Injectafer Side Effects Spark Lawsuits
Makers of the popular intravenous (IV) iron supplement are being named in lawsuits for neglecting to provide a fair warning of Injectafer’s serious side effects. Because drug manufacturers are bound by laws that require them to disclose risks associated with their products, they can be found liable for negligence when they don’t.
Injectafer patients have reported suffering from severe hypophosphatemia, a disorder caused by dangerously low levels of phosphate in the blood. This is a frightening condition, as severe hypophosphatemia can be deadly and its effects sudden.
The defective drug lawyers at Searcy Denney have provided this page of frequently asked questions about Injectafer side effects and what you should know about Injectafer lawsuits. Our law firm is actively investigating cases for injuries due to hypophosphatemia from the drug.
If you don’t find the answers you are looking for here and want to know whether you or a loved one qualifies for compensation, please contact our offices to speak with a defective drug attorney at (800) 780-8607. We are here to assist you during this difficult time.
What is hypophosphatemia?
Hypophosphatemia is a disorder marked by unusually low levels of phosphate in the blood. Phosphate is an electrolyte that’s essential for helping the body carry out many daily functions. For example, it’s necessary for bone growth, healthy teeth, nerve function, and muscle contraction. Complications include osteomalacia (bone softening) and bone fractures.
Hypophosphatemia is not common overall, except among those with conditions such as anorexia, alcoholism, nutrient deficiency, or diabetic ketoacidosis. Since phosphorus is found in many foods, it’s rare that an average person without other health conditions would have hypophosphatemia.
It can be particularly difficult for patients with anemia, who already struggle with low energy levels, to determine whether they have hypophosphatemia. The conditions have similar symptoms.
What are severe hypophosphatemia symptoms?
Since hypophosphatemia doesn’t often trigger symptoms, it’s possible that a patient may not notice it until it becomes severe.
Severe hypophosphatemia includes symptoms such as:
- Bone pain
- Osteomalacia (bone softening)
- Muscle weakness
- Loss of appetite
- Bone fractures
- Loss of sensation or tingling
If you have been treated with Injectafer and are experiencing any of these symptoms, you should contact your doctor right away.
Why is phosphate deficiency dangerous?
Consider the fact that 85% of phosphorus is found in your body’s bones (Science Direct). While phosphate deficiency is typically rare, it can have serious or life-threatening consequences if it goes undetected or untreated.
Severe hypophosphatemia due to phosphate deficiency can lead to dangerous drug side effects, such as:
- Respiratory failure
- Rhabdomyolysis (muscle death)
- Fatal heart arrhythmias
- Red blood cell destruction (acute hemolytic anemia)
Severe phosphate deficiency, such as that occurring with Injectafer side effects, can ultimately kill a person. This is why it’s critical that you seek medical attention if you are experiencing any of the aforementioned symptoms. It could save your life.
Studies Show Injectafer’s Link to Severe Hypophosphatemia
Several independent studies have revealed Injectafer’s connection with triggering abnormally low phosphate levels in patients, leading to severe hypophosphatemia.
The first study by Spanish researchers included 47 subjects who used the iron injections (National Center for Biotechnology Information). After just one dose of Injectafer, all subjects showed a significant decrease in phosphorus levels after three weeks, and 35 were considered hypophosphatemic. Three months after the initial study, a follow up showed phosphorus levels were still low after a single round of Injectafer.
In 2016, another study based in Austria revealed that almost half — 45% — of subjects treated with intravenous iron injections were hypophosphatemic, with 32% developing severe hypophosphatemia.
Yet, a more recent study from the Journal of Clinical Investigation offers perhaps the most impactful evidence of Injectafer side effects. The randomized, double-blind clinical trial showed that the rate of hypophosphatemia was almost six times higher in patients who took Injectafer versus another kind of iron injection.
Half of the patients in the study (50.8%) had hypophosphatemia, compared to 0.9% of those in the trial who took ferumoxytol.
These studies, along with other alarming reports of information, are quickly coming to light in recent months as questions about Injectafer’s side effects continue to rise.
Injectafer FDA Info
It may surprise many to know that Injectafer’s manufacturer, Luitpold Pharmaceuticals, Inc., was aware of the danger for severe hypophosphatemia back in 2007 when the IV treatment was first denied FDA approval.
Injectafer was denied twice by the FDA, once in 2008 and again in 2011. Both times, it was due to clinical safety concerns that included “excess mortality and severe hypophosphatemia” (see page 3).
This wasn’t the only discrepancy the FDA had with the drug. In 2015, Luitpold Pharmaceuticals was again slapped with an FDA non-approval letter for a tv commercial with misleading information about Injectafer side effects that minimized its risks.
When it finally gained approval in 2013, it was with restrictions. Injectafer could only be prescribed to those with iron deficiency anemia who hadn’t responded well to oral treatment or those with chronic kidney disease that didn’t require dialysis.
At this time, Injectafer is still being prescribed without proper warning of the risk for severe hypophosphatemia. However, new lawsuits may begin to change that.
