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Opioids

Manufacturers of opioid pain relievers are facing thousands of lawsuits filed by patients and family members of those who became addicted to the medications. Manufacturers, including Purdue Pharma, have been accused of hiding information about the dangers of their prescription pain relievers, leading to an epidemic of drug addiction and overdose deaths.

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Opioid Crisis Statistics

The National Institute of Drug Abuse states that the opioid epidemic claims more than 47,000 American lives every year. While most people think that overdoses occur with those using illegal or “street” drugs, thousands of overdoses are caused by prescription opioid medications. In addition to overdoses, an estimated 1.7 million Americans suffer from substance abuse disorder related to prescription pain killers.

  • 21-29% percent of patients prescribed an opioid for chronic pain abuse the medications
  • 8-12% develop  of patients prescribed an opioid for chronic pain develop an opioid use disorder
  • 4-6% of those who misuse prescription opioids will transition to heroin
  • 80% of heroin users started on prescription opioids
  • Opioid overdoses are increasing at a rate of about 30% annually, faster in some large cities

Purdue Pharma and OxyContin

Much of the blame for the current opioid crisis has been laid on one pharmaceutical company, Purdue Pharma. Its flagship drug, OxyContin (oxycodone), has been responsible for

In 1995, Purdue Pharma introduced OxyContin, a controlled release formulation of oxycodone. It was marketed as a “safe” alternative to currently existing painkillers due to the controlled release formulation. Purdue promoted the drug as abuse-proof and virtually non-addicting. Purdue had a marketing strategy of  obtaining 70% of prescriptions written for pain relievers. By 2002, OxyContin sales topped 7.2 million prescriptions per year and Purdue spent about $200 million to market the medication. At the same time OxyContin sales were rising, and by 2000, there had already been a significant increase in the number of opioid-related deaths.

In 2003, the Food and Drug Administration (FDA) issued a warning letter to Purdue stating that advertising was misleading regarding the information about the dangers of addiction and about overstated efficacy. The agency also required that several “black box warnings” be added to the prescribing information. Black box or boxed statement warnings are the most severe warnings that can be issued or required by the FDA. OxyContin’s black box warning stated that the higher strength tablets should only be used in opioid-tolerant patients and that the tablets should not be broken or crushed. OxyContin’s manufacturer was also required to issue a black box statement warning of the risk of addiction, overdose and death.

In 2010, OxyContin was reformulated in an attempt to make it “harder” to abuse the medication. The abuse-deterrent formulation was harder to crush and snort or inject but abuse of the medication continued to increase. Some industry critics have speculated that the reformulation was done under pressure by the DEA and FDA but was, in reality, simply a ploy to ensure that Purdue maintained patent protection against generic competition for a longer period of time.

A 2015 study on OxyContin use and abuse showed that two-thirds of OxyContin abusers continued to abuse the drug after changing to the new formula, another third had discontinued OxyContin abuse in favor of other drugs, including heroin. Of the abusers who continued with OxyContin us, about half transitioned to oral use but nearly one-third were able to circumvent the anti-abuse mechanism in the pills.

In 2017, the agency required that labeling include a new black box statement with information that abuse-deterrent properties of OxyContin does not prevent or reduce the chance of addition and that abuse by IV or intranasal (snorting) is still possible.

Opioid Lawsuits and Settlements

In 2007, Purdue Frederick Co (Purdue Pharma) pled guilty to misbranding of OxyContin and agreed to pay over $600 million in fines when it was shown that a 10mg tablet could be dissolved and withdrawn into a syringe to be injected. Purdue was also accused of misrepresenting how much an OxyContin user could experience “euphoria” after taking the medication and how much withdrawal symptoms could be expected. There is also some evidence that shows Purdue simultaneously invested in drug rehab facilities, even though they claimed their product was not addicting, showing financial benefit of continuing to sell a dangerous drug that harmed people.

