The U.S. Food and Drug Administration announced (April 1, 2020) it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example, NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans. The FDA conducted thorough laboratory tests and found NDMA in ranitidine at low levels. At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines, and continued its investigation and warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.
New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.
With today’s announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.
The FDA continues its ongoing review, surveillance, compliance, and pharmaceutical quality efforts across every product area, and will continue to work with drug manufacturers to ensure safe, effective and high-quality drugs for the American public.
The FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program:
Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
3 habits that are hurting your back
Back pain is one of the most common health complaints among North Americans. It also tends to be the result of bad habits. Here are three common culprits.
1. Bad posture
If you regularly slump while watching TV or spend hours slouched at your desk, chances are your back is paying the price. Try to sit in a straight, upright position as often as possible.
2. Sleeping on your stomach
3. Carrying a heavy bag
Walking around with a heavy bag every day is likely to cause back pain. This is especially true if you carry it on only one shoulder, as this increases strain on your back.
In addition, back pain can be caused by a sedentary lifestyle, inadequate mattress or pillow, kidney problems, and even certain types of cancer. If you suffer from persistent back pain, be sure to consult a doctor.
4 conditions acupuncture may help with
Derived from traditional Chinese medicine (TCM), acupuncture is a therapeutic technique that involves stimulating specific areas of the skin using fine needles. Though it’s used to treat a wide range of conditions, research suggests it may be particularly effective for the following:
1. Seasonal allergies. Acupuncture can be used as a complementary treatment for common seasonal allergy symptoms such as sneezing and teary eyes.
2. Joint and muscle pain. Acupuncture has been shown to be an effective pain relief treatment, including in cases of arthritis and back pain.
3. Nausea and vomiting. Acupuncture can ease nausea and vomiting typically experienced while undergoing chemotherapy or recovering from surgery.
4. Headaches and migraines. Treatments may reduce headaches and migraine symptoms.
In all cases, studies have found that acupuncture provides the best results when combined with conventional treatments and when patients expect it to work. It’s also important to choose a reputable practitioner.
Eat cherry pie, ease arthritis symptoms? (Sadly, no)
Ok, a cherry pie analgesic is admittedly a whole lot of wishful thinking. But if you like cherries, you’re in luck! They’re listed among the foods that can help fight arthritis.
Arthritis, a catch-all term for any of 100 conditions and related diseases that affect joints and connective tissues, usually involves joint pain and stiffness. May is Arthritis Awareness Month. More than 50 million adults and 300,000 children suffer from joint pain or disease, with the most common types being osteoarthritis, rheumatoid arthritis, psoriatic arthritis, fibromyalgia, and gout.
While you should always consult your doctor and take any medicines as prescribed, consider these foods, which CureArthritis.com says help fight arthritis:
* Tart cherries: With anti-inflammatory and antioxidant benefits, tart cherries can help provide joint relief and lower the risk of flares in those with gout (one type of arthritis).
* Colorful vegetables: Sweet potatoes, carrots, red or green peppers, and squash. Peppers contain an abundant amount of vitamin C, which preserves bone and may protect cartilage.
* Seafood: Salmon, tuna, sardines, and mackerel can help decrease inflammation and protect the heart.
* Walnuts: High in alpha-linoleic acid (say that three times fast, or just say ALA), a type of anti-inflammatory omega-3 fatty acid, walnuts can also lower cholesterol, relax blood vessels, and reduce blood pressure.
* Garlic: Use fresh garlic if you can to help fight pain, inflammation, and cartilage damage.
Psoriasis vulgaris, commonly known as plaque psoriasis, is a non-contagious and chronic autoimmune skin condition. It usually presents on the skin as raised, inflamed red lesions or plaques covered with a silvery-white scaly layer that easily flakes off.
Although they can manifest anywhere, lesions most commonly appear on the scalp, knees, elbows, and torso. Affected areas of skin are likely to become sensitive and prone to inflammation and bleeding. The lesions can also be painful or itchy.
The severity of psoriasis is determined based on how much of the body is affected: mild (less than three percent), moderate (from three to 10 percent), and severe (more than 10 percent).
Psoriasis can’t be cured. However, the following treatments can help manage symptoms:
• Topical corticosteroids, vitamin D and moisturizers (mild cases)
• Different forms of UV phototherapy (moderate cases)
• Systemic agents, including immune suppression drugs, biologic immunomodulators and vitamin A (severe cases)
Unfortunately, phototherapy and systemic agents come with significant side effects. The former increases the risk of developing a variety of skin cancers while patients treated with the latter need to be closely monitored for medication toxicity.
To learn more about psoriasis, visit the National Psoriasis Foundation website at psoriasis.org.
Access to phototherapy
Despite its effectiveness, access to phototherapy can be limited for some people. Therefore, it’s common for patients to visit tanning facilities with booths that emit UVB light as a way to treat their psoriasis. However, it’s important to be aware that booths emitting UVA light may not be effective. Additionally, patients should always disclose any form of self-treatment to their doctor.
Get some social distance with a bike ride
It’s commuting and fitness melded together: Faster than walking and as much exercise as jogging. It lets you enjoy the scenery, which, depending on your time in quarantine, could mean a lot.
If you aren’t already a regular rider, you’ll want to ease yourself into cycling. Begin with half-hour rides every other day or three days a week. And practice your basic skills in an empty parking lot.
Learn to shift gears without wobbling and to look over your left shoulder while steering straight ahead.
When you take to the roads, always ride with traffic, ride in the street on the right. Use hand signals, and obey all the traffic rules.
Buying a bike
If you decide that you like riding, you may want to get a new bike. Be sure to shop for one that suits your normal riding distance. Traditional 3-speeds are good for short rides, and 10-speeds are best for longer rides. Then there are all-terrain bikes that provide an all-purpose alternative.
When riding to work, put your belongings in a backpack or tie them down in a basket or rear carrier. Carry a tool kit to fix flat tires.
You’re never too old to take up cycling and benefit from it for the rest of your life. Studies at the University of California at Davis compared three forms of exercise: Jogging, bicycling, and tennis. Middle-aged sedentary men were assigned to one of the three activities for 30 minutes a day three times a week. After 20 weeks, the joggers and cyclists had an equal improvement in endurance, and both groups lost a substantial amount of body fat.
When riding after dark, make sure you have lights on the bike, reflective tape on your helmet, and wear light-colored clothing.
Coronavirus can mimic heart attack
In New York City, doctors began emergency surgery on a patient who had all the signs of a heart attack. An electrocardiogram showed a dangerous heart rhythm. A blood test revealed high blood levels of troponin, a sign of damaged heart muscle.
But, on the operating table, the patient showed no blocked arteries.
What he did have, it turns out, was coronavirus.
Now recovered after a 12-day stay, the patient was one of the similar cases reported around the world.
For doctors the case is troubling.
Should the cardiac test for troponin routinely be administered to Covid-19 patients? Should heart patients immediately be tested for Covid-19?
A March study published in the Journal of the American Medical Association was conducted by doctors in Wuhan, China, where the virus was first identified. The small study was limited to a review of records of 188 patients, according to JAMA. The study found that 20 percent of the Covid-19 patients were found to have heart damage. Upon admission, Covid-19 patients without heart disease were found to show signs of heart injury, including elevated troponin, and abnormal electrocardiograms. Patients showing these symptoms had a four times greater risk of death than a Covid-19 patient with no abnormal heart readings, according to the New York Times.
Some experts believe heart problems are caused by the body’s immune and inflammatory response to the virus.