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Articles Posted in Drugs

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In the past two years, the Food and Drug Administration (FDA) and Pfizer have made several announcements on the drug Xeljanz. None of them have been good.

The FDA has reported on Xeljanz’s association with pulmonary embolisms, severe heart issues, cancer, and death. This comes nine years after the FDA approved it to treat psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Former Xeljanz patients have begun to file lawsuits against Pfizer. These Xelijanz lawsuits allege that the drug caused them to suffer severe side effects.

Xeljanz

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A federal class-action lawsuit on Elmiron was filed in October 2020. Its plaintiffs allege that it causes pigmentary maculopathy. This comes after recent studies have reported on Elmiron’s association with retinal damage.

These Elmiron eye damage lawsuits are expected to explode as people are learning that their eye injuries may be associated with Elmiron.  This could be an extremely large mass tort and it has earned the interest of drug injury lawyers everywhere.

Elmiron

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Beovu was supposed to be the big new revenue-making drug for pharmaceutical giant Novartis last year. Beovu was designed for the treatment of wet age-related macular degeneration (wet AMD), a common eye condition that can cause blindness if not treated. Novartis invested heavily in the development of Beovu and was counting on the drug’s dosing advantages to help it tap into the massive market share currently held by the leading AMD drug – Eylea. But an onslaught of major safety concerns and anticipated Beovu lawsuits quickly crushed the money-making potential of Beovu. Rather than abandon its investment, Novartis is now trying to repurpose Beovu to treat other eye conditions.

Development of Beovu

The treatment of certain common eye conditions, particularly age-related macular degeneration, is big business in the pharmaceutical world. Really big. Age-related macular degeneration (AMD) comes in 2 forms (wet and dry) and it is the leading cause of blindness in the world today. An estimated 11 million people in the U.S. suffer from AMD. If not properly managed and treated, AMD can result in serious vision impairment or blindness.

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According to the findings of a recent study, taking benzodiazepines such as Xanax or Valium during pregnancy could significantly raise a woman’s risk of having an ectopic pregnancy. In this study, published by Stanford University in the journal Human Reproduction, scholars found that pregnant women taking these drugs to reduce anxiety or induce sleep have a 50% increased chance of developing life-threatening complications.

Normal Pregnancies vs. Ectopic Pregnancies

In a normal pregnancy, a fertilized egg will attach itself to the lining of the uterus in order to begin the growing process. However, an ectopic pregnancy will occur if the fertilized egg implants and grows outside of the main cavity of the uterus.

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A November 2018 article in the BMJ reported a study concluding what many lawyers have known for a long time: patients who use sodium-glucose cotransporter 2 (SGLT2) inhibitors are twice at risk of having lower limb amputations than other diabetes medications. The scientists also reported that SGLT2 inhibitors are also linked to diabetic ketoacidosis.

What Are SGLT2 Inhibitors?

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are medications that lower blood sugar in adults who have type 2 diabetes. They are used to complement diet and exercise. SGLT2 inhibitors may be available as a single-ingredient product or combined with other diabetic medications including metformin. They reduce the amount of glucose being absorbed by the body through the kidneys. This helps to reduce blood sugar by removing excess glucose through urine.

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A lawsuit recently filed in the U.S. District Court District of New Jersey alleges that someone received stomach cancer because of taking proton pump inhibitors (PPIs) Prilosec, Nexium, and the variations of both drugs. PPIs are used to treat many stomach conditions but can create even worse problems in the stomach as well. Before informing yourself on this lawsuit, you must first inform yourself on PPIs, specifically Nexium and Prilosec. You must also inform yourself about their potential side effects.

What are proton pump inhibitors?

Proton pump inhibitors (PPIs) are medications that reduce the amount of stomach accident found in the stomach lining. They help relieve symptoms of acid reflux, a condition in which food or liquid goes back up to the esophagus. PPIs can also help treat stomach ulcers. Also, they can treat lower esophagus damage resulting from acid reflux. PPIs can be used to treat heartburn as well. They come in various brand names such as Prilosec, Nexium, Prevacid, AcipHex, Protonix, Dexilant, or Zegerid.

What are PPI side effects?

Commonly found side effects may include a headache, diarrhea, constipation, nausea, and itching. Serious long-term side effects may include infections and bone fractures. PPIs can also be very bad for your kidneys as well. According to an April 2016 study published in the Journal of the American Society of Nephrology, PPIs are linked to serious kidney complications. It showed that patients who took PPIs were about 96% more likely to get kidney failure than those who did not. PPIs users were also 28% more likely to develop chronic kidney disease after five years of taking PPIs. According to a 2017 study published in Gut, there may be a link between PPIs and gastric cancer. This study was documented by Hong Kong-based researchers. They looked at 63,000 adults in Hong Kong over a nine-year span that ranged from 2003 to 2012. They discovered that those who took PPIs such as Nexium and Prilosec doubled their risk of gastric cancer. This contrasts with other heartburn drugs, which did not increase any risk. The study is very relevant to the current lawsuit involving Nexium and Prilosec that is being filed in the New Jersey court.

