Pharmaceutical 7375 articles

Third hypertension drug found to contain probable carcinogen

A third medication for high blood pressure has been found to contain trace amounts of a suspected cancer-causing agent, prompting another recall. This time, Sandoz Inc., recalled one lot of losartan potassium hydrochlorothiazide tablets after trace amounts of the impurity N-nitrosodiethylamine (NDEA) was detected. The active pharmaceutical ingredient losartan was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz’s losartan potassium hydrochlorothiazide is manufactured by Lek Pharmaceuticals dd, Ljubijana, Slovenia. NDEA is classified as a probable human carcinogen by the World Health Organization’s International Agency for Research on Cancer (IARC). Losartan potassium hydrochlorothiazide tablets are used to treat hypertension. The drug ... Read More

More doctors face discipline in opioid Death Certificate Project

A total of 23 physicians face new disciplinary actions by the Medical Board of California after being flagged because a patient they had prescribed opioids to suffered a fatal overdose. California’s Death Certificate Project, launched three years ago, was designed to curb the nation’s growing opioid epidemic that accidentally kills thousands each year. The project takes death certificates in which prescription opioids were listed as the cause, then matches them with the provider – or providers – who prescribed any controlled substance to that patient within three years of death. The provider is flagged regardless of whether the particular drug ... Read More

FDA committee supports approval of first-of-kind postpartum depression treatment

A Food and Drug Administration (FDA) advisory committee voted overwhelmingly to recommend the approval of a first-of-its-kind treatment for postpartum depression. Members of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee enthusiastically voted in favor of the drug for its effectiveness and safety despite six patients out of the 140 observed losing consciousness during the 60-hour-long intravenous infusion. Instead, committee members said the drug, brexanolone, was an “exciting breakthrough” and “one of the greatest approvals ever” since the antidepressant Prozac was cleared for marketing. Brexanolone’s manufacturer Sage Pharmaceuticals provided an entourage of patients, ... Read More

FDA approves potent new opioid despite public health concerns

In the midst of the nation’s opioid epidemic, the Food and Drug Administration (FDA) has approved a new, highly potent opioid for severe acute pain in adults that is five to 10 times more potent that fentanyl and 1,000 times stronger than morphine. Dsuvia is a sublingual (under the tongue) formulation of sufentanil that is delivered to patients through a disposable, pre-filled, single dose applicator. Its use is restricted for certified medically supervised health care settings – such as hospitals, surgical centers and emergency departments for administration by a health care professional. Dsuvia has some “unique features in that the ... Read More

Another heart drug recalled due to presence of cancer-causing agent

Another medication used to treat hypertension is being recalled after it was found to be contaminated with a suspected cancer-causing agent, the Food and Drug Administration (FDA) announced in a Safety Communication. Manufacturer ScieGen is recalling certain lots of the heart drug irbesartan. Affected products have printed on their labels the words “Westminster Pharmaceuticals” and “GSMS Inc.” The announcement comes on the heels of a recall of several lots of the high blood pressure and heart failure medication valsartan. Both irbesartan and valsartan are in a class of heart drugs called angiotensin II receptor blockers, or ARBs. And both were ... Read More

J&J agrees to settle many Invokana side effects lawsuits

Johnson & Johnson has agreed to pay an undisclosed amount to settle a large number of lawsuits pending in a multidistrict litigation in New Jersey accusing the company’s diabetes drug Invokana of causing kidney failure, diabetic ketoacidosis or amputations, according to the New Jersey Law Journal. A settlement fund is expected to be ruled on by Nov. 19. It’s unclear how many of the more than 1,000 cases are included in the settlement, but attorneys say more settlements are likely. Bellwethers from the multidistrict litigation were set to go to trial as early as January 2019, but those orders were ... Read More

J&J revamps baby line to win back sales

Johnson & Johnson is revamping its Johnson’s baby product line, starting with removing the chemical dye from its golden-colored baby shampoo. The company is also making updates to the packaging of its baby products and rolling out a new digital marketing campaign in an effort to regain the dominancy it held for decades in the baby-care market. J&J jumped into the baby-care market as an afterthought. The company was founded in 1886 as a supplier of medical products like bandages and plasters. But removing them was painful, so the company’s chief scientist offered talcum powder to soothe the skin. Parents ... Read More

Trump signs ‘landmark’ legislation to fight opioid epidemic

President Donald Trump signed into law sweeping legislation to combat the opioid epidemic crippling the United States. The 660-page SUPPORT for Patients and Communities Act is aimed at doing just that – loosening the grip the opioid crisis has had on human lives and the economy. Many of the policies overseen by the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) are affected by the law. Trump described the new bipartisan achievement as “landmark legislation.” The provisions focus mostly on pilot projects involving addiction treatment and studies on prescribing limits and abuse-deterrent opioids. But ... Read More

Woman blames ovarian cancer on J&J talc

The year before Evelyn Hampton was born, the first study appeared linking talc to ovarian cancer. But neither she nor her family were warned about this association. Instead they trusted Johnson & Johnson when the company promoted its talcum powder products as safe enough for everyday use. Hampton became a loyal customer. By 1982, when Hampton was 10, researchers conducted the first epidemiological study on genital use of talcum powder for feminine hygiene and found that women who used talc in this fashion had a 92 percent greater risk of developing ovarian cancer, Hampton claims. One scientist, Daniel Cramer, even ... Read More

Workers, women seek compensation for asbestos-related cancer

The initial reaction to a cancer diagnosis is often shock and disbelief, and it’s not uncommon for patients to try to understand why their cancer developed in the first place, according to the consumer publication CURE (Cancer Updates, Research & Education). Ovarian cancer and mesothelioma victims often find out too late that they were exposed to the carcinogenic mineral asbestos either at the workplace or from using talcum powder products. Ovarian cancer is the most deadly form of cancer of the female reproductive organs. Studies suggest using talcum powder products on the genitals for feminine hygiene could put women at ... Read More