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Opioid Lawsuit | Prescription Painkillers
Opioids are powerful drugs that are designed to relieve pain. However, over-prescription has led to an epidemic of addiction and overdoses – sometimes fatal – across the nation, as well as several other health complications.
What’s the Problem with Opioids?
There are several drugs that fall under the opioid classification, such as hydrocodone, morphine, oxycodone and others. Some of the more commonly known brand names include:
Many cities and states across the U.S. have sued opioid manufacturers, alleging that deceptive marketing has contributed to the addiction epidemic. Plaintiffs in these lawsuits are alleging that manufacturers downplayed the risks of addictions and other complications. This allegedly led to the over-prescription of painkillers, which often led to devastating consequences. And since litigation in this area is still unfolding, much more information will likely be revealed.
If these allegations are proven true, this will help explain why deaths and injuries associated with opioid addiction and overdoses have exploded in the United States. According to the Centers for Disease Control, deaths attributed to drug overdoses have tripled since 1990. In 2014 alone, the CDC reports, more than 16,600 people lost their lives due to prescription painkiller overdoses. Even though state and federal lawmakers have passed legislation in order to reduce the number of overdoses, opioid painkillers continue to be over-prescribed.
As devastating as opioid addiction and overdoses can be, there are several other health complications that have been linked to prescription painkillers. These include:
- Serotonin Syndrome – This is a condition that causes high levels of serotonin in the body. While this chemical is essential to the functioning of the brain and nerve cells, too much can cause serious problems. These range from minor (shivering and diarrhea) to severe (fever, seizures and muscle rigidity). This problem can even be fatal if it is not properly treated.
- Androgen Deficiency – Androgen deficiency is a chronic problem that is often under-diagnosed. Opioids can inhibit the secretion of androgen, a hormone the body needs for sex drive as well as proper sexual functioning.
- Adrenal Insufficiency – This is a rare hormonal disorder that occurs when the adrenal glands cannot produce enough of the hormone cortisol. Cortisol not only helps with cardiovascular functioning and blood pressure maintenance, it also helps regulate the metabolism of fats, proteins and carbohydrates.
One of the biggest problems with opioids is that manufacturers have allegedly marketed these powerful painkillers for relatively mild discomfort rather than for patients suffering debilitating pain. Plaintiffs in lawsuits are alleging that manufacturers have known for years opioids are addictive and debilitating, yet they wanted to expand the market for these drugs in order to maximize profits.
One example is the drug OxyContin, released in 1996. Sales exploded from $40 million to approximately $1 billion in just five years, according to a 2009 article that appeared in the American Journal of Public Health, largely due to the fact that the manufacturer marketed the drug as being far less addictive than other opioid medications.
This is just one example of the aggressive marketing that helped contribute to the deadly epidemic of opioid addiction that has swept the country. According to the CDC, consumers spend four times as much money on opioids than they did in 1999, and approximately 40 Americans die each day due to opioid overdoses.
Opioids and the FDA
On March 22, 2016, the U.S. Food and Drug Administration (FDA) announced it is requiring that immediate release opioids (drugs that are typically intended for use every four to six hours) carry black-box warnings informing users of the risk of abuse, addiction, overdose and death. The goal of the warning, according to the FDA, is to fight what it describes as “an epidemic of addiction.”
Warnings on medications such as hydrocodone and oxycodone will now have to state they should only be used for patients with pain so severe no other treatments have been effective. In addition, the FDA is now requiring that dosage instructions should be clarified regarding how much of a drug should be taken initially and how that dosage should be adjusted.
According to the announcement, 87 brand-name drugs and 141 generic drugs will be affected by the new warning labels. In addition, the warning labels will state that the babies of pregnant women taking opioids could develop a potentially fatal condition known as neonatal opioid withdrawal syndrome.
Labels of both immediate release and extended release opioids will need to provide information regarding the risk of serotonin syndrome, adrenal insufficiency and androgen deficiency. Extended release opioids are typically taken one or two times a day. These tend to be more addictive because they contain more opiates per pill. In 2013, the FDA required that extended release opioids carry a black box warning.