FDA Recommends Avoiding NSAIDs for Pain Relief in Pregnancy at 20 Weeks or Later

MedicalResearch.com Interview with:
Catherine Y. Chew, PharmD, BCGP

Deputy Director, Division of Drug Information
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Catherine Y. Chew, PharmD, BCGP Deputy Director, Division of Drug Information Center for Drug Evaluation and Research U.S. Food and Drug Administration
Dr. Chew

MedicalResearch.com:  What actions is FDA taking regarding NSAID use during pregnancy?

Response: The U.S. Food and Drug Administration (FDA) is warning that use of prescription or over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) from around 20 weeks of pregnancy through the end of pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the unborn baby and possible complications.

For prescription NSAIDs, FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies; these kidney problems can result in low amniotic fluid. FDA is recommending that pregnant women avoid NSAIDs from around 20 weeks of pregnancy. Prescribing information already recommends avoiding NSAIDs from around 30 weeks through the end of pregnancy because NSAIDs can cause a problem that may result in heart issues in the unborn baby. If NSAID use is necessary between 20 and 30 weeks of pregnancy, NSAID use should be limited to the lowest effective dose for the shortest possible duration. Health care professionals should consider ultrasound monitoring of amniotic fluid if a pregnant woman uses NSAIDs beyond 48 hours.

FDA will also work with sponsors to request updates of the Drug Facts labels of OTC NSAIDs intended for use in adults. These labels already warn to avoid using NSAIDs during the last three months of pregnancy because the medicines may cause problems in the unborn baby or complications during delivery. The Drug Facts labels also already advise pregnant and breastfeeding women to ask a health care professional before using these medicines.

MedicalResearch.com: What did FDA find?

Response: These labeling changes are based on cases reported to FDA about low amniotic fluid levels or kidney problems in unborn babies associated with NSAID use during pregnancy. FDA’s medical literature review also contributed to the basis for the labeling changes.

Among the 35 cases of low amniotic fluid levels or kidney problems reported to FDA through 2017, all were serious. Two newborns who died had kidney failure and confirmed low amniotic fluid when mothers took NSAIDs while pregnant; three other newborns who died had kidney failure without confirmed low amniotic fluid when mothers took NSAIDs while pregnant. The low amniotic fluid levels started as early as 20 weeks of pregnancy. In 11 cases where low amniotic fluid levels were detected during pregnancy, the fluid volume returned to normal after the woman stopped taking the NSAID.

FDA’s medical literature review yielded similar findings. In these publications, low amniotic fluid levels were detected with NSAID use for varying amounts of time, ranging from 48 hours to multiple weeks. In most cases, the condition was reversible within three to six days after stopping the NSAID. In many reports, the condition was reversed when the NSAID was stopped; the condition reappeared when the same NSAID was started again.

MedicalResearch.com: What are NSAIDs? Are all NSAIDs included in the new FDA recommendations to avoid NSAID use from around 20 weeks through the end of pregnancy?

Response: For decades, people have used NSAIDs to treat pain and fever from many different long- and short-term medical conditions, such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs work by blocking the production of certain chemicals in the body that cause inflammation. There are both prescription and OTC NSAIDs.

NSAIDs are available alone and combined with other medicines for the temporary relief of pain and fever, including pain or fever symptoms associated with colds, flu, and insomnia. Examples of NSAIDs include ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac (Voltaren), and celecoxib (Celebrex) and aspirin.

An exception to these new FDA recommendations is the use of the low-dose aspirin (81 mg) for certain pregnancy-related conditions at any point in pregnancy under the direction of a health care professional. Low-dose aspirin may be an important treatment for some women during pregnancy. The recommendations also do not apply to NSAIDs administered directly to the eye.

MedicalResearch.com: NSAIDs already carry a warning about use in late pregnancy. What is different about these labeling changes?

Response: Warnings to avoid taking NSAIDs after about 30 weeks of pregnancy are already included in the prescribing information because taking these medications during this time may lead to heart issues in the unborn baby. The new labeling changes recommend avoiding NSAIDs as early as about 20 weeks of pregnancy because of the risk of kidney problems that result in low amniotic fluid.

