Invokana belongs to a new class of drugs that have been widely hailed by the manufacturers as a revolution for individuals suffering from diabetes. This class of drugs focuses on kidneys to get rid of the excess blood sugar whereas other common drugs for diabetes sufferers usually focus on producing more insulin in the body. However, over the past few years, there have been several cases where users have reported some severe side effects with the continuous use of this drug.
This drug was first introduced in the market in the year 2013 after many years of trials. It is made by a subsidiary of Johnson & Johnson which is a pharmaceutical giant. Shortly after its introduction in the market, some users of this drug reported kidney issues. It is to be noted that many types I diabetes sufferers suffer from a condition known as ketoacidosis that increases blood acid. In this condition, the body of a diabetes patient cannot use glucose as an energy source, and the body breaks down fat cells. However, this also results in the production of ketones that are a kind of blood acid.
If the level of ketones increases to dangerous levels in the body, it may lead to coma and eventual death. While this condition is commonly found in type I diabetes sufferers, type II diabetes patients rarely suffer from this condition. However, many users suffering from type II diabetes have reported this condition after taking this drug. Due to many adverse event reports, FDA issued a safety communication in May 2015 warning users of the enhanced risk of ketoacidosis due to continuous use of this class of medication for type II diabetes patients.
FDA continued to be vigilant about the other side effects of this drug and in 2016, the agency decided to issue a black box warning which means an additional warning was added on to the prescription drug label warning patients of the risk of ketoacidosis. Usual symptoms of ketoacidosis include fatigue, nausea, and dizziness among others. Any person on this medication with these symptoms should immediately seek medical attention. However, this was not all, and the FDA soon decided to add a new warning to the drug's label as many users reported severe urinary tract infections after continued use of this drug.
In 2017, FDA also issued a communique stating that a clinical study has found a link between enhanced risk of lower limb Invokana amputation from continuous use of Invokana. The clinical study found that patients that continue to use this drug are twice as likely to lose their lower limbs as compared to patients on a placebo. The study found that almost 7/1000 type II diabetes sufferers are likely to lose their lower limbs on this medication as compared to 3/1000 type II diabetes sufferers on placebo.
Has Invokana Been Recalled?
The simple answer is No.
Neither the company manufacturing this drug nor its parent company has issued a recall of this drug. Keep in mind that this drug has not only been linked to various kidney issues such as kidney failure but also enhanced the risk of loss of lower limbs with continued usage. FDA also hasn't asked the company to recall this drug and has only issued a black box warning.
While there has been no recall, some individuals have filed hundreds of individual lawsuits against the manufacturer for harm suffered due to use of this particular product. There are several law firms all across the country willing to represent individuals who have suffered harm due to the above mentioned side effects of this particular drug.
It is believed that the manufacturer failed to warn users about the serious side effects. In other words, the manufacturer chose to place profits over consumer safety, and this is the reason many law firms devoted to protecting the rights of patients have started looking for potential Invokana lawsuits. These law firms believe that the users of this drug may be entitled to fair financial compensation through a personal injury settlement.
They are likely to raise complaints indicating that the manufacturer of the drug should have either recalled the drug or provided much stronger warnings after several reports of amputations, kidney failure, ketoacidosis and several other such issues began to surface among users. Many users might have avoided serious harm if they had received sufficient warnings as they could have chosen not to use this new drug.
If you or someone you know has suffered serious harm due to the side effects of Invokana, you should get in touch with a reputed attorney to get fair financial compensation for your injuries. Most attorneys usually represent individuals in such cases under a contingency fee arrangement. The contingency fee agreement means that the individuals are not required to pay law firms unless they are successful in obtaining a recovery from the other party.
For more related information, please visit http://www.huffingtonpost.ca/2013/03/29/fda-approves-first-in-cla_n_2980723.html.