Category: Opioids

According to a new study, opioid use during pregnancy may have a negative neurological or behavioral impact on children later in life. While previous studies have drawn a link between prenatal opioid use and adverse health outcomes in infants, the University of Missouri study found that exposure to opioids in utero can have damaging long-term effects on children, potentially impacting them into their adult years.

At issue is how opioids impact the various bacteria and microorganisms (known as the gut microbiome) inside the developing fetus. The gut microbiome serves as a measuring stick for the overall health and wellness of humans and animals.

About the Study

The University of Missouri study compared the gut microbiome of adult mice exposed in utero to the opioid oxycodone with the gut microbiome of adult mice who were not exposed to any opioids. The goal of the study was to find out how opioid exposure in gestation impacts offspring in their later years. According to the researchers, the gut microbiome of humans is very similar to the gut microbiome of mice.

The researchers identified significant disruptions to the natural balance of bacteria in the guts of the mice exposed to oxycodone in utero. The changes were linked with potential long-term impacts on both neurological and behavioral health.

More Pregnant Women Using Opioids 

It’s become increasingly common for women to use opioids during pregnancy, either due to dependency or as a result of a medical prescription. According to the Journal of the American Medical Association, from 2010 to 2017, the number of opioid-related diagnoses documented at delivery increased by 131 percent. Meanwhile, the number of babies in the U.S. born with neonatal abstinence syndrome (NAS) increased by 82 percent from 2010 to 2017.

Neonatal abstinence syndrome occurs when a baby is exposed to a drug in utero and experiences withdrawal from the drug after birth. NAS is most often caused when a mother takes opioids while pregnant and can lead to serious problems in a baby. NAS is associated with withdrawal symptoms such as irritability, seizures, vomiting, and poor feeding in newborns. One of the researchers who led the University of Missouri study noted that children exposed to opioids during gestation are at increased risk for developing an addiction to opioids later in life.

According to the Centers for Disease Control and Prevention, there has been a trend toward opioids being prescribed for pain that may not be serious, despite the risks associated with these drugs.

Other Risks of Prenatal Opioid Use

Beyond the potential long-term harm posed to children whose mothers take opioids while pregnant, prenatal opioid use is associated with other risks to infants, including:

• Neural tube defects
• Congenital heart defects (problems with the structure of a baby’s heart)
• Gastroschisis (a birth defect of the baby’s abdomen)
• Stunted growth
• Preterm delivery (birth before 37 weeks)

When it comes to opioid use during pregnancy, a significant concern is that a woman may be taking opioids without knowing she is pregnant. A baby’s cells multiply rapidly and the baby may have been exposed to the opioid for a long time before the mother knows she is pregnant.

As courtrooms continue to fill with opioid lawsuits across the U.S., researchers provide more insight into the role that pharmaceutical companies played. A recent study revealed a connection between the amount of money spent on opioid-related marketing and the number of overdose deaths in various counties across the U.S. The study showed that pharmaceutical marketing of opioids towards physicians was associated with higher prescription rates and higher amounts of overdose deaths in certain counties.

Researchers Link Opioid Deaths to Pharmaceutical Marketing 

In a study published by the JAMA Network Open, researchers found that when pharmaceutical companies spent more money on opioid marketing in a particular county, there were higher prescription rates and higher amounts of overdose deaths in that same county. The most common type of opioid marketing to doctors was in the form of incentives such as dinners or meals with company representatives. Dr. Scott Hadland from Boston Medical Center explained that the amount of each marketing payment was not as important as the frequency of visits and company interactions with doctors. The study included suggestions for lawmakers, such as imposing limits on pharmaceutical marketing. But researchers also noted that this may not be an effective solution because meals can be relatively cheap. Opioids attorneys have cited such marketing as a way to increase prescription rates of the drugs.

Millions Spent on Physician-Targeting Likely to Be Citied by Opioid Attorneys

The U.S. exceeds the rest of the developed world regarding opioid prescriptions. From 2013 to 2015, drugmakers spent almost $40 million in opioid marketing, targeting about 67,500 physicians. Researchers discovered that for every three additional payments made to physicians per 100,000 people in a county, the number of opioid overdose deaths went up 18 percent.

Birth Defects Lead to Opioid Lawsuits

Opioid prescriptions are most commonly used for pain management. They are made either from an opium plant or synthesized in a lab. Commonly misspelled as “opiods,” these drugs relax the body, can disrupt the natural release of endorphins, and can be highly addictive even when used for a short amount of time. Opioid treatment was originally limited to traumatic injuries and terminal cancer. However, drug manufacturers decided to capitalize on patients with long-term, chronic pain without informing them of the drug’s highly addictive nature. Opioids have also commonly been prescribed to new mothers recovering from childbirth, putting them at risk of chronic opioid use. There are three major categories of opioid drugs: non-synthetic, synthetic, and semi-synthetic. Within the three broad categories, there are several different opioid prescriptions such as:

