Pharmaceutical 7375 articles

Flu season is officially underway; FDA gives update on seasonal flu shot

Flu season has officially begun, and the Food and Drug Administration (FDA) along with its partners across the Department of Health and Human Services are updating the public on steps that are being taken to improve readiness and effectiveness of the 2018-2019 flu vaccine, and to reiterate the importance of getting vaccinated. “I know that there are questions about the effectiveness and benefits of the flu vaccine,” said FDA Commissioner Scott Gottlieb, M.D., in an FDA statement, referencing issues with the effectiveness of last season’s vaccine. “While the effectiveness of the vaccine may vary year to year, I want to ... Read More

Two Risperdal cases allowed to seek punitive damages

Two boys can seek punitive damages from Johnson & Johnson’s Janssen Pharmaceuticals on their claims that the company failed to warn them that its antipsychotic Risperdal could cause them to develop female-like breasts, a Pennsylvania judge ruled. The cases were a part of a mass tort program in the Philadelphia County Court of Common Pleas, where about 6,700 cases are pending. In May 2014, Judge New had issued a global order for the Risperdal mass tort program that because of Janssen’s business ties to New Jersey, the company could fall under that state’s law, which protects drug companies against punitive damages ... Read More

Drug prices increase despite Trump’s promise

An Associated Press (AP) analysis of brand-name prescription drugs shows that drug companies are increasing the prices of their medications more than decreasing them, a trend that goes against President Donald Trump’s promise in May that drug companies would be announcing “massive” price cuts within the very near future. Since most price changes are made during the first seven months of the year for pharmaceutical companies to make meaningful year-to-year comparisons, the AP’s analysis focused on drug price changes for brand-name pharmaceuticals from Jan. 1 to July 31 during the years 2015 to 2018. Their review involved more than 26,000 ... Read More

Pain Clinic Operator Busted for Opioid, Medicare Fraud

A nurse practitioner whose New Hampshire pain clinic wrote hundreds of opioid painkiller prescriptions for Medicare beneficiaries in “drive-by” office visits has pleaded guilty to charges of health care and prescription fraud, federal officials announced. New Hampshire U.S. Attorney Scott Murray said that Kristen Khanna, the operator of Total Pain Care and Wellness of Salem, New Hampshire, allowed a non-professional office worker to write opioid prescriptions to Medicare beneficiaries. According to the U.S. Attorney’s announcement, Ms. Khanna left the office employee with a pad of blank prescription forms that she signed. The employee would then fill them out and give ... Read More

Jury deadlocked in latest J&J talc-asbestos case

A deadlocked jury after a week of deliberations in a case blaming Johnson & Johnson’s talcum powder products for causing a woman’s mesothelioma has prompted a mistrial. During the week-long deliberations, the Pasadena, California jury had indicated to Los Angeles Superior Court Judge Margaret Oldendorf that it couldn’t reach a consensus in the case brought by Carolyn Weirick and her wife Elvira Escudero. The couple alleged that J&J’s talc-containing products contained asbestos and Weirick’s regular use of the products caused her to develop mesothelioma, a rare but deadly cancer linked to asbestos exposure. Before declaring a mistrial, Judge Oldendorf questioned ... Read More

FDA places immediate-release opioids on new risk strategy plan

In another move to quell the nation’s opioid epidemic, the Food and Drug Administration (FDA) announced this week that it is requiring a new Risk Evaluation and Mitigation Strategy (REMS) plan for immediate-release (IR) opioids prescribed for outpatient use. The new plan includes several measures to better communicate the serious risks involving the use of opioid pain medication to both patients and health care professionals. This is the first REMS for IR opioids intended for outpatient use. IR opioids make up about 90 percent of all opioid pain medications prescribed for outpatient use. Extended-release and long-acting (ER/LA) opioids have been ... Read More

Motion suggests pharmacy benefit managers adopt opioid guidelines

The top pharmacy benefit management (PBM) companies, like CVS Caremark, Express Scripts Inc., and OptumRx Inc., should be required to follow opioid prescribing guidelines consistent with the Centers for Disease Control and Prevention (CDC) in light of the opioid epidemic, according to a new motion in the growing opioid multidistrict litigation (MDL). The motion for preliminary injunction came out of two MDL cases – one filed by union benefit plans for Ohio residents, and another filed by Webb County, Texas. PBMs have, for the most part, flown under the radar in the opioid MDL, until now. The opioid MDL consolidated ... Read More

Widower blames J&J’s baby powder for his wife’s ovarian cancer

The label on Johnson’s Baby Powder states it is “clinically proven gentle and mild.” Even its name suggests it’s safe enough for babies. But Ronald Osband says the talcum powder product killed his wife. And he wants justice. Osband is yet another person to sue Johnson & Johnson and its talc supplier Imerys Talc America, alleging the companies knew the talc contained cancer-causing asbestos but allowed it to be used in products and sold to consumers under the guise that was safe for a variety of uses, including personal hygiene. Osband’s wife Maria trusted the product and used it for ... Read More

Second cancer-causing impurity found in valsartan heart drug

Another suspected cancer-causing impurity has been found in the high blood pressure and heart failure drug valsartan manufactured by Torrent Pharmaceuticals. The Food and Drug Administration (FDA) announced in July that several pills containing the drug ingredient valsartan by various manufacturers were being recalled because they were contaminated with an “unexpected impurity” called N-nitrosodimethylamine, or NDMA. The ingredient is considered a possible carcinogen by the Environmental Protection Agency (EPA). NDMA is an organic chemical byproduct of manufacturing some pesticides and processing fish, and can unintentionally make its way into manufacturing through certain chemical reactions. Not all valsartan-containing drugs are affected ... Read More

Mesothelioma victim deserves $29 million for using J&J talc

Attorneys for a woman who claims that Johnson & Johnson’s talcum powder products are contaminated with asbestos and contributed to her mesothelioma diagnosis said in closing arguments that the consumer health care giant and its talc supplier should pay the woman $29.2 million plus punitive damages because they sold talc products to consumers knowing they were tainted with cancer-causing asbestos. The Pasadena, California trial involving the case of Carolyn Weirick and her wife Elvira Escudero also names Imerys Talc America, Johnson & Johnson’s talc supplier. Defense attorneys argue that the companies are not to blame because the women’s case is ... Read More