More details below or download a Valium CMI risks fact sheet.

2. Dependence

The information given to health professionals by Roche warns that the risk of dependence increases with higher doses and longer use[4]. However, this warning is not included in the CMI for the consumers who take the medication.

This is an important warning as the Department of Health advises that many people are not aware they are dependent on pharmaceutical medicines and that it can lead to addiction, abuse and withdrawal symptoms[5][6][7].

4. Abuse

Prescription medication abuse is the use of the drug other than as prescribed by a doctor, it generally occurs when a person becomes dependent or addicted to the drug.

The TGA states that benzodiazepines must be used with caution because of the risk of dependence and abuse, even when used at therapeutic doses for short periods[11][12], yet this risk is not present in the CMIs the TGA regulates.

5. Pregnancy

According to Roche, the safety of Valium for use in human pregnancy has not been established. Use during pregnancy can cause premature birth or miscarriage, and the baby may suffer from respiratory depression, withdrawal syndrome, congenital malformation, or delayed development[13][14]. None of this information is contained in the Valium CMI.

7. Prescription Opioids and Antidepressants

ABS data shows that the combination of opioids (e.g. Endone) and benzodiazepines is one of the leading causes of drug deaths in Australia over the last decade[16]. The Endone CMI[17] warns that combining it with benzodiazepines can result in severe drowsiness, decreased awareness, breathing problems, coma, and death.

However, this warning is not included in the Valium CMI, in fact, it has never even mentioned opioids or these risks, once in 20 years. The same issue exists for antidepressants, a medication commonly prescribed with Valium.

It is uncommon for benzodiazepines to be the sole medication in drug deaths. The ABS states that in over 97% of drug-induced deaths where benzodiazepines were present, they were taken in conjunction with other drugs like prescription opioids, antidepressants and alcohol[18]. 3 deadly risks not included in the Valium CMI. 

TGA Failures

The Department of Health advises that for information about diazepam you can read the CMI leaflet which is regulated by the TGA. Professor John Skerritt, the head of the TGA, stated that the TGA would not review the CMIs to include these 8 warnings.

The written reason he gave was that Australians have a low level of medical literacy and including these risks could confuse consumers and delay treatment. However, Professor Skerritt could not explain why these risks are contained in Roche Valium US consumer warning guide.

Due to the increase in anxiety-related mental health conditions during COVID-19, there are reports of an increase in benzodiazepine prescriptions by as much as 31%[21]. Based on PBS data, that would see the total number of prescriptions increase from 6 million to around 8 million a year.

Potentially that could see the loss of life due to benzodiazepines increase by several hundred Australians, to around 1,200-1,300 each year. Yet the TGA has not responded to do anything to avert these medications taking more and more lives.