Codeine medicines seems to have attracted all the attention right now. Not for the ways they are to be used, but for the ways they need to be labelled and advertised. To protect children from serious risks, two top most health authorities, the US Food and Drug Administration (USFDA) and the Therapeutics Good Administration (TGA) have rolled out label and advertisement changes. Let us take a quick look at the individual announcements. FDA requires label changes for codeine and tramadol containing drugs Several prescription pain and cough medicines and few over-the-counter (OTC) cough medicines contain two opioids namely codeine and tramadol. It has been noted that in case of some children, especially below 12 years of age or adolescents suffering from obesity, medicines containing two ingredients have caused life-threatening situations and have also increased the intensity of existing health conditions like breathing problem or lung disorder. To keep such grave incidents at bay, the USFDA announced label changes of all medicinal products containing codeine and tramadol. The additional “Contraindications & Warnings” would include the following updates among several others.

  • Contraindications for use of codeine or tramadol in all children younger than 12 years
  • Warnings about their use in children 12-18 years of age with certain medical conditions
  •  Stronger warning recommending against their use in nursing mothers
  • Tramadol-containing products to get a contraindication for post-operative pain management in children up to 18 years of age

TGA states medicines containing codeine to become prescription drugs Beginning February 1, 2018, all medicines containing codeine will become prescription drugs. Since it is an offence in Australia to advertise prescription medicines to the public, the medicines in question are strictly not allowed to be advertised to the public from this date. During the interim period, i.e., prior to the actionable date, pharmacy-only medicines containing codeine may be advertised to the public, but only if the advertisements are compliant to the Therapeutic Goods Administration (TGA) advertisement guidelines. Points to remember for advertising to the public prior to February 1, 2018

  • All advertisements need pre-approval under Regulation 5G of Therapeutic Goods Regulations 1990 before they are broadcast or published in any specified media platform
  • Once approved and unless withdrawn, advertisements are valid for two years from the date of issue
  • Section 4(2)(d) of the Therapeutic Goods Advertising Code prohibits use of language that could cause fear and distress for consumers

In the quest of constant evolution of the pharmaceutical industry, patient safety remains the key. In today’s diversified global pharmaceutical market and medications, it is even more important to ensure safe drug administration for both healthcare providers and consumers alike. Right from providing accurate information about medicine composition, potential side-effects, contraindications and so forth, any compromise on the content could lead to untoward incidents. To handle the nuances of this critical task, it is a sensible idea to get in touch with one of the regulatory industry experts with adequate expertise and experience in the labeling domain.


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