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FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs
Next time you reach into the medicine cabinet seeking relief for a headache, backache or arthritis, be aware of important safety information for non-steroidal anti-inflammatory drugs.
FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death. Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.)
The OTC drugs in this group are used for the temporary relief of pain and fever. The prescription drugs in this group are used to treat several kinds of arthritis and other painful conditions. Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple remedies with the same active ingredient.
The Risks and What’s New
Prescription NSAIDs are an important treatment for the symptoms of many debilitating conditions, including osteoarthritis, rheumatoid arthritis, gout and other rheumatological and painful conditions. OTC NSAIDs are used to temporarily reduce fever and to treat minor aches and pains such as headaches, toothaches, backaches, muscular aches, tendonitis, strains, sprains and menstrual cramps. Common OTC NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve). In addition, some combination medicines that relieve various symptoms, such as multi-symptom cold products, contain NSAIDs.
“Be careful not to take more than one product that contains an NSAID at a time,” says Karen M. Mahoney, M.D., deputy director of FDA’s Division of Nonprescription Drug Products. How will you know? Check the list of active ingredients in the Drug Facts label.
The labels for both prescription NSAIDs and OTC NSAIDs already have information on heart attack and stroke risk. In the coming months, FDA will require manufacturers of prescription NSAIDs to update their labels with more specific information about heart attack and stroke risks. FDA will also request that the manufacturers of OTC NSAIDs update the heart attack and stroke risk information in Drug Facts labels.
FDA added a boxed warning to prescription drug labels for this risk in 2005. More recent data and information are prompting FDA to update NSAID labeling. Today we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks.
“There is no period of use shown to be without risk,” says Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.
People who have cardiovascular disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk for cardiovascular adverse events associated with NSAIDs.
FDA is adding information in the drug label for people who already have had a heart attack. This vulnerable population is at an increased risk of having another heart attack or dying of heart attack-related causes if they’re treated with NSAIDs, according to studies.
But the risk is also present in people without cardiovascular disease. “Everyone may be at risk – even people without an underlying risk for cardiovascular disease,” Racoosin adds.
What Consumers Should Do
NSAIDs are effective treatments for pain, inflammation and fever. Consumers can still take them but should be aware of this increased risk of heart attack or stroke, especially at higher doses.
“As always, consumers must carefully read the Drug Facts label for all nonprescription drugs. Consumers should carefully consider whether the drug is right for them, and use the medicine only as directed. Take the lowest effective dose for the shortest amount of time possible,” Mahoney says.
When using prescription NSAIDs, read the consumer-friendly Medication Guide attached to your filled prescription, which provides important safety information.
If you have heart disease or high blood pressure, consult a health care provider before using an NSAID. Balance the benefits of NSAIDs with the possible risks and weigh your options. If you take low-dose aspirin for protection against heart attack and stroke, you should know that some NSAIDs, including ibuprofen and naproxen, can interfere with that protective effect.
Stop taking NSAIDs and seek medical help if you experience symptoms that might signal heart problems or stroke, such as chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech.
Reduce your risk factors for heart disease and stroke. “Smoking, high blood pressure, high cholesterol and diabetes are significant risk factors for these conditions,” Mahoney says. “If you smoke, work on quitting. See your doctor regularly to find out if you have these other strong risk factors, and commit yourself to taking care of them and of your health.”
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
July 9, 2015
To Read the original article and learn more about FDA warning please visit http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm453610.htm
Related Consumer Updates
FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death
New safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use
In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.
The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications. This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.
“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said Robert Califf, M.D., FDA commissioner. “Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”
Opioid analgesics are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among others. Prescription opioids are divided into two main categories – IR products, usually intended for use every four to six hours; and extended-release/long-acting (ER/LA) products, which are primarily intended to be taken once or twice a day, depending on the individual product and patient. Certain opioids, such as methadone and buprenorphine, are also used as a form of treatment for opioid addiction, and in combination with behavioral therapy and counseling, are known as medication-assisted treatment, or MAT.
The updated indication clarifies that because of these risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient.
As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts. NOWS may occur in a newborn exposed to opioid drugs for a prolonged period while in utero.
In 2013, the FDA required class-wide labeling changes for ER/LA opioid analgesicsthat included modifications to the products’ indications, limitations of use, and warnings, including boxed warnings to more effectively communicate to prescribers the serious risks associated with these drugs. Today, the FDA is requiring similar changes to the labeling of IR opioid analgesics.
“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products,” said Douglas Throckmorton, M.D., deputy center director of regulatory programs, FDA’s Center for Drug Evaluation and Research. “Today, we have taken an important next step in clarifying and making more prominent the known risks of IR opioid medications.”
Additionally, the FDA is requiring updated labeling for all opioids (both ER/LA and IR products) to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome. Updated labeling will also include information about opioid effects on the endocrine system, including a rare but serious disorder of the adrenal glands (called adrenal insufficiency) and decreased sex hormone levels (androgen deficiency). These labeling changes will also make it clear that these negative outcomes can occur whether a patient is taking an opioid to treat pain or if the product is being used for MAT. Today, the FDA issued aDrug Safety Communication outlining these risks.