• Fentanyl (Duragesic®)
• Hydrocodone (Vicodin®)
• Meperidine (Demerol®)
• Oxycodone (Oxycontin®, Percocet®)
• Oxymorphone (Opana®)

In pregnant women, opioids can cross the placenta and enter the fetal central nervous system, putting the fetus at risk for birth defects. Since these painkillers relax the body and alter the natural release of the body’s endorphins, they risk the health of the mother and baby. Opioid use either prior to pregnancy or while pregnant can cause various birth defects, including:

• Spina bifida (a type of neural tube defect)
• Hydrocephaly (buildup of fluid in the brain)
• Glaucoma
• Gastroschisis (defect in the abdominal wall)
• Congenital heart defects

Although opioids can be very effective pain management medications, the impact of opioid exposure is not fully known and can have dangerous long-term effects. The opioid epidemic has impacted not only our health system, but also our legal system. State and local governments have brought thousands of opioid lawsuits as people fight to hold pharmaceutical companies and manufacturers accountable for the part they played in this crisis. This epidemic has put a strain on our courts and on our medical emergency workers and their ability to combat the effects of opioids and overdoses.

Drug manufacturers hid the truth about the dangerous side effects of opioids in misleading advertisements. Now we know opioids could cause birth defects, and victims are turning to opioid attorneys to hold the corporations responsible.

Even though advertisements claimed that opioids are safe for long-term use, drug manufacturers prioritized profits by downplaying the now well-known dangerous side effects, including opioids’ highly addictive nature. Their strategy resulted in a misinformed public and an epidemic of prescription opioid use. But the opioid crisis doesn’t just affect those prescribed the drug, especially if the patient is a pregnant woman. The drug also affects their babies.  Researchers found a connection between women who use opioid painkillers before or during pregnancy and birth defects in their children. These recent stories show the connection between opioids and birth defects.

New Study Links Prenatal Opioid Use and Birth Defects

Opioid treatment during pregnancy can have long term effects for both the mother and growing fetus according to a study. Yet, 2% to 3% of mothers reported that they received treatment with opioid painkillers before or during pregnancy. The mothers used opioids as a result of surgical procedures, infections, chronic diseases, injuries, and other various reasons. To convince doctors of the drug’s safety, manufacturers focused on the benefits but ignored the dangerous side effects of opioids.

Opioids, Birth Defects, and Fetal Health

Birth defects caused by opioid use, specifically synthetic opioids, continues to increase at an alarming rate. The American Medical Association (AMA) reported that from 2013 to 2014, the number of deaths related to synthetic opioids rose 80% compared to the 9% increase for non-synthetic opioids. Opioid prescriptions have benefits but also pose risks to expecting mothers. Even when prescribed by a doctor, opioid painkillers may cause birth defects when used before or during pregnancy.

Gastroschisis Trends and Ecologic Link to Opioid Prescription Rates (U.S., 2006-2015) 

Gastroschisis is a birth defect in the abdominal wall, causing the child to be born with some abdominal organs outside the body. A CDC study included a comparison between the incidence of gastroschisis and opioid prescription rates and found a higher gastroschisis prevalence in areas with high and medium opioid prescription rates. Results from the study suggest that self-reported prescription opioid use in the first trimester was associated with gastroschisis. And the association between opioid prescription rates and gastroschisis seem to be more distinct in mothers who are 25 and older.

Opioid Medications Linked to Birth Defects 

Opioids, commonly misspelled as “opiods,” are pain management medications made either from an opium plant or synthesized in a lab. They relax the body by activating opioid receptors and can disrupt the natural release of endorphins. Therefore, opioids are highly addictive, even when used for a short period of time. Opioid treatment was originally limited to traumatic injuries and terminal cancer. However, drug manufacturers decided to capitalize on patients with long-term, chronic pain without informing them of the drug’s highly addictive nature. There are three major categories of opioids: non-synthetic, synthetic, and semi-synthetic. Within these categories, there are multiple prescription opioids, such as:

• Fentanyl (Duragesic®)
• Hydrocodone (Vicodin®)
• Meperidine (Demerol®)
• Oxycodone (Oxycontin®, Percocet®)
• Oxymorphone (Opana®)

Opioids can cross the placenta and enter the fetal central nervous system, putting the fetus at risk for birth defects. Since these painkillers relax the body and alter the natural release of the body’s endorphins, they risk the health of the mother and baby. Opioid use either prior to pregnancy or while pregnant can cause various birth defects, including:

• Spina bifida (a type of neural tube defect)
• Hydrocephaly (buildup of fluid in the brain)
• Glaucoma
• Gastroschisis (defect in the abdominal wall)
• Congenital heart defects

Although opioids can be very effective pain management medications, the impact of opioid exposure is not fully known and can have dangerous long-term effects.

Opioid Lawyers Confront Drug Manufacturers 

While the epidemic grows and opioid-induced birth defects continue to increase, opioid lawyers at Waters Kraus & Paul confront drug manufacturers, holding them responsible for their role in the current crisis.

