Tag Archives: Hypertension

A Drug I Am Taking is Being Recalled. Should I Freak Out?

Most pharmacists, including myself, have been directly involved in the process of managing and following up on FDA prescription drug recalls. Fortunately, many of the drug recalls are not to the patient level because of a medication causing harm. Most medication recalls I’ve dealt with were not likely to cause adverse health consequences if a patient continued to take the meds. My role as a pharmacist was usually to deal with following through on returning of recalled products and contacting patients to give them information, instructions and reassurance when needed.

Both prescription and over-the-counter medications are evaluated by the FDA’s Center for Drug Evaluation and Research (CDER) before a medication can be sold. They do not actually test the products at the center, but they conduct research on each product for drug quality, safety and effectiveness. The drug manufacturer is responsible for researching and testing the new product for safety and effectiveness, and providing that information to the FDA for evaluation.

When a pharmaceutical company develops a new prescription medication and wants to bring it to market, they submit a new drug application (NDA) to the FDA. Over-the-counter medications can be brought to market through a similar NDA process or by submitting a drug monograph. A drug monograph is like a “recipe” of acceptable ingredients, doses, formulations and labeling requirements for that particular product to be marketed. Products conforming to the FDA monograph can then be evaluated for approval and marketing.

Most Recalls Are Voluntary

Occasionally, unforeseen problems arise after an FDA-regulated product is marketed and in use. If a product is defective or potentially harmful, the product could be recalled. Recalling the product is the most effective way to protect the public. Most product recalls are voluntary and initiated by the manufacturer when they discover problems. The role of the FDA then is to monitor the recall process and assess its effectiveness.

The FDA evaluates each recall and classifies them into three categories:

Class I: A dangerous or defective product that could cause serious health problems or death.
Class II: A product that might cause a temporary health problem, or pose slight threat of a serious nature.
Class III: A product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.

The public is not always notified about FDA recalls, and they’re not always in the news. Some product recalls can be as simple as an issue with the product labeling or packaging, or some other discrepancy that does not cause a health problem. Usually your pharmacist or doctor will notify you if there is a need for you to discontinue a recalled medication or return a recalled prescription product.

When the FDA issues a recall it is very specific as to which products are included. The manufacturer must provide comprehensive information including, but not limited to, product name, use and description. Just because a product is recalled by one manufacturer — hydrochlorothiazide, for example — doesn’t mean that all hydrochlorothiazide by other manufacturers is necessarily recalled. This can lead to some confusion for consumers.

Hypertension Drug Recalls

There have been a number of recalls of prescription drugs used to control high blood pressure in the news since last year. These recalls have been hyped up and sensationalized by the news media lately. News stories about drug products being contaminated with ingredients used to “make liquid rocket fuel” or pesticides are alarming when read by the public. They also do very little to educate consumers about how to deal with a prescription medication recall.

You can search product recalls on an FDA website or at Recalls.gov if you have questions about a drug recall. However your best source of information would be your pharmacist or the healthcare provider who prescribed the medication for you. They can provide clear, concise information (without the hype) and give you clear instructions about what to do.

Quick Hits: Light Exercise and Hypertension, Using Acupuncture to Relieve Menopause Symptoms & More

Just 30 minutes of exercise a day can reduce blood pressure in older people who are overweight or obese almost as much as taking medication. Researchers enrolled 67 people between the ages of 55 and 80. Depending on the day of the study, participants either did no exercise all day, did 30 minutes of morning exercise (walking on a treadmill at moderate intensity) followed by sitting the rest of the day or 30 minutes of morning exercise followed by light walking for a few minutes every 30 minutes. Results showed that blood pressure was reduced when participants took part in morning exercise compared to days when they didn’t. Women who took breaks throughout the day to walk saw additional reductions in blood pressure, though this same effect was not seen in men who engaged in walking. Posted February 20, 2019. Via Hypertension.

Acupuncture may provide a viable alternative to hormone replacement therapy for women suffering from menopause symptoms. A study enrolled 90 menopausal women who were randomly assigned to get acupuncture for six weeks or no acupuncture. For those in the former group, each session was weekly and lasted for 15 minutes. After six weeks, 80% of the women in the acupuncture group said they felt their symptoms had improved. Compared to women who didn’t get acupuncture, those who did had significantly fewer day and night sweats, sleep problems, emotional symptoms and skin and hair problems. Posted February 19, 2019. Via BMJ Open.

