FDA Recalls Belviq Due To Cancer Risks

On February 13, 2020, the Food and Drug Administration (FDA) requested a recall of the prescription weight loss medications Belviq (lorcaserin) and Belviq XR after a study associated long term use with certain cancers. Belviq’s manufacturer, the Japanese pharmaceutical company Eisai Inc., voluntarily recalled the drug in response to the FDA’s recommendation.

What Is Belviq?

Belviq was approved by the FDA in 2012 as a prescription weight management treatment. It is approved for use for adults who have a body mass index (BMI) of over 30 or adults who have a BMI of 27 or more and have additional health risks.

What Did The FDA Study Find?

Shortly after Belviq was approved, the FDA authorized a clinical study to analyze cardiovascular problems associated with the drug. The double blind, placebo-controlled study involved 12,000 patients over a five year period and found occurrences of certain types of cancer in 7.7 percent of patients taking Belviq. This compares to occurrences of cancer in just 7.1 percent of patients taking a placebo. The study found more incidences of cancer among patients taking Belviq over a longer period of time.

What Cancers Is Belviq Linked To?

Patients taking Belviq developed a range of cancers, but the most common cancers reported included:

  • Lung Cancer
  • Pancreatic Cancer
  • Colorectal Cancer

Why Did The FDA Recall Belviq?

The FDA initially issued a Drug Safety Communication in January 2020 warning the public of a possible link between Belviq and increased cancer risks. Less than a month later, the agency issued an updated Drug Safety Communication recommending that Eisai Inc. recall Belviq from the U.S. market. The agency concluded that “the risks of lorcaserin outweigh its benefits” after its review of the clinical study.

How GoldenbergLaw Can Help

GoldenbergLaw is currently handling cases where an individual has taken Belviq and developed lung cancer, pancreatic cancer, or colorectal cancer. Contact us today for a free Belviq cancer lawsuit evaluation. Our Minnesota Cancer Attorneys have been litigating complex cancer cases for over three decades, let us deliver the Gold standard advocacy you deserve.

How Safe is Hernia Mesh?

Concerns over the lack of clinical evidence and medical device testing of hernia mesh products has led to an outcry in the United Kingdom.

New data shows that there are more than 100 different types of surgical hernia mesh that were purchased by the National Health Service (NHS) Trusts from 2012-2018 in England and Scotland to perform the approximately 100,000 hernia operations every year; however, there are concerns about the safety of these products. In the United Kingdom, hernia mesh devices can be approved if they are ‘similar’ to older products—older products which may not have been required to undergo any rigorous testing or clinical trials to determine their safety.

International guidelines estimate that one in 10 patients will experience “significant chronic pain” following mesh repair. Professor Carl Heneghan, a medical device expert at the University of Oxford, explained that the complications may be due to a lack of testing before the hernia mesh products enter the market.

He explained that some devices have only been required to be tested on animals such as rabbits for a short period of time, with the implanted mesh only left inside the animal for a few days. He reported that “if there’s no remaining immune reaction, you pass the test” and the product goes to the market. Professor Heneghan stresses the inadequacy of these tests due to their limited nature and the fact that they cannot test for pain, which is the most common complication of surgeries involving hernia mesh.

Professor Heneghan asserted that there was “no chance” that the more than 100 types of hernia mesh devices used by the NHS were all individually tested because there have not been 100 trials in this area of medical device testing. He calls for the NHS to “immediately” stop using those devices that have “no clinical evidence attached to them whatsoever.”

Exposed Hernia Mesh Manufacturer Video

The UK’s news agency, the BBC, recently viewed a leaked promotional video intended for the medical community that was funded by Ethicon—one of the world’s largest mesh manufacturers.

The video, which is over a decade old, shows a surgeon discussing how some older types of mesh can become “hard as stone” after only one year inside of a patient and can cause damage to the body, including chronic pain. However, the product mentioned in the video is still being sold by Ethicon and used by the NHS in England and Scotland.

How has the UK Government Responded to these Findings and Concerns?

Director of Devices at the Medicines and Healthcare Products Regulatory Agency (MHRA) Graeme Tunbridge said that “the benefits and risks of using mesh for hernia repair have been considered in detail by clinicians and the professional bodies who represent them. We continue to monitor and review evidence as it becomes available and will take any appropriate action on that basis.”

Mr. Tunbridge acknowledged that the medical device testing system “does need strengthening” and said that new legislation on medical device testing, which would include strengthening requirements on manufacturers to ensure that sufficient clinical evidence is in place for their products, would take effect in May 2020.

A spokeswoman for the Department of Health and Social Care said that “on the rare occasion where a patient has suffered as a result of a mesh procedure, we are taking steps to improve patient safety- including improving how we listen to patients and how the system learns when concerns are raised.”

How has the U.S. Responded to Hernia Mesh Complications?

