Pharmaceutical 7071 articles

High-dose antipsychotics raise risk of death in children, adolescents

Children and adolescents treated with high doses of antipsychotic medication for conditions not listed on the medication’s label have a significantly higher risk of unexpected death, according to a new study by Vanderbilt University Medical Center researchers. Antipsychotic medication, which includes the brand-name Risperdal, is intended to treat various mental illnesses. For example, Risperdal is used to treat symptoms of schizophrenia, bipolar disorder and irritability in autism in both adults and children. But it is often prescribed off-label to treat behavorial conditions like attention deficit hyperactivity disorder (ADHD) and Tourette’s syndrome. Researchers found that children and adolescents between the ages ... Read More

Johnson & Johnson’s bad week reflected in its slumping market value

It’s been a bad week for Johnson & Johnson, and it’s taking a toll on its market value. First, there was the Reuters report about internal documents that showed the consumer health care giant knew the talc it used in its baby powder and body powder contained cancer-causing asbestos, which resulted in a more than 10 percent decline in its stock prices. Then the company failed to convince a Missouri judge to strike a $4.69 billion jury verdict awarded to 22 women who claimed its talcum powder products contained asbestos that caused them to develop ovarian cancer. (J&J plans to ... Read More

Olympus pleads guilty for not disclosing infection risks with duodenoscopes

Olympus Corp., was hit with $85 million in fines and forfeiture by the U.S. Department of Justice (DOJ) for distributing specialized endoscopes in the United States without disclosing that the device could spread infections in patients. Both Olympus and the Japanese medical technology’s former top regulatory official, Hisao Yabe, pled guilty to the charges in separate suits in New Jersey federal court. The instruments, called duodenoscopes, are threaded down the throats of patients to treat or diagnose problems with the bile ducts and pancreas. They had been linked to a number of infections in Europe in 2012 and 2013. By ... Read More

FDA updates consumers on tainted heart drugs investigation

The Food and Drug Administration (FDA) issued a warning letter to the China-based manufacturer of the active pharmaceutical ingredient (API) in the heart medication valsartan that is under investigation by the agency after the presence of a probable cancer-causing impurity was found in the drugs. The FDA’s warning letter outlines several manufacturing violations at Zhejiang Huahai Pharmaceutical Co. Ltd (ZHP), in Linhai, Taizhou Zhejiang China, including impurity control, change control and cross contamination from one manufacturing process line to another. The FDA is still looking for the root cause of the impurity, which the agency said previously may have been ... Read More

J&J can’t escape $4.69 billion talc verdict

The $4.69 billion verdict by a St. Louis jury last July against Johnson & Johnson in a case brought by 22 women who linked their use of the company’s talcum powder to their ovarian cancer diagnoses, is “fair and reasonable” compensation considering the substantial amount of evidence introduced during the trial, a Missouri judge ruled. St. Louis Circuit Court Judge Rex Burlison said that due process was followed when the jury reached its verdict in the case. The verdict included $550 million in compensatory damages and $4.14 billion in punitive damages. Both Johnson & Johnson and its unit Johnson & ... Read More

J&J announces plans to repurchase shares after scathing news report

Days after a scathing Reuters report accusing consumer health care giant Johnson & Johnson of a decades-long cover-up of evidence that its talcum powder products contained cancer-causing asbestos, the company’s market value plummeted more than $50 billion. In response, J&J announced it plans to repurchase $5 billion shares. “Based on our continued strong performance and more importantly, the confidence we have in our business going forward, the Board of Directors and management team believe that the company’s shares are an attractive investment opportunity,” CEO Alex Gorsky said in a statement. The company also published a video on its website and ... Read More

Opioids, benzos and stimulants the cause of most drug overdose deaths

Drug overdose deaths jumped a whopping 54 percent – to 63,632 – in the United States from 2011 to 2016, and opioids, benzodiazepines (benzos), and stimulants were the drugs most often to blame, according to a new report by the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS) in the wake of the opioid epidemic. The opioid oxycodone, known by the brand name OxyContin, was the most cited drug on death certificates in 2011. But the illegal opioid heroin took the lead for the subsequent years. According to the National Institute on Drug Abuse, about 21 to ... Read More

J&J cannot escape failure-to-warn lawsuit brought by Mississippi AG

Johnson & Johnson and one of its distributors cannot skirt a lawsuit brought by Mississippi Attorney General Jim Hood alleging the companies did not warn Mississippians that their talc-containing products could put women at risk for ovarian cancer, Hinds County Chancellor J. DeWayne Thomas ruled. Hood’s lawsuit accuses J&J and Valeant Pharmaceuticals, distributor of its Shower to Shower talc-containing body powder, of violating the Mississippi Consumer Protection Act (MCPA) by not putting a warning on the label that genital use of the product for feminine hygiene could increase the risk for ovarian cancer. The two companies sought to have the ... Read More

Lawsuit knocks Kellogg for not disclosing its breakfast foods contain glyphosate

California resident Mason Kein is leading a group of angry consumers in a proposed class action lawsuit against Kellogg Co. for selling breakfast foods without revealing that they contain a possible cancer-causing chemical. Kein told the Southern District of California that testing by the nonprofit Environmental Working Group revealed that Kellogg Co.’s strawberry Nutrigrain Soft Baked Breakfast Bars and Cracklin’ Oat Bran cereal contain the herbicide glyphosate, a chemical deemed a “probable carcinogen” by the World Health Organization’s International Agency for Research on Cancer (IARC). Glyphosate is the same chemical found in Monsanto’s Roundup, the controversial weed killer that was ... Read More

Higher-than-expected rate of contamination with specialized endoscopes

Specialized endoscopes used during medical procedures to diagnose problems and perform therapies on bile ducts or the pancreas have a higher-than-expected rate of contamination even after cleaning and disinfecting, the Food and Drug Administration (FDA) cautioned. The agency also reminded health care professionals of the importance of manually cleaning the medical instruments prior to disinfecting or sterilizing, and of properly servicing the devices. The instruments, known as duodenoscopes, are flexible, lighted tubes that are threaded through the mouth, down the throat and stomach to the top of the small intestines. They are complex by design with many small, working parts. ... Read More