Both the FDA and opioid drugmakers failed to monitor the use of a fast-acting formula of the extremely powerful opioid fentanyl, leading to thousands of people getting the drug who shouldn’t have. A new study found that 51% of patients who were prescribed what are known as transmucosal immediate-release fentanyls (TIRFs) – which are nasal sprays, quick-dissolve tablets or lozenges designed to get the drug into the bloodstream quickly – didn’t require them. TIRFs are usually reserved for people who have constant, severe pain, such as those with cancer. If given to a patient who has not taken opioids before or is not tolerant to a strong opioid such as fentanyl, they run the risk of overdose and even death. Posted February 19, 2019. Via JAMA.

Most Cardiovascular Drugs Safe in Pregnancy

Most drugs used to treat various cardiovascular conditions are safe to use in pregnancy, according to a new analysis.

Researchers examined study data, guidelines and recommendations regarding the use of cardiovascular drugs during pregnancy. These include medications for irregular heartbeat (antiarrhythmics), hypertension drugs, heart failure drugs, statins and blood thinners (anticoagulants).

In their review, published in the Journal of the American College of Cardiology, the researchers note that precautions should be taken if a pregnant mother is on one of the medications.

“The lowest effective dose should be used. The woman should be counseled on risks and benefits, and provided current data, acknowledging limitations…. Maternal fetal medicine specialists should be consulted to assist in medication management during pregnancy, and the
pediatrician postpartum during lactation.”

Although the majority of the drugs are safe, the researchers caution that most of the drugs will enter breast milk, which could impact a newborn baby.

Some of the drugs that should not be used during pregnancy, according to the review, include the following: amiodarone, atenolol, angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers, statins, and direct oral anticoagulants (DOACs) such as Eliquis (apixaban), Pradaxa (dabigatran) and Xarelto (rivaroxaban).

FDA Warns Recalls Causing Shortage of Common Blood Pressure Drug

The FDA is warning that there is a shortage of the commonly prescribed blood pressure drug valsartan due to ongoing manufacturing issues in which the drug is being contaminated with a possible carcinogen. The agency also said other angiotensin receptor blockers (ARBs), such as losartan and irbesartan, may become in short supply too.

Since the summer, the FDA has issued recalls for all three drugs – though valsartan has been impacted the most – from some generic manufacturers. Most of the recalled valsartan was made in China. The recalled drugs contain potentially dangerous contaminants, N-nitrosodimethylamine (NDMA) or N-Nitrosodiethylamine (NDEA) , which laboratory studies have shown can cause cancer or liver damage.

“Valsartan products are in shortage, and we know that other types of products may fall into shortage soon,” FDA Commissioner Scott Gottlieb said in a statement.

“We remind patients taking these medications or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option,” he added.

Going forward, the FDA’s focus “is to balance the risk of patients ingesting low levels of the impurities (below the interim acceptable levels) for a short period of time with the risk that there is a shortage.”

Cold Medicines Can Impact Those With High Blood Pressure, Heart Issues

With cold and flu season in full swing, people with high blood pressure that is not controlled well or who have heart disease need to be careful with over-the-counter cold medicines, as they may cause a spike in blood pressure.

Many cold medicines contain decongestants and nonsteroidal anti-inflammatory drugs (NSAIDs), both of which can raise blood pressure. Examples of decongestants are pseudoephedrine and phenylephrine. Some NSAIDs are Advil (ibuprofen) and Aleve (naproxen).

“People with uncontrolled high blood pressure or heart disease should avoid taking oral decongestants,” Sondra DePalma, a physician assistant at UPMC Pinnacle in Pennsylvania, told American Heart Association News. “And for the general population or someone with low cardiovascular risk, they should use them with the guidance of a healthcare provider.”

Guidelines released last year by the American Heart Association and the American College of Cardiology dealing with high blood pressure management say that decongestants should be used for as short a time as possible, and to try alternatives such as nasal saline or antihistamines.

Regarding NSAIDs, guidelines say to use Tylenol (acetaminophen) or topical NSAIDs as other options.

