For new medicines, the manufacturer then has to recruit children and newborns into trials (unless the medicine is not going to be used in children and newborns) and subsequently amend the PIL with the approved information. Older medicines may have been used effectively for many years in children without problems but the manufacturer has not been required to collect data and amend the licence. This does not mean that it is unsafe for children and young people to be prescribed such a medicine ‘off-licence/off-label’. However, if you are concerned about any conflicts of information, please discuss with your doctor, nurse or pharmacist.
Epidural steroid injections are commonly prescribed for patients with a disc injury or spinal arthritis causing nerve irritation, and generally consist of local anesthetic (numbing medication such as lidocaine) and cortisone (a steroid that reduces inflammation and pain). Lidocaine is often injected initially so patients experience minimal, if any, pain during the procedure. The injection may be performed by placing the needle posteriorly between the spine bones (Translaminar or interlaminar) and injecting the medicine into the space around the spinal nerves. A transforaminal ESI means the injection is placed slightly to one side of the spine, and the medicine is injected near the ruptured disc and inflamed spinal nerve. A caudal ESI is performed by placing the needle near the tailbone, and injecting the medicine into the region of the sacral nerves and lower lumbar spinal nerves. Epidural steroid injections, as well as most spinal injections, are performed using a special x-ray guidance system called fluoroscopy. This allows the doctor to immediately see an x-ray image on a television screen and inject the medicine precisely into the right spot. The procedure time is often less than 10-15 minutes.
People who experience a sudden hearing loss (SSNHL) are often treated with systemic steroids, which are taken orally. Studies however show that people with sudden sensorineural hearing loss (SSNHL) who do not respond to this treatment can benefit from intratympanic steroid injections. Studies carried out at universities in USA and Thailand show intratympanic steroid injections to be very effective and that the treatment does not have any side-effects.
Dr. David Haynes from Vanderbilt University Medical Center, Nashville, USA, carried out the study of 40 people who had experienced sudden sensorineural hearing loss (SSNHL). Overall, 40% showed some kind of improvement when treated with intratympanic steroid injections.