Diabetes Drug Possibly Linked to Higher Rate of Amputations
In February of 2017, the European Medicines Agency provided warnings about a potential risk associated with medications used to manage type 2 diabetes. The EMA explained that the medications canagliflozin, dapagliflozin, and empagliflozin, all types of SGLT2 inhibitors, may increase the risk of lower limb amputation. The risk of amputation is highest for the toes.
Sodium-glucose co-transporter-2 inhibitors block the SGLT2 protein in the kidneys. This protein absorbs glucose in the urine and puts it back into the blood stream as the kidneys filter the blood. When SGLT2 is blocked, additional glucose is released through the urine, instead of accumulating in the blood.
Patients who have been prescribed these medications should examine their feet carefully and report any discoloration or wounds to their physicians. Additionally, they should tell their doctors if they have any tenderness or soreness in their feet. Physicians should advise their patients on proper foot care.
In two clinical trials, researchers concluded that canagliflozin resulted in higher rates of lower limb amputations. Patients who took canagliflozin were compared with patients who took a placebo. All of the patients were at a high risk of suffering heart problems.
These studies were the CANVAS and CANVAS-R studies. CANVAS stands for CANagliflozin cardiovascular Assessment Study. The CANVAS study examined whether canagliflozin helps reduce cardiovascular disease. The study received authorization between 2009 and 2010 in 13 countries in the European Union. Approximately 4,300 patients were included in the study. By September of 2016, the incidence of a lower limb amputation was approximately 7 in 1000 patient-years in those who took 100 mg of canagliflozin a day. For those who took 300 mg a day, the incidence was 5 in 1,000 patient-years. In the placebo, the incidence was 3 in 1,000 patient-years.
In the CANVAS-R study, canagliflozin and the presence of albumin in the urine were assessed in patients with type 2 diabetes. This condition is called albuminuria and is one of the early symptoms of kidney disease. The subjects had been diagnosed with type 2 diabetes, but their blood sugar was poorly controlled. The study was authorized in 10 European Union countries.
By September of 2016, the incidence of lower limb amputation was 8 in 1,000 patient-years, as compared to 4 in 1,000 patient-years with the placebo. The CANVAS-R study was larger than the CANVAS study, with more than 5,800 subjects.
A patient-year is the equivalent of a patient taking the medication for one year.
All patients who have diabetes are more susceptible to ulcers and infections. If left untreated, these conditions may lead to amputations. If a person’s diabetes is not controlled, or if that person has blood vessel or heart issues, the risk of amputation is even higher.
Although data is limited, so far, the same risk of amputation has not been established with other drugs. However, this does not mean that the risk does not exist. Ongoing studies should provide additional information on risks associated with other diabetes medications.
In the prescribing materials included with these medications, the warning of possible toe amputation has been noted. For canagliflozin, lower limb amputation has been listed as an uncommon side effect, impacting between 1 and 10 patients per 1,000. However, if patients experience infections or ulcers in the feet, physicians may decide to switch to a different medication.
At this time, it is not fully known why these medications increase the risk of amputation.
What happens if a medication causes an injury?
Drug manufacturers are liable for injuries medications cause. It does not matter that the drug manufacturer did not mean to produce a drug that injured consumers; the drug manufacturer may still face liability. Generally, drug injury claims fall under products liability claims.
In products liability claims, a consumer alleges that a defective product caused an injury.
There are three types of product defects:
- Manufacturing defects
- Design defects
- Marketing defects
Manufacturing defects occur during the production or distribution of a product. Consider a medication that was mistakenly produced with double the amount of a certain ingredient. The formulation causes a number of consumers to become seriously ill. Those who became ill may have a valid claim for a manufacturing defect case.
With design defects, the issue is inherent in the way the product was designed. In the above example, if the medication was intentionally designed with a formulation that causes illness in a number of consumers, the problem is a design defect. The drug company may face liability for such a design defect.
Marketing defects occur when products, including medications, are released with inadequate instructions or without warnings of dangerous risks. If a medication could cause birth defects, for example, drug manufacturers have a duty to warn consumers about this risk. If a pregnant woman takes the medication because she was unaware of the risk of birth defects and her baby is injured, she may have a marketing defect claim against the manufacturer.
Proving that a product was defective requires testing, consulting with experts, a careful review of documents and studies, and a number of other analyses. It is best to hire an experienced attorney as soon as possible after suffering a drug injury to ensure your legal rights are thoroughly protected.
Showing that a product was defective is not enough to file a products liability claim. Additionally, the claimant must show that he or she was injured by the product, and that the defective nature of the product is what caused the claimant’s injuries. A clear relationship must be established between the product’s defect and the claimant’s injuries; otherwise, the claim will fail. If the claim fails, the victim will be solely responsible for all medical expenses and other costs associated with the harm caused by the defective product.
To establish the harm a medication has caused, medical records and other types of documents must be provided. Drug injury attorneys know which types of documents and other evidence to submit to support these claims.
Depending on the nature of the claim, a variety of damages may be available.
Damages may include:
- Medical bills
- Lost wages
- Pain and suffering
- Emotional distress
- The cost of altering a home to accommodate an injured or disabled person
- The cost of future medical care
- Loss of consortium
- If the manufacturer’s behavior was reckless or egregious, punitive damages may also be available
Other damages may also be available, depending on the case.
Drug injury attorneys pursue all available avenues of recovery to ensure their clients obtain the compensation they deserve. Without an attorney’s guidance, it would be difficult to navigate the complex legal system, meet various deadlines, and understand what types of evidence are acceptable in these claims. It would also be difficult to fight back against the drug manufacturer’s team of attorneys. However, drug injury attorneys are not intimidated by these drug companies and will take their cases to trial if necessary.
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