Healthcare professionals also say if your cold symptoms are mild or moderate, rest and drink plenty of fluids. Avoiding dehydration can help reduce body aches and may reduce the need for decongestants.

I’m Starting on a Blood Pressure Drug. What Should I Know?

If you read my previous “Ask the Pharmacist” column, you might remember that my doctor recently prescribed a statin medication to help lower my cholesterol. After taking Lipitor (atorvastatin) for several weeks, I haven’t experienced any side effects, but I’m still monitoring my progress just the same. Now, to help lower my blood pressure, he wants me to start taking lisinopril, an angiotensin-converting enzyme (ACE) inhibitor. And, again, I’m concerned about possible side effects, especially taking it in combination with the cholesterol-lowering medication.

The ‘A’ in ACE Inhibitors

Angiotensin is a substance in your body that regulates blood pressure. But too much of it causes your blood vessels to squeeze down (vasoconstriction), which causes your blood pressure to rise and make your heart work harder to circulate blood through your body. ACE inhibitors reduce the amount of angiotensin in your body, helping to relax your blood vessels and lower your blood pressure. ACE inhibitors may also be used in patients with chronic kidney disease or congestive heart failure.

Medications like lisinopril and other ACE inhibitors (captopril, benazepril, fosinopril and others ending in “pril”) help to lower the amount of angiotensin in your body by preventing an enzyme in your body from producing angiotensin.

The Common Side Effects

ACE inhibitors are generally well tolerated but do have a few side effects worth looking out for. One of the most famous ones, cough, was seen with the much higher doses of captopril used in the past, but is also seen in some patients taking other ACE inhibitors at standard doses. If you experience a persistent dry cough, your doctor will likely prescribe another class of hypertension medication, angiotensin receptor blockers (ARBs).

For the most part, major side effects are not common with the doses of ACE medications prescribed today. But you should still watch out for a dry cough, fatigue, dizziness, headache or loss of taste. Your doctor may find high potassium levels in your system after taking ACE inhibitors, but this is uncommon in patients under 70 years of age with normal kidney function.

And Then There Are ARBs

ARBs are another group of medications that block the effects that angiotensin has in your body to help lower blood pressure. Azilsartan, candesartan, irbesartan and losartan (and others ending in “artan”) are prescribed for high blood pressure and other conditions much like the ACE inhibitors. They work a little differently — not by lowering the amount of angiotensin in your system, but by blocking the effects of angiotensin. If you block the blood vessel constriction angiotensin causes, you can prevent high blood pressure.

The potential but infrequent side effects of ARBs are similar to the ACE inhibitors and include dizziness, headache, drowsiness, nausea, vomiting, diarrhea, cough or elevated potassium levels. Rare side effects for both groups of medications are sexual dysfunction, kidney or liver failure, or tissue swelling (angioedema). Do not take these medications if you are pregnant or plan to become pregnant.

The good news — for me, anyway — is that ACE inhibitors and ARBs can be taken with the statin medications. The other good news is, I’ve experienced no side effects from using these medications together so far. In fact, I’ve felt better since I started taking the lisinopril to lower my blood pressure, having fewer headaches and more energy.

So, Your Doctor Wants You to Take a Statin. What Are the Risks?

Seems my doctor wants me to take one too. I had my annual check-up with my physician a few weeks ago and was disappointed when I received my lab results. Even after losing 25 pounds over the past 12 months, my overall cholesterol and LDL (low density lipoproteins), also known as “bad cholesterol” because high levels of it boost your risk for a heart attack, have both gone up.

I’m an active person who exercises regularly, my blood sugar level is low and I think I eat a fairly good diet. Generally speaking I consider myself to be healthier than I’ve been for a long time.

My cholesterol level has been a little high for many years, probably due to genetics. Both my father and mother and their parents had high cholesterol. This familial hypercholesterolemia has never seemed to be a problem over the years for me but now my doctor wants me to start taking a statin to lower it. I have some concerns about potential side effects from taking this cholesterol-lowering medication. But more on this later.

