The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Health professionals are advised that the Product Information (PI) documents for methylphenidate products have been updated with new information about use in pregnancy. The pregnancy category has now been changed from Category B3 to Category D and the PI documents include updated safety information relating to birth defects and malformations.
Methylphenidate is a central nervous system stimulant. Its mode of action in humans is not completely understood, but methylphenidate presumably exerts its stimulant effect by an inhibition of dopamine and norepinephrine reuptake into presynaptic neurons and thereby increasing these neurotransmitters in the extraneuronal space.
Methylphenidate is marketed in Australia under the brand names Ritalin, Concerta as well as other generic brands.
Ritalin is available as immediate-release tablets (Ritalin 10) and modified-release capsules (Ritalin LA) and is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). Ritalin 10 tablets are also indicated for the treatment of narcolepsy. Concerta is formulated as modified-release tablets and is indicated for the treatment of ADHD.
The pregnancy category for methylphenidate was changed from pregnancy Category B3 to Category D due to a small increased occurrence of foetal cardiac malformations in women who received methylphenidate during the first trimester of pregnancy, compared with non-exposed pregnancies seen in large observational studies.
The PIs for both Ritalin and Concerta - external site have been updated to include this new information in their respective '4.6 Fertility, Pregnancy and Lactation' sections.
Adverse event reports in Australia
As at 4 June 2021, no cases of foetal cardiac malformations associated with methylphenidate had been reported to the Therapeutic Goods Administration. However, the World Health Organization's global individual case safety report database, VigiBase, has received 28 reports of this adverse event.
Information for health professionals
Methylphenidate should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks.
What to report?
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
Reports may be submitted:
- online at www.tga.gov.au
- by fax to 02 6232 8392
- by email to ADR.Reports@tga.gov.au
For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.