|FDA Nonsteroidal Anti-inflammatory Drugs (NSAIDs) FDA||10/15/2020||FDA||Document Link|
|FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid FDA||10/16/2020||FDA||Document Link|
|FDA Warning NSAID Drugs (NSAIDs)- Drug Safety Communication - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later FDA||10/28/2020||FDA||Document Link|
|FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications FDA||10/15/2020||FDA||Document Link|
The FDA Reports That NSAIDs May Cause Rare Kidney Problems in Unborn Babies
The FDA Recommends All Pregnant Women to Stop Using NDAIDs at 20 Weeks and Beyond
According to the FDA’s 10-15-2020 FDA Drug Safety Communication regarding expectant mothers and NSAIDs, women who are pregnant “should not take Nonsteroidal anti-inflammatory drugs (NSAIDs) at 20 weeks or later unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby.”
The FDA stated that the use of NSAIDs at approximately 20 weeks or later in pregnancy could result in “rare but severe kidney problems in an unborn baby.” The condition might lead to dangerously low levels of amniotic fluid around the unborn baby and may cause serious complications to the baby. NSAIDs are typically used to relieve fevers and pain. NSAIDs include drugs such as ibuprofen, aspirin, diclofenac, naproxen, and celecoxib. At about 20 weeks of pregnancy, an unborn baby’s kidneys bring to produce a majority of the amniotic fluid. If the unborn baby suffers kidney problems, then the baby’s kidneys may not produce enough amniotic fluid. The purpose of amniotic fluid is to provide the unborn baby with a protective cushion and to help the unborn babies’ digestive system, lungs, and muscles develop properly.
The FDA recommends that pregnant women speak with their doctors and other health care professionals about the risks of taking NSAIDs and other medications while pregnant and especially when the expectant mother has been pregnant for 20 weeks or later.
Several OTC over-the-counter and prescription medicines contain NSAIDs. Therefore, it is imperative to review all “Drug Facts” labeling to determine if the medicines you or your pregnant loved one is taking contains NSAIDs. If you or your pregnant loved one are uncertain of a medication contains an NSAID, contact your health care professional or a pharmacist for assistance.
The FDA states that there may be safer alternatives, such as acetaminophen, which may be recommended by your health care provider to any fever, discomfort, or pain during pregnancy
What are NSAIDs, and how do NSAID medications work?
Prostaglandins are a class of chemicals created by the body’s cells that serve several essential functions. However, inflammation produces fever and pain. Prostaglandins are produced inside the body’s cells by a chemical called cyclooxygenase (COX). Cyclooxygenase is an enzyme, and the body produces two different types of cyclooxygenase enzymes- COX-1 and COX-2. The two cyclooxygenase enzymes create prostaglandins in order to promote inflammation, pain, and fever, which are integral parts of the body’s natural healing process. COX-1 forms prostaglandins to protect the stomach lining and to support blood platelets.
Nonsteroidal anti-inflammatory drugs (NSAIDs) work by blocking COX enzymes. When the COX enzymes are blocked, the amount of prostaglandins in the body decreases. As the amount of prostaglandins flowing through the body decreases, the amount of pain, inflammation, and fever also decrease.
The History of NSAIDs and Links to Severe Adverse Effects
In 1897, Felix Hoffmann, a German chemist, and the Bayer company developed a process of converting salicylic acid (a naturally occurring substance) into acetylsalicylic acid. This new acid was later named aspirin by Heinrich Dreser. In the 1950s’ companies began producing different classes of NSAIDs such as ibuprofen.
The popularity and diverse uses for NSAID medications has led to a number of reports concerning side effects and some severe adverse effects. Today, there are approximately 70,000,000 NSAIDs prescriptions sold each year in the United States. Another 30 billion over-the-counter doses of NSAIDs are sold each year in the United States. In the 1990s, prescription NSAIDs were linked to severe upper gastrointestinal adverse events causing bleeding and deaths. NSAIDs are some of the most studied medications on the market
What NSAIDs are approved in the United States?
The following list of NSAIDs is listed by generic name and by brand name. The NSAID medications that are available “Over-the-counter” are marked with an (*) asterisk.
