In June, Oxford University researchers announced preliminary clinical trial results that showed the low-dose steroid dexamethasone appeared to lower the risk of death in COVID-19 patients. Further details of the study were not revealed with the announcement.

Dexamethasone has been effective in treating inflammation related to arthritis, asthma, and similar conditions. With this thought in mind, the clinical trial team wanted to test the drug’s effectiveness in treating lung inflammation in high-risk, hospitalized COVID-19 patients. For the clinical trial participants, it cut the risk of death by a third for patients on ventilators and by a fifth for patients on oxygen. Had the drug been used in the United Kingdom from the start of the outbreak, up to 5,000 lives could have been saved.

Additionally, the adoption of dexamethasone may be a major breakthrough for COVID-19 patients in poorer countries, as it only costs six dollars per patient. It’s also widely available: the United Kingdom currently has 200,000 courses available — enough to handle a potential second wave and spike in hospital admittance.

However, Dr. Kirsten Lyke , an infectious disease specialist at the University of Maryland School of Medicine, believes that we should “be extremely cautious” when using treatments that have not completed a full-scale vetting process. Given the urgency in finding treatment options for COVID-19, “people want to get results out quickly,” she explains. “But at the same time, if things are released too early or there’s harm that occurs from the intervention, that really erodes public trust.”

Read more about Covid-19 and your health, here >

Potential Risks and Downfalls

Patients who suffer from pulmonary embolisms often are prone to clotting complications which leads to lifelong use of medications such as warfarin or direct oral anticoagulants (blood thinners). Inferior Vena Cava (IVC) Filters have been shown to be used in preventing pulmonary embolisms when blood thinning therapy has failed or cannot be used due to complications. The Food and Drug Administration (FDA) has deemed IVC filters to have relatively low morbidity and mortality associated with placement and removal. However, complications have been seen that we will discuss below.

What is a Pulmonary Embolism?

A pulmonary embolism occurs when a blood clot is formed and breaks loose which travels to the lungs through the bloodstream. This can cause chest pain and shortness of breath which are the main signs and symptoms of the disorder. When a blood clot travels to the lungs, it blocks blood flow in the arteries which can cause impaired lung function and eventual lung failure if untreated.

Pulmonary embolisms are responsible for about 100,000 to 200,000 deaths in the United States each year. Unfortunately, many cases are undiagnosed and it is important to understand how you can prevent clotting risks associated with them.

Complications of IVC Filters

An IVC filter consists of a filter being placed inside a large vein called the vena cava; which carries blood from your lower body to your heart and lungs. This is a surgical process consisting of using a camera-guided probe through a vein in your neck. 

In general, there are three complications that can arise during IVC filter placement. The first complication can occur during the access to your vein. There may be unforeseen clots in the access vein which would indicate use of an ultrasound to guide the probe through the vein. The second complication has to do with the placement of the IVC filter. If the filter is placed in a location that doesn’t properly filter the blood, another filter must be placed in the correct location. The third complication arises when the filter does not expand correctly which can lead to poor filtration or dislodging. This means that the filter can migrate to a different part of the vein and need removal. 

Let’s say the IVC filter is correctly placed and the surgical procedure is a success. There are additional risks that can occur afterwards as well. Another clotting condition called a Deep Vein Thrombosis (DVT) can occur which is a clot that develops in the legs. A study showed that up to 40% of patients can develop a DVT after filter placement. This shows that even with successful placement, there can be risks for additional clotting factors.

There are two different types of filters that can be used based off the severity of risks: temporary or permanent filters. Temporary filters must be removed through another surgical process since they do not contain materials built to last in the body. Permanent filters are indicated for long-term use and are generally not removed unless problems arise. The same risks apply for IVC filter removal as insertion with additional risks which can warrant longer procedure time and non-standard techniques for removal. 

There are other complications that were not discussed that can contribute to other risks regarding IVC filter placement and retrieval. Studies do not have strong data with these other potential risks and were not included for that reason. Studies do suggest that there are higher complications relating to temporary filters, however, based on self-reported rates by patients who have received the surgery.

