The most commonly reported adverse reactions in patients 6 years and younger were infusion reactions reported in 35% (7 of 20) of patients and included pyrexia (30%), chills (20%), blood pressure increased (10%), tachycardia (10%), and oxygen saturation decreased (10%). Other commonly reported infusion reactions occurring in ≥5% of patients were pallor, tremor, respiratory distress, wheezing, crepitations (pulmonary), pruritus, and rash. "A Phase IV clinical trial is currently recruiting participants to investigate whether Aldurazyme passes through breastmilk and whether it has any effect on nursing infants. Regulation
Aldurazyme was the first drug approved by the United States Food and Drug Administration to be marketed as a treatment for MPS I. It was approved in April 2003. Marketing authorization in the European Union was granted in June 2003 by the European Commission. Aldurazyme enjoys orphan drug status in both the United States and the European Union, though in both its orphan drug exclusivity period has expired. (Orphan drug exclusivity, which prevents the FDA or similar European body from approving the same drug proposed by another company for the same listed use lasts only seven years in the United States and ten years in the European Union.) Aldurazyme was granted orphan designation for Treatment of patients with mucopolysaccharidosis-I on September 24, 1997.As of 2014, Aldurazyme was mandated to be produced using Good Manufacturing Practices (GMP) and, along with several other recombinant enzyme products produced by Biomarin, was manufactured at the production facility located in Novato, California. Both packaging and vialing were performed by contractors.
While language development is not directly affected by the socioeconomic level of a family, the conditions that are associated with the socioeconomic level affects the process of language development to a certain extent. A childs early vocabulary development can be influenced by socioeconomic status via maternal speech, which varies according to the socioeconomic status of the family. Mothers with higher education levels are more likely to use rich vocabulary and speak in longer utterances when interacting with their children, which helps them develop their productive vocabulary more than children from a lower socioeconomic status.Poverty is also a high risk factor for language delay as it results in a lack of access appropriate therapies and services. The likelihood of those requiring early intervention for language delays actually receiving help is extremely low compared to those that dont actually need it. Natural/medical factors
Hearing loss
The process of children acquiring language skills involves hearing sounds and words from their caregivers and surroundings. Hearing loss causes that lack of these sound inputs, causing these children to have difficulties learning to use and understand language, which will eventually lead to delayed speech and language skills. For example, they may struggle with putting sentences together, understanding speech from other people or using the correct grammar, which are some language skills that typically developing children possess. Autism
There is strong evidence that autism is commonly associated with language delay. Children with autism may have difficulties in developing language skills and understanding what is being said to them.