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FDA Recalls Popular Blood Pressure Drug for Cancer Risk

The U.S. Food and Drug Administration (FDA) has issued a recall for the popular blood pressure drug irbesartan (Avapro) after determining the medication may be contaminated with a known cancer-causing agent.

About the Ibesartan Recall

According to Fortune, FDA testing of the drug found pills contained the carcinogen N-nitrosodiethylamine (NDEA) which is believed to be a byproduct of the manufacturing process.

According to the U.S. Environmental Protection Agency, N-nitrosodimethylamine is human carcinogen, meaning it causes cancer in humans. The chemical can be found in water supplies and food in very small amounts.

In June, the FDA also recalled valsartan for NDA contamination. Irbesartan is the first non-valsartan pharmaceutical found by the FDA to contain the NDEA impurity.

Products Covered by the Irbesartan Recall

The following batches are included in the irbesartan recall. All batches were manufactured by ScieGen and distributed to Westminister Pharmaceuticals.

NDC# Product Description Lot# Expiration Date
69367-119-01 Irbesartan 75mg Tablets, 30 count bottle B160002A Sep-19
69367-119-03 Irbesartan 75mg Tablets, 90 count bottle B160002B Sep-19
69367-120-01 Irbesartan 150mg Tablets, 30 count bottle B161005A Sep-19
C161002A Feb-20
69367-120-03 Irbesartan 150mg Tablets, 90 count bottle B161005B Sep-19
C161002B Feb-20
69367-121-01 Irbesartan 300mg Tablets, 30 count bottle B162008A Sep-19
C162002A Feb-20
69367-121-03 Irbesartan 300mg Tablets, 90 count bottle B162008B Sep-19
C162002B Feb-20

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

Thyroid Drug Recalled By FDA

The Food and Drug Administration (FDA) announces a voluntary recall of a thyroid medication over concerns of potential problems with an ingredient.

About the Thyroid Medication Recall

The FDA’s statement says that the recalled medications were “manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s import alert.”

However, because these drugs may be used to treat serious medical conditions, the FDA advises patients taking the medication to continue to do so until they can get a replacement.

CEO of Westminster Pharmaceuticals Gajan Mahendiran has said the following regarding the precautionary recall:

“Westminster Pharmaceuticals aims to ensure that integrity is embedded in our reputation through the products we develop and market. We will never compromise when it comes to providing our patients with the caliber of medication they deserve. While we stand behind the quality of our product, we are taking the utmost precaution by recalling our Thyroid, USP Tablets only to the wholesale level due to a recent inspection by the FDA at one of our active ingredient manufacturers.”

Details of the Thyroid Drug Recall

The following Levothyroxine and Liothyronine thyroid tablets are included:

  • 15 mg
  • 30 mg
  • 60 mg
  • 90 mg
  • 120 mg

A recorded statement is available at 1-800-354-9939, where Westminster Pharmaceuticals says, “If your medication is dosed in micrograms (mcg), your medication is not included in this recall.”

A full list of the affected products with lot numbers and expiration dates can be found here: https://www.fda.gov/Safety/Recalls/ucm616601.htm

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

FDA Expands Recall On Blood Pressure Drug

The Food and Drug Administration (FDA) has once again expanded their recall of the high blood pressure medication Valsartan due to concerns that it could contain a cancer-causing ingredient.

About the Recalled Medication

According to the FDA, Valsartan is a drug that is commonly used to treat high blood pressure and congestive heart failure. The medication was first recalled on July 13 after tests suggested that it could contain a cancer-causing substance known as N-Nitrosodimethylamine (NDMA).

Research by the Environmental Protection Agency (EPA) shows that NDMA was previously used in the production of rocket fuel, as well as antioxidants and softeners for copolymers. It is now only used for research purposes.

