Tag: defective drug attorneys

Are You Affected by the Clonazepam Recall?

Posted on by Loni Liss

The FDA Food and Drug Administration has issued a recall for 16 lots of Clonazepam manufactured by Endo, Inc., following a critical labeling error. The product safety recall is hoping to prevent medication errors.

According to the safety alert, the strength listed on the product cartons (0.125 mg) did not match the actual strength of the tablets inside (0.25 mg).

This discrepancy means the tablets were 100% stronger than what patients were led to believe. The wrong Clonazepam dose poses significant health and safety risks for individuals taking the medication.

Clonazepam Recall Lawsuit for mislabeling drug dosage

Clonazepam Recall Lawsuits: What You Need to Know Now

In an official statement, Endo shifted the blame for this mishap onto a “third-party packager”:

“The product … is being recalled due to mislabeling where an incorrect strength appears on the cartons … due to an error at a third-party packager.”

But Endo hired this company. And the product belongs to Endo. Therefore, this is their responsibility to bear, as it puts thousands of people at risk of overdosing on its drug.

Given the recall, the FDA agrees. And with that safety warning, The Yost Legal Group has taken action to represent people harmed by the potentially deadly mislabeling.

If you or a loved one has suffered an adverse reaction due to the mislabeling of Clonazepam, The Yost Legal Group is here to help.

Patient Risks for Taking Mislabeled Clonazepam Medication

FDA Recalls Clonazepam Drug for Safety Concerns

With over 30 years of experience in representing victims of accidents caused by negligence, our defective drug attorneys will provide compassionate and experienced support as you seek the justice you deserve.

Pharmaceutical errors are unacceptable, and we believe in holding Big Pharma accountable for its mistakes.

Contact The Yost Legal Group product liability lawyers today for a free consultation. Call 1-800-967-8529 to speak with our caring and experienced legal team.

Clonazepam: The Generic Name for Klonopin

The brand name for Clonazepam is Klonopin, which is more widely recognized by the general public. However, it is essential to note that any potential litigation against Endo, Inc. regarding the mislabeling of its product applies only to Clonazepam, not to other products.

Klonopin is a brand name owned by a different company. Clonazepam is the generic name. There are also several other manufacturers of Clonazepam, but they are not relevant to this potential litigation.

We are only focusing on Endo’s version of the drug, as that is, to this point, the only version that was distributed with the potentially harmful mislabeling.

FDA Recalls Clonazepam Drug for Safety Concerns

What Is Clonazepam?

Clonazepam is a generic medication belonging to the benzodiazepine class of depressant drugs. That is a fair amount of pharmaceutical jargon and terminology, so let’s break it down piece by piece.

  • Depressants: You are probably familiar with depressant drugs. As a slang term, they are often referred to in casual conversations as “downers.” These types of drugs affect the brain’s activity.

They slow neurotransmission levels and decrease electrical activity in the brain. Depressants also inhibit an individual’s ability to feel arousal and stimulation.

While this might sound negative, this reduction in brain activity is precisely why depressant drugs can be effective when used correctly by the discretion of a medical professional to relieve disorders and symptoms such as various anxiety disorders, depression, insomnia, obsessive-compulsive disorder, and seizures.

Alcohol, benzodiazepines, and cannabis are some of the most common types of depressant drugs.

  • Benzodiazepines: As mentioned above, benzodiazepines, known colloquially as “benzos,” are a class of depressant drugs. This type of drug derives its name from its chemical compound, which is a fusion of a benzene ring and a diazepine ring.

Medically, benzodiazepines are used to treat anxiety and panic disorders, insomnia, and seizures.

Common types of benzodiazepines include alprazolam (Xanax®), clonazepam (Klonopin®), and diazepam (Valium®).

Mislabeling Medication Could Affect Your Safety

Clonazepam and benzodiazepines, in general, are often used to treat anxiety disorders, bipolar mania, and seizures as their structural formulae target certain receptors in the brain (GABAA) to produce a calming effect, thus reducing anxiety, preventing seizures, and promoting relaxation.

People living with conditions such as anxiety, bipolar disorders, or epilepsy depend upon their medicine to help them get through their days. Their medications are vital to their mental and physical health.