The U.S. Food and Drug Administration (FDA) considers the mesh used for hernia mesh repair surgeries to be safe, but acknowledges that ‘in rare cases’ complications may occur and that the most severe of these complications may be deadly. The FDA also recognizes that complications with the mesh may result in, at the very least, severe pain and require revision surgery.

However, the FDA claims that many of the more severe complications associated with hernia mesh repair pertain to recalled mesh products that are no longer on the U.S. medical device market.

A 2016 study analyzing the long-term recurrence and complications associated with elective incisional hernia repair reported that the number of complications after hernia surgeries increased over a five year span. Out of the 3242 participants in the study, 1050 participants required another abdominal surgery.

What is a Hernia?

A hernia occurs when an organ, intestine, or fatty tissue squeezes through a hole or weak spot in the surrounding muscle or connective tissue. Most commonly, hernias occur at the abdominal wall and sometimes may be visible as an external bulge particularly when straining or bearing down.

Types of Hernias

  • Inguinal hernias occur in the inner groin
  • Femoral hernias occur in the upper thigh or outer groin
  • Incisional hernias occur through an incision or scar in the abdomen
  • Ventral hernias occur in the general abdominal or ventral wall
  • Umbilical hernias occur near the belly button
  • Hiatal hernias occur inside the abdomen, along the upper stomach

How Common are Hernia Repairs?

Hernia repairs are extremely common; more than one million hernia repairs are performed each year in the U.S. Since the 1980s, there has been an increase in mesh-based hernia repairs. Surgical mesh is supposed to strengthen the hernia repair and reduce the rate of recurrence. Currently, more than 90% of the one million plus hernia surgeries performed each year in the U.S. use hernia mesh to perform the repairs.

Surgeons cutting hernia meshWhat is Surgical Hernia Mesh?

Surgical hernia mesh is a medical device used to provide additional support to tissue that has been weakened or damaged by a hernia. Hernia mesh is a surgical implant which often made of a synthetic plastic called polypropylene or animal tissue that reinforces torn or damaged tissue around hernias and strengthens it as it heals.

Synthetic materials can be absorbable, non-absorbable or a combination of both types of materials. Animal-derived mesh is made of animal tissue that has been processed and disinfected to be suitable for use in an implanted device; animal-tissue based mesh is absorbable. Non-absorbable mesh will stay in the body forever and is considered a permanent implant intended to provide permanent reinforcement to the repaired hernia. However, absorbable mesh will degrade over time and is not intended to provide permanent reinforcement. As the material disintegrates, new tissue grows and ideally provides strength to the repair.

What are Hernia Mesh Complications?

The most serious complications of hernia mesh are also some of the most common:

  • Adhesion- Scar-like tissue that sticks together and leads to bowel obstructions.
  • Bowel obstruction – Occurs if the mesh adheres to the intestines and cuts off blood flow.
  • Bowel perforation – Occurs when the hernia mesh punctures or erodes into the bowel.
  • Infection – Chronic infection symptoms may not occur until years after hernia mesh surgery.
  • Rejection – Materials within the hernia mesh may trigger the body’s immune system and cause the body to reject the mesh.
  • Migration – If the hernia mesh detaches after surgery, it can migrate through the abdomen and lead to adhesions, fistulas, abscesses, and bowel obstruction or perforation.
  • Recurrence – A common complication of hernia surgery is that hernias may return.
  • Chronic pain

Nearly one-third of people who have hernia surgeries experience some type of complication—excessive pain is the most frequent complication. These complications may appear shortly after surgery or years later.

How GoldenbergLaw Can Help You

GoldenbergLaw is currently investigating hernia mesh failure cases where an individual required a revision surgery. If you need a hernia mesh lawyer, we have the expertise and experience to help bring you justice. Contact us today for a free consultation, and let us deliver the Gold Standard you deserve.

Is Metformin Safe? Global Health Agencies Investigating Link to NDMA

Over the past year, world regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have uncovered, investigated, and recalled medications due to nitrosamine impurities such as NDMA. In 2018, many of the blood pressure ‘sartan’ medications (angiotensin II receptor blockers known as ARBs), including Valsartan and Losartan, were recalled due to NDMA contamination. In 2019 and 2020, various companies have issued voluntary recalls of popular heartburn medication Zantac and other ranitidine products after uncovering NDMA contamination.

In December 2019, the global investigations of NDMA impurities extended to the type-2 diabetes drug Metformin after the public health agency of Singapore recalled three out of the 46 locally marketed Metformin medications due to the presence of NDMA.

Singapore Metformin Recalls

Singapore’s Health Sciences Authority (HSA) tested all 46 locally distributed Metformin medicines and three were found to have trace amounts of NDMA which were “above the internationally accepted level.”

As a result, on December 4, 2019 the HSA recalled the three medicines as a “precautionary measure” but also announced that the other 43 Metformin medications were not contaminated.

Which Metformin Medications were Recalled in Singapore?

