Do NSAIDs Accelerate Progression of Knee Osteoarthritis?

PainRelief.com Interview with:
Dr Thomas Perry PhD| Postdoctoral Research Fellow
Versus Arthritis Centre for Sport, Exercise and Osteoarthritis Research 
Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences

Dr Thomas Perry PhD| Postdoctoral Research Fellow
Versus Arthritis Centre for Sport, Exercise and Osteoarthritis Research 
Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences
Dr. Perry

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

Response: Management of knee osteoarthritis (OA) is multi-factorial and routinely involves the use pharmacological interventions; with most medications aimed at alleviating painful symptoms and improving function.

Little is known of the long-term effects of such medications on the structural progression of radiographic knee OA. Through examining the relationship between pharmacological interventions and the disease pathway, this may, in turn, identify potential areas for disease-modifying treatment development.

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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

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Voltaren® Arthritis Pain Provided Meaningful Pain Relief in Knee Osteoarthritis

PainRelief.com Interview with:

Jeffrey Fudin, B.S., Pharm.D., FCCP, FASHP
Diplomate, American Academy of Pain Management
Section Editor, Pain Medicine

Dr. Fudin

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

Response: Osteoarthritis (OA) affects over 14% of the United States population. As such it is important to establish effective, well-tolerated, and safe medication options. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) act locally and are strongly recommended for patients with knee osteoarthritis as a first line option prior to chronic oral NSAID use in an effort to minimize systemic exposure, as oral products, result in tremendously higher blood levels compared to their topical counterpart.

PainRelief.com: What are the main findings?

Response: Diclofenac sodium gel 1% (DSG 1%), a topical NSAID, provided better pain relief than non-drug vehicle alone for patients with knee osteoarthritis in 3 clinical trials. A post-hoc meta-analysis of these trials was conducted to determine the percentage of patients achieving a minimal clinically important improvement (MCII) in pain and other symptoms of OA to gain insight into the real world clinical impact of topical diclofenac for patients. The MCII is defined as the smallest improvement in symptoms viewed as clinically meaningful for patients. In short, the MCII represents an improvement of relevance in a clinical trial and the minimal meaningful change at an individual level.

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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.

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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.

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Fixed-Dose Combination Acetaminophen/Ibuprofen for Postoperative Dental Pain

PainRelief.com Interview with:

Prof Chris Frampton PhD Department of Medicine University of Otago Christchurch, New Zealand

Prof. Frampton

Prof Chris Frampton PhD
Department of Medicine
University of Otago
Christchurch, New Zealand

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

Response: Acute pain is a significant burden to the individual and to society. In light of the ongoing opioid crisis, there is a need for effective nonopioid pain medications that provide improved analgesia over common analgesics, without compromising tolerability. Multimodal analgesia combines multiple drugs with different mechanisms of action to improve pain relief while limiting side effects. Fixed-dose combination tablets containing acetaminophen and ibuprofen are already available in many countries; however, the therapeutic advantages of such products are not available to patients in the United States. The US Food and Drug Administration (FDA) has restricted the dose of acetaminophen in prescription drugs to 325 mg per tablet, therefore an existing product containing acetaminophen 500 mg + ibuprofen 150 mg per tablet (two tablets per dose) has been downscaled to comply with FDA restrictions (acetaminophen 325 mg + ibuprofen 97.5 mg, three tablets per dose). The goal of this study was to determine the efficacy of the new fixed-dose combination of acetaminophen 975 mg and ibuprofen 292.5 mg (FDC 975/292.5) relative to acetaminophen or ibuprofen monotherapy, or placebo following the surgical removal of at least two impacted third molars.

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