MedicalResearch.com: What should pregnant women and health care professionals do? What are other options for pain relief during pregnancy?

Response: Women should not use NSAIDs after around 20 weeks in pregnancy unless specifically advised to do so by a health care professional. Because many OTC medicines contain NSAIDs, pregnant women should read the Drug Facts labels to determine if the medicines contain an NSAID. If pregnant women are unsure if a medicine contains an NSAID, they should ask a pharmacist or health care professional for help.

Other medicines, such as acetaminophen (Tylenol), are available to treat pain and fever during pregnancy. Pregnant women should ask their pharmacist or health care professional for help deciding which medication might be best.

Health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. If NSAID treatment is determined necessary, health care professionals should limit use to the lowest effective dose and shortest duration possible. They should also consider ultrasound monitoring of amniotic fluid if the pregnant woman regularly uses NSAIDs longer than 48 hours and discontinue the NSAID if low amniotic fluid levels are found.

Citation:

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
NSAIDs may cause rare kidney problems in unborn babies

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

Pain Relief from NSAIDS and COVID-19 Outcomes

PainRelief.com Interview with:
Anton Pottegård DMSc PhD

Professor (MScPharm, PhD, DMSc)
Clinical Pharmacology and Pharmacy, Department of Public Health
University of Southern Denmark
Head of Research, Hospital Pharmacy Funen
Odense University Hospital

PainRelief.com:  What is the background for this study?

Response: Early in the COVID-19 pandemic, concerns were raised that use of the common painkiller ibuprofen – a so-called NSAID – to treat symptoms of COVID-19 might lead to more severe disease. This started with tweets from the French health minister and culminated with a warning issued by the WHO. This warning was later retracted, but naturally patients and physicians were concerned regarding the safety of ibuprofen. We therefore established a nationwide Danish collaboration between researchers and regulators and established a prospective cohort of all Danish patients that contracted COVID-19, including data on what prescription medicines they used. We used these data to evaluate whether users of ibuprofen or other NSAIDs on average had a more severe course of COVID-19 than those not using these drugs.

Continue reading

ACP Recommends Non-Pharmacologic Treatments for Pain Relief From Acute Non–Low Back, Musculoskeletal Injuries

PainRelief.com Interview with:
Timothy Wilt, MD, MPH
Chair ACP Clinical Guidelines Committee
Professor of Medicine
Minneapolis VA Center for Care Delivery and Outcomes Research.

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: Acute non-low back musculoskeletal pain is common, disabling and costly. Most are treated in outpatient settings. Numerous pharmacologic and nonpharmacologic treatment options exist but there is uncertainty of their benefits, harms and costs. Additionally, opioid prescriptions are common for acute musculoskeletal injuries but have harms and can lead to chronic opioid use including dependence and overdose. ACP and AAFP developed these evidence based guidelines to assist clinicians in providing the highest quality care to their patients by considering information on benefits, harms and costs alongside patient values and preferences. Our main recommendations are as follows:

1)      ACP and AAFP recommend that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with topical nonsteroidal anti-inflammatory drugs (NSAIDs) with or without menthol gel as first-line therapy to reduce or relieve symptoms, including pain; improve physical function; and improve the patient’s treatment satisfaction.

2)      ACP and AAFP suggest that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with oral NSAIDs to reduce or relieve symptoms, including pain, and to improve physical function, or with oral acetaminophen to reduce pain.

3)      ACP and AAFP suggest that clinicians treat patients with acute pain from non–low back, musculoskeletal injuries with specific acupressure to reduce pain and improve physical function, or with transcutaneous electrical nerve stimulation to reduce pain.

4)      ACP and AAFP suggest against clinicians treating patients with acute pain from non–low back, musculoskeletal injuries with opioids, including tramadol.

Continue reading

Animal Study Finds Ibuprofen for Pain Relief Can Cause Liver Damage

PainRelief.com Interview with:
Aldrin V. Gomes, Ph.D., FAHA
Professor and Vice-Chair for Teaching,
Department of Neurobiology, Physiology, and Behavior
University of California, Davis
Davis, CA 95616

Dr. Gomes

PainRelief.com:  What is the background for this study?