- Aspirin*: Anacin, Ascriptin, Bayer, Bufferin, Ecotrin, Excedrin, Aggrenox®, Alka Seltzer®, Anacin®, Arthritis Foundation Pain Reliever®, Arthritis Pain Formula, ASA Enseals®, ASA Suppositories®, Ascriptin A/D®, Ascriptin®, Aspergum®, Asprimox®, Axotal®, Azdone®, Bayer® (most formulations), BC® Powder and Cold formulations, Bufferin® (most formulations), Buffets II®, Buffex®, Cama® Arthritis Pain Reliever, COPE®, Dasin®, Easprin®, Ecotrin® (most formulations), Empirin® Aspirin (most formulations), Epromate®, Equagesic Tablets, Equazine®, Excedrin®, Excedrin® Migraine, Extra-Strength Analgesic Tablets and Caplets, Fiorgen®, Fiorinal® (most of the formulations), Fiortal®, Gelpirin®, Genprin®, Gensan®, Headrin®, Heartline®, Isollyl®, Lanorinal®, Lortab® ASA Tablets, Magnaprin®, Marnal®, Micrainin®, Momentum®, Norgesic Forte® (most of the formulations), Norwich® Aspirin, Orphengesic®, PAC® Analgesic Tablets, Painaid®, Panasal®, Percodan® Tablets, Persistin®, Robaxisal® Tablets, Roxiprin®, Saleto®, Salocol®, Sodol®, Soma® Compound Tablets, Soma® Compound with Codeine Tablets, St. Joseph® Adult Chewable Aspirin, Supac®, Synalgos®-DC Capsules, Tenol-Plus®, Trigesic®, Vanquish® Analgesic Caplets, Wesprin® Buffered, Zee-Seltzer®, ZORprin®
- Choline and magnesium salicylates: CMT, Tricosal, Trilisate
- Choline salicylate: Arthropan
- Celecoxib: Celebrex
- Diclofenac (Cambia, Cataflam, Zipsor, Zorvolex)
- Diclofenac potassium: Cataflam
- Diclofenac sodium: Voltaren, Voltaren XR
- Diclofenac sodium with misoprostol: Arthrotec
- Diflunisal: (Dolobid is a discontinued brand)
- Etodolac: (Lodine and Lodine XL are a discontinued brand)
- Fenoprofen calcium: Nalfon
- Flurbiprofen: Ansaid
- Ibuprofen: Advil*, Pediatric Advil, Advil/Motrin, Advil Migraine, Medipren, PediaCare, Children’s Pain Reliever/Fever Reducer, PediaCare Infant’s Pain Reliever/Fever Reducer, Caldolor, Duexis, Children’s Motrin, IBU-Tab, Motrin*, Motrin IB, Nuprin, Neoprofen (ibuprofen lysine), Proprinal, Rufen
- Indomethacin: Indocin, Indocin SR
- Ketoprofen: Actron, Orudis, Orudis KT, Oruvail. ketoprofen (Active-Ketoprofen and Orudis are discontinued brands)
- Ketorolac (Toradol is a discontinued brand)
- Magnesium salicylate: Arthritab, Bayer Select, Doan’s Pills, Magan, Mobidin, Mobogesic
- Meclofenamate sodium: Meclomen
- Mefenamic acid: Ponstel
- Meloxicam: Mobic
- Nabumetone: (Relafen is a discontinued brand)
- Naproxen – Naproxen sodium: Aleve*, Aleve-24*, Anaprox, Anaprox DS, EC- Naprosyn, Naprosyn, Naprelan, Treximet (combination with sumatriptan), Vimovo (combination with esomeprazole)
- Oxaprozin: Daypro
- Piroxicam: Feldene
- Rofecoxib: Vioxx (Taken off the market after killing hundreds of thousands)
- Salsalate: Amigesic, Anaflex 750, Mono-Gesic, Salflex, Salsitab, (Disalsate and Amigesic are discontinued brands)
- Sodium salicylate: various generics
- Sulindac: (Clinoril is a discontinued brand)
- Tolmetin sodium: (Tolectin is a discontinued brand)
- Valdecoxib: Bextra
If your unborn baby sustained complications such as kidney damage or if you were diagnosed with low amniotic fluid (Oligohydramnios), contact Parker Waichman LLP for your free initial case review. Call 1-800-YOURLAWYER (1-800-968-7529) for your free consultation.
What are the side effects of Nonsteroidal anti-inflammatory drugs (NSAIDs)?