  • One batch of Glucient XR Tablet 500mg—supplied by Glorious Dexa Singapore
  • All batches of Meijumet Prolonged Release Tablet in 750mg and 1000mg –supplied by Pharmazen Medical

Singapore’s HSA claims that the risk to patients who have been taking the affected medications is “very low” because the potential risks of nitrosamine contamination is associated with long-term use of the affected drugs, and the recalled medicines have only been sold in Singapore since 2018.

Have Any Other Government Health Agencies Recalled Metformin?type-2-diabetes-pills

Currently, only Singapore’s HSA has issued recalls for Metformin medications. However, as a result of the recalls, worldwide regulatory agencies such as the U.S. FDA, Health Canada, European Medicines Agency (EMA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have opened investigations into possible NDMA contamination in their Metformin medications.

In statements from the FDA, EMA, Health Canada, and MHRA, the agencies claim that there is no evidence that any Metformin medications distributed in their respective territories are affected and have advised patients to continue taking their medications.

U.S. FDA’s Metformin Investigation

The FDA reacted to Singapore’s Metformin recalls by announcing an investigation into potential NDMA impurities in Metformin available in the United States. Currently, no Metformin recalls have been issued by the FDA and no NDMA contamination has been found in lots sold in the United States.

Pertaining to the affected samples outside of the United States, the FDA claims that “based on the information we have available, the levels of NDMA seen outside the U.S. are within the range that is naturally occurring in some foods and in water.”

The investigation will determine whether there is NDMA in Metformin, and if so whether that amount is above the United States’ acceptable daily intake limit of 96 nanograms. The FDA “will recommend recalls as appropriate if high levels of NDMA are found,” according to a statement from Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

Dr. Woodcock recommends that U.S. patients should continue taking Metformin while the investigation continues to keep their diabetes under control because “there are no alternative medications that treat this condition in the same way.”

European Medicine Agency’s Metformin Investigation

The EMA—the drug advising department for the European Union—has partnered with companies manufacturing and distributing Metformin within the EU to test the medication for NDMA. The results have thus far found no data indicating that EU Metformin medicines have been affected and recommends that patients in the EU should continue taking Metformin as prescribed.

The EMA is aware of trace amounts of NDMA found in a small number of Metformin medications outside of the EU; however, the organization claims that the levels of NDMA found in affected non-EU Metformin medicines are very low and appear to be within or even below the range people can be exposed to from other sources including water and certain foods.

Health Canada’s Metformin Investigation

Health Canada has asked drug manufacturers and distributors of Metformin to “test their own Metformin products” and will be “collecting samples from those companies to conducts its own testing.”

After the investigation, Health Canada announced that it is not aware of any Metformin products available in Canada that contain NDMA above the acceptable limits; however, it is working closely with international regulatory agencies to continually assess the concerns.

What is Metformin?

Metformin is a prescription medication available in both generic and brand name forms that helps those suffering from type 2 Diabetes by lowering blood sugar levels. The immediate-release form of the medication is Glucophage and the extended-release forms of the medication are Glucophage XR, Fortamet, and Glumetza.

How Does It Work?

In patients suffering from type 2 Diabetes, insulin (the hormone that helps the body remove extra sugar from the blood) naturally produced by the pancreas is unable to get sugar into the body’s cells where it can be properly converted into energy. Metformin, which belongs to a class of drugs known as biguanides, works by reducing the amount of glucose (sugar) made by the liver, decreasing the amount of glucose absorbed by the body, and increasing the impact of naturally produced insulin within the body.

What is NDMA Contamination?

N-nitrosodimethylamine (NDMA) is classified as a probable human carcinogen—meaning that the substance can cause cancer and belongs to class of impurities known as nitrosamines.

NDMA is commonly found in drinking water, some processed foods (pickled vegetables, salted fish, and processed meat products such as bacon and sausages), and as a result of air pollution.

NDMA was once used to make rocket fuel. However, after high levels of NDMA were uncovered in the air, soil, and water samples near manufacturing plants, NDMA use was discontinued. However, NDMA contamination occurs today through unintentional chemical reactions at industrial sites or in the manufacturing process of drugs.

Low levels of NDMA exposure are not dangerous. However, if more than 96 nanograms of NDMA are ingested daily, there is an increased risk of cancer.

Overexposure to NDMA can lead to:

  • Jaundice
  • Fever
  • Vomiting
  • Abdominal cramps
  • Dizziness

Prolonged Exposure to NDMA Contamination can lead to tumors and cancer of the:

  • Liver
  • Stomach
  • Colon & Intestines
  • Esophagus
  • Kidneys
  • Pancreas
  • Bladder

How GoldenbergLaw Can Help You

If you or a loved one contracted cancer after taking a drug recalled due to NDMA contamination, contact the dangerous drug attorneys at GoldenbergLaw. We are committed to promoting safety through accountability and providing you with the gold standard of advocacy.