Amiodarone Lawsuit Information – Is Amiodarone a Lifesaver or Killer Drug?
[Updated September with FDA Recall Information] Amiodarone is one of the most controversial pharmaceutical drugs available in the United States. From its first beginnings as a prescription anti-arrhythmic drug in 1985 to the hundreds of lawsuit claims to day, this powerful prescription drug has always had plenty of detractors. Although conditionally approved by the FDA, even regulators call it a “drug of last resort”. And for good reason, in our opinion when misused or improperly prescribed, amiodarone’s side effects often lead patients to suffer a slow, horrific death.
According to the pharmaceutical companies that make the drug, amiodarone is prescribed to help patients maintain a regular, steady heartbeat. Although usually sold today in its generic form, common brand names for the drug are Cordarone, Nexterone and Pacerone.
The FDA says amiodarone is a last resort drug only to be used when other treatments or drugs fail. That is because the drug has many deadly side effects including lung failure, liver damage, blindness and death. Unfortunately, some manufacturers tell doctors that it is safe to use for purposes other than its FDA approved use for ventricular fibrillation. These some companies sometimes don’t tell doctors it is a last resort drug or provide pharmacies with proper warnings documents for patients.
Amiodarone Lawsuit Claims
If you or a loved one died or suffered serious side effects from taking amiodarone, you may be eligible for substantial compensation. In this post we explain how to make a claim for monetary damages against the makers of amiodarone.
Our law firm is currently investigating claims and accepting amiodarone death and injury cases in California, New Jersey and Wet Virginia. Our contact information appears throughout this post in bold. We invite victims or their families to contact us for a no obligation evaluation of your case. The time to file an amiodarone lawsuit, however, is limited. (More on that below.)
Amiodarone and Simvastatin (Zocor)
We are issuing a special plea for patients that were prescribed both Amiodarone and Simvastatin. The combination of these two drugs is especially dangerous. When mixed together, these drugs may cause a deadly disease called Rhabdomyolysis. This disease is associated with the breakdown of muscles and kidney failure.
How Amiodarone Came to the United States
Amiodarone has been around since the 1960’s. Licensed in Europe, there were questions about its safety which caused the drug’s American debut to be delayed for many years. In 1985, Wyeth Pharmaceuticals (once known as Wyeth-Ayerst Laboratories) received FDA approval to sell amiodarone hydrochloride under the brand name Cordarone ®.
The FDA’s approval of Cordarone was anything but normal. It was one of the few modern day drugs granted approval by the FDA without clinical trials. That story could fill a book, suffice it to say that very few drugs are approved without rigorous safety and efficacy trials. (Even after approval, the FDA still wanted Wyeth to conduct these trials.)
Cordarone received an approval by the FDA but only as a drug of “last resort.” The FDA wanted physicians to try other treatment options before prescribing amiodarone. Typically last resort drugs have dangerous side effects.
The drug is so dangerous that it carries the FDA’s “black box warning.” That is the strictest warning reserved only for drugs with serious or life threatening risks.
Not only was amiodarone approved as a last resort drug, it was only approved for patients suffering from documented life-threatening ventricular fibrillation and ventricular tachycardia. We believe, however, that Wyeth aggressively promoted Cordarone as a first line anti-atrial arrhythmic drug.
As recently as this week I have spoken with two cardiologist that prescribe amiodarone as a first line drug even though the FDA has never approved for that purpose.
Cardarone is Wyeth’s brand name for the drug. (Wyeth is today owned by Pfizer). Complicating matters is that many pharmaceutical companies are promoting and selling generic versions of amiodarone.
Sandoz and Off Label Amiodarone
Sandoz is one of several companies making and distributing amiodarone hydrochloride. Based in New Jersey, Sandoz is a lot like Pfizer. Both companies are no strangers to government fraud allegations regarding their pharmaceutical marketing practices.
In 2010, Eon Labs, a subsidiary of Sandoz, paid millions of dollars to settle claims that the company was peddling nitroglycerine pills that the FDA said weren’t effective. Who paid for that? Taxpayers, of course.
Today we believe that Sandoz is one of the companies marketing amiodarone for off label uses including to treat atrial fibrillation. We also believe that they have pushed the product as a first line drug instead of a drug of last resort.
Is Off Label Use Legal?
A physician can prescribe a drug for a disease or use not approved by the FDA. That is called an “off label” use. There may be many legitimate reasons for a physician to do so.
Because doctors primarily must rely on drug companies for current information about drug safety and effectiveness, drug companies are severely limited in how they market drugs to doctors. Although a doctor can use a drug off label, drug companies generally can’t market it for off label uses.
If a drug company believes a product has other legitimate uses it should first seek FDA approval, a process that ordinarily means safety studies and clinical trials.
Who Makes Amiodarone?
Although we have significant concerns with the amiodarone marketing practices several manufacturers of the drug including Wyeth, Zydus and Sandoz, they aren’t the only ones whose sales practices have been questioned. Manufacturers of Amiodarone sold in the United States include:
- Par Pharmaceutical, Inc
- Sandoz Pharmaceuticals.