Nonsteroidal anti-inflammatory drugs (NSAIDs) have been associated to several side effects. The type and frequency of side effects vary among NSAIDs and the patient taking the medication
A few of the most common NSAIDs side effects are:
- decreased appetite,
- rash, and
Fetal-related NSAIDs side effects that have been reported:
- Low amniotic fluid
- Fetal kidney injury
- Oligohydramnios (low amniotic fluid) – is associated with:
- Kidney problems of the in utero fetus
- Dialysis of the fetus in utero
- Dialysis of the neonate when born
- Poor fetal growth
- Placental abruption
- Chronic high blood pressure of the mother
- Diabetes of the mother
- Club foot
- Hypoxic ischemic encephalopathy (HIE)
- Cerebral palsy
- Preterm birth
- Meconium aspiration
Other more serious side effects associated with NSAIDs include:
- allergic reactions (asthmatics),
- bleeding and perforation of the stomach,
- bleeding and perforation of the intestines,
- extended bleeding after surgery or injury,
- fluid retention that may lead to edema,
- heart attacks,
- kidney failure (primarily with chronic use),
- liver disease,
- liver failure,
- Reye’s syndrome
- shortness of breath,
- swelling of the ankles, and
If your unborn baby suffered kidney injury or if you were diagnosed with low amniotic fluid (Oligohydramnios), contact Parker Waichman LLP for your free initial case review. Call 1-800-YOURLAWYER (1-800-968-7529) for your free consultation.
What are the Symptoms of Oligohydramnios (low amniotic fluid)?
Oligohydramnios is a medical condition, in which there is not enough amniotic fluid surrounding the unborn baby. Amniotic fluid is the watery fluid, produced by the baby’s kidneys while inside the amniotic sac (membrane). Oligohydramnios is a condition that occurs in approximately 4% of all pregnancies. In order for your baby to develop and grow properly, the proper volume of amniotic fluid must be present in utero.
The following are some of the possible signs and symptoms of Oligohydramnios:
- Mother dehydrated.
- Uterus measures small for the gestational age.
- Fetus not growing as fast as it should.
- Low pregnancy weight of the mother.
- Baby’s heart rate has a sudden drop.
- Low amniotic fluid on ultrasound.
- Was the mother informed of the Amniotic Fluid Index (“AFI”) score?
- An AFI score is a quantitative estimate of amniotic fluid. The AFI score is an indicator of fetal well-being. AFI is the score (expressed in cm) given to the amount of amniotic fluid seen on ultrasonography of a pregnant uterus.
- Little movement of the fetus.
- Was the mother informed of the Amniotic Fluid Index (“AFI”) score?
What is FDA Doing to Protect Pregnant Women?
The FDA is now requiring prescription NSAIDS to inform patients about the “potential risk of kidney problems in unborn babies that result in low amniotic fluid.” The FDA is also advising pregnant women who are at 20 weeks or later in pregnancy to stop using NSAIDs. If the health care provider deems it necessary that a pregnant patient uses an NSAIDs, the FDA is advising to health care professional to limit the NSAID dosage to the lowest effective dose and to limit the usage to the shortest duration possible.
The FDA is requiring several labeling changes and advises health care professionals to consider ultrasound monitoring of amniotic fluid if a pregnant mother uses an NSAID beyond 48 hours. The FDA is also requiring an update on all NSAID Drug Facts labels on adult over-the-counter NSAIDs. The “Drug Facts” labels currently warn women who are pregnant or who are breastfeeding to speak to their health care professional before taking NSAID medicines.
Why Should You File an NSAID Fetal Kidney Injury Lawsuit?
October 15, 2020 – According to a press announcement, the U.S. Food and Drug Administration published a new Drug Safety Communication requiring labeling revisions for all nonsteroidal anti-inflammatory drugs (also known as NSAIDs). These label modifications will include a new warning to pregnant women alerting them of the risk of a severe kidney condition that may develop in their unborn babies when taking NSAIDs during pregnancy. This kidney condition can lead to low levels of amniotic fluid (the fluid that protects the unborn baby) which increases the risk for kidney damage, low amniotic fluid (Oligohyramnios), and fetal kidney injuries.
NSAIDs come in both over-the-counter (OTC) and by prescription-only. These medications work by obstructing the creation of specific chemicals inside the body that create inflammation. Although aspirin is classified as an NSAID, the FDA’s warning and recommendations do not pertain to low-dose aspirin (81 mg) usage. Low-dose aspirin is often used as an important treatment for certain conditions during pregnancy. Low-dose aspirin should only be taken by pregnant women as indicated by their doctor.