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On July 13, 2018, the Food and Drug Administration (FDA) recalled Valsartan because they contain the contaminant N-Nitrosodimethylamine (NDMA). The FDA noted that valsartan products pose an unnecessary risk to patients. There are seven things you should know about this recent recall.

  1. What is NDMA?

NDMA is a contaminant. According to the EPA, it is a semivolatile organic chemical. It can be either naturally occurring or synthetically made. It is not currently produced in the United States. NDMA can be unintentionally produced through chemical reactions, especially those that involve alkylamines. It is also an intended by-product of chlorination of wastewater through the use of chloramines. These chloramines are used to disinfect the water. There is a risk that NDMA is a possible drinking contaminant.

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Sprue-like enteropathy is an intestinal condition involving chronic diarrhea, nausea, stomach severe stomach discomfort, and rapid weight loss.  Sprue-like enteropathy is very similar to celiac disease, which causes adverse reactions to the consumption of gluten.  Much like celiac disease, sprue-like enteropathy can damage and erode the intestinal villi (tiny finger-like fibers on the inside of the intestines that help absorbs nutrients from food).  This type of damage or erosion of the intestinal villi is referred to as villous atrophy.  When villous atrophy is caused by an adverse reaction to gluten, the condition is classified as celiac disease. Sprue-like enteropathy is used to categorize villous atrophy resulting from other causes such as drug reactions (see below). If left untreated, sprue-like enteropathy and villous atrophy can permanently damage the body’s ability to process and absorb nutrients in food resulting in chronic malnutrition.  The condition is very serious and can easily become life-threatening.

Sprue-Like Enteropathy Caused by Blood Pressure Medications

shutterstock_151822316-200x300Sprue-like enteropathy can be caused by the use of olmesartan – a popular high blood pressure medication sold under the brand name Benicar.  It is also sold under the names Benicar HCT, Tribenzor, and Azor.  Benicar works to treat blood pressure problems by causing blood vessels to relax and expand, making blood flow easier and lowering overall blood pressure.  Benicar is manufactured by the Japanese pharmaceutical company Daiichi Sankyo, Inc.  After first being released in 2002, Benicar has rapidly gained popularity and has been prescribed to over 12 million patients in the U.S.  In 2012, a study by the Mayo Clinic first established a link between prolonged use of Benicar and sprue-like enteropathy.  This prompted the FDA to conduct its own review, and in 2013 the FDA released a public safety announcement warning that Benicar can cause sprue-like enteropathy.  After the FDA announced the warning label for Benicar was amended to include this safety risk.

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The FDA has recently expressed concern about a certain group of medications called SGLT2 Inhibitors. This category of drugs includes popular prescription medications such as Invokana and Farxiga. Although these drugs have been, by all accounts, fairly successful when treating Type 2 diabetes. But they have produced their fair share of side-effects. Specifically, users of drugs such as Invokana are now reporting high levels of blood acid, the effects of which have landed some users in the ER.  While no deaths have been reported, there is no question that if these reports are accurate, these levels of blood acid could cause serious injury and death.  Accordingly, plaintiffs’ lawyers are investigating whether there is a connection between these drugs and these high acid levels and, if so, whether these drug makers knew about these risks and simply failed to inform patients and doctors.   If these dots are connected – and there is reason to think they might be – there are likely to be both serious injuries and lawsuits seeking compensation for those injuries.

The preceding paragraph was written some time ago.  In May 2017, there are 230 lawsuits pending in a federal MDL in New Jersey.

SGLT2 Inhibitors

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pills2According to a recent news release, regulators in Europe have concluded that there is little evidence that widely used drugs to treat Type 2 diabetes could cause pancreatic inflammation or pancreatic cancer.

Besides the European agency, the Food and Drug Administration has been reviewing the safety of a big class of drugs that includes Januvia by Merck and the drugs Byetta, Bydureon, and Onglyza, which are sold by Bristol-Myers Squibb and AstraZeneca.  These drugs, called incretin mimetics by the FDA, increase the body’s levels of a hormone that helps to control blood sugar levels.

They have, however, been linked to pancreatic inflammation known as pancreatitis.  While the European agency said that the clinical trials had shown no increased risk of pancreatic cancer, the FDA said the trials were too small to draw firm conclusions.