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GSK's antibiotic gets FDA priority review for oral treatment of gonorrhoea

GSK's antibiotic gets FDA priority review for oral treatment of gonorrhoea

Reuters8 hours ago
Aug 11 (Reuters) - British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for priority review of gepotidacin, an oral antibiotic to treat sexually transmitted uncomplicated gonorrhoea.
GSK is counting on new infectious disease treatments, such as its recently launched respiratory syncytial virus vaccine, to help offset revenue losses from its top-selling drugs and anticipated patent expirations for its HIV therapies.
The drug gepotidacin has already been approved in the United States under the brand name Blujepa for a common type of urinary tract infection (UTI) in women and adolescent girls.
The FDA's decision on the drug's treatment of uncomplicated urogenital gonorrhoea is expected in December. If approved, it would provide an oral option to patients who currently rely on injectable treatments.
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Warning as woman, 27, suffers horrifying reaction to one of UK's most taken pain medications - skin 'fell off in sheets'
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Warning as woman, 27, suffers horrifying reaction to one of UK's most taken pain medications - skin 'fell off in sheets'

A mother-of-three has told of her horrifying ordeal after she was put in a 21-day coma after suffering a rare reaction to ibuprofen that caused her skin to 'fall off in sheets.' Aleshia Rogers, 27, from Nebraska, took two of the over-the-counter tablets a day in August 2020 following the birth of her son Jaxon via c-section. The young mother had been taking ibuprofen, which she described as her 'go-to med', for years to help relieve her period cramps. However, after three weeks of taking the painkiller, she started suffering flu-like symptoms including a fever and a burning sensation when she swallowed. She also noticed a rash on her chest and her eyes beginning to swell. 'They were bloodshot and burning so I went to the ER where they told me I had pink eye and sent me home,' the child and education technician recalled. But the next day whole face was swollen, making it difficult to breathe. 'The next day both my eyes were swollen shut so I went back to the ER. They told me I had scarlet fever and to go home.' She said she was also advised to carry on taking the painkiller to alleviate her pain and reduce the swelling. Within hours, her symptoms rapidly escalated and she developed burning blisters across her face, eyes and chest causing her skin to peel off. She rushed to the hospital once again where she was eventually diagnosed with Stevens-Johnson syndrome (SJS) and later toxic epidermal necrolysis—which doctors suspected was triggered by the ibuprofen. As her condition rapidly deteriorated and she developed sepsis and multiple organ failure, doctors put her in a coma—which she wouldn't wake up from for three weeks. At this point, the mother-of-three had lost around 95 per cent of her skin, causing her to into organ failure. Her family were told she had just a 10 per cent chance of surviving the ordeal. The rare skin condition causes the immune system to overreact to a trigger, in this case ibuprofen, and attack healthy skin, the eyelids and genitals. Five years on, Ms Rogers is still recovering from long-term complications associated with SJS. Recalling the moment she woke up from the coma she said: 'The doctors told me my skin had died and detached. 'They called it sloughing. It fell off in sheets. But I had absolutely no idea what had happened to me,' she added. 'I even forgot that I had given birth. I lost a lot of memories. 'My family told me it really was touch and go as to whether I'd make it through. I've been told so many times I'm a miracle so I try and live my life like tomorrow isn't promised and try not to live in fear.' Now, the young mother is determined to raise better awareness for the life-threatening condition and remind people that all drugs come with a risk. 'We believe it was all triggered by taking ibuprofen,' she explained. 'There's no prevention [for the condition] and once it starts, there's nothing you can do to stop it. There's also a chance I can get it again at any time. 'I don't want people to be afraid of medicines, but I want people to be aware and mindful of what can happen.' Ms Rogers is not believed to have suffered an adverse reaction to ibuprofen before with doctors unable to say for sure why the reaction occurred. SJS often begins with flu-like symptoms, including a high temperature, sore throat and joint pain, followed by a red or purple rash that usually starts on the upper body before spreading to the face, arms, legs and other areas of the body. Blister will then appear on the skin, which burst to leave painful sores. The same happens inside the body, primarily affecting the mucous membranes—the soft layers of tissue which line the digestive system, inside of the nose and mouth and the genitals. 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