Real World Concerns

Due to the risks associated with IVC filter placement, there have been hundreds of injuries and multiple lawsuits involving this procedure. Many cases involved filter fragments breaking off and traveling to different parts of the lungs or heart. This caused punctures and injuries to the local organs as a foreign sharp object floated through the bloodstream. These cases resulted in ongoing health problems for those effected and lifelong medication use. Many IVC filter companies have recalled their products due to these injuries as it became a public concern. The positive outcomes have been limited with these filters and is a reason they are a last line option for pulmonary embolism prevention.

How to Prevent Blood Clots

Preventing blood clots before any complications of a pulmonary embolism is ideal. This can be done by anyone to reduce your risk of a clotting event such as regular exercise, maintaining a healthy body weight, and quitting smoking for those who smoke. Regular exercise should consist of at least 30-minutes of activity 3-5 times a week. A healthy body weight is measured by someone’s body mass index (BMI) which is calculated based off the height and weight of the person. A healthy BMI ranges from 18.5-24.9 in the general public. There are many online calculators you can search for to calculate your BMI. Smoking cigarettes can increase the thickness of your blood putting you at a higher risk for developing a clot. It is important to know that quitting is the best prevention method for current smokers for developing a clot. 

Less common preventative measures that many people may not think of is during long travels. When we are in a seated or laying down position for extended periods of time, our blood does not flow as easily throughout the body. This can lead to blood pooling in the legs creating a clot which can lead to a pulmonary embolism if the clot breaks loose. Best prevention methods for long travels is to stand or walk every hour, drink lots of water, and to not smoke/drink alcohol during travels.

What This Means For You

By now I hope you feel knowledgeable about the many risks associated with IVC filters. It is something that should be avoided if possible when prone to a pulmonary embolism. The preferred method of prevention is through a healthy lifestyle with or without medication management. As discussed, this includes a healthy diet, physical activity, a healthy BMI, and quitting smoking. Medication treatment may require frequent follow-up visits and monitoring but has much more safety information and proven effectiveness. 

IVC filters are a last-ditch effort in most people to prevent a pulmonary embolism when medications don’t work or in emergency situations. It is important to understand the signs and symptoms of the disease and what preventative measures you can make to reduce your risk of a blood clot.

Chances are you have taken medicine in the last six months.  Over the counter medications are taken by four out of five adults while prescription drugs are used by almost half of American Adults, according to the Centers for Disease Control.  Drug companies continue to produce new medications that, for the most part, weave seamlessly into the industry causing little stir.

However, there are potentially dangerous consequences for going blindly into using any medication, regardless of it being prescribed or over the counter. Fortunately, it is easier than ever to learn about medications before we take, or continue to take them. 

Speaking with your doctor before taking any over the counter medications, including pain relievers, allergy medicines, and even nutritional and vitamin supplements, is the first and best measure to take before introducing any medication into your body.  This is especially important for people who have a history of kidney or heart disease, or who take blood thinning medications. 

Many supplements and over the counter drugs can react badly with existing prescription drugs or have the dangerous effect of making important prescription medications less effective than they should be.  Even taking too much of a seemingly harmless medication or supplement can pose a serious threat, even to an otherwise healthy person.

If you have questions, speaking to a pharmacist can also be an easy and quick way to find out what you need to know when it comes to any medication or supplement.  Most stores that carrie medications have in house pharmacists that can be helpful, and if that is not the case, local pharmacists in your community are more than happy to address any questions or concerns that you may have when it comes to drug safety and drug interactions.

It is always a good idea to check the safety of a drug or medication that you are about to take, or may already be taking.  Many times certain medications are deemed harmful, even after years of extended production and use.  Checking with the Drug Law Journal website is the most effective way to seek continued up to date information on drugs that are considered harmful or ineffective.

This site makes it easy to find out current information on your medication and up to date breaking information on drug recalls.  The Drug Law Journal also contains studies and articles on various topics relating to medications that can be useful when determining what you may need to address with your doctor or pharmacist.

It is worth remembering that you are your best advocate when it comes to your health.  Keeping up to date on prescription drugs and over the counter medication safety may seem to be something that you hope to delegate solely to your physician, but it is wise to take an active role in understanding what you are taking into your body.

Proton pump inhibitors (PPI’s) have an excellent safety profile and have become one of the most commonly prescribed class of drugs in primary and specialty care. Long-term, sometimes lifetime, use is becoming increasingly common, often without appropriate indications. This article is a short review of the current evidence on this important topic, focusing on the potential adverse effects of long-term proton pump inhibitor use that have generated the greatest concern. Some of the side effects are indicated below. 

