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FDA Calls for New Powers to Regulate CBD Products
  + stars: | 2023-01-26 | by ( Julie Wernau | ) www.wsj.com   time to read: 1 min
The FDA says CBD oil and other cannabis-derived products should be regulated more closely because of health risks. The Food and Drug Administration said cannabis-derived products need closer oversight than the agency can currently provide due to safety risks, and it will seek new powers from Congress. The agency said Thursday that products made from legal cannabis shouldn’t be regulated as dietary supplements or food additives, as its current powers allow, given the products’ risk to human and animal health, and especially to children and women who are pregnant.
When she goes out, singer-songwriter Kalie Shorr always ensures she’s carrying the basics: wallet, keys—and fentanyl test strips. “When I’m at clubs, people just whip out cocaine—on the dance floor, sometimes,” said Ms. Shorr, who is 28 and lives in Los Angeles. When she sees drugs at a party or club, Ms. Shorr will nonchalantly offer up a test strip so people can test them for fentanyl, the dangerous synthetic opioid increasingly making it into a range of drugs across America.
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A worker with the Brooklyn Community Recovery Center demonstrates how to use an overdose-reversal drug. A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription. Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.
A worker with the Brooklyn Community Recovery Center demonstrates how to use an overdose-reversal drug. A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription. Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.
The revised label for the Plan B emergency contraceptive warns against use if a woman is already pregnant. The Food and Drug Administration revised the label for the Plan B emergency-contraceptive pill to make clear it shouldn’t be used for abortion. Under the changes made Friday, the drug’s label says the pill usually works before the release of an egg from an ovary.
Chinese chemical companies are playing a major role in the U.S. fentanyl crisis as the main producers of ingredients needed to make the drug. Strained relations between Beijing and Washington are undermining efforts to stop the flow of those chemical building blocks, and thus impeding the struggle against illicit fentanyl.
U.S. Life Expectancy Fell to Lowest Level Since 1996
  + stars: | 2022-12-22 | by ( Julie Wernau | Jon Kamp | ) www.wsj.com   time to read: 1 min
U.S. life expectancy fell to 76.4 years in 2021, down from 77 years in 2020. Life expectancy in the U.S. fell again last year to the lowest level since 1996, federal data showed, after Covid-19 and opioid overdoses drove up the number of deaths. Covid-19 was the third-leading cause of death for a second consecutive year in 2021, the Centers for Disease Control and Prevention said Thursday, and a rising number of drug-overdose deaths also dragged down life expectancy. Overdose deaths have risen fivefold over the past two decades.
Can Drugs Treat Addiction? Prisons Offer an Answer
  + stars: | 2022-12-09 | by ( Julie Wernau | ) www.wsj.com   time to read: 1 min
Sheriff Peter Koutoujian worked for years to get drugs into Middlesex County jail. Operating the facility northwest of Boston had come to feel like living in a bad rerun, he said. Inmates arrived addicted to opioids, went through detox, lived without drugs and were eventually released. Then they started using again, overdosed and died, or landed back in jail.
The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of naloxone to combat the overdose crisis from bootleg fentanyl. A startup vying to produce one of the first over-the-counter overdose-reversal medications said it had submitted results to the Food and Drug Administration showing that its drug works more quickly than prescription-only versions. The randomized trial of 60 healthy volunteers evaluated naloxone absorption from Pocket Naloxone Corp.’s nasal swab versus a 4 milligram nasal-spray delivery and found 74% higher exposure 2.5 minutes after dosing and 19% higher exposure at 5 minutes. Naloxone works by blocking the effects of opioids.
Vending machines stocked with overdose-reversing nasal spray are part of the latest attempt to diminish a record tide of drug deaths. The Food and Drug Administration and some states have loosened restrictions on drugs including Narcan that are sprayed into the nose to reverse an opioid overdose.
Marijuana May Hurt Smokers More Than Cigarettes Alone
  + stars: | 2022-11-16 | by ( Julie Wernau | ) www.wsj.com   time to read: 1 min
Nearly half of the marijuana smokers whose chest scans were reviewed for a study had mucus plugging their airways. Marijuana might do more damage to smokers than cigarettes alone. A study published Tuesday in the journal Radiology demonstrated higher rates of conditions including emphysema and airway inflammation among people who smoke marijuana than among nonsmokers and people who smoked only tobacco. Nearly half of the 56 marijuana smokers whose chest scans were reviewed for the study had mucus plugging their airways, a condition that was less common among the other 90 participants who didn’t smoke marijuana.
Marijuana May Hurt Smokers More than Cigarettes Alone
  + stars: | 2022-11-15 | by ( Julie Wernau | ) www.wsj.com   time to read: 1 min
Nearly half of the marijuana smokers whose chest scans were reviewed for a study had mucus plugging their airways. Marijuana might do more damage to smokers than cigarettes alone. A study published Tuesday in the journal Radiology demonstrated higher rates of conditions including emphysema and airway inflammation among people who smoke marijuana than among nonsmokers and people who smoked only tobacco. Nearly half of the 56 marijuana smokers whose chest scans were reviewed for the study had mucus plugging their airways, a condition that was less common among the other 90 participants who didn’t smoke marijuana.
The recommendation was part of the CDC’s first update to its opioid guidelines since 2016. Federal officials said inflexible rules around the prescription of opioids have harmed some patients, urging doctors to exercise compassion in alleviating pain. In an update to opioid-prescription guidelines, the Centers for Disease Control and Prevention said Thursday that a crackdown on opioid prescriptions to address rampant abuse had led to some patients being deprived of medicines they needed.
The Sinaloa and Jalisco organizations have taken over from Chinese sellers as a dominant source of the potent synthetic opioid, a leading cause of the U.S.’s record overdoses. Among the reasons, it is easier and less expensive to produce than heroin.
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