Pharmaceutical 7375 articles

J&J settles lawsuit alleging Risperdal caused boy to grow breasts

Johnson & Johnson and its unit Janssen Pharmaceuticals have agreed to settle a lawsuit brought by a Mississippi family that claimed the companies’ antipsychotic drug Risperdal caused their son to develop breasts, a disfiguring condition known as gynecomastia, according to Law360. The announcement came just days before the case was slated to go to trial in Pennsylvania state court. The settlement follows a Superior Court ruling in January during which a global order barring punitive damages on gynecomastia claims with Risperdal in the Philadelphia County Court of Common Pleas was upended. Suddenly faced with the potential of  punitive damages, Johnson ... Read More

Xarelto trial halted early due to excessive harmful events

A phase III clinical trial, called GALILEO, comparing the blood thinner Xarelto to the antiplatelet Plavix with aspirin in patients who have undergone transcatheter aortic valve replacement, was stopped early after a preliminary analysis showed excesses in key adverse events in patients treated with Xarelto. Among patients in the Xarelto group, 11.4 percent suffered thromboembolic events compared to 8.8 percent of patients in the Plavix/aspirin group; and 4.2 percent of Xarelto patients experienced bleeding compared to 2.4 percent of patients in the Plavix/aspirin group. There was also a 6.8 all-cause mortality risk in Xarelto patients compared to 3.3 percent among ... Read More

Thousands of Illegal Opioid Prescriptions Dispensed by Houston Clinic

After a Houston clinic owner and physician went to prison for writing thousands of fraudulent prescriptions for opioid painkillers and other prescription drugs, Drug Enforcement Administration (DEA) agents shared with the press some of the clinic’s inner workings to demonstrate how insidious the opioid epidemic has become. Houston’s KPRC-TV featured the case of Gulfton Community Health Center, which ran an illegal opioid distribution operation that dispensed about 34,000 illegal prescriptions (about 2.1 million units of hydrocodone alone) to opioid addicts and dealers. DEA agent Wendell Campbell told KPRC that agents usually saw lines of 30-40 people at the doors of ... Read More

Liveyon recalls stem cell products due to report of adverse events

Liveyon LLC, a marketer and distributor of stem cell products manufactured by Genetech Inc., is recalling products from its ReGen Series after receiving reports of adverse events. Liveyon was contacted in September 2018 by the Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER), which oversees human cells and tissue-based products, regarding concerns that products manufactured by Genetech and reports of possible adverse reactions in patients who were treated with the ReGen Series products. “Liveyon immediately suspended shipment of all product pending an inquiry by CBER into the source of the adverse reactions,” the company said in ... Read More

Medtronic updates heart device software to address cybersecurity risks

Medtronic is notifying health care professionals and patients that some of its cardiac implantable electrophysiology devices (CIEDs) used to treat patients with heart failure or heart rhythm problems may pose a safety risk caused by cybersecurity vulnerabilities. The company will implement a network update to address the issue. The issue involves Medtronic CareLink and CareLink Encore Programmers, models 2029 and 29901, which are used during implantation and regular follow-up visits for Medtronic CIEDs, including pacemakers that provide pacing for slow heart rhythms, implantable defibrillators that provide an electrical shock or pacing to stop dangerously fast heart rhythms, cardiac resynchronization devices ... Read More

Funeral directors stocking up on opioid antidote

The National Funeral Directors Association is recommending its funeral directors recognize the symptoms of drug overdose and stock the opioid antidote naloxone in order to protect embalmers from exposure to highly potent pain killers like fentanyl and carfentanyl. The medications can be deadly in even the smallest quantities when inhaled or absorbed through the skin. Protecting funeral home employees is yet another aspect of the opioid epidemic. Funeral directors are calling themselves “last responders” in the opioid crisis, and have been seeing overdose victims in record numbers in recent years. Opioids have become more potent, killing users and putting those ... Read More

High levels of cancer-causing impurity found in heart drug valsartan

Levels of a carcinogenic impurity found in several brands of the high blood pressure and heart failure drugs containing the active ingredient valsartan are up to more than 2.5 times higher than what is considered “reasonably safe for human ingestion based on lifetime exposure,” according to a Food and Drug Administration (FDA) news release. The agency reported earlier that the impurity may have been present in some of the drugs for as long as four years. The impurity is called N-nitrosodimethylamine or NDMA. For reference, the FDA says that consuming up to 0.096 micrograms (mcg) of NDMA per day is ... Read More

Opioid package passes Senate in latest push to fight U.S. opioid epidemic

The Senate voted almost unanimously voted to pass a sweeping opioid package intended to combat the nation’s opioid epidemic, with provisions to prevent illegal drug shipments from entering the United States, encourage innovative research on pain treatments, extend support for those seeking substance abuse, and provide help for babies born addicted to opioids. The package overwhelmingly passed the House at the end of September. The legislation will now be sent to the White House, providing lawmakers fodder just ahead of the November midterm elections. The bill includes legislation developed by dozens of lawmakers – a rare bipartisan response to the ... Read More

U.S. Injects $320 Million into Fighting Opioid Crisis

The U.S. government is expanding its fight against the nationwide epidemic of opioid abuse and addiction by dumping nearly $320 million in programs and causes it believes will beat back the drug crisis. The U.S. Department of Justice made its announcement on the first day of National Substance Abuse Prevention Month, saying the “unprecedented funding will directly help those most impacted by the deadliest drug crisis in American history, including crime victims, children, families and first responders.” Attorney General Jeff Sessions said the giant investment will fund prevention efforts, treatment and enforcement – the three aspects of the opioid crisis on ... Read More

Mistrial declared in second J&J talc trial alleging meso link

The latest case accusing Johnson & Johnson of knowing its talcum powders caused cancer ended in a deadlock. Kirk Von Salzen, 74, sued the consumer health care giant alleging he used Johnson’s Baby Powder for about 30 years, as well as talc products from other manufacturers. He claimed that J&J knew the talc it used contained cancer-causing asbestos but refused to warn consumers of the risks of asbestos exposure. As a result, he claims he developed mesothelioma in 2017, and was seeking more than $12 million in damages. Mesothelioma is a rare and deadly form a cancer that develops in the ... Read More