Manufacturer: Sage Therapeutics, Inc.
FDA Approval Date: March 19, 2019
Treatment For: Post-partum depression
Dosage Form: Injection
Availability: Prescription Only
Inactive Ingredients: sodium citrate dihydrate, citric acid monohydrate, betadexsulfobutyl ether sodium, and water for injection.
On March 19, 2019, the U.S. Food and Drug Administration (FDA) announced the approval of Zulresso (brexanolone), a drug that aims at treating post-partum depression.Existing treatments for PPD include psychotherapy, standard antidepressants, and even shock therapy. Zulresso is the first and so far the only drug specifically approved to treat post-partum depression, the most common medical complications of childbirth. The medicine is administered by a continuous intravenous (IV) infusion in the course of 2.5 days (60 hours). The IV must also be administered in a health care facility as the drug causes sudden loss of consciousness, which may create the risk of serious harm to the mother or the child.
About Postpartum Depression
Postpartum depression is a serious condition known to affect one in nine women who’ve given birth in the United States. It is the most common medical complication of childbirth and when severe, it can be life-threatening. PSS is a distinct major depressive disorder that occurs after childbirth. And while it is termed postpartum, it might as well begin during pregnancy. There are variations in expert opinions on the onset of PPD with some holding that it occurs during pregnancy up to 12 months following delivery while others having the opinion that it occurs during pregnancy up to 4-weeks postpartum.
PDD is characterized by significant functional impairment, loss of interest in newborn, feelings of worthlessness or guilt, decreased ability to feel pleasure, loss of interest in activities that one used to enjoy, anxiety, motor challenges, loss of energy, lack of concentration, self-esteem, difficulty sleeping. Women may also experience suicidal ideation and thoughts of harming themselves or their child. PDD can also interfere with the maternal-infant bond. Suicide instigated by PDD is one of the leading cause of maternal deaths after delivery.
How Zulresso Works
Experts involved in the trials and approval of Zulresso claim that the drug is completely different from drugs currently approved for depression. It is a synthetic version of a steroid known as allopregnanolone, which is naturally produced by the body. Allopregnanolone, or also as it’s also known, is produced in the ovaries and brain as well as the placenta when a woman is pregnant. It is a breakdown product of the sex hormone progesterone. Research has shown that during pregnancy, the blood levels of allopregnanolone increase significantly (along with progesterone, which breaks down into allo) but then drop rapidly following delivery. Researchers believe that fluctuations in the steroid may cause changes in the brain by destabilizing and decreasing the levels of GABA, which then contributes to postpartum anxiety and depression in women. It’s still not clear exactly how Zulresso works to treat PPD. But it’s thought that Brexanolone is an allosteric modulator of extrasynaptic and synaptic GABA receptors. This means that it modifies the body’s stress response, which is abnormal in women with PPD. The medicine binds to GABA receptors, which are crucial in boosting brain functions. The binding may work to reset or reverse various brain activities tied to symptoms of post-partum depression. Rather than a complete inhibition or activation of the targeted receptors, brexanolone results in various degrees of desired activities and brain function.
Brexanolone works differently than other anti-depressants, which basically don’t bind to GABA receptors. However, there’s a class of drugs known as benzodiazepines or tranquilizers, which also bind to GABA receptors in the brain, but they tend to bind to a different type of GABA receptors that have a different function to the receptors that brexanolone binds to. Allopregnanolone has for a long time been linked to antidepressive effects but the main challenge was formulating potential treatments based on it. Due toits mechanical makeup, the body does not easily absorb allopregnanolonewhen taken orally. Zulresso is therefore manufactured as an injectable version of allopregnanolone to get around this limitation.
The FDA Approval of Zulresso
Studies of brexanolone found that the medicine quickly and effectively worked than other drugs for depression. The FDA approval of Zulresso was based on two clinical trials involving about 250 women with moderate and severe postpartum depression, who were less than 6 months postpartum and experienced symptoms during the third trimester and within the first month following delivery. Some participants received a 60-hour continuous intravenous infusion of brexanolone while others received a placebo. They were then followed for four weeks to evaluate the safety and effectiveness of the drug.
The primary measure in the study was a mean change from baseline in a measure of depression severit on the Hamilton Rating Scale for Depression (HAM-D). In both placebo-controlled studies involving patients with moderate PPD and others with severe PDD, patients who received brexanolonehad superior outcomescompared to those who useda placebo. With brexanolone, depressive symptoms reduced at the end of the first infusion. It was observed that a single infusion maintained improvement in depression to at least 30 days, the maximum follow-up period during the studies.It’s still unclear how Zulresso works so quickly than other antidepressants, which can take weeks and even months to have an effect.Doctors are expected to get a better understanding of how long the effects last as they prescribe the medicine.
Serious Side Effects of Zulresso
- Excessive Sedationand Sudden Loss of Consciousness
Zulresso may cause you to feel very sleepy or pass out. During the clinical trials, there were dose interruptions or reductions every time that sedation or loss of consciousness occurred during treatment. There’s no clear association between sedation or unconsciousness and timing of dose. Healthcare providers are required to monitor the patients for symptoms of excessive symptoms every 2 hours. During the Zulresso infusion, patients should report if they feel like they’re going to pass out (lose consciousness) or feel very sleepy (sedated) during the time they’re normally awake. Patients who have children during treatment are also required to be accompanied by another adult to help care for the child.