Now, with Endo’s labeling error, which the company itself has referred to as “possibly life-threatening” in the FDA safety warning, some patients may lose confidence or trust in the medication that helps them manage their condition.

If you or someone you care about has been affected by a defective drug or Endo’s Clonazepam due to a labeling error, you may be eligible for compensation.

Contact the skilled defective drug attorneys at The Yost Legal Group for a free, confidential consultation.

Protecting your health and well-being is important, so don’t wait. Call 1-800-967-8529 now to learn more.

Side Effects of Clonazepam

Even when taking a benzodiazepine such as Clonazepam in the appropriate doses and dosage, there is still the potential for adverse effects because of the change to the brain’s chemical composition.

The most common side effects of Clonazepam include the following:

  • Depression
  • Dizziness
  • Drowsiness
  • Fatigue
  • Forgetfulness
  • Lack of coordination

Know Your Rights After Endo’s Labeling Error

If one has taken a dose that is 100% higher than what a doctor has prescribed because the labeling on the packaging lists an incorrect strength, these side effects become much more harmful and potentially deadly.

Overdosing on benzodiazepines like Clonazepam or combining them with opioid medications can lead to profound sedation that is hard to wake from, respiratory depression that can lead to suffocation, coma, and, in the absolute worst case, death.

Endo must be held responsible for its mistake, even if it plans to shift the blame to the third-party packager that printed and applied the labels. After all, it was Endo who hired the third-party packager in the first place.

Furthermore, as previously stated, there are several manufacturers of Clonazepam. Endo is not alone in the production of this benzodiazepine.

However, Endo is the only company to have its version of Clonazepam recalled by the FDA. And if people have been harmed, we will help them hold the company to account.

Patient Risks for Taking Mislabeled Clonazepam Medication

A two-fold overdose of Clonazepam poses serious risks for children and adults. Potential adverse effects include:

–             Significant sedation

–             Dizziness

–             Ataxia

–             Confusion

There is also a considerable likelihood of severe and potentially life-threatening respiratory depression. This risk increases for individuals with:

–             Pulmonary disease

–             Those prescribed near-maximal dosing

–             Those taking other medications that may contribute to respiratory depression

Your Health May Be at Risk After a Drug Recall

To check if your Clonazepam is affected by a recall, follow these steps:

  • Check your packaging

Look for the lot number on the carton of your Clonazepam product.

  • Compare the lot number.

Visit the FDA website for the complete list of recalled lot numbers. Or check the list below. Endo USA, Inc. is recalling certain Clonazepam Orally Disintegrating Tablets due to potential mislabeling of the carton strength.

  • Contact your healthcare provider or pharmacy.

If your lot number matches one on the recall list, reach out to your healthcare provider or the pharmacy that dispensed the medication for next steps.

Taking these precautions is essential for ensuring the safety and appropriateness of your medication.

Lots Affected by the Clonazepam Recall

Potential Product Description / NDC Number 

Lot Number Expiry Date

Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02

550176501 Feb 2027

550176601 Feb 2027

Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02

550174101 Jan 2027

Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02

550142801 Aug 2026

550142901 Aug 2026

550143001 Aug 2026

550143101 Aug 2026

550143201 Aug 2026

550143301 Aug 2026

550143401 Aug 2026

550147201 Aug 2026

550147401 Aug 2026

Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02

550145201 Aug 2026

550175901 Feb 2027

550176001 Feb 2027

550176201 Feb 2027

According to ClinCalc.com, Clonazepam was the 57th most prescribed drug in the United States in 2022. In 2022, more than 11.5 million prescriptions of Clonazepam were distributed to nearly 2 million patients.

Fight Back Against Medication Risks, Protect Your Rights

This mislabeling potentially puts millions of people at risk. While it is true that Endo has acknowledged the error and acknowledged the risk (as evidenced by their “possibly life-threatening” quote), its claim that there have been no reports of adverse events rings hollow.

Defective Drug Lawyers Protecting Your Rights

The Yost Legal Group is representing clients harmed by Clonazepam overdose from mislabeled packaging. If you have experienced serious side effects or if a loved one has died from an overdose due to this mislabeling error, call us for help.