Although the company has already paid hundreds of millions in fines, more federal, state and local government agency lawsuits have been filed. Now, the company and other manufacturers are facing thousands of lawsuits filed by people who have experienced addiction or overdosed or by family members of those whose loved ones died after using OxyContin or other prescription opioid medications.

Past medical injury lawsuits have provided compensation for medical costs, lost wages, pain and suffering and in some cases, punitive damages when the plaintiffs could prove that the company knew about the dangers and sold a product anyway. Some family members have also been able to gain compensation for wrongful death if a loved one died due to a dangerous medication.

Users of OxyContin or other prescription opioid pain reliever drugs who suffered addiction, overdose, or whose loved one died due to these medications should seek legal advice from an opioid lawsuit attorney.

What Are Opioids?

Opioids are a class of drugs which work to relieve pain by interacting with certain types of receptors, known as opioid receptors, in the brain and areas of the nervous system to stop pain messages from reaching the brain.  They are used as prescription medications for severe pain in cases of injury or surgery or for longer-term treatment for chronic pain conditions.

Over 11% of people living in the U.S. report that they are living with chronic pain.  Opioids are very effective drugs at treating severe pain, but they have serious drawbacks.  Opioids cause a number of side effects, some of which may be life-threatening.  In addition to relieving pain, opioids also produce feelings of euphoria and have calming or sedative effects.  These effects make opioids subject to abuse.

The opioid drug classification includes opiates, which are naturally derived, and synthetic medications which affect the same receptors.  The opioid category includes a number of prescription, controlled substance pain relievers along with illegal drugs like heroin.  Both natural and synthetic opioid medications, whether legal or illegal, can be addictive.

In the U.S. there has been a 300% increase in the number of pain prescriptions over the last 20 years even though Americans do not report an increase in severe pain.  Overuse and abuse of opioid medications have resulted in a health crisis in the U.S. with an epidemic of overdose deaths and cases of drug addiction.  Because of these effects, a number of health and law enforcement authorities at the state, county, local and tribal levels have filed lawsuits against companies who manufacture, market and distribute opioid medications.

Side Effects of Opioids

All drugs cause side effects but opioid side effects can be bothersome, dangerous or even life-threatening.  Common side effects of opioids include:

  • Nausea
  • Vomiting
  • Drowsiness
  • Dizziness
  • Constipation

In more severe cases, opioids can also cause more serious side effects.  These may include:

  • Allergic reaction
  • Decreased breathing response
  • Slowed heart rate
  • Loss of consciousness
  • Death

Opioids are known to be drugs of abuse and can produce physical dependence, both of which may increase the risk of addiction.  Even with careful management, there is some risk of abuse and dependence, but patients should be instructed to follow directions and to avoid taking more medication than prescribed.  Patients who are given pain medication prescriptions should discuss the risks of addiction with their physician.

Opioids have sedating effects and can interact with other sedative medications to cause additive effects.  These may antianxiety agents, sleeping pills, antidepressants, anticonvulsants and also includes alcohol.  Patients should be advised to discuss all of their medications with their doctor and to avoid drinking while taking opioid pain medication.

Like all medications, opioids should be kept out of reach and away from children, but they should also be kept away from people who may be susceptible to drug abuse, including older children and teenagers.  A significant number of Americans have become addicted to opioid pain medications which were originally prescribed for a family member or someone they knew.  It is illegal for someone to take controlled substance medication like opioid pain medications which have not been prescribed to them.

Type of Opioids

There are many members of the opioid drug class, including legally prescribed pain medications and illegal drugs like heroin.  Prescription opioids come in a number of dosage forms, including injections solutions, oral liquids, transdermal medications to be absorbed through the skin and the most common, oral tablet or capsule medications.  Prescription opioids are also considered controlled substances which are strictly regulated by state and federal drug agencies.

