Actavis cough syrup, also known as promethazine-codeine cough syrup, was a prescription cough medicine made by the pharmaceutical company Actavis. Promethazine-codeine cough syrup contained the drugs promethazine and codeine, which function as a cough suppressant and cough reliever.
When did Actavis stop making promethazine-codeine cough syrup?
Actavis discontinued production and sale of promethazine-codeine cough syrup in 2014. This followed growing concern about the recreational abuse of the medication, especially among young people and rap musicians who promoted a culture of drinking “purple drank” or “lean” – slang terms for a concoction made by mixing the cough syrup with soft drinks.
What led Actavis to discontinue their cough syrup?
Several factors contributed to Actavis’ decision to stop making promethazine-codeine cough syrup:
- Increasing rates of recreational abuse and overdose deaths related to the medication
- Regulatory pressure from the U.S. Food and Drug Administration (FDA)
- Bad publicity and reputational damage associated with recreational use of their product
- Lawsuits related to the effects of recreational abuse
- Availability of alternative cough medicine formulations less prone to abuse
The growing trend of mixing Actavis cough syrup with soda and hard candy gained popularity in the 1990s underground hip hop community in Houston, Texas. Rappers began promoting a “purple drank” concoction in lyrics, which glamorized and spread awareness of misusing the cough syrup to achieve intoxicating effects. This culture went mainstream in the 2000s, raising concerns about increased recreational use and overdose deaths involving the medication.
Data on recreational promethazine-codeine cough syrup use
According to national survey data from the Substance Abuse and Mental Health Services Administration (SAMHSA):
- About 1.2% of youths aged 12 to 17 reported recreational use of promethazine-codeine cough syrup in 2018.
- Emergency room visits involving promethazine-codeine cough syrup increased nearly 3-fold between 2004 and 2011, reaching about 33,000 visits in 2011.
- Estimated ER visits from cough syrup abuse were 10 times higher for patients aged 18 to 25 compared to other age groups.
This concerning pattern of recreational use and adverse health effects, especially among adolescents and young adults, created pressure for regulators and pharmaceutical companies to act.
FDA regulatory actions
In 2010, facing rising rates of misuse, the FDA required new labeling for promethazine-codeine cough syrup with an expanded “Boxed Warning” – the agency’s strongest safety warning:
- Highlighting the risks of misuse, overdose, and death
- Contraindicating use in children under 18 years old
- Limiting prescription to no more than 120mL per prescription
Additionally, in August 2013, the FDA announced plans to have an outside panel review the safety of codeine-containing cough/cold medications for children under 18. This increased regulatory scrutiny factored into Actavis’ subsequent decision to halt production of their cough syrup.
When did sales and distribution end?
In April 2014, Actavis officially initiated a voluntary recall of their promethazine-codeine cough syrup. The company cited concerns over misuse and abuse as the reason for the recall.
Actavis continued the process of retrieving recalled shipments from wholesalers, distributors, and pharmacies over the following months. The company confirmed completing the recall process in October 2014.
After this date, any remaining stock of Actavis promethazine-codeine cough syrup was expired and officially discontinued. No further production or sales took place after 2014.
What products were discontinued?
The Actavis cough syrup formulations discontinued in 2014 included:
- Promethazine hydrochloride and codeine phosphate syrup, 6.25-10mg/5mL
- Promethazine hydrochloride and codeine phosphate syrup, 10-10mg/5mL
These prescription cough syrups came in pint-sized plastic bottles with an Actavis label. Some of the popular street names included:
- Purple drank
- Lean
- Sizzurp
- Purple jelly
Discontinued flavors and varieties included grape, fruit punch, and cherry, though grape was the most popular. The “purple drank” name referred to the purple hue of the cough syrup.
What replaced Actavis cough syrup?
After halting production of their promethazine-codeine cough syrup, Actavis transitioned to manufacturing and selling alternate cough medicine formulations less prone to recreational misuse and abuse:
- Hydrocodone-only cough syrups (without promethazine)
- Cough syrups containing antihistamine and decongestant ingredients without opioid drugs
- Expectorant cough syrups containing guaifenesin as the active ingredient
Additionally, other pharmaceutical companies that continued to manufacture promethazine-codeine cough syrup worked quickly to implement tamper-resistant mechanisms for their bottles along with enhanced security during shipment.
Impact of discontinuing Actavis cough syrup
The 2014 recall and discontinuation of Actavis promethazine-codeine cough syrup aimed to decrease availability and curb abuse of the misused medication. Research suggests the effort achieved measurable success:
- Recreational use – Estimated past-month cough syrup abuse among high school seniors dropped from 2.2% in 2014 to 1.4% in 2015.
- Overdoses – Suspected promethazine-related overdose hospital visits declined nearly 50% from 2011 to 2018.
- Prescriptions – The number of cough syrup prescriptions filled at retail pharmacies declined by nearly 75% from 2006 to 2015.
While recreational use remains an issue, the decline across key metrics after 2014 indicates Actavis’ action served as an effective supply-side intervention. However, critics argue tighter restrictions simply displaced misuse towards other medications like codeine pills and fentanyl-laced substances.
Conclusion
Actavis voluntarily recalled and permanently discontinued their promethazine-codeine cough syrup products in 2014 amid rising public health concerns related to recreational misuse of the medication. This followed years of increasing “purple drank” cough syrup abuse, overdoses, and regulatory scrutiny. While the decision successfully reduced availability and misuse of the diverted cough syrup, it also highlighted the ongoing challenges of preventing harmful misdirection of legitimate prescription medications.
