5 recalls on blood pressure meds so far this year

By | July 3, 2019

Many of the small decisions you make each day have a compound effect on your overall health, including what you eat and drink, how much you exercise and even how you breathe. Sometimes small changes may pay big dividends and the same is true of the small, unhealthy decisions you may make.

The rising number of people suffering from high blood pressure, increasing their risk for heart disease and stroke, is a testimony to the changing health habits experienced around the world. Lifestyle choices have a significant effect on your blood pressure.

The updated guidelines1 released in 2017 have increased the number of Americans now recognized as being at risk for heart attack and stroke. According to the American Heart Association,2 an estimated 103 million adults in the U.S. have high blood pressure, which is nearly half of all adults.

The U.S. Centers for Disease Control and Prevention (CDC) reports that 32% of adults in the U.S. had high blood pressure and another 33% had prehypertension before the guidelines were changed.3 While the old guidelines listed high blood pressure as a measurement higher than 140/90, the new guidelines read as:4

  • Normal: Less than 120/80 mm Hg
  • Elevated: Systolic between 120-129 and diastolic less than 80
  • Stage 1: Systolic between 130-139 or diastolic between 80-89
  • Stage 2: Systolic at least 140 or diastolic at least 90 mm Hg

The new guidelines were developed in response to a mounting body of evidence suggesting early intervention may reduce the number who suffer the secondary effects associated with rising blood pressure. Cardiologist Dr. Kenneth Jamerson, who was an author of the new guidelines, commented:5

“Before this guideline, if your blood pressure was at 130, you weren’t supposed to do anything. With the new [high blood pressure] guideline, we’re having patients do something about it.”

Blood pressure drug recalls after toxin found — Again

One of the common interventions recommended by physicians is the use of antihypertensive medications to reduce high blood pressure. While these medications usually come with a long list of side effects, one side effect that is not expected is contamination with a known human carcinogen.6 The first recall in the U.S. happened only after the medication was recalled in 22 other countries7 when concerns grew over the active ingredient valsartan, which is sourced from China.8

The first recall in the U.S. occurred in mid-2018 after the drug was recalled across Europe9 following information that an impurity, N-nitrosodimethylamine (NDMA), had been identified as part of the manufacturing process. The antihypertensive medication is commonly used to control high blood pressure and heart failure.

NDMA was originally used to make rocket fuel,10 but its use was discontinued when it was found to contribute to the development of liver and lung cancer.11,12 The initial recall included drugs sold by three pharmaceutical companies. However, the recalls did not stop there.

The U.S. Food and Drug Administration (FDA) announced it expanded the recall of blood pressure medications for the fifth time in 2019 to losartan. This included dozens of batches recalled by the FDA, as they contained trace amounts of the nitrosamine N-Nitroso N-Methyl 4-amino butyric acid (NMBA), linked to the development of bladder cancer in animal studies.13,14

The discovery of the contamination was announced March 1 by the FDA15 in a press release. Three weeks later The New England Journal of Medicine16 announced the FDA would allow manufacturers to temporarily sell the contaminated medication and expected losartan to be back on the shelf without impurities in six months.

The FDA is advising those taking the recalled drugs to continue their medication but work with their physician immediately to find an alternative. The FDA says there is not a current shortage of losartan but suggests any future recalls may lead to shortages. An FDA spokesperson told NBC News they could not predict how long the recalls would continue, and:17

“Currently, valsartan, olmesartan and eprosartan products are in shortage, and we know that other types of products have the potential to fall into shortage soon.

It is important to know that not all ARB [angiotensin II receptor blockers] products contain impurities, so pharmacists may be able to provide a refill of medication from batches that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications.”

Contamination found in more than blood pressure pills

CNN18 reports Valisure, an online pharmacy that says they batch test all their medications,19 tested Valsartan and found n-dimethylformamide (DMF) in levels higher than expected. It shared the details with the FDA in a citizen’s petition.

DMF is a chemical solvent easily absorbed through the skin with known adverse effects,20 including liver damage.21 Additionally, some reports have suggested an increasing number of cancers in those who are exposed to DMF.22

Contamination of high blood pressure medications are not the only challenges faced by the pharmaceutical industry. In a news report by Kaiser Health News,23 journalists uncovered thousands of issues reported since 2013. Pharmaceutical companies based in the U.S. or Europe have recalled 8,000 different medications that have entered the U.S. drug supply.

These recalls represent only a fraction of the drugs shipped, but KHN24 reported the products contained a range of pollutants from dangerous bacteria, fungi or tiny glass particles. The recalled medications may also have had too much or too little of the drug’s active ingredient.

Over the same time period, 65 manufacturing facilities recalled nearly 300 products. However, some of these recalled medications had already damaged patients’ health. One was a stool softener contaminated with the bacterium Burkholderia cepacia, which was given to a young child on a heart transplant list.