I’ve avoided taking a statin for several years. I’ve tried the diet/exercise route. In 2007, I started cycling again and have logged nearly 15,000 miles either riding outside or peddling my bike on a trainer in the garage. In December 2017, I had a check up and decided I needed to lose weight to reduce my blood pressure and cholesterol. I started a keto diet and lost 25 pounds since then. But the high protein, high-fat diet seemed to kick up my cholesterol rather than lowering them. Now I feel it’s time to start a statin, rethink my diet and see what happens.

How Often Should You Get Your Cholesterol Checked?

The American Heart Association (AHA) recommends that all adults should have their cholesterol level checked every 4-6 years starting at age 20. As we age our cholesterol levels tend to rise. If your cholesterol level is high it should be checked more frequently — at least annually. And if you have a family history of high cholesterol, it should be monitored several times a year.

Your doctor will conduct a risk assessment to determine if you need to take a cholesterol medication. If you have high cholesterol but are considered “heart healthy” and have no additional risk factors, you might not need to take medication. If you have additional risk factors like diabetes, high blood pressure, a smoker or family history of heart disease or high cholesterol, they will usually recommend you take medication to control your cholesterol. If you’ve already suffered a heart attack or stroke, chances are you will be prescribed medication to prevent a future one if you’re not already taking one.

Statins are generally considered the first-line treatment for high cholesterol. There are a number of these medications available including Lipitor (atorvastatin), Crestor (rosuvastatin), Zocor (simvastatin) and Pravachol (pravastatin). Your doctor’s personal prescribing habits will determine which statin you are prescribed, though they are all available as generics, so they are cheap.

What Are The Minor and Serious Side Effects?

Generally speaking statins are safe and well tolerated by your body with minimal or temporary side effects such as headache, nausea, drowsiness, flushing of the skin or difficulty sleeping at times. Some of the more serious side effects that have been reported are muscle aches and pain. Mild muscle soreness, tiredness or weakness might be a minor discomfort in most cases but can be severe enough to make daily activities difficult in a few individuals. Very rare serious side effects may include muscle damage (rhabdomyolysis), liver or kidney failure but the risks are very low with incidence being calculated as only a few cases per million statin users.

The AHA issued a statement this week that based on an analysis of decades of clinical studies involving different statins, side effects are very rare and the benefits of them greatly outweigh the risks. The AHA’s action was likely a response to a study that came out last week that argued that statins are overprescribed and for some people who take them, the risks outweigh the benefits.

Treatment needs to be individualized for you based on your risk factors. You (and I include myself) need to understand the risks of not taking a statin vs. your risk of having a heart attack or stroke. Make sure you have this conversation with your doctor. And, as always, ask questions if you don’t understand.

Are Statins Overprescribed? For Many, Their Risks May Outweigh Their Benefits

A new study is arguing that statins may be overprescribed since in many people, the risks of the cholesterol-lowering drugs outweigh their benefits.

Current US guidelines recommend that statins be prescribed to those who have a 10% risk of having a heart attack within the next 10 years and who have one or more risks for cardiovascular disease (CVD), such as high cholesterol, high blood pressure and diabetes. With those guidelines, as many of 40% of older Americans should take a statin to curtail their risk of developing heart disease or having a cardiovascular event.

Statins, however, are considered a must for those that have experienced a heart attack or stroke, as clinical evidence is strong that they can prevent another one from occurring.

Researchers looked at data from more than 40 studies on four commonly prescribed statins: Lipitor (atorvastatin), Zocor (simvastatin) Pravachol (pravastatin) and Crestor (rosuvastatin). They used a computer model to analyze the benefits and risks of statins. Possible side effects included muscle weakness, kidney or liver dysfunction, diabetes, cataracts and headaches.

Results, published in the Annals of Internal Medicine, found that the harms of the drug outweigh the benefits until a patient’s risk is much higher than the 10% threshold cited in the US guidelines.

For example, a net benefit was not seen in men between 70 and 75 unless their 10-year CVD risk was at least 21%. Among men 40 to 44, the benefit was not greater than risk unless their risk was at least 14%.

Milo Puhan, MD, PhD, a senior author of the study with the University of Zurich, told NPR that as people age, the benefits of statins diminish compared to harm. He added that only 15% to 20% of older adults should be taking statins, much less than the 40% under the current guidelines.

