Concerta Users: Find Out About Pregnancy: Teratogenic Effects and Concerta

Pregnancy Category C: Methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively.

A reproduction study in rats revealed no evidence of harm to the fetus at oral doses up to 30 mg/kg/day, approximately 15-fold and 3-fold the maximum recommended human dose of CONCERTA® on a mg/kg and mg/m2 basis, respectively. The approximate plasma exposure to methylphenidate plus its main metabolite PPA in pregnant rats was 2 times that seen in trials in volunteers and patients with the maximum recommended dose of CONCERTA® based on the AUC.

There are no adequate and well-controlled studies in pregnant women. CONCERTA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

If you or someone you know has suffered a serious Concerta side effect, you may be entitled to compensation for your pain & suffering. To find out if you have a case, fill out the form below for a free case evaluation.

Weitz & Luxenberg is no longer accepting Concerta cases.

see also:

Conditions Concerta - Find out more about conditions resulting from the drug
Learn about specific conditions related to Concerta use

Information for Patients Find out important information regarding the ADHD medication Concerta
Information you need - What the FDA thinks Concerta users should know

Precautions Find out about the FDA's Precautions for the ADHD medication Concerta
Concerta may be putting your health at risk - Know the Precautions