People are suing AstraZeneca for its drug’s alleged harmful side effects. Kombiglyze XR (saxagliptin and metformin) is a drug developed to help treat type two diabetes. It is the extended version of another drug called Onglyza (saxagliptin), a drug that can help lower glucose levels and prevent diabetic complications from developing in patients with type 2 diabetes.
Unfortunately, research shows that Kombiglyze XR may cause heart failure and other cardiovascular issues in some patients. Thus, in February 2014, the Food and Drug Administration (FDA) filed a Drug Safety Communication for Kombiglyze, after it was determined that the drug can increase a person’s risk of congestive heart failure.
With the aid of top law firms such as Schmidt & Clark, LLP, dozens of patients are filing lawsuits against the drug’s manufacturer, AstraZeneca, as well as its former partner Bristol-Myers Squibb.
If you or a loved one has suffered any of the harmful or fatal side effects of taking Kombiglyze XR, you are eligible to file a lawsuit against AstraZeneca and recover just compensation for your loss and suffering. Let’s learn more about this case.
Inadequate Research and Undisclosed Risks
The majority of plaintiffs allege the manufacturers AstraZeneca and Bristol-Myers Squibb failed to disclose the harmful side effects of their medication i.e., higher risk of heart failure, congestive heart failure, and even death.
The FDA announced in 2008 that it would issue new guidelines for assessing the potential dangers of new Type 2 diabetes treatments. The FDA specifically requested that manufacturers do "a more comprehensive study of their medications' cardiovascular hazards during the development stage of the product."
Kombiglyze XR fulfilled the defined criteria for cardiovascular events (such as heart attacks) established in the FDA Guidance from 2008; however, the FDA had concerns about the adequacy of AstraZeneca’s pre-market studies provided to meet said criteria.
They were not convinced of the drug's cardiovascular safety.
Instead of testing Kombiglyze XR much more closely before FDA clearance, the company (AstraZeneca) waited well until after approval to conduct more evaluations. This resulted in thousands of patients being unnecessarily exposed to heart failure and death risks.
According to the FDA, approximately 386,000 people were prescribed Onglyza or Kombiglyze XR in 2015. Given the number of people who use these drugs, any side effects that are severe enough to require hospitalization should be taken seriously.
Common Side Effects of Kombiglyze XR
Apart from the increased risk of heart failure and early death, there are other side effects related to Kombiglyze XR that patients need to watch out for. These are:
- Upper respiratory tract infection
- Stuffy or runny nose and sore throat
- Urinary tract infection
- Nausea and vomiting
There may also be some instances where a patient may be allergic to Kombiglyze XR’s ingredients. Allergy symptoms often manifest as the following:
- Swelling of your face, lips, throat, and other areas on your skin
- Difficulty with swallowing or breathing
- Raised, red areas on your skin (hives)
- Skin rash, itching, flaking or peeling
Furthermore, taking Kombiglyze XR with other medication such as sulfonylureas or insulin can cause your blood sugar levels to drop.
Watch out for the following symptoms of low blood sugar:
- Rapid heartbeat
- Change in vision
- Change in mood
If you experience any such side effects, it’s important that you inform your doctor IMMEDIATELY to avoid serious consequences.
Have You Been Affected by Kombiglyze XR?
Confer with personal injury firms to find out how you can get just compensation for the complications you’ve suffered while taking the drug Kombiglyze XR.