Response: While many over the counter non-steroidal anti-inflammatory drugs (NSAIDs) now include a warning about potential cardiovascular disease, warnings about liver injury are hardly mentioned. This is because most NSAIDs including ibuprofen is considered to have very little potential to cause liver toxicity.

However, a 2018 publication (doi: https://doi.org/10.1016/j.cgh.2017.07.037) showed a relatively high prevalence of ibuprofen -induced liver injury in Spanish and Latin-American DILI (Drug induced liver injury) registries. As such, we were interested in determining what effects, if any, ibuprofen had on mice liver.

All Over-the-Counter Pain Relief Medications Contain Both Risks and Benefits

PainRelief.com Interview with:

Charles H. Hennekens, M.D., Dr.P.H, FACPM, FACC
Sir Richard Doll Professor and Senior Academic Advisor
Charles E. Schmidt College of Medicine
Florida Atlantic University

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: About 29 million Americans use over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) to treat pain. Every year in the United States (US),  NSAID use is attributed to  approximately 100,000 hospitalizations and 17,000 deaths. In addition, the U.S. Food and Drug Administration recently strengthened its warning about risks of non-aspirin NSAIDs on heart attacks and strokes. 

While each over the counter and prescription pain reliever  has benefits and risks, deciding which to use is complicated for healthcare providers and their patients.

Continue reading

Knee Osteoarthritis: Orthopedists Prescribing More NSAIDS and Less Lifestyle Management for Pain Relief

PainRelief.com Interview with:

Samannaaz Khoja, PT, PhD
Research Assistant Professor
Department of Physical Therapy
University of Pittsburgh School of Health and Rehabilitation Sciences

Samannaaz Khoja, PT, PhD Research Assistant Professor Department of Physical Therapy University of Pittsburgh School of Health and Rehabilitation Sciences
Dr. Khoja

PainRelief.com: What is the background for this study? 

ResponseThe purpose of this study was to describe and compare rates of physicians’ recommendation for physical therapy (PT), lifestyle-counseling, and pain medication for knee osteoarthritis (KOA) between 2007 and 2015. The study also aimed to identify patient, physician and practice-level factors associated with each treatment recommendation.   We used survey data from the National Ambulatory Medical Care Survey, data from this survey is publicly available and is housed within the CDC. We identified 2297 knee OA related visits, which approximated to 67 (±4) million weighted physician visits between 2007 and 2015 (around 8 million visits/year).

Knee Osteoarthritis: NSAIDS Offer Short-Term Pain Relief

PainRelief.com Interview with:

Raveendhara R. Bannuru MD, PhD, FAGE

Raveendhara R. Bannuru MD, PhD, FAGE
Director, Center for Treatment Comparison and Integrative Analysis (CTCIA)
Deputy Director, Center for Complementary and Integrative Medicine (CCIM)
Asst Professor of Medicine, Tufts University School of Medicine
Asst Professor of Clinical & Translational Science
Sackler School of Graduate Biomedical Sciences
Division of Rheumatology, Tufts Medical Center
Boston, MA

Director, Center for Treatment Comparison and Integrative Analysis (CTCIA)
Deputy Director, Center for Complementary and Integrative Medicine (CCIM)
Asst Professor of Medicine, Tufts University School of Medicine
Asst Professor of Clinical & Translational Science
Sackler School of Graduate Biomedical Sciences
Division of Rheumatology, Tufts Medical Center
Boston, MA

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: Though the higher rates of certain adverse events due to NSAIDs are well documented, we were curious about how soon these adverse events can begin to manifest. We were similarly interested in the efficacy trajectories of NSAIDs, because previous studies had conducted analyses of the last reported follow-up times for the drugs, but we noticed that many of the studies had only very short-term follow up ranging between 1-4 weeks which didn’t provide a more complete picture of the therapeutic effect over time.

The key findings of our study are that the widely used NSAIDs are very effective for short-term pain relief but their efficacy wanes over a period of 12 weeks. The adverse events though mild in nature start appearing within 4 weeks of treatment.

Continue reading