The mother of a Mentor woman describes alarming changes in her daughter after being prescribed a popular antibiotic that she suspects played a role in her daughter's death.47-year-old Deana Poghen was struck and killed on I-90 in Mentor last Christmas Eve. Food and Drug Administration issued new warnings and label changes for drugs like Cipro that belong to a family of antibiotics known as fluoroquinolones."Serious side effects," warned the FDA, "outweigh the benefits for many patients.""Treatment should be stopped immediately if side effects are reported."But the FDA warning came too late for Poghen who believed the drug was safe. Florence Summers suspects Cipro, one of the nation's most widely used antibiotics, caused serious side effects that contributed to her death."She was beautiful, she was vibrant and happy," said Summers, "she loved life--and lit up a room when she came in."But our exclusive investigation found that within months--it all began to unravel."If she would take a shower, her skin would hurt," said Summers, "she lost the sensation of warmth and cold."Poghen's mother says her daughter took the drug for only a few days four months earlier but immediately serious side effects began to surface."After the very first dose," said Summers, " she had a severe reaction"Summers said her daughters "skin began crawling" and she would beg her to "keep her safe."The family said it did everything they could--but nothing helped and the "bad thoughts" continued. One of the nation's leading drug safety advocates says Poghen is not an isolated case and the FDA has found at least 600 suicide related cases reported in the last 18 years--133 deaths. Charles Bennett says "even as few as one or two doses--they can develop serious, permanent and disabling psychiatric toxicity.""These are things like being unable to work, unable to concentrate, body pain, and very, very disabling."Bennett also remains concerned that new warning labels do not go far enough."The medication guides in the July 26, 2016 updated fluoroquinolone labels do not include the Boxed Warnings stating that the fluoroquinolone antibiotics may result in disabling and potentially irreversible serious adverse reactions."Bennett also says drug companies have not sent health care professionals letters informing them of serious changes contained in new labels. The FDA, responding to our requests, says health professionals are "advised to counsel patients regarding disabling and potentially irreversible serious adverse reactions" may occur. In medication guides for patients, the FDA says it also warns that "some of these serious side effects can happen at the same time and could result in death."Read the entire FDA statement here: Prescribing Information is intended for the health care professional, and the Medication Guide is intended for the patient. In the Prescribing Information (Section 17), the health care professional is advised to counsel patients regarding disabling and potentially irreversible serious adverse reactions that may occur. The Medication Guide is written at the 6th to 8th grade level using simplified wording that is consistent with the Prescribing Information. Under the beginning section of the Medication Guide entitled, “What is the most important information I should know about DRUG? Millions of us are successfully treated with ciprofloxacin and other fluoroquinolone antibiotics each year. But for some patients the drugs are linked to severe adverse reactions involving terrifying physical and mental health impacts. Andrew Wasley reports Patients who say they’ve suffered severe adverse reactions to a common antibiotic are calling for action to prevent others from experiencing a 'frightening' number of alleged physical and mental side effects. The victims, who say they were poisoned by ciprofloxacin, want more research into the drug’s side effects, greater education of health professionals and clearer warnings for consumers. The calls come as an investigation revealed the antibiotic has been linked to more than forty deaths in the UK in recent years, and been the subject of hundreds of suspected adverse reactions. Ciprofloxacin, part of the fluoroquinolone class of antibiotics, is prescribed to treat a range of medical conditions, including bacterial infections. Fluoroquinolones are also – controversially – used to treat diseases in poultry, pig and cattle farming.
Fluoroquinolones have caused at least 67 cases of life-threatening hypoglycemic coma, including 13 deaths and 9 permanent and disabling injuries, according to an internal safety review by the Food and Drug Administration. Most cases (44) were associated with The review also found new neuropsychiatric side effects associated with fluoroquinolones, including disturbances in attention, memory impairment, and delirium. Considering these findings, the agency will strengthen warning labels on all fluoroquinolones, which already warn that the antibiotics may cause hypoglycemia and mental health issues, especially in older people, the FDA said in a press .“Health care professionals should be aware of the potential risk of hypoglycemia, sometimes resulting in coma, occurring more frequently in the elderly and those with diabetes taking an oral hypoglycemic medicine or insulin,” the statement said. “Alert patients of the symptoms of hypoglycemia and carefully monitor blood glucose levels in these patients and discuss with them how to treat themselves if they have symptoms of hypoglycemia. Inform patients about the risk of psychiatric adverse reactions that can occur after just one dose. Stop fluoroquinolone treatment immediately if a patient reports any central nervous system side effects, including psychiatric adverse reactions, or blood glucose disturbances and switch to a non–fluoroquinolone antibiotic if possible. Stop fluoroquinolone treatment immediately if a patient reports serious side effects involving the tendons, muscles, joints, or nerves, and switch to a non–fluoroquinolone antibiotic to complete the patient’s treatment course.”The statement also warned not to prescribe fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risks outweigh the benefits in these patients. For several years, Call 6 Investigates has been looking into potential safety issues and concerning side effects associated with fluoroquinolone antibiotics sold under brand names like Levaquin, Cipro and Avelox. Food and Drug Administration is requiring drug label changes for commonly prescribed antibiotics, including more prominent and consistent warnings for mental health side effects. Purdue University student Shea Mc Carty died in 2013 after jumping out of a second story window and crashing his car into a cement embankment. His mother, Heather Mc Carthy, said Shea was agitated and suffering mental health side effects from taking the antibiotic Levaquin. Charles Bennett with the Southern Network on Adverse Reactions (SONAR), have been pushing the FDA to better warn the public about the psychiatric effects of the drugs. On September 11, 2014, Bennett filed a petition with the FDA calling on the federal agency to change the drug labels to better warn patients of the risks. On July 10, 2018, the FDA responded with a safety announcement in which it called for label changes on fluoroquinolones including more prominent and consistent warnings for mental health side effects. Heather Mc Carthy told Call 6 Investigates Monday the FDA’s announcement is a breakthrough in acknowledging the drugs’ effects.“While justice is slow - this label will now open the doors to accountability for doctors who chose to ignore patient complaints,” Mc Carthy said in an email to RTV6 Monday. “I personally believe there is a never a reason for doctors not to listen to patients and with this labeling, there is no longer a viable excuse to ignore patient complaints associated with fluoroquinolones.
Cipro is a purely synthetic chemotherapeutic antibiotic in the fluoroquinolone also. People have also suffered osteonecrosis bone death as a result of taking. Cipro. Cipro has active ingredients of ciprofloxacin hydrochloride. It is often used in urinary tract infection. latest outcomes from Cipro 24,540 users Death. Death has been reported by people with multiple myeloma, primary pulmonary hypertension, pain, chronic myeloid leukaemia, diabetes latest reports from 484,550 Death patients.