The FDA Announces a Major Amiodarone Recall – Some Patients May Have Received the Wrong Drug

Google “Is amiodarone dangerous” and you will receive 292,000 search results. A so-called drug of last resort, amiodarone is very dangerous. In our opinion, the cure is often far worse than the disease it is intended to treat. 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.

In this post we will provide a litigation update and discuss the new FDA announcement recalling amiodarone manufactured by Mylan. Before addressing the amiodarone recall, we will first provide brief information on why amiodarone is so dangerous and what how patients who were harmed by this drug can get compensation.

Why Is Amiodarone so Dangerous?

As noted above, the FDA considers amiodarone a “drug of last resort”. When misused or improperly prescribed, amiodarone’s side effects often lead patients to suffer a slow, horrific death.

Amiodarone is prescribed to help patients maintain a regular, steady heartbeat. Although often in its generic form, common brand names for the drug are Cordarone, Nexterone and Pacerone.

The FDA says amiodarone is 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 same companies sometimes don’t tell doctors it is a last resort drug or provide pharmacies with proper warnings documents for patients.

Amiodarone and Simvastatin (Zocor)

One of the biggest dangers of amiodarone occurs when the patient is also taking Simvastatin (Zocor). Used in patients suffering high cholesterol and triglyceride level, Simvastatin is common for patients with arrhythmias. Because both high cholesterol and arrhythmias are common in cardiac patients, it common to see patients prescribed both drugs. Unfortunately,  when mixed together, these drugs may cause a deadly disease called Rhabdomyolysis. This disease is associated with the breakdown of muscles and kidney failure.

Other medications that may cause serious reactions with amiodarone may include Bepridil, Colchicine, Fingolimod, Grepafloxacin, Ketoconazole, Mesoridazine, Pimozide, Posaconazole, Saquinavir,  Terfenadine, Tipranavir, Ziprasidone, Amisulpride, Cisapride, Dronedarone, Fluconazole, Indinavir, Levomethadyl, Nelfinavir, Piperaquine, Ritonavir, Sparfloxacin, Thioridazine and Vernakalant.

Because of the high risks associated with amiodarone, we suggest that you discuss any other medications you may be taking both with your cardiologist and pharmacist.

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.

Many doctors primarily must rely on drug companies for current information about drug safety and effectiveness. Knowing this, the FDA says drug companies can only market their drugs for FDA approved uses. Doctors have more freedoms but drug companies are restricted in their marketing efforts and 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 the company affected by the recall, more on that below)
  • Generic drug companies

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:

  • Death
  • 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
  • Blindness
  • Depression
  • 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.

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.)

More information about Amiodarone and Amiodarone Lawsuits

The above discussion is just a summary. We have detailed information on our Amiodarone Lawsuit Claims page. Included are actual patient stories and a short video.

As of September 2020, we are only considering new cases in the following states: California, New Jersey and West Virginia.

We think drug companies are well aware of the dangers of amiodarone. They know that amiodarone causes many life threatening complications  including lung problems, 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? Act Now!

As noted above we are presently still taking amiodarone lawsuits but only in the following states: California, New Jersey and West Virginia.

The time period in which to file lawsuits against the manufacturers of dangerous drugs is quite short. In some states, that period may only be one or 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. Each passing day makes them more difficult to prove.

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.

Each case is different making it hard to know what a case is worth without extensive research. 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? Was the patient taking Zocor or other medications that could have cause a reaction? What were the side effects?

No one can 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.

Damages available in  Amiodarone lawsuit claims include:

  • 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.

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.

FDA Announces Amiodarone Recall!

On August 31st, the FDA announced that Mylan N.V. was recalling several lots of amiodarone.

Mylan is a multi-billion dollar Dutch pharmaceutical company and one of several manufacturers of amiodarone.

According to the FDA, Mylan has 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.

While four lots doesn’t seem like much, single dose  injectable drugs usually are usually in lots of 40,000. That means there could be tens of thousands of people who received the wrong drug. To date, there have been no adverse incident reports filed with the FDA but medical staff wouldn’t have known that the drug they were providing to a patient was mislabeled and possibly the wrong drug.

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 many patients were provided the wrong medications. Proving that occurred will likely be difficult but can be done as the company’s shipping documents should indicate what facilities received the questionable drug shipments.

Although we are limiting new amiodarone lawsuits 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.

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.[photo from]

The post FDA Announces Amiodarone Recall & Amiodarone Lawsuit Revisited appeared first on Mahany Law.