Specific prescription opioids include:

  • Morphine – available in oral liquid, tablet, and injectable form. Used for severe acute and chronic pain, as a sedative in hospital settings and to treat certain heart conditions.
  • Fentanyl – available in injectable, transdermal and sublingual (under the tongue) forms as a treatment for chronic or severe pain and as an anesthetic during surgical procedures.
  • Hydromorphone – available in injectable, oral liquid and tablet formulations. Used for severe acute and chronic pain and other conditions in a hospital or closely supervised setting.
  • Oxycodone – available in tablet formulation for severe and chronic pain. One of the most commonly abused prescription medications and is considered responsible for a significant portion of the opioid epidemic.
  • Hydrocodone – available in tablet and liquid formulation, usually in combination with acetaminophen or ibuprofen, for the treatment of moderate to severe pain or in liquid form in combination with respiratory medications for excessive coughing. Likely the second most commonly abused prescription medications in the U.S.
  • Codeine – available in tablet formulation in combination with acetaminophen and other ingredients for the treatment of moderate pain, and in combination with other ingredients for the treatment of excessive coughing.
  • Methadone – available in oral liquid and oral tablet form. Used for pain relief and narcotic maintenance dosing for heroin addicts.

Heroin, an illegal drug, is also an opioid.  It is most commonly injected intravenously but is used (smoked) as an inhalant.  Some people who have been prescribed opioid pain medications but become dependent or addicted and are no longer able to get prescription painkillers, turn to heroin to fulfill their need for opioids.

Even when obtained through a legal prescription for a legitimate medical purpose, it is illegal to buy, sell or share a prescription opioids such as OxyContin (oxycodone).  Opioids should only be taken, as prescribed, and by the person who received them by prescription.

Dangers of Opioid Use

Even though opioids are effective medications for the treatment of severe and chronic pain, and used for other medical conditions, they are considered highly dangerous.  Abuse, misuse, and overuse of opioids can lead to addiction and other medical complications, up to and including death.

Opioid prescription users who become addicted to their medications but are no longer able to obtain legal prescriptions may turn to illegal methods to continue to use opioids.  This may include buying prescription drugs from dealers or over the internet, stealing drugs from other users or ultimately, turning to heroin to avoid withdrawal.

The dangers of illegal opioid use are high, including criminal concerns which may result in prison time.  Often, however, the danger is in the drug itself.  The purity of drugs purchased on the street, particularly with a drug like heroin which may vary from purchase to purchase, is questionable.  Overdose may be caused by a sudden increase in potency but also by adulteration with stronger opioids like fentanyl which has been mixed in with the heroin.

Many people may believe that prescription opioids are safe because they have been prescribed by doctors.  Unfortunately, this is not the case and many opioid addicts were once, prescription pain patients who failed to follow instructions or to note the signs of addiction and continued to abuse the drugs.

Opioid Abuse, Dependence and Addiction

The concepts of abuse, dependence, and addiction are often interchanged but each is a different occurrence.

Opioid abuse – Opioid abuse is the use of opioids in a manner that was not prescribed.  It may mean that they are used more frequently or in larger doses than prescribed or used for reasons other than pain relief, for the euphoric effects.

Opioid dependence – Opioid dependence is a physical occurrence in which the body has adapted and developed tolerance to the drug.  Once dependence has developed, more and more of the drug will be needed to obtain the same effect.  Discontinuing the drug once physical dependence develops will result in symptoms of withdrawal.

Opioid addiction – Opioid addiction causes a compulsive need to seek and use the drug.  The user is unable to stop and will lose interest in other activities, discarding them in preference to drug use.  Addiction occurs with dependence, but it is possible to be physically dependent upon opioids and not display addiction behaviors.

Opioids are highly addictive but also cause extreme physical dependence.  Discontinuation of the drugs will lead to withdrawal symptoms which can be extremely painful and debilitating.  Withdrawal symptoms add to the significant challenges of addiction and even if desiring to quit, addicts may be unable to stop seeking opioids in order to avoid withdrawal.  In most cases, opiate addicts will not be successful at recovery without assistance.

