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Pharmaceutical 7071 articles

Abuse-deterrent OxyContin may have contributed to rise in hepatitis C

When the first abuse-deterrent formulation of the opioid OxyContin was introduced in 2010 as a way to deter misuse of the drug, it may have set off an increase in hepatitis C infections by pushing users toward injectable heroin, a new study suggests. Acute hepatitis C infections in the United States were declining in the 1990s and plateaued around 2003. But beginning in 2010, rates have been rising. Researchers with RAND Corporation told Medscape Medical News that while hepatitis C infection rates rose nationwide after abuse-deterrent OxyContin was introduced, states with higher rates of OxyContin misuse prior to the reformulation ... Read More

Recalls cause shortage of high blood pressure drugs

Sweeping recalls of a class of high blood pressure drugs known as ARBs, or angiotensin II receptor blockers, has resulted in a shortage, Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb and FDA director of drug evaluation and research Dr. Janet Woodcock said in a joint statement. And the problem will probably get worse. The shortage is among ARBs that contain the active drug ingredient valsartan, and may soon also affect other ARBs that contain losartan and irbesartan. The shortage is due to recalls of the drug over an unexpected impurity, which was identified as a chemical called NDMA ... Read More

FDA approves new treatment for people addicted to opioids

The Food and Drug Administration (FDA) has approved a new prescription digital therapeutic (PDT) for people with Opioid Use Disorder (OUD). reSET-O is immediately available and is another effort to help curb the effects of the nation’s opioid epidemic. Sandoz Inc., a division of Novartis, and Pear Therapeutics Inc., are jointly launching reSET-O, a 12-week cognitive behavioral therapy intended as an outpatient therapy for patients addicted to opioids but trying to stay clean. reSET-O includes a transmucosal buprenorphine, a commonly used medication to treat opioid addiction, as well as contingency management that provides incentives to reinforce behaviors. Once reSET-O is ... Read More

Insys founder paid kickbacks to docs to prescribe its addictive fentanyl

Insys Therapeutics Inc.’s founder and four of its executives stooped to new lows to entice doctors to prescribe their pricey opioid spray Subsys, treating them to lavish dinners, putting them on its payroll, and even giving one top prescriber of the drug a lap dance, Assistant U.S. Attorney David G. Lazarus told a federal jury in Boston in the trial of former Insys chairman and founder John Kapoor. Kapoor, along with other company executives, is facing charges of using bribes and kickbacks to increase sales of Subsys, a highly addictive spray version of the opioid fentanyl. “This is a case ... Read More

Recovered opioid addict shares her struggle to come clean

Sara, 29, didn’t believe she would ever become addicted to opioids because a doctor had prescribed the medication. During treatment for a medical condition, Sara was put on a morphine drip. The drip continued throughout the duration of her hospital stay. When she left the hospital, she was given a supply of pain killers. “I didn’t realize for another year or two that I probably left the hospital that day dependent on opioid pain medication.” As the physical addiction took hold of Sara, she began to feel sick. Her tolerance to the drugs increased, and she needed more and more ... Read More

As drug companies recall heart drug valsartan, other companies hike prices

Beginning in July, Teva Pharmaceuticals and Prinston Pharmaceuticals rolled out a series of recalls on the high blood pressure and heart failure medicine valsartan after a probable carcinogen was found in the drug. Another company, unaffected by the issue, saw a rare opportunity. Alembic Pharmaceuticals rushed to hike the prices of its similar drugs anywhere from 329 percent to 469 percent. And when the same potentially cancer-causing impurity was found in another high blood pressure medication, irbesartan, Alembic hiked the price of its irbesartan, too. The tactic proved an overwhelming success for the company, which reported “massive growth” in U.S. ... Read More

Infants’ ibuprofen drops recalled due to higher concentrations

Six lots of generic Ibuprofen Oral Suspension Drops for infants manufactured by Tris Pharma Inc., and sold at CVS Pharmacy, Wal-Mart Stores, and Family Dollar are being recalled because some units may contain a higher levels of ibuprofen concentration. Some bottles of the ibuprofen concentrate were found to contain as much as 10 percent above the limit specified on the packaging. Infants who are already susceptible to ibuprofen side effects may be at a slightly higher risk if they are given a higher concentration of the medication from an affected bottle. For example, these babies may be more vulnerable to ... Read More

Ethicon hit with $41 million verdict over defective transvaginal mesh claims

A woman who endured nine surgeries and nearly a dozen chemical cauterizations after her transvaginal mesh device eroded inside her body was awarded $41 million by a Philadelphia jury. Jurors found Johnson & Johnson subsidiary Ethicon Inc., had negligently designed the mesh implant and never warned that the device could erode though the body’s soft tissue in the pelvis and cause permanent scarring, debilitating pain, and other problems, Law360 reported. Transvaginal mesh was designed to treat conditions such as pelvic organ prolapse (POP) or stress urinary incontinence. The mesh was implanted through the vagina. It was billed as a minimally ... Read More

Life-threatening birth defect linked to opioid use

A potentially deadly birth defect in which a baby’s abdomen doesn’t develop properly and his intestines poke outside the body may be tied to the mother’s opioid use during pregnancy, according to an analysis published by the Centers for Disease Control and Prevention (CDC). The defect, called gastroschisis, occurs early in pregnancy. Researchers don’t know what it is about opioids that may cause this defect, just that there is “a higher prevalence (of the defect) in areas where opioid prescription rates were high,” the report said. Gastroschisis is more often seen in teen mothers and mothers who drink and smoke. ... Read More

FDA takes unprecedented step to support OTC naloxone

The U.S. Food and Drug Administration (FDA) is taking unprecedented steps to support the development of over-the-counter naloxone to reverse the effects of opioids in an effort to reduce opioid overdose deaths. “With the number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017, it’s critical that we continue to address this tragedy from all fronts,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. When someone overdoses on opioids, they can lose consciousness and their breathing may become shallow or stop altogether, which can quickly lead to ... Read More