Details of the FDA Recall

Valsartan tablets distributed by the following pharmaceuticals are included in the recall:

  • AvKare
  • A-S Medication Solutions LLC
  • Bryant Ranch Prepack Inc
  • Camber Pharmaceuticals, Inc.
  • H J Harkins Company
  • Northwind Pharmaceuticals
  • NuCare Pharmaceuticals Inc.
  • Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC)
  • Proficient Rx LP
  • Remedy Repack
  • Teva Pharmaceuticals (labeled as Major Pharmaceuticals)
  • Teva Pharmaceuticals USA (labeled as Actavis)

Several other medications containing Valsartan have also been recalled. A full list can be found here.

Any adverse reactions to the drug should be reported to the FDA, and consumers taking Valsartan tablets are urged to immediately contact their doctors for a prescription change. Contact Qualanex, LLC at 1-800-505-9291 with any further questions or concerns.

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

Essure Removed from Market, Experts Question Payments from Bayer to Doctors

As Bayer announces its plans to remove the contraceptive device Essure from the market, experts are questioning the ethics behind Bayer’s paying millions of dollars to doctors.

Payments Made to Essure Prescribing Doctors “Looks Like a Bribe”

Last week, the United States Food and Drug Administration (FDA) expressed new safety concerns about Essure, and Bayer Pharmaceuticals announced that they would be pulling the device off the market on December 31.

To make matters more alarming, a CNN analysis of federal data found that between August 2013 and December 2017, Bayer paid 11,850 doctors $2.5 million related to Essure for consulting fees and similar services. While technically legal, these payments remain very controversial.

Three doctors were paid more than $100,000 by Bayer for services linked back to Essure.

In statements to CNN, a patients who suffered adversely from side effects related to Essure noted that her doctor was “very pushy” when prescribing the device.

Dr. Martin Makary, a professor of surgery and patient safety expert at Johns Hopkins Medicine, said that while payments from pharmaceutical company to doctors for research are not uncommon or unethical, he doubted that the more than 11,000 doctors paid by Bayer were involved in such work.

He added, “That looks like a bribe. That looks like gaming the system. That looks like the pharma company is paying of doctors.

Opinions Differ on Why Essure Was Removed from the Market

Bayer has announced that the reason they would be pulling the product is due to declining sales. adding that they completely stand by the safety of this product.

On Friday, Bayer published an “Open Letter to Patients and Providers About Essure,” which states that the company’s decision to stop selling Essure “was not based on concerns about the safety and efficacy of Essure. Essure has been on the market for more than 15 years and has been successfully used by hundreds of thousands of women.”

According to an FDA statement put out the same day, however, the device has been associated with “serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen.”

So far, the FDA has received more than 20,000 adverse event reports from women using Essure, with 11,854 of those reports being filed in 2018 along.

Oddly enough, Bayer’s announcement also came just days before Netflix premiered a documentary about the dangers of Essure and other medical devices, “The Bleeding Edge.”

Essure Side Effects and Warnings

The FDA estimates that Essure has been used by more than 750,000 patients worldwide since it was approved on November 4, 2002. At the time, Essure was manufactured and marketed by Conceptus Inc., which Bayer acquired in June 2013.

From 2002 through 2017, the patient problems most frequently reported to the FDA were:

  • Pain/abdominal pain (21,215)
  • Heavier menses/menstrual irregularities (9,846)
  • Headache (7,231),
  • Fatigue (5,842)
  • Weight fluctuations (4,970)

According to the FDA, reported adverse events “cannot be interpreted or used in isolation to reach conclusions about the existence, severity or frequency of problems associated with devices” and “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.”

In April, the FDA restricted sales of Essure to only doctors who give patients FDA-approved patient education materials that describe the risks. The FDA also ordered a black box warning be added to product packaging in May 2016.

