New Medications Aren’t Always Better
Onglyza, which was first introduced into the market after receiving an FDA approval on July 31st, 2009, was created to compete with other new Type 2 diabetes medications that fall into the DPP-4 inhibitors classification. These drugs work by encouraging the pancreas to produce more insulin and also stops the liver from producing extra sugar. While there may be benefits to managing diabetes through these medications, it doesn’t mean that Onglyza is safe.
Whenever a company creates a new medication, even if it is FDA approved, they are responsible for making sure that any potential side effects are listed on the warning label so that doctors and patients are aware of the risks. If they fail to do so, they can be held legally responsible under product liability laws.
Study Links Onglyza To Heart Failure
In 2013, the New England Journal Of Medicine published a study, the results of which showed that patients treated with Onglyza instead of a placebo had a 27% increase in the rate of hospitalization for heart failure.
While everyone understands that heart failure is a life-threatening condition, want isn’t always discussed is that once the heart is in distress, there are numerous complications that stem from this one condition that can also harm a patient, such as:
When the heart isn’t working properly blood clots can form. If these blood clots travel to other parts of the body and become lodged in a vein that is too small for it to pass through, serious damage can be done or the patient may even die. DVT’s and pulmonary embolisms are two of the most deadly medical conditions caused by blood clots.
Heart failure can result in reduced blood flow. If the blood isn’t flowing into the kidneys normally, this may ultimately result in kidney failure.
Fluid buildup in the body is common with heart failure and if it isn’t controlled, the extra fluid can put extreme pressure on the liver, resulting in damage because it can’t function normally.
The FDA’s Decision
When the U.S. Food and Drug Administration learned of the 2013 study, they requested that the manufacturers AstraZeneca and Bristol-Myers Squibb submit clinical data to the FDA for review. Then a panel was convened in April of 2015 where fifteen committee members reviewed that information. One of the committee members voted to remove the drug from the market entirely, however, the other fourteen decided to issue a black box warning instead.
What Is A Black Box Warning?
A black box warning is the most serious warnings that the FDA can issue and alerts the medical community and the public to dangerous side effects.
Hundreds Of Patients Pursue Justice
Those who have already been harmed by Onglyza have chosen to file lawsuits against the manufacturers, hoping to recover compensation for their medical expenses, lost earnings, physical pain and suffering, and even emotional trauma.
How Our Law Firm Can Help
Our team operates on the belief that each case is unique and there is no such thing as “just another case” to us. Together with each client, we carefully review all information available, determine what legal avenues are available, go over each option in detail, work to collect evidence, fill out paperwork, speak with insurance companies, and prepare our client for a possible experience in court. We strive to provide excellent communication and update our clients every step of the way.
What If My Loved One Died After Taking Onglyza?
If you lost someone to heart failure after they were prescribed Onglyza, you may be eligible to pursue a wrongful death lawsuit on their behalf. In addition to providing compensation for their medical expenses and lost wages, these complaints can also give the surviving loved ones compensation for funeral and burial expenses, lost income, lost inheritance, and loss of consortium.