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Pharmaceutical 7432 articles

Opioids offer little relief for chronic pain compared to placebo

Opioids are intended to treat pain, but they’ve become controversial since they were found to be highly addictive, contributing to hundreds of thousands of overdose deaths in recent years and creating a national opioid epidemic. Now, a new study published in JAMA reveals that the potent painkillers provide little benefit for patients with chronic pain, contrary to popular belief. The study, led by Jason Busse, an associate professor and researcher at McMaster University’s Michael G. DeGroote Institute for Pain Research and Care, found that compared to placebo, opioids only offered small improvements in pain, physical functioning and sleep quality in ... Read More

Imerys released as defendant in Florida talc lawsuit

Talc mining company Imerys Talc America Inc., was released from a Florida product liability lawsuit involving claims that the talc mining company, Johnson & Johnson Companies Inc. and Publix Super Markets Inc. contributed to a woman’s ovarian cancer diagnosis. The court ruled that Florida courts have no jurisdiction over Imerys because the company has no contacts in the state. “Here, Imerys produced a component in one state (not Florida) and sold it to a different company in a different state,” Florida’s Fourth District Court of Appeals said. The lawsuit was filed by Judith Rickets against Imerys, Johnson & Johnson, and ... Read More

Senator calls for FDA investigation into J&J talcum powder

Sen. Edward Markey, a member of the U.S. Senate’s Environment and Public Works Committee, urged the U.S. Food and Drug Administration (FDA) to investigate claims that consumer health care giant Johnson & Johnson knew for decades that the talc it used in some of its widely sold products like Johnson’s Baby Powder contained cancer-causing asbestos. The call-to-action came a week after Reuters published an investigative report titled, “Johnson & Johnson knew for decades that asbestos lurked in its baby powder,” and claimed “that J&J kept that information from regulators and the public.” Reuters’ investigation turned up internal documents dating back ... Read More

Olympus settles with two widows over faulty endoscopes

Olympus Corp. is feeling the burn for manufacturing and selling specialized endoscopes without warning that they could transmit bacteria from patient-to-patient, leading to life-threatening superbug infections. Last week, the U.S. Department of Justice (DOJ) ordered the Tokyo-based medical-scope maker to pay $80 million in fines and $5 million in criminal forfeiture over its defectively designed duodenoscopes. The company’s former executive, Hisao Yabe, also pleaded guilty for distributing the instruments and not filing reports with the U.S. Food and Drug Administration (FDA) about infections related to Olympus’ duodenoscopes. On the heels of that announcement, Olympus also agreed to pay an undisclosed ... Read More

NECC employees convicted of charges related to fungal meningitis outbreak

Five former employees of the New England Compounding Center (NECC) blamed for manufacturing and distributing contaminated steroid injections to medical facilities across the country, which led to the 2012 outbreak of fungal infections and meningitis that sickened nearly 800 and killed 64, were found guilty Thursday morning by a Boston federal jury. A sixth employee who was also tried was found not guilty. The seven-week trial resulted in the convictions of mail fraud; conspiracy to defraud the U.S. Food and Drug Administration; and violations of the Food, Drug and Cosmetic Act, for the employees, according to Law360. Cleanroom pharmacist Gene ... Read More

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