- Increased Risk of Suicidal Thoughts or Behaviors
Zulresso and other antidepressant drugs may increase the incidence of suicidal thoughts and action in patients 24 years of age or younger. However, the level of risk posed by brexanolone is unknown because of the comparatively low number of exposure to Zulresso.
Other common side effects of Zulresso include:
- Dry mouth
- Dizziness, vertigo, presyncope
- Tachycardia (rapid heart rate)
- Dyspepsia (indigestion or upset stomach)
- Hot flush
- Flushing of the skin or face
- Oropharyngeal pain
Due to these adverse effects, women can only be treated with Zulresso through a restricted distribution program at a certified pharmacy or healthcare setting, including hospitals, where they’ll be closely monitored by a healthcare provider while Zulresso is being administered. As such, Zulresso is only available under the Risk Evaluation and Mitigation Strategy (REMS). All patients should be registered to help characterize the risks and safety use.
Zulresso should not be given to patients who have kidney problems, especially end-stage renal disease (ESRD) because the solubilizing agent has the potential to accumulate in the body. Zulresso should not be taken by pregnant women as there isinsufficient data to show the effects on the unborn baby. Also, Zulresso passes into breast milk and for this reason, it may be important to evaluate the risks and benefits of breastfeeding while receiving Zulresso.
Drug Interaction Overview
Zulresso may interact with other drugs and increase the severity or likelihood of adverse reactions. A person should tell his or her healthcare provider about all medicines they take, including over-the-counter medicines, prescription medicines, vitamins, herbal supplements as well as illegal drugs. This is especially important to avoid co administration with opioids, other antidepressants, or Central Nervous System (CNS) depressants such as benzodiazepines. During the trials, a higher percentage of patients who used concomitant antidepressants while being treated with brexanolone reported sedation-related events.
The FDA’s Accelerated Approval for Drugs
The FDA is increasingly giving expensive drugs the green light despite little-known or dangerous side effects and inconclusive evidence that they cure or curb the disease. Today, the FDA is reviewing and easing more drugs’ path to the market than any other regulatory agency in the world. 2018 was FDA’s record year as the drug “okayed” 59 novel drugs and biologics, jumping over the 46 new drugs approved in 2017. These “novel” drugs are typically medications whose chemical structure hadn’t been approved before. As the FDA approves more drugs, it’s at the same time rejecting fewer medications.
A study by the Yale School of Medicine found that nearly a third of drugs approved from 2001 to 2010 and made available to patients were later withdrawn due to major safety issues. Drugs with higher rates of safety interventions included those introduced through the FDA’s accelerated approval process. These approvals generally rely on surrogate endpoints. Experts worry that such approvals will open doors for drugs that haven’t been adequately tested and do not show “sufficient” evidence of health gains. As the study notes, the majority of drugs approved through the accelerated program were trialed in 6 months or less and involved not more than 1,000 participants.
Take Zulresso for example. The study was small and short and only involved 250 women. The follow-up period was a maximum of 30 days. The study was sponsored by the company, which was involved in the design and interpretation of results. Some of the participants were also using some other antidepressants, which work slower. Zulresso may work by “dampening neural activity,” according to the lead physician of the study. Industry experts believe that more research is needed before it’s certain that the medication is not just another drug offered as a quick fix efficacy with the potential for adverse side effects.
While it’s impossible for the FDA to prevent the sale of drugs that have unexpected side effects, many drugs fall through the cracks and get the green-light as the agency is overloaded by pharmaceutical companies rushing to have their products approved. As such, many drugs are introduced to the market without adequate trials or research to back their safe use. And with FDA approval, many physicians and patients believe that the drugs are safe. Unfortunately, drug manufacturers can only be held liable for their reckless practices and disregard for consumers’ health after many people have been harmed by the product.
Often times, the FDA gets involved once there is a direct link between adverse reactions and the medication. However, in most cases, most of the side effects are not clearly communicated to consumers. Despite the knowledge of potential complications, drug manufacturers may try to conceal data on adverse reactions to avoid placing the drugs on the FDA’s radar. The FDA is often slow acting as the agency first requests for disclosure of complication and only takes a step to withdraw the drug when the problems persist. The motivation for omitting information is that most patients will not be willing to take medications that may cause adverse reactions and doctors will only prescribe to patients with the least risk of complications.
Dangerous Drug Mass Tort Lawsuits
Anti-depressants can be of great benefit to patients, but in some cases, adverse reactions and side effects can be dangerous and life-threatening. Dangerous drugs can end up costing you and your loved one significant financial loss in hundreds of hours of lost time from work and family, costly medical expenses, and may even exacerbate the medical condition you originally had.
