The Adverse Drug Reactions (ADRs) (upper) abdominal pain, chest pain and headache should be added to the Summary of Product Characteristic (SmPC) of noscapine. This concluded the Dutch Medicines Evaluation Board (MEB) in response to an analysis carried out by the Pharmacovigilance Centre Lareb. The MEB will request the Marketing Authorization Holders to adjust the SmPC.
Insufficiently labelled ADRs
This analysis was done in response to a Lareb and Uppsala Monitoring Centre collaborating meeting. This meeting had a focus on patient reports in de World Health Organization (WHO) database. One of the goals was to detect ADRs that were not fully covered in the patient information leaflets. Noscapine and several ADRs were highlighted. The WHO database contained a total of 130 reports of (upper) abdominal pain, chest pain and headache associated with noscapine. It turned out that the ADRs were insufficiently labelled in some European countries. For instance, abdominal pain, chest pain and headache were labelled in the Swedish, Norwegian and German SmPC, but not in the Dutch SmPC.
Lareb received fifteen reports of (upper) abdominal pain, four of chest pain and two reports of headache associated to the use of noscapine. In most reports, the symptoms appeared within a few hours after intake. Also, the symptoms disappeared without treatment, after a few hours. Some reporters mentioned that they experienced the same adverse event before while taking noscapine. In some cases the symptoms were severe and the patient had to consult a doctor.
Noscapine is an antitussive drug. It reduces the cough reflex. Noscapine is used for the treatment of non-productive cough. It is available without prescription.
Read the analysis of the Dutch reports