They are: B12 deficiency; iron deficiency; hypomagnesemia; increased susceptibility to pneumonia, enteric infections, and fractures; hypergastrinemia and cancer; drug interactions; and birth defects.

The benefits of proton pump inhibitor use outweigh its risks in most patients. Elderly, malnourished, immune-compromised, chronically ill, and osteoporotic patients theoretically could be at increased risk from long-term therapy. Digestive Diseases and Sciences April 2011, Volume 56, Issue 4, pp 931–950

The average person may see the term Protein Pump Inhibitors (PPI’s) and think it is something from outer space, or that it is physics related. In layman’s terms it is quite simple. They reduce stomach acids.

Proton-pump inhibitors are a group of drugs whose main action is a pronounced and long-lasting reduction of stomach acid production. Within the class of medications, there is no clear evidence that one agent works better than another. (Google Scholar)

The Layman (Joe Q. Public) may not know what a PPI is, but with some degree of certainty the names will ring a bell. Some examples of proton pump inhibitors approved in the U.S. as provided by Medline Plus:

• aspirin and omeprazole (Yosprala)
• dexlansoprazole (Dexilent, Dexilent Solutab)
• esomeprazole (Nexium, Nexium IV, Nexium 24 HR)
• esomeprazole magnesium/naproxen (Vimovo)
• lansoprazole (Prevacid, Prevacid IV, Prevacid 24-Hour)
• omeprazole (Prilosec, Prilosec OTC)
• omeprazole and sodium bicarbonate (Zegerid, Zegerid OTC)
• pantoprazole (Protonix)
• rabeprazole (Aciphex, Aciphex Sprinkle)

The most common side effects of proton pump inhibitors are:

• Headache
• Diarrhea
• Constipation
• Abdominal pain
• Flatulence
• Fever
• Vomiting
• Nausea 
• Rash 

Serious risks of PPI use may include:

• Bone fracture
• Acute kidney injury
• Chronic kidney disease
• Acute interstitial nephritis
• Low magnesium levels
• Heart attack
• Stroke
• Dementia

As a registered nurse of 28 years I took care of patients with the above serious illnesses. And never for a moment did I associate these illnesses with the usage of PPI’s. As a trained professional I knew of the general side effects. It must make you wonder what Joe Q. Public knows? 

Legal Actions Are Being Taken Against Proton Pump Inhibitors

The concern over serious complications associated with proton pump inhibitors has been brought on by a series of studies and reports that have been conducted on these drugs. A recent study published in the Journal of the American Society of Nephrology concluded that taking PPIs may dramatically increase the risk of kidney failure and kidney disease. 

 The study determined there was a significant difference in the rates of acute kidney injury and acute interstitial nephritis in patients who took PPIs compared to those who did not — the risk of end-stage renal disease was 96% higher in those who took PPIs.

Wow. I went into nursing for various reasons. One of them was that I was poor at mathematics. The risk of end stage renal disease is 96% higher in those who took PPI’s! As a patient there are 2 options when it comes to end stage renal disease (ESRD). Death or living your life surrounded by a renal dialysis machine. In my experience many people would prefer death.

PPIs and Bone Fractures

In May 2010, the U.S. Food & Drug Administration (FDA) announced it was revising the safety labeling for PPIs to warn that they might be associated with a higher risk of hip, wrist and spine factures. The new safety information was based on the FDA’s review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with PPI use. 

What Specific Legal Action Has Been Taken Against Proton Pump Inhibitors?

 In the last few years, multiple lawsuits against PPI manufacturers have been settled for large amounts. In 2013, Nexium manufacturer AstraZeneca settled a lawsuit that alleged deceptive marketing tactics were used in promoting the product. The class action lawsuit settled for $20 million.

Then, in February 2015, AstraZeneca settled another lawsuit for $7.9 million against the United States Government alleging that the company engaged in a kickback scheme that was in violation of the False Claims Act.

Another PPI manufacturer, Teva Pharmaceuticals, settled a class action lawsuit for $24 million in June 2015. This lawsuit alleged that Teva intentionally withheld a generic version of Nexium off the market after it was found that they were paid off by AstraZeneca.