Trisenox is the brand name for arsenic trioxide. This medication is a very specialized formulation that has limited use. It is combined with Tretinoin to treat a certain type of leukemia, specifically when it is first diagnosed, and is low-risk acute promyelocytic leukemia. It is further designed to treat this specific type of leukemia when it has a specific type of gene expression.
The exact definition of the type of leukemia treated by Trisenox is very technical.
Tretinoin is a medication used to treat acne and acute promyelocytic leukemia. It is in a cream and applied to the skin to treat acne. It is taken by mouth for up to three months as a treatment for leukemia.
Leukemia is cancer of the bone marrow, the tissue inside some of the bones in the human body. Bone marrow tissue produces new blood cells. Most of the blood cells in a person’s body come from the cells in the bone marrow.
Acute promyelocytic leukemia is a cancer of the white blood cells. When it was first identified in 1957, the median survival time was less than a week. Today, 80 to 90% of people who develop the disease have a 10-year survival rate.
How Is Trisenox Administered?
Patients with a new diagnosis of the specific type of leukemia for which Trisenox is the treatment are given the drug in two cycles. The first is called the “induction cycle.” In the induction cycle, the Trisenox is administered intravenously every day, along with Tretinoin, until cancer goes into remission, but not for more than 60 days.
The next phase of treatment comprises the “consolidation cycles.” Again, the necessary dose is administered intravenously, along with Tretinoin, every day for 5 days per week during weeks 1 to 4 of each 8-week cycle. It is used for a total of 4 cycles. Tretinoin is not used during weeks 5 and 6 of the fourth consolidation cycle.
Other protocols are also used with Trisenox, but they would be of interest to physicians specializing in treating leukemia.
What Are the Side-effects of Trisenox?
Three warnings for significant side effects can develop with the use of Trisenox. The first one is for Differentiation Syndrome. Differentiation Syndrome is a condition that can be fatal. The symptoms of Differentiation Syndrome are as follows:
- Unexplained fever;
- Shortness of breath;
- Hypoxia: Hypoxia is a condition in which an inadequate amount of oxygen reaches the tissues of the body or the tissues in a region of the body, e.g., the hands;
- Acute respiratory distress: Acute respiratory distress syndrome (ARDS) is a type of respiratory failure. Acute respiratory distress involves the rapid development of inflammation in the lungs. In addition, the person experiences shortness of breath and rapid breathing, and their skin turns blue from lack of oxygen. Survivors of ARDS often experience a decreased quality of life;
- Pulmonary infiltrates: A pulmonary infiltrate is a substance that is denser than air, e.g., blood, that enters and stays in the lungs;
- Pleural or pericardial effusions: The pleura is a membrane inside the chest wall containing the lungs. When a person has pleural effusion, fluid builds up between the layers of the pleura. The pericardium is a membrane-like sac that contains the heart. Pericardial effusion is a build-up of fluid in the layers of the pericardium;
- Weight gain;
- Peripheral edema;
- Low blood pressure;
- Kidney failure;
- Liver disease; and
- Multi-organ dysfunction, with or without high white blood cell count.
A person with Differentiation Syndrome requires immediate treatment with corticosteroids and monitoring until it subsides. Treatment with Trisenox should be stopped if the patient develops Differentiation Syndrome.
Yet another significant side-effect of treatment with Trisenox is cardiac conduction abnormalities. Trisenox can cause abnormalities with the QT interval. This is a characteristic of the heartbeat that is measured with an electrocardiogram. This assesses some of the electrical properties of the heart.
In addition, Trisenox can cause a condition known as “atrioventricular block.” A person’s heart runs on electricity. An electrical signal travels from the upper right chamber, the atrium, to the lower chambers, the ventricles. Trisenox can cause the current to be blocked, and this is known as an atrioventricular block or heart block.