- Taro Pharmaceuticals USA, Inc.
- Zydus Pharmaceuticals USA, Inc.
- Teva Pharmaceuticals USA, Inc.
- Barr Laboratories, Inc.
- EON Labs, Inc. (Sandoz)
- Wyeth-Ayerst Laboratories, Inc.
- Mylan N.V. (Mylan is currently the subject of a massive recall, more on that below)
Beware Amiodarone’s Serious Side Effects
The dangers from amiodarone are huge. In fact, there is some thought that at its maximum approved dose, over 1% of patients may die simply from the drug’s side effects.
We have heard stories about improper marketing practices of Zydus, Sandoz and Wyeth but wish to speak to anyone suffering serious side effects no matter who was the manufacturer.
So what are the common side effects of amiodarone? Our experts tell us common effects are painful shortness of breath, wheezing, and lung damage. But that’s not all. The complete list of amiodarone side effects include:
- Pulmonary fibrosis (permanent scarring of lung tissue)
- Hepatic failure (chronic liver failure) / hepatitis /cirrhosis
- Neurotoxicity (damage to central nervous system)
- Peripheral neuropathy (damage to nerves in spinal cord)
- Congestive heart failure
- Kidney failure / Rhabdomyolysis (when combined with Simvastatin)
With most pharmaceutical drugs, simply stopping their use is all that is necessary to reverse any dangerous reactions or side effects. Not with amiodarone.
The drug is fat soluble meaning it is stored in the body. Long after a patient discontinues use, the deadly side effects can continue. With some drugs, simply discontinuing use ends the dangerous side effects. Unfortunately, that is not the case with amiodarone. That means even after a patient stops using the drug, the harmful effects can continue or even worsen.
Amiodarone is so dangerous that the FDA requires a separate warning from whatever instructions or warnings the physician may give. The drug must also be accompanied by a medication guide.
Simply because a drug becomes generic doesn’t change things. In drugs of last resort, all manufacturers remain responsible for making sure pharmacists have proper medication guides to provide patients. (Our investigation tells us that Sandoz doesn’t always provide the proper warnings or the separate medication guide.)
Sandoz Amiodarone Patient Dies of Amiodarone Toxicity – Case Study One
An elderly Philadelphia woman died after being prescribed amiodarone for atrial fibrillation, a non FDA approved use of the drug. Her family claims she was not informed that her prescription was considered “off label” nor was she provided the required warnings.
Shortly after beginning treatment, she began hacking and could not breathe. Her final weeks of life were terrible. By the time she was admitted to the hospital and diagnosed with Amiodarone Pulmonary Toxicity, it was too late. Remember, because amiodarone is stored in body fat, simply discontinuing use doesn’t stop the drug’s deadly side effects.
Zydus Pharmaceuticals Patient Dies – Case Study Two
Ricardo Garcia, Sr lived in Pharr, Texas, a thriving border city along the Rio Grande. His family claims he was prescribed amiodarone for a non-life threatening atrial fibrillation. If that isn’t bad enough, the family claims he wasn’t provided with the required warnings including the FDA mandated medication guide.
Soon after beginning the medication, Ricardo began losing his eyesight and coordination. He also suffered lung damage. His son says that was the beginning of his father’s slow and painful death. The amiodarone in this case was manufactured by Zydus Pharmaceuticals USA.
The families of both patients filed an amiodarone lawsuit claim. Hopefully if the juries believe us and the families, they will award enough damages to give the drug companies the financial incentive to stop peddling their poison for unapproved uses. Until the drug companies are forced to pay, we believe that many put profits before patients.
Are these two cases isolated? We certainly don’t think so. That is why hundreds of lawsuits have been filed around the country. We believe Sandoz, Wyeth, Zydus and many of the other manufacturers know of the dangers of their products yet mislead doctors, fail to report adverse events, and fail to provide proper warnings so that patients can make an informed choice. [Sandoz and the other manufacturers that have been sued deny the allegations.]
Both patients mentioned above developed horrible lung problems that ultimately resulted in their death. We think that the drug companies know that amiodarone also causes many other life threatening complications including liver damage, nerve damage, neurotoxicity, peripheral neuropathy, optic neuritis, blindness, depression and congestive heart failure.
Even if they did not know of their drug’s deadly side effects, drug companies are still required to report deaths and other adverse events to the FDA. They should have also conducted safety studies, warned physicians about of the dangers of amiodarone hydrochloride, and made sure that pharmacists and doctors had proper medication guides to provide patients.
Did You or a Loved One Die or Suffer Complications from Amiodarone? Please Act Quickly
All fifty states limit the time period in which to file lawsuits against the manufacturers of dangerous drugs. In some states, that period may only be two years. Thankfully, many states will extend that time in certain circumstances such as where it wasn’t reasonable for the victim to know that his or her death or symptoms were caused by a drug.
Although the drug companies all claim they have done nothing wrong, we worry that they will also claim that the time to file suit has expired for those that passed away or were diagnosed long ago with amiodarone toxicity. No matter what the statute of limitations may be in any particular state, these cases don’t improve with age.
