Recently, the State Food and Drug Administration issued a notice requiring enterprises to modify the relevant drug instructions. For injection containing benzyl alcohol in the prescription, the instructions must clearly indicate that "this product contains benzyl alcohol, which is prohibited for intramuscular injection of children". This is because benzyl alcohol may cause gluteal muscle contracture in children when injected intramuscularly.
Gluteal muscle contracture in children is a kind of hip joint abduction and external rotation deformity and hip flexion disorder caused by gluteal muscle and its fascia fiber degeneration and contracture. Children with gluteal muscle contracture walk like ducks, wobbling, and their gait is like a figure of eight; Jumping when walking or running quickly; When standing, the two legs turn outward, and the two legs cannot be completely together, and cannot cross the legs; The posture of squatting is more special. The knees must be separated to both sides before squatting. The heels do not touch the ground, like a big frog, commonly known as frog legs. Some children have difficulty squatting down and have to urinate while standing. These children's buttocks are not as thick as those of normal people's buttocks. Instead, they are replaced by many hard knots, which are like a hard and thick band firmly restraining the gluteal muscles, hindering muscle movement, and making the gluteal muscles form a skin depression like a dimple; Severe cases may include pelvic obliquity, lumbar curvature, etc.
It is directly related to benzyl alcohol
Gluteus contracture in children is not a disease with a long history. In 1970, it was first reported by Dr. Wadlama, but it was only reported in 1978 in China. Since the 1980s, gluteal muscle contracture in children has been increasing in China: 310 children aged 2-14 years in Yichang, Hubei Province, 22 cases were diagnosed in a small mountain village in Zaozhuang, Shandong Province, and the incidence of gluteal muscle contracture in children in a village in Hebei Province in 1991 was 1.94%. By 1999, the incidence of gluteus contracture in children had risen to 9.17%, and almost one in 10 children was disabled due to gluteus contracture.
How did this disability come into being? After investigation, it was found that these children had been given penicillin intramuscularly for many times when they were young children. Is penicillin the culprit? However, why did some children who often injected penicillin not get sick? So doctors thought of the penicillin solvent.
Penicillin can be injected intramuscularly only after being dissolved with solvent during treatment. Water for injection, normal saline and benzyl alcohol can be used as the solvent for penicillin. Doctors continue to investigate and find that children who use water for injection and physiological saline as penicillin solvent rarely suffer from gluteal muscle contracture, while most of the children who suffer from gluteal muscle contracture use benzyl alcohol as solvent. After repeated animal experiments, it was finally determined that benzyl alcohol was the culprit of gluteal muscle contracture in children. Since benzyl alcohol has an anesthetic effect and can alleviate the pain after penicillin intramuscular injection, benzyl alcohol was especially popular as the solvent for penicillin after the 1970s, so this disease appeared and became more and more popular.
Children under 10 years old are the most common
Gluteal muscle contracture in children does not occur immediately after benzyl alcohol injection, but gradually occurs 2 to 3 years after injection, and the smaller the child is, the easier it is to get sick after injection. Therefore, gluteal muscle contracture is often seen in children aged 4 to 10 years.
Benzyl alcohol is not easily absorbed by human body. Children have delicate muscles, strong metabolism and strong response to foreign body stimulation. After multiple intramuscular injections, benzyl alcohol accumulated at the injection site for a long time can lead to drug-induced fasciitis and myofibrositis, which further develops into hip muscle fiber degeneration, fibrous tissue proliferation, forming scar tissue and muscle spasm. The contracture of gluteal muscle fibers in children will inevitably affect their activities and normal growth and development, leading to disability.
In 2005, the State Food and Drug Administration and the Ministry of Health successively issued a document prohibiting benzyl alcohol from being used as penicillin solvent for injection. However, recently, the State Food and Drug Administration found a case report of gluteal muscle contracture in children after intramuscular injection of benzyl alcohol injection through ADR monitoring. In order to ensure the safety of drug use for children, the State Food and Drug Administration decided to organize the inspection of the injection instructions containing benzyl alcohol, requiring that the instructions of all injections using benzyl alcohol as the solvent must clearly indicate that "benzyl alcohol is used as the solvent for this product, and it is forbidden to be used for children's muscle injection". The local drug supervision departments shall immediately organize the inspection of the drug instructions of enterprises within their jurisdiction, and the drugs that have not been revised as required shall not be listed. The listed drugs that fail to mark the above contents as required shall be ordered to be recalled immediately and investigated and dealt with according to relevant regulations.
Take oral medicine as much as possible when children are ill
After a child falls ill, many parents often ask the doctor to give the child an injection because it is more troublesome to give medicine to the child and it is not as convenient as injection. Although intramuscular injection is simple and feasible, the side effects of injection drugs are often more than oral drugs, among which gluteal muscle contracture in children is an adverse reaction caused by injection drugs.
In addition to benzyl alcohol, repeated intramuscular injections of streptomycin, gentamicin, kanamycin, vitamins, antipyretic analgesics, etc. may also lead to gluteal muscle contracture in children. Therefore, children should try to take oral medication after illness to avoid unnecessary intramuscular injection; If intramuscular injection is really needed, the course of treatment should be 3-5 days, instead of repeated injections at the same site for a long time; If there is induration at the injection site, apply the hot towel externally as soon as possible to promote the blood circulation of the local injured tissues, accelerate the absorption of the drug solution, and help the muscles recover their functions as soon as possible. If there are symptoms similar to frog legs, you should go to the hospital for surgery in time to avoid lifelong disability.
Cai Guidong, Distinguished Expert of ADR Monitoring Center of Beijing Municipal Food and Drug Administration
