PETITION

 Consumer Medicines Information (CMI) and Product Information (PI) leaflets are meant to give patients and prescribers accurate information about medicines to help them make an informed decision about if it is the right choice.

I'm a community pharmacist and recently, I was shocked to discover just how many antidepressant CMIs and PIs in Australia contain outdated and misleading information about the causes of depression and how antidepressants work, as well as a complete lack of warning about the potential to experience withdrawal symptoms when stopping. These withdrawal symptoms are common and can be severely debilitating. People need to slowly taper off these medications after long term use to reduce the risk of withdrawal, yet they are not warned about this in the information sheet. It's not good enough. 

We are asking the "Sponsors" (drug companies) of these antidepressants to urgently update their CMI and PI documents to improve patient and prescriber awareness about these issues and ultimately improve patient safety. There are three main points we wish to address:

• Remove any reference to depression being caused by a chemical imbalance in the brain, and/or antidepressants working by “correcting” this imbalance. The chemical imbalance theory of depression has been debunked and it is misleading to include reference to it in these documents. 
  
  
• Ensure there is an appropriate warning about physical dependence and withdrawal, with common and severe withdrawal symptoms listed. 
  
  
• Include reference to the need to slowly taper off the medication when stopping, which can take months to years in some cases. 

In Australia, the Therapeutic Goods Administration (TGA) regulates medicines and stores a repository of CMI and PI documents for all registered medicines, however the documents themselves are written and supplied by the “Sponsor” (drug company). The Sponsor has a responsibility to update the documents when new information becomes available.

We will send a formal petition letter to each Sponsor company requesting them to update their CMI and PI documents in accordance with current evidence. By signing this petition, your voice will be included in these letters to show how many people support these recommendations and increase pressure on the Sponsors to do the right thing by updating their documents!

*If you have experienced withdrawal symptoms, please report them to the TGA here. You can also ask your doctor or pharmacist to submit the report on your behalf. It is imperative that the TGA is made aware of how serious withdrawal can be. They may consider pressuring the Sponsors to update their documents or even issuing a "boxed warning" about withdrawal symptoms if enough reports are made.*

If you have experienced withdrawal symptoms, please consider reporting them to the TGA. It's a simple online form which can be completed anonymously if you prefer. You can also ask your doctor or pharmacist to submit the report on your behalf.  It is imperative that the TGA is made aware of how serious withdrawal can be. They may consider pressuring the Sponsors to update their documents or even issuing a "boxed warning" about withdrawal symptoms if enough reports are made. 

From the TGA website: 

The TGA monitors adverse events (such as side effects) related to medicines and vaccines to safeguard and enhance the health of the Australian community. Unfortunately, it is not possible to know all potential adverse events of a medicine or vaccine before it is approved for use.

When people tell us about their experiences using a particular medicine or vaccine, it helps us to monitor the safety of those products.

We prioritise issues that may:

• have adverse health consequences for consumers as a result of public access to dangerous or inappropriate goods,
• affect confidence in our regulatory processes or contribute to a loss of confidence in therapeutic goods in Australia.