Release date: 2017-09-11
Mylan announced the recall of the EpiPens adrenaline pen in the US last spring. The recall was due to two equipment failures due to potential defects in the supplier components.
EpiPen is an adrenaline pen from Mylan Pharmaceuticals. This injection will be the most widely used prefilled adrenaline injection device on the market, just like the existing products on the market. It is designed for use outside the hospital for serious fatal allergic reactions. First aid treatment, also known as life-saving drugs. The facts also confirmed the need for this recall.
Recently, the US Food and Drug Administration (FDA) issued a warning letter to Meridian Medical Technologies, a subsidiary of Pfizer, stating that there were serious violations in the manufacturing process. The company is a manufacturer of EpiPen, a allergy first aid drug from Mylan Pharmaceuticals. The FDA noted that the company failed to conduct a thorough investigation of product safety incidents, including patient deaths and serious illnesses. The FDA inspected a manufacturing facility in Missouri from February to March this year.
The FDA said in the letter that the company received hundreds of complaints and that there were a large number of cases in which EpiPen could not be used normally in a life-threatening emergency, which directly led to the death of some patients.
The regulator asked the company to complete a reassessment of its manufacturing survey within 15 days to provide a security risk solution. If the above violations are not dealt with in a timely manner, the company may face legal proceedings and the FDA may not pass all approval requests related to the manufacturer. Shares of Melan Pharmaceuticals fell nearly 1% in the afternoon on Thursday, Pfizer's volume rose 0.3%, and the S&P 500 index (SPX) fell 0.1%.
In response, Pfizer responded by e-mail today: "Patient safety is critical to Pfizer. We insist on quality, safety and efficiency, and the products we manufacture. We will continue to work with FDA to resolve the issues raised in the letter. From 2015 Over the years, we have shipped more than 30 million EpiPen auto-injectors worldwide, and it is not uncommon to receive product complaints. There is currently no information showing any causal relationship between these product complaints and any patient death."
For many years, the adrenaline pen has been the most commonly used product for emergency treatment of severe allergic reactions, including allergic reactions. In fact, its widespread use has led to a political and public rebound, as Mylan has been continually raising prices for the product, rising five times in 10 years, and the drug has become the number one public enemy of the Americans. The patient complained, even the Hollywood actress, "Sex and the City" actress Jessica Parker also stood up and said, "The price is too expensive." Her son is allergic to peanuts, has been using EpiPen injection, even she joined the protest crowd, so The price increase is too unreasonable.
Mylan Pharmaceuticals announced in March that it would recall approximately 81,000 EpiPen devices in countries outside the United States. Mylan Pharmaceuticals recalls EpiPens outside the United States, and recalls only affect equipment distributed in Australia, New Zealand, Japan and Europe. Instead, a week later, the company recalled thousands of devices in the United States.
The FDA believes that in the face of more and more patient complaints, the company did not find out the cause of the problem in time. Repeated occurrences indicate that supervision and control of pharmaceutical manufacturing equipment is insufficient.
In China, due to the lack of equipment manufacturers, this pre-filled injection equipment is still blank in the market. It is reported that there have been hospital-made Chinese adrenaline pens and anaphylactic shock rescue boxes in China. The cost is less than RMB 20, which is convenient and suitable for China's national conditions and suitable for most Chinese people. Adrenaline is used properly and is life-saving for some patients, but it is fatal for some special patients (such as asthma caused by acute left ventricular dysfunction). Therefore, the State Food and Drug Administration has carefully introduced this product. Be cautious. However, due to the huge market demand for patients, it is expected that the future market prospects of such prefilled injection equipment will be considerable.
Source: Sina Pharmaceutical News
Walking aids is an auxiliary device to assist the human body to support weight, maintain balance and walk. It can also be called walking aids, walking stands or walking aids. Among walking aids, walking aids can provide the greatest support and stability. Therefore, it is mainly used for patients with weak strength and poor balance, such as the elderly after orthopedic surgery, patients with poor coordination and Parkinson's disease, and children with cerebral palsy or developmental retardation. With the support of equipment, people with less flexible legs can walk and take care of themselves.
According to the structure and function of Walker, it can be divided into two categories: stick walker and frame walker. The walking aid is simple and light in structure, but its supporting area is small and its stability is poor; The frame walker has a complex structure, but it has a large supporting area and good stability.
Before using the walker, the user's physical condition and use environment should be comprehensively evaluated, including balance ability, lower limb bearing ability, gait, upper limb ability, cognitive ability, lifestyle and use environment.
Select a walker
1. The texture should be light and easy for patients to move.
2. The walker should be placed stably on the ground;
3. The height of the walker should be suitable or adjustable. When the patient stands in the walker and his hands are naturally sagging, he can hold the handrails on both sides and apply pressure on the handrails to ensure the support of weight and balance control;
4. The width of the walker should be moderate, not too wide.
TRUTECH CO., LTD. is an enterprise specializing in the research, development, production and sales of professional OTC products.The main products include shower chairs, armrests, toilet racks and toilet armrests, bedside armrests, elderly chairs and sofas, crutches and walking aids, knee pads, waist supports and other equipment.
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TRUTECH CO., LTD. , https://www.trutechealth.com