Delayed Reporting of Adverse Reactions Uncovered in Opdivo Clinical Trials
Ono Pharma Korea received a warning from the Ministry of Food and Drug Safety for late reporting of adverse reactions during the Opdivo clinical trials, a medication to treat cancer. A patient participating in the Opdivo clinical trials, “ONO-4538,” was hospitalized due to a urinary tract infection and pneumonia. The … [Read more...] about Delayed Reporting of Adverse Reactions Uncovered in Opdivo Clinical Trials
Premarket Approval for Essure Birth Control Device Was Fraudulent, Patients Say
Patients involved in the clinical trials conducted in connection with the premarket approval application (PMA) for the Essure birth control device say that patient records were altered to show favorable results despite patient reports of problems. The Food and Drug Administration (FDA) approved Essure in 2002. Essure is considered … [Read more...] about Premarket Approval for Essure Birth Control Device Was Fraudulent, Patients Say
Eli Lilly Abandons Development of New Cholesterol Drug
Eli Lilly Ceased Work For New Cholesterol Drug. Drug maker Eli Lilly announced that it was ceasing work on a new cholesterol-lowering drug, after the drug failed to perform well in a phase 3 clinical trial. The drug, evacetrapib, was designed to prevent heart attacks and other cardiovascular problems by modifying cholesterol … [Read more...] about Eli Lilly Abandons Development of New Cholesterol Drug
Newly Published Data Raises Concerns about Essure Contraceptive Device
Though the Essure contraceptive device was hailed as a breakthrough for women when it came on the market, a citizens group is calling on the FDA to take the device off the market and newly published data may bolster their claims. Essure, a permanent birth control method, is a non-surgical sterilization procedure that can be … [Read more...] about Newly Published Data Raises Concerns about Essure Contraceptive Device
FDA identifies stumbling blocks for new diabetes drug
Rash of Diabetes Drug Side Effects. The Food and Drug Administration issued a statement this week indicating that a clinical trial of a new type 2 diabetes drug has suffered some setbacks as there have been a rash of dangerous side effects reported among its participants. According to a Reuters report, the FDA published a report … [Read more...] about FDA identifies stumbling blocks for new diabetes drug
Xigris Worldwide Recall
Xigris recall was called the PROWESS-SHOCK trial. Xigris patients in a clinical trial did not experience any added survival benefit compared to those treated with placebo, prompting Eli Lilly to issue a worldwide recall of the drug. ‘Xigris’ was approved a decade ago to treat sepsis and septic shock in patients admitted to hospital … [Read more...] about Xigris Worldwide Recall
Multaq Alert after Clinical Trial Halted
FDA Has Issued A Multaq Alert. The U.S. Food & Drug Administration (FDA) has issued a safety alert for the drug Multaq, after a clinical trial for the drug was halted due to a higher-than-expected number of heart problems among study participants. The agency is advising Multaq users to speak with their doctors as … [Read more...] about Multaq Alert after Clinical Trial Halted
Avastin Study Patients Develop Congestive Heart Failure
Avastin Study Patients. Enrollment in an Avastin clinical trial has been halted after six patients developed clinical congestive heart failure. According to a report in The Wall Street Journal, the trial protocol requires that enrollment stop if six or more cases of clinical congestive heart failure are seen in the first 200 … [Read more...] about Avastin Study Patients Develop Congestive Heart Failure
Widower Sues Over Wife’s Death During Trial for Biogen Drug
Biogen Drug Clinical Trial. A Colorado widower whose wife died after participating in a clinical trial for one of Biogen Idec's multiple sclerosis drugs has sued the company, saying his wife "didn't have to die." The wrongful death suit filed Wednesday on behalf of Walter Smith, of Colorado Springs, also named Cambridge-based … [Read more...] about Widower Sues Over Wife’s Death During Trial for Biogen Drug
FDA, Eli Lilly Warn of Sepsis Drug Risk
FDA Warn of Sepsis Drug Risk. The Food and Drug Administration and Eli Lilly Co. (LLY) issued a warning Thursday about a treatment used in patients with severe sepsis, saying it might increase their risk of death, based on an analysis of two clinical trial databases. The warning, however, only applies to patients who … [Read more...] about FDA, Eli Lilly Warn of Sepsis Drug Risk
Lawmaker Seeks Release of Antidepressant Data
Antidepressant Unpublished Clinical Trial. A congressional lawmaker wants four big drug makers to provide unpublished clinical trial data about their antidepressant pills. U.S. Rep. James Greenwood (R-Pa.), who chairs the Subcommittee on Oversight and Investigations, wrote a letter to the companies "in light of … [Read more...] about Lawmaker Seeks Release of Antidepressant Data