Learn About the Injectafer Lawsuit
Drugmakers have a responsibility to give fair and adequate warning about adverse reactions associated with their products. Because Injectafer’s makers failed to do this, anyone who has suffered injury due to hypophosphatemia may qualify for legal action.
The expectation here is that a manufacturer should have or could have known about these risks had they done the necessary research before presenting the drug for use. Often times, these side effects aren’t known until years down the line or when it’s too late to prevent serious harm.
The consequences of this can be disastrous. For many, their lives are changed or even lost altogether. If this describes yourself or a loved one’s situation, it is highly recommended that you seek legal counsel for your losses. However, your case outcome will directly depend on your lawyer’s knowledge, skill, and experience in this area.
You can trust the personal injury attorneys at Searcy Denney to fight for the maximum compensation you deserve. We have won over $5.8 billion for our clients and are nationally-renowned for our work pursuing large, powerful pharmaceutical companies.
Find out if you or a loved one qualifies to join the lawsuit against Luitpold Pharmaceuticals for Injectafer injuries. Call today and receive a free, private legal consultation with Searcy Denney at (800) 780-8607.
Contact an Injectafer Lawyer
If you’re thinking of seeking compensation for your injuries due to Injectafer side effects, now is the time to file a lawsuit. Deadlines apply for seeking compensation, so don’t wait to contact an attorney.
Searcy Denney is a national leader in pharmaceutical litigation. We have won billion-dollar cases against some of America’s largest corporations. We not only have the resources to compete with Luitpold Pharmaceuticals, but we have also been doing this for over 40 years and have a successful track record of verdicts and settlements to prove it.
Find out today if you qualify to join and contact the offices of Searcy Denney.
What is Injectafer?
Injectafer, also known as ferric carboxymaltose, is an intravenous iron complex injected directly into the patient’s vein. It is designed to treat adults with Iron Deficiency Anemia (IDA) who don’t respond well to oral iron treatments and do not have chronic kidney disease requiring dialysis.
It is manufactured by American Regent, a subsidiary of Luitpold Pharmaceuticals, Inc
What is Iron Deficiency Anemia (IDA)?
Iron Deficiency Anemia (IDA) is the most common type of anemia that marks low levels of red blood cells. When iron is deficient, the body lacks hemoglobin, which is an essential oxygen carrier throughout the body. Iron is critical for supporting normal bodily functions.
Those with IDA may show symptoms such as severe fatigue, shortness of breath, weakness and headache or dizziness, among other signs. It is prevalent in both children and adults, though women are at an overall greater risk for IDA due to reproductive events such as menstruation and pregnancy.
IDA can make daily living more challenging, as responsibilities such as work shifts, driving for longer periods of time, or caring for children can be taxing. It can interfere with many personal and professional activities.
Why are Injectafer’s makers being sued?
Patients are suing Injectafer’s makers, Luitpold Pharmaceuticals, for failing to properly warn of the risk for severe hypophosphatemia.
Put simply, hundreds of Americans already dealing with the challenges of anemia have suffered doubly with severe hypophosphatemia — and Luitpold Pharmaceuticals didn’t list it in Injectafer’s side effects.
They have been accused of downplaying the risk, even by the FDA in past tv commercials.
Not even their website makes any mention of hypophosphatemia, let alone severe hypophosphatemia. It simply lists “low levels of phosphate in the blood” as a common side effect.
Considering how Injectafer was repeatedly denied FDA approval over hypophosphatemia and mortality rate concerns, allegations against Luitpold Pharmaceuticals for Injectafer side effects conclude that the drug maker should have known of these risks. They knew about them, yet neglected to warn patients.
Should you join the Injectafer lawsuit?
Any person who has experienced severe hypophosphatemia as an Injectafer side effect might be eligible for compensation through a mass tort lawsuit. Many of those seeking legal counsel have had serious adverse reactions to the drug, including respiratory failure, seizures, and muscular tissue breakdown.
If you’ve suffered injuries like these or were diagnosed with severe hypophosphatemia, it is highly recommended that you speak to a dangerous drug attorney. Your attorney will be able to assess the details of your circumstances and help you understand your options moving forward.
To find out if you or a loved one qualify to join the Injectafer lawsuit, call our offices today at (866) 288-0375. Searcy Denney offers 100% free, private legal consultations to Injectafer patients at no obligation.
How can an Injectafer lawyer help?
When you’ve been injured, your physical, mental, and emotional well-being should be your highest priority. Hiring an experienced attorney to represent you allows you to do just that. Not only will filing a lawsuit turn over all the details and workload to a qualified lawyer, but a successful case resolution could also help you receive compensation to cover the costs of:
- Hospital stays
- All costs related to your injury
- Lost wages due to time away from work
- Childcare while you heal
- Emotional pain and suffering
- Loss of a loved one, if necessary
In addition to these practical benefits, many of our clients have expressed the invaluable benefit of having an advocate during such a difficult time in life. You can read their stories here.