarding drugs that fall into the category of SGLT2 inhibitors. These drugs include Johnson & Johnson’s Invokana (canagliflozin), AstraZeneca’s Farxiga (dapagliflozin) and Eli Lily’s Jardiance (embagliflozin), which the company produces in partnership with Boehringer Ingelheim, a German pharamaceutical company.
According to the FDA, these drugs can lead to high levels of blood acids known as ketones and a condition called diabetic ketoacidosis.
According to the FDA’s Adverse Event Reporting System, 20 cases of ketoacidosis were reported to the agency between March 2013 and June 2014. All of those patients required emergency room visits or hospitalizations to treat their conditions. The agency has also stated that they have received additional reports of ketoacidosis related to use of SGLT2 inhibitors since June 2014.
History of SGLT2 inhibitors
SGLT2 inhibitors were first introduced in 2013 as an alternative treatment for patients with type 2 diabetes that were unable to effectively control their blood sugar levels on other types of medication. These drugs are designed to work by causing sugar to be eliminated through the urine. The drugs gained popularity quickly, since in addition to their ability to manage blood sugar, they also led to modest decreases in blood pressure and weight loss.
Despite their perceived benefits, concerns over ketoacidosis risk have been mounting. Diabetic ketoacidosis is a serious medical condition that develops when the body is unable to produce sufficient insulin. This causes a build-up of ketones in the bloodstream, which can eventually lead to loss of consciousness and even death if it is not treated promptly.
Treatment typically involves hospitalization so that fluids, electrolytes and insulin can be administered in proper dosing amounts.
Other drugs could see spike
A report at Reuters suggested that this new revelation about potential dangers of SGLT2 inhibitors could increase prescriptions for other types of diabetes drugs, such as Merck’s Januvia. However, Januvia has also raised concerns in recent months as reports have increased regarding serious side effects with this drug as well. Side effects might include pancreatitis, pancreatic cancer, thyroid cancer and kidney damage. Patients that have been injured by these drugs have begun filing lawsuits against Merck and other manufacturers of drugs in this category.
Speak with a drug injury attorney today about your case
If you or someone you love has been injured while taking an SGLT2 inhibitor like Invokana or Farxiga, help is available. Victims of dangerous or defective drugs can turn to the professional team at The Sanders Firm to get a complimentary evaluation of their case and answers to their legal questions.
Now is the time to file your lawsuit against the manufacturers of these potentially dangerous drugs and pursue the compensation you are entitled to for medical bills, lost wages and other non-economic losses. Contact The Sanders Firm today at 888.972.8566.
- Reuters, FDA Warns on Newer Class of Type 2 Diabetes Drugs, http://www.reuters.com/article/2015/05/15/us-fda-diabetes-idUSKBN0O01P520150515
- FDA, FDA Drug Safety Communication: FDA Warns that SGLT2 Inhibitors for Diabetes may Result in a Serious Condition of Too Much Acid in the Blood, http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
- American Pharmacists Association, SGLT2 Inhibitors for Type 2 Diabetes: Clinical Considerations, https://www.pharmacist.com/sglt2-inhibitors-type-2-diabetes-clinical-considerations
- Mayo Clinic, Diabetic Ketoacidosis, http://www.mayoclinic.org/diseases-conditions/diabetic-ketoacidosis/basics/definition/con-20026470