Pharmaceutical 7432 articles

Opioid epidemic killing a growing number of youth in America

The death rate among children and adolescents due to opioid overdoses nearly tripled from 1999 to 2016, according to a report published in the journal JAMA Network Open, an indication that the opioid epidemic is also affecting youth in America. “What began more than two decades ago as a public health problem primarily among young and middle-aged white males is now an epidemic of prescription and illicit opioid abuse that is taking a toll on all segments of U.S. society,” the researchers wrote. “Millions of children and adolescents are now routinely exposed in their homes, schools and communities to these ... Read More

Wearable device alerts when opioid overdose is imminent

The nation’s opioid epidemic is killing tens of thousands of Americans each year. A group of students from Michigan’s Carnegie Mellon University hopes to curb that trend with a wearable device that alerts the wearer when overdose is imminent, allowing enough time to administer the life-saving opioid reversal agent, naloxone. There’s no question the opioid crisis is crippling the nation. More than 115 people die from opioid overdoses every day, and that number continues to creep higher as more people become dependent on the highly addictive painkillers. Measures have been made to tackle the prescribing and misuse of opioids, and ... Read More

FDA chief tweets agency’s status amid ongoing government shutdown

Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb has taken to Twitter to offer updates on how the agency is managing to do its job during the partial government shutdown and showing that some employees are showing up for work despite not knowing whether they will be paid for their time. “Many asked if #FDA can accept new medical product applications during the shutdown. The #FDA can’t collect FY 2019 user fee payments during the shutdown, which means we can’t accept new applications for products under user fee programs,” Gottlieb tweeted Dec. 29, early into the shutdown, which has ... Read More

India tests talc samples to check for cancer-causing asbestos

There is more fallout from a recent Reuters investigation that found internal documents showed Johnson & Johnson was aware for decades that its talcum powder products contain cancer-causing asbestos but did not warn consumers of this risk. First, a U.S. senator on the Senate’s Environment and Public Works Committee pressed the Food and Drug Administration (FDA) to investigate the claims. Now drug regulators in India announced they are collecting new samples of talcum powder to determine if it is contaminated with asbestos. In recent years, Johnson & Johnson has been trying to shield itself from a growing number of lawsuits ... Read More

HHS recommends opioid antidote be prescribed to at-risk patients

In order to reduce the risk of overdose death, health care providers should strongly consider prescribing the opioid antidote naloxone to patients at high risk of opioid overdose, the Department of Health and Human Services (HHS) recommended in new guidance released this week. “Because this ongoing crisis and the continued deaths from opioids (prescription opioids, heroin, and illicit synthetic opioids like fentanyl), we must continue an ‘all hands on deck’ approach to prevent opioid misuse and treat those with opioid use disorder, to decrease the deadly effects of addition until sustained recovery is achieved,” HHS said in a statement. “One ... Read More

Woman blames J&J talcum powder for her ovarian cancer diagnosis

Krystal Kim’s ovarian cancer was found by chance, during a minor surgery. She had no symptoms like bloating or pain. “That’s why it’s known as the silent killer,” she told The Philadelphia Tribune.  She underwent six rounds of chemotherapy before going into remission. When the cancer returned, she had a hysterectomy and had parts of her colon and intestines removed. That’s when she randomly took a quiz on social media asking if she had ovarian cancer and had she ever used talcum powder on her genitals for personal hygiene. She said yes to both. Then she was contacted by attorneys who ... Read More

Rapid tapering from opioids can be dangerous, experts warn

Rapidly forcing patients off highly addictive opioids can destabilize patients, lead to a worsening of pain, precipitate severe opioid withdrawal symptoms and cause a profound loss of function, medical experts warned in an open letter published in the journal Pain Medicine. In the wake of the nation’s opioid epidemic, which took more than 48,000 lives last year, the U.S. Centers for Disease Control and Prevention (CDC) has advocated for tapering and discontinuing opioids in some patients who use them for long-term pain management. But Beth Darnall of Stanford University in California, and coauthors, say that such “aggressive” dose reductions over ... Read More

FDA promises continued oversight of Essure despite its withdrawal from market

Bayer’s controversial permanent nonsurgical contraceptive device Essure will no longer be sold or distributed in the United States after the first of the year in response to thousands of complaints, but the Food and Drug Administration (FDA) will continue its oversight of the device still implanted in thousands of women. Its manufacturer also is required to continue to study Essure side effects for the next five years and provide reports to the FDA. “When new safety concerns arise for particular devices, we’re committed to taking action to develop post-market information that can help patients and providers make more informed decisions ... Read More

More heart drugs recalled due to presence of cancer-causing impurity

Two lots of Torrent Pharmaceuticals Limited’s Losartan potassium tablets are the latest heart drugs to be recalled due to the presence of a probable human carcinogen called N-nitrosodiethylamine (NDEA). Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and for the treatment of nephropathy in type 2 diabetic patients. Patients currently taking Losartan should continue taking the medication because the risk of harm may be greater if the treatment is stopped abruptly without an alternative medication. Patients should contact their pharmacist or physician with concerns. Torrent’s recalled Losartan potassium tablets include Losartan Potassium Tab, USP, 100mg, 30-count ... Read More

Fluoroquinolone antibiotics linked to dangerous aortic aneurysms

Rare but serious tears in the main artery of the body, called aortic dissections or aortic aneurysms, have been associated with the use of antibiotics called fluoroquinolones, the Food and Drug Administration (FDA) cautioned in a Safety Communication. These serious side effects can lead to dangerous bleeding or even death. The risk was seen in patients who received the drug either systemically, by mouth, or by injection. Patients at increased risk for aortic dissections from fluoroquinolone use include those with a history of blockages or aneurysms of the aorta or other blood vessels, high blood pressure, certain genetic disorders that ... Read More