Quick Hits: Statins and Seniors, ‘Magic Mushrooms’ As Depression Treatment & More

Almost half of patients 65 and over that are prescribed statins stop taking them within a year — and side effects may be to blame. Researchers looked at 22,340 seniors who started statin therapy and found that 45% stopped taking the medication within a year of receiving the prescription. Results also showed that patients 85 and older were even more likely to stop taking the pills. Some people on statins do experience muscle aches and pains and some studies have indicated that statins are associated with a higher risk of developing diabetes. The researchers noted that having diabetes and anxiety was associated with a higher rate of discontinuation. Posted November 6, 2018. Via British Journal of Clinical Pharmacology.

The FDA has granted “Breakthrough Therapy” status to a drug company’s treatment-resistant depression medication that contains psilocybin, the active ingredient in psychedelic mushrooms. The designation means that the agency will fast-track review of the drug. However, it may be some time before the FDA approves the drug as the company, COMPASS Pathways, has just started to conduct a large-scale clinical trial. In a news release, the company said a 2015 study in which psilocybin was given to 19 patients in a clinical setting “found promising signals on efficacy and safety.” Treatment-resistant depression affects 100 million people worldwide. Posted October 23, 2018. Via COMPASS Pathways.

Some lots of the hypertension drug irbesartan are being recalled because they may contain an impurity that can cause cancer. The irbesartan affected was manufactured by ScieGen Pharmaceuticals and may contain N-nitrosodiethylamine (NDMA), a probable human carcinogen. You can check to see if the irbesartan you are taking is impacted by the recall here. If your medication is on the recall list, do not stop taking it. Instead, talk to your doctor or pharmacist about an alternative treatment. Irbesartan is the second high blood pressure medication recalled because of NDMA this year. Over the summer, the FDA recalled certain lots of valsartan. Posted October 30, 2018. Via FDA.

Common Blood Pressure Drugs May Raise Lung Cancer Risk

A commonly prescribed class of drugs used to treat high blood pressure may slightly increase the risk of developing lung cancer.

The class, angiotensin converting enzyme (ACE) inhibitors, includes drugs such as Altace (ramipril), Lotensin (benazepril) and Prinivil (lisinopril).

In a new study, researchers looked at nearly one million people that were prescribed blood pressure-lowering drugs in the United Kingdom. Once prescribed, they were followed for an average of 6.4 years. Some people received an ACE inhibitor, some received another class of drugs, angiotensin receptor blockers (ARBs), and others received both groups of drugs.

Common ARBs include Benicar (olmesartan), Cozaar (losartan) and Diovan (valsartan). The patients that took an ACE inhibitor had a 14% increased risk of lung cancer compared to those on an ARB, the researchers reported in the BMJ.

The risk also increased the longer a patient was on an ACE inhibitor. After 10 years, the increased risk rose to 31% compared to ARBs.

The researchers surmise that the increased lung cancer risk may be the result of ACE inhibitors promoting the production of protein-like chemicals known as bradykinin and substance P, which can stimulate lung cancer growth.

An editorial accompanying the study said that the long-term risk of lung cancer associated with ACE inhibitors should be “balanced against gains in life expectancy associated with use.”

3 Things Every Consumer Should Know About Blood Pressure Drug Recall

By Caitlin Hoff
ConsumerSafety.org

For most consumers, a significant drug recall that impacts them is a rare occurrence. Many times, drugs are recalled as a precautionary measure for minor issues. Some recalls are addressed at the pharmacy level. In this second instance, consumers never interact with the recalled medications. For thousands of Americans, however, this summer brought about a series of important and potentially dangerous recalls from the FDA, exposing a lack of consumer knowledge surrounding consumer drug recalls.

On July 13, the FDA joined 22 other countries recalling certain generic medications containing valsartan, a popular blood pressure lowering drug also known as Diovan. These products were recalled because the valsartan was found to be contaminated by a cancer-causing impurity. With further investigation, the recall was expanded as more contaminated medications were found. To see the FDA’s complete updated list of medications in this recall, click here.

Last month, the FDA discovered an additional impurity -– also a carcinogen — within several of the medications already recalled. Investigations are still being conducted into the contamination and the potential health impacts that these impurities could have on the lives of patients.

To ease concerns and answer a few common questions, here is what you, as a consumer, should know and take away from the recent valsartan recalls.