We handle cases involving medication errors, FDA pharmaceutical recalls, and recalled drugs. If a prescription medication like Clonazepam tablets caused you harm, contact our drug recall lawyers.

If a defective drug has harmed you or a loved one, contact The Yost Legal Group today. Our experienced defective drug lawyers will immediately begin working on your case. We will help you understand your rights and seek the compensation and justice to which you are entitled.

Every consultation is free, and there are no fees unless we win your case.

FDA Recall List – Drug Recall FDA – Clonazepam Use – Prescription Drug – Drug Interactions

Oxbryta Medication Recall for Sickle Cell Disease

Posted on by Loni Liss

In September 2024, Pfizer Inc. published a press release announcing it voluntarily recalled all Oxbryta (Voxelotor). Oxbryta was used to treat sickle cell disease and was once thought of as a breakthrough treatment for the deadly disorder.

The following day, the United States Food & Drug Administration (FDA) published a safety alert regarding Pfizer’s recall. It recommended that healthcare providers stop prescribing the drug and that patients contact their doctors. The FDA’s safety alert explained that Oxbryta was recalled because of severe adverse side effects in Oxbryta treatment groups relative to controls.

You may be entitled to compensation if you experienced severe adverse reactions after taking Pfizer’s Oxbryta. Contact the experienced defective drug lawyers at The Yost Legal Group today for a free consultation regarding your claim. We are available by phone or text at 410-659-6800.

Severe Side Effects From Sickle Cell Medication Oxbryta

Oxbryta Recall Linked to Vaso-Occlusive Crises – Find the Facts

Two FDA-mandated studies have revealed a concerning risk associated with Oxbryta. Research shows that Oxbryta may increase the likelihood of experiencing a life-threatening vaso-occlusive crisis, a condition that can result in organ failure, stroke, or even death.

Following these findings, the FDA has concluded that the risks of Oxbryta outweigh its benefits. Symptoms of vaso-occlusive crisis may include:

  • Fever
  • Pain
  • Swelling
  • Kidney Failure
  • Stroke
  • Death

If you or a loved one have taken Oxbryta and suffered severe side effects, it’s important to act now. Consult your healthcare professional and contact our product liability lawyers for guidance.

Our experienced product liability attorneys are ready to help you understand if you qualify to join the Oxbryta lawsuit.

stroke from Oxbryta medication for treating sickle cell anemia

The Benefit of Pfizer Sickle Cell Drug “No Longer Outweighs the Risk”

Pfizer, a multinational biopharmaceutical giant valued at over $140 billion, markets itself as “one of the world’s premier biopharmaceutical companies.” With such immense resources, it’s no surprise that Pfizer has a legal team to match its stature, prepared to defend the company at all costs.

But what about the individuals harmed by Big Pharma’s actions? If you’ve been negatively impacted, you need an experienced, compassionate, and relentless legal team—someone who will stand up to billion-dollar corporations and fight for justice on your behalf.

At The Yost Legal Group, we’ve advocated for ordinary people for over 35 years. Our defective drug attorneys have fought—and won—against some of the largest pharmaceutical companies for our clients, ensuring they receive the justice they deserve.

Pfizer prioritized profits over safety, putting lives at risk to fast-track its drug. It’s time to hold the drug manufacturers accountable. Contact The Yost Legal Group today for a free consultation.

Oxbryta lawsuit for sickle cell patients

What Is Sickle Cell Disease?

The recalled drug Oxbryta is the brand name of Voxelotor, a medication used to treat sickle cell disease (SCD). SCD is a group of blood disorders that affect the hemoglobin. You might be most familiar with sickle cell disease, which is known as sickle cell anemia.

This is all very technical and heavy on medical terminology, so we will go through each portion piece by piece.

First, we will discuss hemoglobin: It is easy to think of blood as just one substance, a bodily fluid that flows through all of us. But blood comprises many other substances, such as nutrients and oxygen. There are red blood cells. There are white blood cells.

In red blood cells, a protein rich in iron called hemoglobin facilitates the transportation of oxygen from the respiratory organs (lungs or gills) to the body’s other tissues.

