Pharmaceutical 7071 articles

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

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