Have You Suffered An Injury from Essure? Call Thomas J. Henry

Defective and faulty medical devices have the potential to cause long-lasting and permanent damage in patients seeking treatment for their injuries and illnesses. In some cases, defective medical devices have caused fatal injuries, causing devastation to the victim’s family. At Thomas J. Henry, we will fight vigorously on you and your family’s behalf. We have the legal and financial resources necessary to properly develop your case and take on the large pharmaceutical and medical device manufacturers.

If you or a loved one have been injured by a medical device, call us today — attorneys are available 24/7, nights and weekends. Our firm has offices in Corpus ChristiSan Antonio, Austin, and Houston, serving clients across Texas and nationwide.

Viagra Trial Stopped After 11 Babies Die

The Amsterdam University of Medical Centre (UMC) announced the end of a clinical trial testing a new use for the pharmaceutical sildenafil, known commercially as Viagra, following the deaths of nearly a dozen babies.

About the Viagra Clinical Trial and the Resulting Deaths

According to reports, the popular erectile dysfunction drug was being tested on pregnant women with doctors hoping that certain properties of the drug, specifically those that improve blood flow, would stimulate the growth of placentas.

Typically, Viagra works by blocking an enzyme that breaks down a messenger compound that helps relax smooth muscles, like those that surround certain blood vessels. The resulting increased blood flow is useful in not only managing erectile function but also in reducing the severity of mountain sickness symptoms and in treating pulmonary hypertension.

What when wrong with the current trial remains a mystery; however, researchers noted that 11 babies died during or shortly after delivery with elevated blood pressure in their lungs. This is presumed to be linked to the drug,

Six other newborns were born with a lung condition that deprived them of sufficient oxygen.

The Risk of Clinical Trials

  • The new treatment being tested may not be as effective or as safe as existing treatments.
  • Drugs and medical devices in clinical trials may carry unexpected side effects.
  • These side effects may be occasional aches and pains or may result in serious adverse events including renal injury, cardiovascular complications, and even death.
  • As the clinical trials progress, drugs may be combined with other medications and dosages may be increased, resulting in increased risks.
  • Insurance and health care providers may not cover the costs of patient care during a clinical trial or injuries and side effects that may result from a clinical trial.

Have You Been Involved in a Clinical Trial?

If you have been involved in a clinical trial and have suffered injury or illness, ask yourself the following questions:

  • Did you understand all of the enrollment paperwork you signed?
  • Were you confused by the consent forms?
  • Did you have lingering questions about side effects?
  • Did your doctor fail to explain all the possible outcomes of the trial?
  • Were you told you had a problem and then told something different by another doctor?
  • Were you referred to several doctors during your initial treatment and/or after the trial?

Contact an Experienced Clinical Drug Trial Attorney

If you or a loved one has been the victim of a dangerous pharmaceutical drug or medical device, you may be entitled to compensation. You deserve dynamic representation from a law firm with the resources necessary to take on the pharmaceutical companies. Thomas J. Henry has a track record of helping clients receive record-breaking verdicts, settlements, and judgments.

Our firm has offices in Corpus ChristiSan Antonio, Austin, and Houston, serving clients across Texas and nationwide. Call us today for a free case review — attorneys are available 24/7, nights and weekends.

FDA Joins 22 Countries in Recall of Common Heart Drug

On Friday, the U.S. Food and Drug Administration (FDA) announced a recall for valsartan, a common drug that is used to control blood pressure and prevent heart failure. The announcement comes one week after 22 other countries recalled it because the drug contains a chemical that poses a potential cancer risk.

Details of the Valsartan Recall

According to the FDA, valsartan is off-patent and is used as a component of other generic medicines; however, regulators note that not all medicines containing the ingredient are involved. Specifically, the U.S. recall only includes versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide (HCTZ) combinatios sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

The director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, offered reassurance to consumers, saying “We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients.”

In Europe and Asia, Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled because they “do not meet our high quality standards.”

Pharmacies in the UK are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.

Details of the Valsartan Cancer Risk

The recall is due to the presence of the impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is an organic chemical that is in a family of potent carcinogens.

