Opioids

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Opioids

Opioids are a class of drugs that act on the nerve cells in the body and brain to relieve pain. There are different types of opioids like Buprenorphine, Butorphanol, Codeine, Fentanyl, Oxycodone. Hydrocodone, Hydromorphone, Hydromorphone are also opioids that are not commonly used.

Buprenorphine - Subutex - FDA Approved Oct 2002 - Actavis Elizabeth LLC , Hi-Tech Pharmacal Co., Inc, Mylan Pharmaceuticals Inc. , Rhodes Pharmaceuticals L.P., Sun Pharmaceutical Industries, Inc, Teva Pharmaceuticals USA, West-Ward Pharmaceuticals

Butorphanol - Stadol - Discontinued, Generic formulations manufactured by Novex, Mylan, Apotex and Ben Venue Laboratories

Codeine - Used in cough syrups, or in a combination with paracetamol (acetaminophen) or a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen. Tylenol/Elixir are brand names.

Fentanyl - Actiq, Duragesic, Fentora - FDA approved 1959 - Janssen

Oxycodone - OxyFast, OxyIR, OxyNorm, Roxicodone - FDA Approved 1995 - Actavis, Apotex, Endo Pharmaceuticals, Mylan and many more

Methadone - Dolophine - FDA approved in 1947 - Eli Lilly, Mallinckrodt Pharmaceuticals

Opioids are in the market since ages and have been used basically for pain relief for post surgical pain, cancer related pain, chronic or persistent pain. Opioids when used in a proper dosage and along with a combination of other pain treatments, work in relieving pain successfully, until unless there is a misuse of abuse of this drug.

Misuse/Abuse of Opioids

Companies manufacturing Opioids convinced the medical community that these medications were not addictive and were purely beneficial. This belief raised the number prescriptions and sales unwarrantedly, resulting in a mass misuse of these drugs, to the extent that this was identified by FDA as a public issue and named it an 'Opioid crisis'.

Serious Alleged Injuries

  • Tolerance with continued use
  • Dependence with continued use
  • Neonatal Opioid Withdrawal Syndrome (NOWS)
  • Addiction
  • Overdose
  • Death

FDA and Lawsuit Allegations

Early 2000s, reports of abuse of Opioids started surfacing which are aggravating till date. Since then, the FDA has taken prompt actions to control the misuse in the form of issuing of warning letters, class-wide label changes, arranging workshops, designing awareness programs, and joint meetings.

The FDA also took an initiative to produce opioids which are abuse deterrent. As defined by the FDA, Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance. OxyContin, Targiniq ER, Embeda, Hysingla ER, MorphaBond ER, Xtampza ER, Troxyca ER, Arymo ER, Vantrela ER, RoxyBond are approved by the FDA with a labeling describing abuse-deterrent properties. This is in consistence with the FDA's Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling.

Allegations are made against manufacturers that they violated the rules by not informing the Federal authorities about the unusual size, suspicious purchases, or how frequently bulk quantities of opioids were purchased. There is an allegation that huge benefits were reaped by manufacturers, and they intentionally failed to inform the medical providers about the addictive nature and consequences of Opioids.

Till date, large amounts of settlements have already been agreed upon by many manufacturers for opioid crisis: McKesson, Mallinckrodt, Costco Wholesale, Cardinal Health are to name a few among them, and the fight still continues.

Evidence to be looked for in potential cases

  • Indication of usage Opioids in Medical and Pharmacy Records
  • Duration of Opioids usage
  • Complications and their treatment after Opioids intake

Medical Record Review and claim validation of Opioid case should take approximately 4 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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