TGA warnings on sleeping tablet Belsomra

On 20 March 2018 the Therapeutic Goods Administration (TGA) released a warning about prescribing practices of Belsomra (also known as Suvorexant). The TGA stated:

Since registration, the TGA has received a number of reports of adverse events, including sleep paralysis, gait disturbance, hallucination, headache and paraesthesia.

These potential side effects, including next day residual effects, are well communicated in the Product Information, but it is important for patients to be warned of these potential adverse events before they are prescribed suvorexant.

The concern is not the action of the drug, but the warnings (or lack of) given by doctors to patients. As we discuss in our article Medications and Medical Negligence doctors have a duty to warn you about side effects. Only after receiving warnings about side effects can a person make an informed decision about whether or not to take a medication.

The risks the TGA reported on can be very severe, particularly if they occur while someone is driving or at work. This latest TGA warning highlights the importance of asking your doctor about risks and side-effects of medications. Our advice in our article Hospital Complications and Negligence rings true with prescriptions of Belsomra, or any other medications. In that article we stated:

“In 2018 the Harvard University recommended 7 questions to ask a doctor when they prescribe a new medication. These are:

Why do I need this medication, and how does it work?
What are the risks and benefits?
Are there side effects?
How do I take this medication?
Do I need to avoid anything while taking this new medication?
How soon will the medication work, and how long will I be taking it?
When will you review how well this is working for me?

These are good questions for patients to ask doctors and other health practitioners who administer treatment in hospital. Be an informed patient. It is your body and you have a right to ask about your treatment. In doing so, you may prevent a hospital complication, like being administered the wrong medication, from happening.”

If you have taken Belsomra, or any other medication, and experienced a side effect or adverse reaction that you were not warned about, you may have a medical negligence claim. For more information see our Medical Negligence homepage or contact us to talk to Matthew Bridger or Tom Maling.

Further resource