However, due to a gene mutation, sickle cell disease occurs when a person inherits two abnormal copies (one from each parent) of the gene that makes hemoglobin. The red blood cells adopt an abnormal sickle-like shape, giving the disorder group its name.

These misshapen red blood cells cause many health issues, such as anemia, bacterial infections, and capillary blockages. Furthermore, all of the significant organs suffer as these deformed red blood cells pass through the body, causing attacks of pain known as “sickle cell crisis.”

Sickle cell disease is a life-long disorder that is often fatal. Without treatment, people with SCD rarely reach adulthood. Even with treatment, though people reach adulthood and even middle age, their life expectancy is significantly lower than that of people without the disease.

What Is the Medication Oxbryta (Voxelotor)?

Oxbryta was an oral medication. Patients were meant to take one tablet daily. Its intended use was for the treatment of sickle cell disease, the hemoglobin-related blood disorder that is, at best, degenerative and, at worst, fatal even before a person reaches adulthood.

As SCD affects the shape of red blood cells and limits hemoglobin’s ability to carry oxygen from the lungs to other parts of the body, Oxbryta was developed to increase hemoglobin’s affinity for oxygen.

In November 2019, Global Blood Therapeutics (a subsidiary of Pfizer since October 2022), received an accelerated approval from the FDA for Voxelotor as a treatment for SCD patients 12 years and older, making it the first hemoglobin oxygen-affinity modulator.

It was the first drug to target the root cause of SCD. This approval was a landmark win in a long and difficult battle against the disease.

In December 2021, the FDA again granted Global Blood Therapeutics an accelerated approval for the prescription drug Voxelotor in sickle c patients between the ages of four and 11.

However, the actual results of the trials were not so conclusive.

Oxbryta Medication Recalled by the FDA

On September 25, 2024, Pfizer, the parent company of Global Blood Therapeutics, the original developer of Voxelotor for nearly two years, withdrew all lots of Oxbryta from worldwide markets.

This recall sent shockwaves through the SCD community five years after the initial breakthrough approval. “Clinicians and patients were shocked to hear that the drug was being withdrawn from the market because of safety concerns.”

According to Pfizer’s own press release:

“Pfizer’s decision is based on the totality of clinical data that now indicates the overall benefit of OXBRYTA no longer outweighs the risk in the approved sickle cell patient population. The data suggests an imbalance in vaso-occlusive crises and fatal events which require further assessment.”

Despite this, many clinicians were still left with more questions as Pfizer did not provide many details to support its claims: “Specifically, the letter noted that the decision was based on the ‘totality of clinical data,’ but did not provide any details on adverse events.”

Charles Abrams, MD, the Francis C. Wood professor of medicine at the University of Pennsylvania School of Medicine, used the opportunity to call into question the FDA’s accelerated approval pathway:

“[Accelerated approval] has always been a double-edged sword. Certainly, it accomplished the idea of getting drugs out there and utilized more quickly. Some drugs that have been approved through this pathway have later been proved to be ineffective and sometimes even unsafe for patients.”

In the intervening time, the European Medicines Agency (EMA) has also recommended the suspension of Oxbryta based on new data from a study that has been ongoing since July 2024.

Injured by Oxbryta? Call for Free Legal Help Today!

Similar to Pfizer, the EMA cited an increase in vaso-occlusive crises in patients taking Oxbryta compared to before they started the treatment.

There is still much to learn, but it is clear that Pfizer had a dangerous drug on the market for about five years. If you have been prescribed Oxbryta, consult with your healthcare professional to discuss a plan for getting off the recalled drug.

If the use of Oxbryta, the sickle cell anemia drug, has harmed you or a loved one, you may have a case. Call the experienced defective drug lawyers at The Yost Legal Group for a free consultation. We are available by phone or text at 410-659-6800 or toll-free at 1-800-659-6800.

When your health and safety are on the line, there is no time to delay. Contact an Oxbryta lawyer who will fight for your rights and help you get the justice you deserve.

Sickle Cell Disease Crisis – Hemoglobin C Disease – Sickle Cell Disease Cause

Oxbryta Side Effects – Oxbryta Death Claim – Oxbryta Claim – Dangerous Drug Lawyers

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