Signs of Opioid Abuse

Opioid abuse will often occur before addiction has developed.  Physical or behavioral signs of opioid abuse may indicate that addiction is a potential problem and include:

  • Constricted pupils (pinpoint) even in dim or low light
  • Symptoms of withdrawal including restlessness, anxiety, sweating, diarrhea, nausea and vomiting and dilated pupils
  • Presence of empty pill bottles, even when a person has not had a prescription or one has ended
  • Medication that belongs to someone else has gone missing
  • Excessive or unexplained spending with no evidence of purchases
  • Selling off of valuable belongings
  • Money that has been stolen or is missing
  • Missing work or school
  • Withdrawing from social activity
  • Excessive irritability
  • Periods of excessive sleepiness or falling asleep at unusual times (nodding off)
  • Complaints of illness or symptoms of flu which seem to appear and disappear frequently
  • Neglecting personal hygiene and/or household duties

Signs of IV drug use may include the presence of paraphernalia including syringes, cotton wads, burnt spoons; needle marks or unexplained bruises on arms, legs or neck; sudden desire to wear clothing that may conceal signs of injection such as long sleeves or scarves even in warm weather.

Opiate or opioid addiction will rarely resolve on its own and usually requires assistance.  The first step in overcoming addiction is to seek help.  There are multiple avenues of support which can be utilized including treatment centers, support groups, and medical programs or procedures which may include drugs like methadone and buprenorphine to assist with withdrawal.

Signs of Opioid Overdose

One of the biggest dangers in opioid use is the threat of overdose, which is often fatal.  The number of opioid overdoses in the U.S. has skyrocketed over the past several years and 63% of all drug overdoses are with opioid drugs.  Overdoses are more likely with injectable, nasal inhalation or smoking methods of opioid use, rather than slower methods of oral or transdermal use.

Oddly, withdrawal symptoms are also a major risk factor for overdose.  If opioids are suddenly discontinued, withheld or unavailable, the user may seek out stronger or unknown forms and use too much, to quickly alleviate symptoms of withdrawal.  When possible, opioid withdrawal should be done slowly and/or should be medically supervised.

Signs of possible overdose include:

  • Vomiting
  • Loss of consciousness
  • Slowed breathing or no breathing
  • Cold skin
  • Fingernails or lips appear purple or blue

Opioid overdose results in depressed respiratory response which can result in death within a few minutes.  A suspected overdose should be treated as a medical emergency.  People who suspect an opioid overdose should immediately dial 911 and inform the operator of the possibility of a drug overdose, telling them what drug was involved.  This will help them send the right type of assistance as soon as possible.

Opioid overdose can be reversed if treated in time.  The drug naloxone is used to counteract the effects and is carried by emergency services personnel and many police officers.  In addition, in some areas, naloxone may be purchased in pharmacies but it must be delivered shortly after respiration stops.

An Opioid Epidemic

In the U.S., about 3 million people may be living with an opioid dependence, many of whom are opiate addicts.  This number has been growing for the past several years and has become a major public health concern.

Overdose deaths quadrupled between 2002 and 2017 and each year, the number of opioid overdose deaths vastly exceeds the number of gun-related deaths – both accidental and intentional.  The opioid epidemic has been called the biggest drug crisis in U.S. history.

Prescription opioid use is a major reason for the opioid epidemic.  Prescription use of opioids has dramatically increased over the last decades and in 2015, one-third of adults in the U.S. received an opioid prescription.  Many of these prescriptions may be unnecessary and are shared with friends, family members, and others.

Recently, public health agencies and law enforcement organizations have begun to sue manufacturers of opioid medications, for marketing their drugs inappropriately and stating falsely that the painkillers are not addicting.  Doctors are under increasingly strict guidelines and politicians are finally attempting to help solve the opioid crisis.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

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