Lawsuits Over Side Effects Of Asthma Medications Parker Waichman LLP is investigating potential lawsuits over the side effects of asthma medications in children. Research suggests that serious adverse drug reactions (ADRs) may occur when asthma medications are used in children, and this information is not fully disclosed in the pre-marketing clinical trials.
If you have questions about the adverse effects of asthma medications in children, contact our firm today for a free, no-obligation legal consultation.
Study Shows Asthma Medications may Pose Dangers in Children
Researchers from the University of Copenhagen and the University of Southern Denmark conducted a study showing that asthma medications may be linked to serious adverse reactions in children. The findings were published in the International Journal of Clinical Pharmacy.
The study was based on European Union (EU) adverse drug reaction reports. Based on this, the researchers found that pre-marketing clinical trials do not fully document the risks associated with using asthma medications in children.
The European Medicines Agency (EMA) has been gathering data on adverse reactions in EudraVigilance, the European ADR database, since 2007. It is mandatory for authorities and pharmaceutical companies to report information about ADRs to the database. Information about dosage, safety and efficacy in children is often lacking. This means it is often up to the physicians to determine the appropriate treatment for pediatric populations. Prescribing medications to children may involve more than simply lowering the dosage to their body weight, because children are not simply smaller adults. In fact, certain medications cannot be appropriately metabolized by children even in the smallest doses.
The research looked at beclometasone, budesonide, fenoterol, fluticasone, formoterol, mometasone, montelukast, salbutamol, and terbutaline, and the combination medications budesonide/formoterol, fenoterol/ipratropium, and fluticasone/salmeterol used by children between 2007 and 2011. Professor Ebba Holme Hansen from the Department of Pharmacy, University of Copenhagen, stated that although the total of 774 ADRs “were not overwhelming” the researchers found that “85% of these ADRs, almost all reported by physicians, are classified as serious,” Dr. Holme conducted the study together with Professor Lise Aagaard from the University of Southern Denmark.
Consequences Of Drugs To Children
“No one knows the consequences of prescribing drugs to children, who constitute a vulnerable patient group, as knowledge of ADRs in this population is very scarce. Infants under one year of age are prescribed asthma medications as cough medicine, as no alternative treatments are available for very young children. However, our study suggests that asthma medications are associated with more – and more serious – ADRs than documented by the clinical trials. Especially in the case of children,” said Aagaard, according to Health Canal.
“We located 326 spontaneous reports corresponding to 774 ADRs for the included asthma medications. Approximately 85 percent of reported ADRs were serious, including six fatal cases,” the authors said. Roughly 57 percent involved boys and one-fourth were reported in children one year or younger. Most of the ADRs and psychiatric disorders were reported by physicians; respiratory, thoracic, and mediastinal disorders; and skin and subcutaneous disorders were seen, mostly with budesonide (21 percent), salbutamol (20 percent), and fluticasone (19 percent). The authors concluded that “only a few ADRs from use of asthma medications in children were identified in the EudraVigilance ADR database, but a large majority of these were serious, including fatal cases.”