“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We have been and will continue to evaluate all new data to ensure that labels of opioid drugs contain appropriate prescribing information about the benefits and risks of prescription opioids.”
The FDA is also aware of, and carefully reviewing, available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids. Once a review of all available scientific information is completed, the FDA will take necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications.
These actions are the latest examples of the agency’s commitment to combat this public health crisis and its profound impact on individuals, families, and communities across our country. Health and Human Services Secretary Sylvia M. Burwell has made addressing opioid misuse, addiction, and overdose a priority. Other work on this important issue is underway within HHS. The evidence-based HHS-wide opioid initiative focuses on three priority areas: informing opioid prescribing practices, increasing the use of naloxone (a rescue medication that can prevent death from overdose) and expanding access to and the use of MAT to treat opioid use disorder.
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.
To read the original article and learn more about FDA warning please visit the FDA at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491739.htm
Please consider the following prior to taking Butterbur for migraine treatment.
The butterbur plant (Petasites hybridus) has known toxic ingredients, which are known carcinogens (cancer causing chemicals), hepatotoxic substances ( cause liver damage) and teratogens (which cause birth defects)
Some butterbur products may contain pyrrolizidine alkaloids (PAs), and that’s the major safety concern.
PAs can damage the liver, lungs, and blood circulation, and possibly cause cancer. Butterbur products that contain pyrrolizidine alkaloids (PAs) are UNSAFE when taken by mouth or applied to broken skin. Broken skin allows chemicals to be absorbed into the body. Do not use butterbur products unless they are certified and labeled as free of PAs.
Short-term treatment with Butterbur
PA-free butterbur products are considered POSSIBLY SAFE when taken short-term, by mouth appropriately. PA-free root extracts seem to be safe when used for up to 16 weeks in adults. There is some evidence that a specific PA-free butterbur extract (Petadolex, Weber & Weber, GmbH & Co, Germany) can be safely used in children who are 6-17 years old for up to 4 months.
Not enough is known about the safety of using PA-free butterbur products on unbroken skin. Don’t use it.
PA-free butterbur is generally well tolerated.
Butterbur can cause the following:
Depression or neurological disorders
Difficulty breathing or exhaling
Halitosis, bad breath
Skin or eye discoloration
Skin and allergic reactions
Butterbur products might cause allergic reactions in people who are allergic to ragweed, marigolds, daisies, and other related herbs.
A condition called reversible cholestatic hepatitis - bile cannot flow properly from the liver due to swelling or blockage.
Possibly increase liver enzymes
So please consult your doctor before taking Butterbur for migraine treatment.
RESOURCE LINKS BUTTERBUR
Mauskop, D. (2014, May 13). Butterbur for Treating Migraines. Retrieved October 14, 2016, from https://migraine.com/blog/draft-herbal-remedies/
Prieto, J. M. (2014, March 10). Update on the efficacy and safety of PetadolexÂ®, a butterbur extra | BTAT. Retrieved October 14, 2016, from https://www.dovepress.com/update-on-the-efficacy-and-safety-of-petadolexreg-a-butterbur-extract--peer-reviewed-fulltext-article-BTAT
Bravo, T. P., MD, & Vargas, B. B., MD. (2015, January 01). Migraine Preventative Butterbur Has Safety Concerns. Retrieved October 14, 2016, from http://www.neurologytimes.com/headache-and-migraine/migraine-preventative-butterbur-has-safety-concerns
“…Despite butterbur’s potential efficacy, doubts are increasing about the long-term safety of this supplement given of the risk of liver damage and the lack of an actively regulated preparation. Due to the mounting concerns, the American Headache Society is currently evaluating a position statement cautioning against its use.”
Note Precautions When Using Feverfew
The use of herbs is a time-honored approach to strengthening the body and treating disease. Herbs, however, can trigger side effects and can interact with other herbs, supplements, or medications. For these reasons, herbs should be taken with care, under the supervision of a health care provider qualified in the field of botanical medicine.
Side effects from feverfew can include abdominal pain, indigestion, gas, diarrhea, nausea, vomiting, and nervousness. Some people who chew raw feverfew leaves may have mouth sores, loss of taste, and swelling of the lips, tongue, and mouth.
Rarely, allergic reactions to feverfew have been reported. People with allergies to chamomile, ragweed, or yarrow may be allergic to feverfew and should not take it.
Feverfew may increase the risk of bleeding, especially if you take blood-thinning medications, such as warfarin (Coumadin), clopidogrel (Plavix), or aspirin. Ask your doctor before taking feverfew if you take blood thinners.
Pregnant and nursing women, as well as children under 2, should not take feverfew.
If you are scheduled for surgery, tell your doctor if you are taking feverfew. It may interact with anesthesia.
DO NOT abruptly stop taking feverfew if you have used it for more than 1 week. Stopping feverfew too quickly may cause rebound headache, anxiety, fatigue, muscle stiffness, and joint pain.
- Feverfew. (n.d.). University of Mayrland Medical Center, Retrieved October 14, 2016, from http://umm.edu/health/medical/altmed/herb/feverfew
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