Patrizia Cavazzoni, M.D., the acting director of FDA’s Center for Drug Evaluation and Research, stated that the FDA is using “its regulatory authority to inform women and their health care providers about the risks of NSAIDs are used after around 20 weeks of pregnancy and beyond.”
As stated in the FDA’s Drug Safety Communication, the FDA’s warning to patients and medical professionals reflects the FDA’s evaluation of the cases reported to the FDA and medical literature concerning low fetal amniotic fluid levels and kidney issues connected to NSAID use by the mother during pregnancy.
An unborn baby’s kidneys start producing most of the amniotic fluid after about 20 weeks of pregnancy. If the unborn baby begins to have kidney complications after 20 weeks, the unborn baby may not produce enough amniotic fluid. Low levels of amniotic fluid is a medical condition called oligohydramnios. Oligohydramnios can develop a few days or weeks after the pregnant mother begins taking a regular regimen of NSAID. Fortunately, oligohydramnios typically disappears quickly after the pregnant mother discontinues taking the NSAID.
In the case of prescription NSAIDs, the FDA now requires revisions to the prescribing information that will now warn pregnant women of the potential risks of kidney problems in unborn babies resulting in low amniotic fluid.
The FDA also reviewed reported cases of kidney problems in unborn babies and low amniotic fluid levels connected with NSAID use during pregnancy. Of the 35 cases of fetal kidney problems and low amniotic fluid levels that were reported to the FDA, all of the reported cases were severe. Two newborns passed away due to kidney failure, and it was later determined that these cases involved low amniotic fluid, and both mothers were taking NSAIDs while pregnant. In three other cases, three other newborn babies passed away due to kidney failure, and the amniotic fluid levels were within normal limits, and all of the mothers were taking NSAIDs while they were pregnant. In 11 additional cases, low amniotic fluid levels were reported during each of those pregnancies, and the amniotic fluid levels returned to normal limits once the NSAID medications were stopped. The information from the cases was similar to what was found in the medical literature. In several reports, the low amniotic fluid condition reappeared once the same NSAID was taken by the pregnant women again.
The new warning will also recommend women avoid the use of NSAIDs at 20 weeks due to the risk of oligohydramnios. Currently, there are existing warnings in the prescribing information about taking NSAIDs at around 30 weeks of pregnancy. The existing warning is already included in the prescribing information since NSAIDs can lead to heart problems in unborn babies during this period of fetal development.
The FDA notice also recommends that health care providers who believe NSAID use is necessary between 20 and 30 weeks of pregnancy should restrict the NSAID dosage to the lowest effective dose and for the “shortest duration possible.” According to the Drug Facts labels, all over-the-counter NSAID manufacturers will update their labeling on their adult NSAID products.
Why Choose Parker Waichman LLP for Your Case?
Parker Waichman LLP’s products liability attorneys pursue complete financial compensation for mothers whose babies suffered NSAID-related injuries. Parker Waichman LLP’s legal professionals understand that no amount of financial compensation could reverse the damage caused to your baby by a dangerous drug. However, our firm will fight to obtain justice and hold the responsible parties liable for the harm they have caused you, your child, and your family.
Parker Waichman LLP’s Awards and Accolades
Parker Waichman LLP has been awarded several distinguished awards and accolades for our firm’s excellence in the legal profession. Some of our firm’s accolades include:
- S. News & World Report’s “Best Law Firms” Honoree,
- 8 rating out of a potential 10.0 on reputable website AVVO,
- Highest Rating of “5 Dragons” based upon peer review,
- Recipient of “Top U.S. Verdicts,”
- Member of Distinguished group of “Billion Dollar Trial Lawyers,” and
- Highest Peer Rating by Martindale-Hubbell.
To date, Parker Waichman LLP has recovered over $2 billion in damages for their clients since the law firm opened.
Contact Parker Waichman LLP For Your Free Consultation
If your unborn baby sustained NSAID complications such as kidney damage or you were diagnosed with low amniotic fluid (Oligohydramnios), contact Parker Waichman LLP for your free initial case review. Call 1-800-YOURLAWYER (1-800-968-7529) for your free consultation.
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