It has been used to make liquid rocket fuel, softeners, and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.

According to the United States department of Health and Human services, animal studies have shown that NDMA can be toxic and cause tumors in the liver, kidney and respiratory tract. It can also be potentially harmful to humans in certain quantities. Exposure to high levels can cause liver damage and is a probable human carcinogen.

Patients are advised to talk to their doctor if they are taking the medication. They should not discontinue taking medication without a doctor’s permission. Going off their medication without supervision could be dangerous, according to the American Heart Association.

The FDA’s investigation into the drug will continue.

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

 

Class I Recall Issued for Abbot HeartMate 3

A Class I recall has been issued for Abbott’s HeartMate 3 left ventricular assist devices due to possible twisting and eventual occlusion of the outflow graft which can create a risk of serious injury or death.

About the Abbot HeartMate 3 Recall

According to Mass Device, the HeartMate 3 devices are being recalled due to a malfunction in the outlaw graft assembly. The defect could result in the outflow graft twisting and occluding over time, which could cause stalled pump flow and a persistent low flow alarm in the system.

Such a reduction in pumping can lead to serious adverse events, including blood clots and death.

In total, the recall affects 4,878 units across the U.S. Recall units will have catalog numbers of 106524US, 106524, or 10652INT. All defective devices were distributed after September 2, 2014.

Class I Recalls Designate Serious Risk of Injury and Death

When issuing recalls, the U.S. Food and Drug Administration will assign a classification designating how serious recall is and the potential adverse health outcomes posed by the recalled product, drug, or device.

The classifications are as follows:

  • Class I: a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death.
  • Class II: a situation in which use of, or exposure to, a product may cause temporary or medically reversible adverse health consequences or where there is a remote probability of serious health consequences.
  • Class III: a situation in which use of, or exposure to, a product is not likely to cause adverse health consequences.

A recall is terminated only after the FDA deems the product no longer in violation of the law and no longer presents a health hazard to patients.

Contact an Experienced Medical Device Recall Attorney

Defective and faulty medical devices have the potential to cause long-lasting and permanent damage in patients seeking treatment for their injuries and illnesses. In some cases, defective medical devices have caused fatal injuries, causing devastation to the victim’s family. At Thomas J. Henry, we will fight vigorously on you and your family’s behalf. We have the legal and financial resources necessary to properly develop your case and take on the large pharmaceutical and medical device manufacturers.

If you or a loved one have been injured by a medical device, call us today — attorneys are available 24/7, nights and weekends. Our firm has offices in Corpus ChristiSan Antonio, Austin, and Houston, serving clients across Texas and nationwide.

FDA Restricts Sale of Essure Birth Control Device

The U.S. Food and Drug Administration (FDA) announced they are restricting the sale of Bayer AG’s implanted birth control device Essure. The decision comes two years after the agency ordered Bayer to put a severe warning label on the product.

Details of the Essure Sale Restriction

According to Reuters, the FDA ruled that some women were not being adequately informed of the risks associated with Essure prior to getting implanted. The new restrictions will limit the sale of Essure to healthcare facilities that provide full information about the device’s risks and benefits.

Among the risks associated with Essure are:

  • Hysterectomy
  • Depression
  • Abdominal pain
  • Abnormal uterine bleeding
  • Device migration
  • Perforated organs
  • Ectopic pregnancy

Essure was originally approved by U.S. regulators in 2002, but it received a black box warning in 2016 following thousands of complaints.

Essure Subject of more than 10,000 Lawsuits

The FDA decision could prove vital to some 10,600 lawsuits pending against Bayer in the U.S. Those lawsuits allege Bayer was aware of the risks associated with Essure, but failed to warn sellers, doctors, and regulators of the dangers.

The FDA revealed in March that is had received roughly 12,000 medical reports concerning Essure in 2017 – more than 90 percent of those reports mentioned issues around device removal.