Even with clinical trials and the FDA approval, the harmful side effects of a dangerous drug can have devastating outcomes on trusting users. Pharmaceutical companies are typically major corporations that make billions of dollars every year. Their main priority is often growing and maintaining their profits rather than focusing on the risks and severe side effects associated with their products. This causes some manufacturers to keep marketing and selling certain drugs even they are unsafe to consumers. Due to the inadequacy in research and development, many patients who use certain drugs are left to deal with devastating outcomes.
When a powerful prescription drug such as Zulresso is used nationwide, the impact can be widespread, affecting thousands of people. When people are harmed by prescription medication, they can be able to obtain compensation to help them pay for related expenses and move forward with their lives. Drug manufacturers need to be held accountable when they sell drugs that are dangerous to the public. This can be possible through a mass tort lawsuit.
In simple legal terms, a tort is an act that causes an infringement of rights or harm, in which case the party responsible has legal liability. This basically means that torts are actions committed against you and you have the right to sue the party that committed the offense. Mass tort laws cover occurrences where an offensive act is committed against a large group of victims and the plaintiffs sue the liable party in a collective agreement. Rather than the cases of different victims being tried separately, especially when the case involves a large company that has the potential to drain the resources of each victim, victims with similar claims combine their cases, collect similar evidence and pool their resources to make litigation more cost-effective and efficient. The cases are then heard by one judge.
Understanding the Differences between Mass Torts and Class Action Lawsuits
While there are similarities that exist with class action lawsuits, mass tort lawsuits are different in that mass torts do not have to be legally certified as a class and that plaintiffs are more individualized when there is a wide variety of injuries suffered. The major difference between class actions and mass torts is the way the large group of plaintiffs is treated. Each plaintiff in a mass tort is treated as an individual, meaning that there’s need to establish certain facts, including the type of harm suffered and how the individual was harmed by the defendant’s action. In a class action, however, a lawsuit is filed on behalf of people who suffered similar harm caused by the defendant’s actions. As such, all plaintiffs are treated as one plaintiff and the lead plaintiff may sue on behalf of the entire class. The number of plaintiffs in a mass tort lawsuit is usually smaller compared to those in class action lawsuits. However, mass torts are broader and may involve different types of injuries that resulted from the defendant or several corporate defendants’ action or inaction.
Who Cases Are Filed Against in Dangerous Drug Mass Torts
Defective drug cases are generally different than other personal injury cases. The usual defendants in dangerous drugs cases are the manufacturers. Pharmaceutical companies make billions of dollars annually with markets all over the world. They have almost endless resources, powerful defense lawyers, and highly paid expert witnesses at their disposal. Manufacturers of dangerous drugs that have caused significant harm and injuries rarely come out and admit fault. They will pull out all of the stops to deny paying damages caused by their products. In fact, compensating victims is the last thing on their mind.
The prescribing physician may also be held at partial fault in some cases. This applies when a doctor prescribes medication without enough information about your conditions in general or when they knew that the drug would be dangerous to you. Drug manufacturers typically place extensive warning labels on their products to indicate who should not take the drug and also warn of the risks associated.
There are many different issues that can result in a drug being dangerous for users. Many products are released without a deeper understanding of their inherent risks, with early consumers often suffering the most harm as a result. However, even after evidence of adverse side effects or death caused by drugs has been noted, pharmaceutical companies still market their products. If drug manufacturers sell defective or unreasonably dangerous products, they are legally liable for resultant injuries. This can happen in several ways. The drug manufacturer might have made the product in a manner that led to harmful side effects, which can be more dangerous than the condition they’re intended to treat. Typically, these are inherent issues with the drugs themselves, which may be caused by testing errors or a lack of proper testing.
The design flaw or manufacturer error may also make the drug dangerous. In some cases, it might be a problem of contamination or incorrect bottling. Furthermore, when labeling fails to warn consumers of possible side effect of the drug due to misinformation or a lack of vital information, the consumer can be seriously harmed.In such cases, the party at fault might be the pharmaceutical company or a testing lab that acted negligently. So, no matter how carefully the product was labeled or produced, the parties liable can be sued for damages even if they were not aware of the dangerous effects of the drug.
Finding Legal Help for a Zulresso Lawsuit Near Me
If you took a prescription medication, thinking that it would help improve your health only for it cause severe side effects, you may have grounds for a product liability lawsuit. With many drugs on the market and others bring introduces every year, it can take months or years to learn about the side effects and dangers posed by certain medication. Before you know it, you may have suffered serious medications or injuries, even though the drug has not yet been officially recalled.
Having experienced mass tort attorneys and legal staff on your side is crucial when filing a lawsuit. An attorney can help you obtain medical records, have a specialist review the records, cross reference your issues with similar lawsuits and recalls, and determine if you have a case. If you do, an attorney can work to get you compensation for pain and suffering, medical bills, travel and out-of-pocket expenses, costs of repeat surgery, lost wages, and future medical costs.
At Consumer Alert Now, we believe that manufacturers of dangerous drugs should be held liable and accountable. That’s why we help those injured by the negligence of others to find legal help. If you or someone you know has suffered adverse side effects after undergoing treatment with powerful prescription drugs such as Zulresso, our defective drug information line via (800) 511-0747. We can connect you with premier mass tort attorneys who serve clients throughout the U.S.