Corex Cough Syrup - Opioid Addiction Over-the-Counter

Codeine is methyl-morphine

Corex Cough Syrup contains codeine – an addiction causing opioid. One 100ml bottle of codeine containing Corex cough syrup has the same effect as a 30mg tablet of morphine. The drug belongs to the same class of substances as heroin. Medicines are routinely purchased over-the-counter at most pharmacies in Pune and cough syrups very frequently so. Always read the fine print.

Codeine suppresses the cough reflex through a direct effect on the cough centre in the brain stem. However, there is little evidence in the medical literature to support its use as a cough suppressant. Several studies show that codeine does not reduce cough frequency, intensity, or duration (Herbert & Brewster, 2000).

Patients who are prescribed Corex cough syrup or those who buy it over-the-counter are not warned of its addiction potential. They subsequently continue using it as they 'feel restless and anxious' without it. These feelings are part of the spectrum of withdrawal symptoms associated with all opioids, and are another sign of addiction. A 36 year old woman who came to me for treatment of lethargy and lack of interest was consuming a bottle of Corex cough syrup every day for more than two years. Patients and parents should be educated about the lack of benefit and the addiction risk of codeine cough syrups (American Academy of Pediatrics, 1997).

Pharmacists dispensing Corex cough syrup know its potential for addiction. They have their 'regulars' who buy litres of Corex cough syrup over the month. The bottles are handed over in a paper bag without the exchange of a word, leave alone a prescription.

Corex is the top selling medication in India earning Pfizer, the drug manufacturer, Rs 1,820,000,000 during the year 2009. U.S.-based Pfizer and Abbott Laboratories are leading players in India's $103-million market for codeine-based cough syrups. The ministry of finance is now pressuring the companies to enable tracking of each batch produced. The sheer malevolence of this entire chain is brought home by the patient who relapses repeatedly during treatment. Every time he tries to fill his prescription for deaddiction the pharmacist takes advantage of his craving cues to resupply him with codeine containing Corex cough syrup.

So it was with a certain joy that I read

Store employee nabbed for selling drugs without prescription

That was the Indian FDA (Food and Drug Administration) in action in Pune. Their sting on a reputed chain of pharmacies gives us new hope for control of over-the-counter codeine opioid addiction. 

Codeine prescription restrictions - Update

Ministry of Health (2016)
Bans codeine containing cough syrups. Ban upheld by Drugs Technical Advisory Board in July 2018

EMA-CMDh (2015)
(European Medicines Agency – Coordination Group for Mutual Recognition and Decentralised Procedures - Human)
Use of codeine for cough and cold

• contraindicated in children below 12 years. This means it must not be used in this patient group.
• not recommended in children and adolescents between 12 and 18 years who have breathing problems

Govt of India Notification 2014

• Codeine cough syrup is not available over-the-counter (OTC) without a prescription
• Record keeping by the dispensing pharmacist is now mandated

References

1. Committee on Drugs, American Academy of Pediatrics. Use of codeine-and dextromethorphan-containing cough remedies in children. Pediatrics 1997;99:918-20
2. EMA-CMDh. Codeine Article-31 referral - Codeine not to be used in children below 12 years for cough and cold. EMA/249413/2015. 24 April 2015
3. Herbert ME, Brewster GS. Myth: codeine is an effective cough suppressant for upper respiratory tract infections. West J Med 2000;173:283.