Currently, there are an estimated 750,000 women using Essure worldwide with about 70 percent of users based in the U.S.

Hurt by a Defective Medical Device? Contact Thomas J. Henry

Defective and faulty medical devices have the potential to cause long-lasting and permanent damage in patients seeking treatment for their injuries and illnesses. In some cases, defective medical devices have caused fatal injuries, causing devastation to the victim’s family. At Thomas J. Henry, we will fight vigorously on you and your family’s behalf. We have the legal and financial resources necessary to properly develop your case and take on the large pharmaceutical and medical device manufacturers.

If you or a loved one have been injured by a medical device, call us today — attorneys are available 24/7, nights and weekends. Our firm has offices in Corpus ChristiSan AntonioAustin, and Houston, serving clients across Texas and nationwide.

 

 

MS Drug Zynbryta Pulled from Market Worldwide

Prescription medication bottles with multiple pills of various colors

Biogen and AbbVie have announced that they will be removing Zinbryta (daclizumab), a treatment for relapsing multiple sclerosis (MS), from the market due to growing concerns about the drug’s safety.

About Zynbryta’s Market Removal

According to Medscape, the drug has been linked to reports of severe liver damage and immune-related conditions.

The announcement on the withdrawal came the same day that the European Medicines Agency (EMA) announced it would be conducting an “urgent review” of Zinbryta (daclizumab)  in reaction to seven cases of serious inflammatory brain disorders in Germany and one case in Spain.

Biogen and AbbVie stated that the nature and complexity of the adverse events made it impossible to accurately characterize Zinbryta’s benefit/risk profile. Both companies felt the market withdrawal would be in patients’ best interests.

Zinbryta was approved in the U.S. in May 2016; however, with the approval, the Food and Drug Administration (FDA) recommended the drug only be used in patients who have not responded to prior therapies.

Side Effects of Zinbryta

The following adverse events have been associated with Zinbryta:

  • Infection of the nose, throat, and sinus
  • Bronchitis
  • Depression
  • Urinary tract infection
  • Anemia
  • Fever
  • Trouble breathing
  • Disease of the thyroid gland
  • Breast tumor
  • Diabetes
  • Failure of small intestines
  • Hepatitis
  • Suicidal thoughts
  • Liver failure
  • Pancreatitis
  • Seizure
  • Death

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

FDA Adds Boxed Warning to Ocaliva Following Dosing Errors

The U.S. Food and Drug Administration (FDA) has ordered a boxed warning and dosing table be added to the liver disease drug Ocaliva (obeticholic acid) following reports that the medication is being incorrectly dosed daily instead of weekly to patients.

About the Ocaliva Black Box Warning

Medscape reports that Ocaliva is prescribed to patients with moderate to severe primary billary cholangitis (PBC) and that the incorrect dosing results in an significantly increased risk of serious liver injury.

In a safety communication, the FDA addressed the issue saying that the dosing errors have resulted in cases of liver decompensation, liver failure, and death. In order to correct the issue, the FDA is clarifying current recommendations for screening, dosing, monitoring, and managing PBC in patients with moderate to severe liver disease taking Ocaliva.

In addition to the boxed warning and dosing table, the FDA said that it will also require Ocaliva carry a medication guide for patients that informs them about the past dosing issues and the risk of such errors.

Additional Guidelines Issued to Healthcare Professionals and Patients

Beyond packaging and label changes, the FDA advises clinicians to take the following actions when treating a patient with Ocaliva:

  • Routinely monitor patients for biochemical response, tolerability, and PBC progression.
  • Closely monitor patients who are at an increased risk of liver decompensation.
  • Make sure both patients and caregivers are educated on the symptoms of worsening liver function.
  • Temporarily stop treatment with Ocaliva if the patient displays evidence of worsening liver function.
  • Consider stopping treatment in patients who have experienced clinically significant liver-related adverse reactions.

Contact an Experienced Drug Recall Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry Injury Attorneys immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

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