1. Not all medications containing valsartan were recalled. Valsartan is used in a number of medications to treat hypertension and heart failure. The reason for the recall comes from a contamination of valsartan supplied by certain manufacturers. Plenty of drugs containing valsartan were not recalled because they use a different supplier. If you are taking a medication that contains valsartan, be sure to check whether or not your medication was impacted by this recent recall.

2. The impurities found are classified as probable human carcinogens. The first impurity which prompted the initial recall is known as N-nitrosodimethylamine or NDMA. What we know of NDMA comes from studies done using animals. As the EPA reported last year, these studies found that increased exposure to the substance contributed to damage and tumor growth in the liver, as well as in the respiratory tract, kidney and blood vessels of the animals.

The second impurity found in September is called N-nitrosodiethylamine (NDEA). It has also been shown to cause liver damage along with other negative health effects. It’s important to note that both NDEA and NDMA are classified as probable carcinogens for humans based on studies using animal test subjects. The full impact of these impurities, however, is yet to be understood for the patients taking the contaminated valsartan drugs.

3. Consumers should not stop taking their recalled medication. Valsartan is used to treat high blood pressure and heart failure, two very serious health conditions. To ensure that greater harm does not come to patients affected by the recall, the FDA and healthcare professionals alike do not recommend stopping the medication until an alternative can be obtained. Those affected by the recall should consult their doctor about a replacement medication. Some people may be switched to another valsartan medication unaffected by the recall, while others may be placed on an alternative medication that does not contain valsartan. The decision will depend on your personal medical history as well as your doctor’s determination.

Medication recalls can cause anxiety and confusion, and can bring questions from consumers. It’s important that we handle these situations calmly and responsibly. If you are impacted by a consumer drug recall, be sure to thoroughly read the recall information provided by the FDA and the drug manufacturer. Both groups typically provide reasons for the recall as well as safety instructions for affected patients. In addition, you should always consult your doctor before stopping a medication or to voice concerns about a prescribed medication.

Finally, it’s important to recognize that the safety of medications in our country does not solely fall upon the authority of the FDA or drug manufacturers. Consumers also have a voice in the matter and can provide critical feedback around the safety of drugs on the market. If you ever experience adverse side effects after taking a medication or notice a defect in your medication such as a packaging issue or irregularities in the pills themselves, you should report this to both your doctor and the FDA.

An important side note: Your doctor is not required to report any side effects that you experience on a medication to the FDA. It is your responsibility to ensure that it gets reported. Visit the FDA’s MedWatch reporting page to learn more and report any consumer drug complaints.

Caitlin Hoff is a health and safety investigator with ConsumerSafety.org. Through her writing, she hopes to guide families and consumers towards smarter decisions that will improve their overall health.

Many Seniors at Risk For Supplement-Drug Interactions

Millions of seniors that take herbal supplements in addition to prescription drugs may be at risk for potentially serious supplement-drug interactions.

Researchers in the UK polled older adults 65 and older, finding that about one-third of them take at least one supplement in addition to their regular medications. Based on an evaluation of those supplements and drugs, researchers say that one-third of that group are at risk for potentially serious adverse events, they reported in the British Journal of General Practice.

Some of the adverse events are a risk of bleeding, an increase in blood sugar concentration and reducing the effectiveness of the medication an individual is taking.

Researchers identified three supplement-drug combinations they say pose a “significant” hazard: calcium and the underactive thyroid drug levothyroxine; peppermint and Prevacid (lansoprazole), which is used for acid reflux; and St. John’s wort and amlodipine, a blood pressure-lowering medication. In the first combination, the efficacy of levothyroxine can be reduced by calcium. Antacids like Prevacid can eat away at protective coatings on peppermint oil pills, potentially leading to nausea and heartburn. And St. John’s wort can reduce the levels of amlodipine in the blood.

Other potentially serious combinations include fish oil pills and bisoprolol, a beta blocker, as well as glucosamine, a supplement used for arthritis relief, and the diabetes drug metformin. The first combination can lead to a potentially unsafe lowering of blood pressure, while the second can increase blood sugar.

The study authors conclude that doctors should ask senior patients about supplement use to potentially avoid interactions with medications.