Sertraline shortage warning

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Sertraline shortage flagged as TGA also issues warning over herbal pregnancy medicines

Australia faces a shortage of sertraline, which could clast until April, the Therapeutic Goods Administration has warned.

In a release this week, the TGA said there are shortage of multiple brands of sertraline 50mg and 100mg products. 

These shortage are expected to last until at least late February, and potentially till April, it says. There are fifteen different products affected by the shortage.

Reasons given for the shortages vary between the products, with six products listed as experiencing ‘unexpected increase in demand’, three list ‘manufacturing’, one is attributed to ‘commercial changes’, while the others do not give a reason.

In order to reduce the impact of the shortages on patients, the TGA has authorised the supply of overseas-registered products under Section 19A of the Therapeutic Goods Act 1989.

“However, given the high demand volume for sertraline tablets, the s19A products may not be sufficient to ensure all Australian patients have access to medicines they need,” it warns.

For this reason, a Serious Shortage Substitution Notice (SSSN) has been issued for sertraline tablets. The notice will allow pharmacists to dispense an alternative strength of sertraline tablets, with the consent of the patient, without requiring a new prescription.

The SSSN will be effective from 16 February 2021 until 30 June 2021. 

Former PSA national president Shane Jackson took to Twitter to express his frustration at the lack of options available for pharmacists trying to “help patients at the coalface”.

The TGA is advising pharmacists to “use your professional and clinical judgement to determine whether a patient is suitable for substitution under the SSSN”.

For patients who are suitable for and consent to substitution, pharmacists should:

  • counsel them thoroughly, including about how to cut unscored 100 mg tablets for a 50 mg dose
  • advise them to monitor for any side effects and to contact a doctor or pharmacist immediately if they have any concerns
  • recommend that they discuss alternative treatment options with their doctor where appropriate.

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Meanwhile, the TGA has issued a warning that “multiple listed medicines are being recalled due to the presence of high levels of Artemisia annua or Artemisia absinthium

The products recalled are:

  • Hilde Hemme’s Herbals Wormwood Herb
  • Paracea Forte Tablets
  • MediHerb Stealth Complex
  • Gloria Herb Liver Detox

“Animal studies of Artemisia annua extracts, artemisinin and related compounds have shown the potential for both pregnancy loss (miscarriage) and developmental abnormalities in animals,” the TGA statement said. 

An investigation identified Artemisia annua and Artemisia absinthium as being high risk as these species “contain higher levels of artemisinin”.

“Sponsors of medicines containing Artemisia annua and Artemisia absinthium were required to provide information to the TGA to enable an assessment of the risk of these products. Subsequently, the TGA identified that the above products may expose consumers to unsafe levels of these ingredients during pregnancy when used as directed.

As these products do not warn consumers against their use during pregnancy, they are being recalled”.

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