The bacterium found its way to the boy’s respiratory tract, which temporarily took him off the transplant list. The infection resurfaced after the transplant and infected his lungs, creating a problem that has required mechanical ventilation ever since.25

Plant passed inspection while medication infected children

Unfortunately, tracking how often tainted medication causes sickness or death is nearly impossible since no governmental agency tracks this information unless it’s linked to a major outbreak.26 The FDA is tasked with inspecting factories producing drugs for the U.S. market, but after reviewing thousands of documents KHN found inspectors were missing serious hazards.

Even after the FDA took enforcement action, drug makers were failing to meet standards and hundreds of plants had not been inspected for years. During one inspection27 of Zhejiang Huahai Pharmaceutical Co. in Zhejiang, China, inspectors found multiple problems. Reinspection one year later came when complaints were received that NDMA was present in drugs produced in the plant.

According to the investigation by KHN,28 the FDA has had no drug quality inspection records available over the past 10 years for more than 1,200 plants in the U.S. and nearly 400 abroad. The stool softener infecting young Anderson Moreno before his heart transplant, made by PharmaTech, was also responsible for the death of a 9-month-old girl in Pittsburgh.

According to federal records reviewed by KHN, the FDA inspectors were at the plant based in Florida during the same time the stool softener was wreaking havoc in lives across the U.S. The plant passed inspection with no citations.

It was later found the bacterium was in the water used to clean equipment and used to make liquid products. PharmaTech CEO Ray Figueroa announced the successful inspection three days after the death of the 9-month-old girl, calling it29 “a testimony to PharmaTech’s commitment to world-class quality.”

The same medication was responsible for 63 confirmed infections and 45 suspected cases in 12 states, according to a report by the FDA.30 The KHN report cites instances when plant employees held up inspections, were tipped off before a “surprise” inspection or relied on translators provided by the drug companies.31

Damage from high blood pressure a long-term challenge

High blood pressure may damage your body in many ways, as it affects your heart, brain and other important organs.32 The condition can hurt you for years before symptoms develop, which is why it’s often called the “silent killer.”

When uncontrolled, you may be left with a disability or even a fatal heart attack. High blood pressure may eventually damage and narrow your arteries and their inner lining. This makes them less elastic and limits blood flow.33

Over time, with higher pressure in the arterial system, a weakened artery may enlarge and form a bulge, called an aneurysm. Aneurysms may potentially rupture, and depending where they are located, can be life-threatening. Long-term high blood pressure may damage your coronary arteries, enlarge your left heart and increase your risk of heart failure.

High blood pressure may also increase your risk of a major stroke as well as mini strokes, called transient ischemic attacks. Vascular dementia may be the result of narrowed and blocked arteries, restricting blood supply to the brain.34

High blood pressure may cause kidney failure and scarring.35 Adults with high blood pressure have a 20% higher risk of chronic kidney disease.36 The delicate blood vessels in your eyes may be damaged if you have high blood pressure, resulting in a condition leading to bleeding in the retina and possibly complete loss of vision.37

Use natural methods to help manage your blood pressure

Before making any decision about your health, it’s important to understand the risks and benefits of each choice you might make. While blood pressure medications have side effects, stopping them suddenly puts you at risk for a heart attack.38

There are multiple lifestyle choices to consider if you would like to seek natural ways of addressing your high blood pressure and keeping it within a normal range. One of the most important dietary changes you may make to affect your blood pressure is to reduce sugar and processed fructose in your diet.39

The easiest way to reduce fructose is to replace processed foods with real, whole foods. This not only addresses insulin and leptin resistance but also helps reduce elevated uric acid levels,40 both of which are significant factors in blood pressure. In one study,41 researchers discovered that those who consumed 74 grams or more per day of fructose had a 77% greater risk of high blood pressure.

By checking your fasting insulin level, you may see whether insulin and leptin resistance are at play. Check with your doctor regarding the right42 levels to reduce your risk of high blood pressure and other cardiovascular health problems. Here are several more tips to help you get started.43 

Keep your weight in check — Being overweight strains your heart, so make sure you maintain a healthy weight to lower your blood pressure. According to the American Heart Association,44 losing as little as 5 to 10 pounds may significantly lower your risk.

Manage your stress — Stress may cause short-term spikes in your blood pressure levels and encourage habits that are bad for your heart. Determine your stress triggers and find a way to manage your emotions when faced with difficult situations.

Some good examples of activities that may help lower your stress levels include yoga, meditation, Emotional Freedom Techniques and breathing techniques.

Make exercising a regular habit — Exercising regularly may help maintain healthy weight and ease stress, which in turn may reduce your high blood pressure. A report by the American College of Cardiology advises moderate- to vigorous-intensity workouts for 40 minutes, three to four times a week.45

Load up on vitamin D — Vitamin D deficiency is found to cause arterial stiffness,46,47 which may lead to high blood pressure.48 You may increase your vitamin D levels through sensible sun exposure49 or by eating foods rich in this nutrient, including wild-caught Alaskan salmon50 and organic eggs.51

Incorporate the Nitric Oxide Dump — The Nitric Oxide Dump workout has multiple benefits, but one key factor is the release of nitric oxide. It is one of the most important molecules for blood vessel health that acts as a vasodilator, which means it causes your blood vessels to expand and dilate, promoting blood flow and lowering your blood pressure.


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