Companies that make medical treatments like Injectafer and other iron infusions have a responsibility to be clear about the risks and benefits associated with their products. Most every drug or treatment has some potential side effects, and manufacturers are required to tell you what those are. Then you and your doctor can evaluate the benefits and the risks, and make a decision that’s best for you.
Injectafer manufactures, however, have so far failed to provide adequate warnings about one very serious potential side effect: severe hypophosphatemia (HPP). Though studies have shown that Injectafer can increase the risk of severe HPP more than other comparable iron infusions, there is nothing on the product label, in the product information, or in the product advertisements about this serious and sometimes deadly condition.
That means if you or a loved one received Injectafer and then developed severe HPP, you could be eligible to file an Injectafer lawsuit to recover your damages. It’s not right that you and your family have to suffer because a large manufacturer failed to live up to its responsibilities. You deserve to go into any treatment completely informed, and when you lack the information you need and then you are injured because of it, the negligent party should be held liable.
Injectafer Linked with Severe Hypophosphatemia
Injectafer is an iron supplement that’s delivered intravenously (IV) to treat iron deficiency anemia in patients who can’t tolerate oral iron supplements, failed to respond to them, or who have non-dialysis chronic kidney disease.
The FDA approved Injectafer in 2013 for this purpose, but after the product was on the market for a few years, reports started coming in about a dangerous side effect known as hypophosphatemia (HPP). This is a condition in which the body becomes low or deficient in phosphate. At mild levels, the patient may experience no symptoms at all. But at moderate and severe levels, HPP can cause symptoms like muscle wasting, respiratory failure, seizures, and fatal heart arrhythmias.
Studies published in 2013, 2015, 2016, and 2017 showed that Injectafer, more than other comparable iron infusions, increased risk of HPP and severe HPP. In the 2016 study, for example, scientists found that those who received Injectafer had a greater risk of HPP (45.5 percent) compared to only 4 percent with the other alternative. They also found that severe HPP occurred only in those treated with Injectafer, with a risk of 32.7 percent.
Injectafer Warnings Inadequate?
Currently, the prescribing information for Injectafer contains a number of warnings. It states that when patients are treated with Injectafer, they may experience:
- Hypersensitivity reactions
- Hypertension (high blood pressure)
- Nausea, vomiting
- Hypophosphatemia (HPP)
The information does not warn about severe HPP, however, which can have serious and debilitating consequences. In other words, it doesn’t state how serious the HPP side effect can be. Instead, it simply lists hypophosphatemia as a possible side effect.
Yet the difference between HPP and severe HPP is large. HPP is a condition in which the body is low on phosphate, an important nutrient. At mild levels, the patient may not notice any symptoms at all. So HPP as a side effect may be no big deal.
Severe HPP, on the other hand, is much more serious, and can be life-threatening. Several studies have found evidence that severe HPP in hospital patients can increase the risk of mortality—by up to 20 percent in those with very low levels of phosphate. In one study, researchers noted that there was a four-fold increase in mortality in hospitalized patients with severe HPP.
Why haven’t the manufacturers warned about this serious risk, particularly when studies show that Injectafer can cause severe HPP in a significantly higher number of patients than other iron products?
Injectafer Side Effects Could Lead to an Injectafer Lawsuit
Injectafer has been linked with the following side effects:
- Severe hypophosphatemia
- Bone pain and fractures
- Rhabdomyolysis (muscle wasting)
- Heart rhythm problems or heart failure
- Respiratory failure
If you were treated with Injectafer and then suffered from any of these, you may be eligible to file an Injectafer lawsuit. Chaffin Luhana stands ready to examine your case and support you in an effort to recover damages. We have experienced Injectafer attorneys who know what it takes to prove that a corporation was negligent in their responsibilities.
You Have the Right to Hire an Injectafer Attorney
As a consumer, you have rights that protect you against things like the following:
- Manufacturer negligence
- Defective design or manufacture
- Failure to warn
- Breach of warranties
Products like Injectafer must comply with a number of safety regulations, to help ensure that doctors and patients are completely informed not only of the products’ benefits, but its risks as well. Injectafer manufacturers conducted clinical trials to gain FDA approval for their product, but even in these studies some patients developed HPP. At one point, the FDA was so concerned about the test results that they withheld approval, requiring the manufacturers to conduct more studies to gather more data.
Our Experienced Attorneys Can Help You File an Iron Infusion Claim
Though the FDA eventually approved Injectafer in 2013, studies published after that continued to raise concerns about HPP and severe HPP. The Chaffin Luhana iron infusion lawyers watched these studies carefully, and realized that despite the evidence showing that some patients were at risk, Injectafer manufacturers did nothing to respond. Years passed and more studies came out, and still the warnings stayed the same.
Meanwhile, more and more patients are being put at risk when they go in for iron treatments, because doctors aren’t aware of the potentially serious consequences. Though HPP can be treated with phosphate supplements, the long-term consequences of severe HPP are still unknown.
In a 2007 study, for instance, researchers noted that severe HPP had been associated with:
- Poor respiratory outcomes
- Poor cardiovascular outcomes
- Poor surgical outcomes
Though it depends on what other conditions patients may have, researchers have evidence that no matter what else is going on, severe HPP can lead to additional problems: “Overall evidence demonstrates an association between hypophosphatemia and poor clinical problems among hospitalized patients, suggesting that hypophosphatemia is an adverse prognostic marker.”
Are You Eligible to File an Iron Injection Lawsuit?
If you’re not sure whether you may be eligible to file an Injectafer lawsuit, contact the iron infusion attorneys at Chaffin Luhana today. We can review the facts of your case and help guide you toward your next step. You should not have to pay for medical expenses that occurred because a manufacturer failed to provide you and your doctor with the information you needed to make the optimal health decision for you. Don’t wait. Contact us today. We can help.