As concern grows over the rise in opioid related deaths, we must also consider how the drugs affect the youngest victims and the link to birth defects in developing babies.

The damages wrought by the opioid epidemic continue to increase. The American Medical Association reports that the number of deaths directly related to synthetic opioids has risen above those resulting from non-synthetic opioids. Not only do these drugs cost innocent men and women their lives, they might also be leading to life-altering outcomes for mother and baby alike.

Opioids and Pregnancy

Approximately one out of every five expecting mothers fills an opioid prescription while pregnant. Because opioids can cross the placenta and enter the fetal central nervous system, they can be deadly for a developing fetus. Opioid use during pregnancy, even when taken as the doctor prescribes, may cause problems including:

• Miscarriage
• Preterm labor and premature birth
• Low birth weight
• Spina Bifida
• Neural tube defects
• Hydrocephaly
• Glaucoma
• Gastroschisis
• Congenital Heart Defects

It is vital that when making treatment decisions just before or during pregnancy that women and their physicians weigh the benefits of taking opioids along with the potential risks for birth defects. Always consult your doctor before starting or stopping any medications or treatments.

What Are Opioids?

According to the U.S. Food & Drug Administration (FDA), opioids are pain-reducing medications that have benefits but also pose serious risks. These drugs are made from an opium (poppy) plant or other synthetic sources that relax the body by connecting to and activating opioid receptors in the body. Because they can disrupt the natural release of endorphins, opioids can be highly addictive even when used for a short time.

There are three major opioid categories:

Non-Synthetic: Hydrocodone (Vicodin®)

Synthetic: Fentanyl

Semi-Synthetic: Oxycodone (OxyContin®, Percocet®) and Oxymorphone (Opana®)

Paul Jassen (founder of Jassen pharmaceuticals) synthesized Fentanyl, the most well-known synthetic opioid, in 1960. It was approved for medicinal use in 1968. Fentanyl is much more potent than semi-synthetic and non-synthetic opioids. The rate of death involving synthetic opioids, including fentanyl, between 2013 and 2014, increased by 80% compared to 9% for natural non-synthetic opioids.

How Galiher DeRobertis & Waxman Can Help You

The attorneys at Galiher DeRobertis & Waxman are committed to fighting for babies and children who have been injured by maternal opioid use and we are dedicated to restoring victims’ families to the fullest extent possible. We will aggressively seek to hold the pharmaceutical manufacturers and distributors responsible for placing corporate earnings ahead of your child’s health and safety. If you or someone you know has given birth to a child with a birth defect after taking prescription painkillers or opioids at any time between one month before or three months after becoming pregnant, you may be entitled to compensation. To find out if you may qualify, contact us free case review.

Larger doses may not be the problem in the opioid crisis.

According to a study of over one million commercially insured patients, the length of opioid prescriptions rather than the dosage is the prime determinant of ongoing opioid misuse among surgical patients. Misuse is defined as dependence, abuse, and/or overdose. Patients were considered opioid-naïve if their opioid use in the 60 days prior to surgery was seven days or less. Subsequent opioid refills after surgery were associated with a 44% increase in misuse among opioid–naïve patients. Along the same lines, with each additional week of prescriptions, opioid misuse increased by nearly 20%. Misuse again increased when patients received more than nine weeks of drugs.

Time vs. Dosage

According to Gabriel Brat, MD of Harvard Medical School in Boston, the recent study suggests that acquiring a refill increases one’s chances of opioid addiction. In turn, he suggests, “for surgical patients, it may be that we should focus less on the dose of opioids immediately after discharge and more on the length of time a patient is exposed to opioids.” In contrast to data from chronic opioid users, who are most routinely the group upon which guidelines are based, this study brings attention to the need to “develop protocols that are tailored for the patient population.” In other words, the one-size-fits-all approach is not working – we need multimodal pain strategies to solve the opioid crisis.

The Research

In the study, researchers pinpointed non-injected drugs with dominant ingredients of codeine, hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone, or tramadol as opioids. The morphine milligram equivalent (MME) dosage was calculated for each individual prescription.

Over half of patients were prescribed opioids after surgery, and 90% of the prescriptions were filled within three days of leaving the hospital. Patient follow-up within 2.67 years demonstrated that opioid misuse took place in 0.6% of the cases. Within one year of surgery, misuse was 0.2%

While misuse percentages were small, they did increase in proportion to the number of prescription refills with just one refill doubling the misuse rate. When post-discharge prescriptions were for less than two weeks, misuse rates remained similar. However, when refills were given for at least nine weeks, misuse rates greatly increased from 475 cases per 100,000 persons to 8,087 cases of misuse.

With such large numbers of opioid misuse based on continuous use, there is still a need for more study to determine best practices for both prescribing medicine and monitoring patients. In response to varying cases and individual patient needs, recovery programs with multiple strategies for managing pain must be studied as well.

Manufacturers play a significant role in the number of opioid prescriptions issued across the country. Aggressive marketing tactics engaged by these companies have had a direct effect on resulting complications, including death.