Trisenox can also cause a condition known as “Torsades de Pointes.” This is a fast heart rhythm. It begins in the ventricles. If it is not treated, it can be deadly. It can be part of an inherited condition or a side-effect of taking certain medications, such as Trisenox. It can be deadly if not treated, but treatment can improve a person’s prognosis.
Before administering Trisenox, the doctor administering the medication is supposed to assess the patient’s QTc interval and address electrolyte abnormalities. If the patient takes drugs known to prolong the QTc interval, the doctor should consider discontinuing these drugs.
A patient who has a ventricular arrhythmia should not be given Trisenox. A person with QTc prolongation should not be given Trisenox. It can be resumed if their condition improves after treatment.
Still another significant side-effect of taking Trisenox is encephalopathy. Encephalopathy is damage or disease that affects the brain. Specifically, Trisenox can cause Wernicke’s encephalopathy.
If the body’s B vitamin reserves are depleted, this can cause biochemical lesions of the central nervous system, which, in turn, can cause the symptoms known as Wernicke’s encephalopathy. If a person develops Wernicke’s encephalopathy, it is a medical emergency. So, a person taking Trisenox should be monitored for their thiamine (vitamin B1) levels, neurological symptoms, and diet. Trisenox should be stopped if Wernicke’s encephalopathy is suspected.
What Are My Remedies If I Am Injured by Trisenox?
Trisenox is a medication that has limited application. It is used to treat acute promyelocytic leukemia, a potentially fatal illness.
Manufacturers of prescription and over-the-counter medications must use testing criteria established by the Food and Drug Administration (FDA) to test the safety and effectiveness of their products. The FDA criteria are considered the standards for the pharmaceutical industry. However, the fact that the FDA has licensed a drug does not affect the manufacturer’s liability to an injured person if the drug proves to be defective in some way.
If a drug is defective and the defect causes harm to a person who takes it, the person may have a case against the manufacturer and distributors for strict product liability. One issue in every case involving medications is whether the drug is “unavoidably unsafe.” Some prescription drugs are unsafe products, but this lack of safety is unavoidable. This means they cannot be made completely safe, no matter how carefully formulated and manufactured. This is because they are going to have negative side effects. Trisenox is an example.
Most prescription drugs usually have harmful side effects, but they still benefit the user. Prescription drugs that have been prepared properly and are sold with warnings that adequately alert doctors and consumers to their dangers; usually, a person cannot successfully sue the manufacturer or distributors for strict product liability.
Trisenox is an example of such a drug. While it has significant negative side effects, a person would take it anyways, under the supervision of a doctor, of course, because it offers a cure for a deadly disease. It is a risk that a person is willing to take.
A person who has experienced a negative side-effect from taking Trisenox or any other medication should consult a personal injury lawyer. The lawyer would enlist medical professionals to determine whether the person has a case for strict product liability. The person may have been injured because of a manufacturing, design, or warning defect for which no warning is on the label.
Another possibility is a lawsuit for medical malpractice against the doctor who treated the person with Trisenox or the pharmacist who dispensed the medication. For example, the doctor may not have assessed a person’s QTc interval before prescribing Trisenox. Or the doctor may not have monitored the person’s QTc interval after the person started taking Trisenox. So, the doctor might not respond as required to the person’s QTc interval prolongation, and this may lead to serious health issues for the person.
Both a lawsuit for strict product liability and one for medical malpractice would lead to an award of compensatory damages. This would reimburse the person for their economic and non-economic damages, including salary loss, the cost of medical treatment, and their pain and suffering.
If a person dies from taking Trisenox, their family members will file a lawsuit for wrongful death.
Do I Need a Lawyer’s Help with My Trisenox Issue?
If you have experienced any negative side effects after taking Trisenox, you want to consult a class action lawyer.
Your lawyer will review your case’s facts to determine if you may have a case for medical malpractice or strict product liability. Your lawyer can advise you on the next available steps, help you protect your rights, and recover damages, if possible.