If you or a loved one suffered from one of the above side effects or died as the result of being prescribed amiodarone, you may be entitled to monetary compensation. [We know that many legal ads say “you must act now.” Here it is true, depending on where you lived when prescribed amiodarone, the time to file an amiodarone lawsuit is quite limited.]
What Is My Amiodarone Lawsuit Worth?
There is no ready answer to this question. Each case must stand on its own merits. Was the drug properly prescribed? Was it prescribed after all other alternatives were tried? What was the dosage? Was the patient suffering from another disease that may have proven fatal? How long did the patient suffer? What were the side effects?
We can’t get back your health. But we can fight hard to make sure you and your family receive adequate compensation. We are also dedicated to preventing other families from having to needlessly suffer.
Amiodarone lawsuit cases are not class actions. Everyone doesn’t ultimately receive the same check in the mail. These are highly complex cases. That means we work hard with our partner law firms, doctors and expert witnesses to learn about the needs and lives of each client.
The first step involves you contacting us. We welcome the opportunity to evaluate your case. Only then can we better tell you what kind of compensation you can expect to receive.
Available Damages in Amiodarone Lawsuit Claims
Monetary compensation is available for:
- Medical bills
- Hospice and nursing home care
- Home health care
- Anticipated future medical needs
- Lost wages (past and future)
- Pain and suffering
- Out of pocket expenses
In tragic cases where the victim dies, compensation may be available for funeral expenses and future earnings.
Depending on the state, punitive damages are sometimes available.
What about Amiodarone Made by Other Manufacturers?
We talked about amiodarone manufactured and distributed by Wyeth, Sandoz and Zydus. There are certainly many other manufacturers. We are interested in any amiodarone lawsuit case, no matter the maker, where the drug was marketed for off label use or where the drug was marketed as a first choice drug (instead of a drug of last resort.) We are also seeking cases where the appropriate warning were not given.
If you or a loved one suffered death or a serious side effect and it appears the drug was improperly dispensed, we want to speak with you. You may be entitled to significant compensation.
From our investigation, amiodarone is made or marketed by:
- Par Pharmaceutical, Inc.
- Taro Pharmaceuticals USA, Inc.
- Zydus Pharmaceuticals USA, Inc.
- Teva Pharmaceuticals USA, Inc.
- Barr Laboratories, Inc.
- EON Labs, Inc.
- Wyeth and Wyeth-Ayerst Laboratories, Inc.
- Mylan N.V.
To see if you are eligible to file an amiodarone lawsuit, simply contact us online, by email or by phone at 833-201-1555. Contact us today. There is no fee and no obligation. If we take your case, you will only owe us legal fees if we are successful and recover money for you. We are presently only considering cases in California, New Jersey and West Virginia.
If you want to know about other dangerous drugs, visit our Dangerous Drug information page.
UPDATE: Amiodarone Recall
On August 31st, the FDA announced that Mylan N.V. was recalling several lots of amiodarone. Typically a lot consists of 40,000 vials meaning this is a massive recall.
According to the FDA, Mylan recalled four lots of Amiodarone HCl Injection and Tranexamic Acid Injection. These lots were distributed to hospitals and nursing homes in the United States between April and July 2020. The vials were for clinical use. (If you take amiodarone in pill form, you are not affected by this recall.)
According to the FDA (as reported by the Cardiovascular Research Foundation), “If amiodarone HCl injection is inadvertently administered it could result in low blood pressure and irregular heartbeat, including lower-than-expected heart rate, which could have immediate life-threatening effects on cardiac function.” Delaying treatment with amiodarone due to accidental use of tranexamic acid would allow for the arrhythmia to continue, with potentially life-threatening effects.
On the other hand, “if tranexamic acid injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with tranexamic acid Injection, when needed, is delayed this could result in limited to serious and life-threatening bleeding events.”
We believe that thousands of patients were given the wrong medications. Through lot tracing, we believe we can prove who may have received the wrong medication. If you suffered serious side effects after receiving an injection of amiodarone, contact us immediately.
Although we are limiting new amiodarone lawsuit claims to only certain states (California, New Jersey and West Virginia) if you or a loved one received the wrong drug AND suffered a significant injury or death, we will consider those cases anywhere in the United States.
Amiodarone Whistleblower? We Want to Hear from You as Well
Our firm began by representing whistleblowers. Our early clients often worked inside pharmaceuticals companies and were horrified by what they saw. They came to us to help stop the fraud and protect patients. Assuming the drugs produced in these plants are Medicare eligible (most are), cash whistleblower rewards may be available.
Pharma insiders are in the unique position of being able to protect patients, save lives and collect a reward. This post is obviously geared towards patients hurt by amiodarone. That doesn’t mean we don’t want to hear from insiders. Even if we can’t help you get a reward, your information is still very important. All inquiries from medical professional and pharmaceutical insiders are protected by the attorney client privilege and kept strictly confidential. To learn more, contact us online, by email or by phone at 414-704-6731 (direct dial). We will never use your information without your approval.
*Cardarone, Pacerone, Nexterone and Zocor are all registered trademarks