Author

Jennifer Walker-Journey

6445 posts

Jennifer Walker-Journey is a professional writer whose 20-year career spans from newspapers and magazines to Ezines and business blogs. Her primary focus is corporate and business writing, though she relishes any opportunity to write features. In her limited free time, Jennifer strives to finish the novel she is writing. She lives in Birmingham with her husband, Rick, and their insatiably curious son, Truman.

Certain antibiotics linked to major birth defects

antibiotics - vials, test tubes

Babies born to women who use certain types of antibiotics while pregnant may be at an increased risk of major congenital malformations, according to a study published in the British Journal of Pharmacology. Other types of antibiotics, however, were not associated with these types of birth defects. The antibiotics of concern include clindamycin, doxycycline, quinolones, macrolides and phenoxymethylpenicillin. Exposure to amoxicillin, cephalosporins, and nitrofurantion did not show this risk. Researchers from the University of Montreal launched the study to better understand the link between gestational antibiotic exposure and major congenital malformations. Using the Quebec pregnancy cohort consisting of nearly 400,000 ... Read More

Bleeding most reported drug-related adverse event

xarelto

There are unacceptably high risks associated with oral blood thinners, most of which involve life threatening bleeding events, according to the Food and Drug Administration (FDA) Adverse Events database and a new systematic study by the Centers for Disease Control and Prevention (CDC). The issue was identified by the Institute for Safe Medication Practices (ISMP) in its fourth quarter QuarterWatch report. ISMP’s annual report focused on drugs and specific adverse reactions that affect large patient populations and involve substantial numbers of serious injuries. There were nearly 22,000 serious adverse events reports linked to use of anticoagulants, and in particular Xarelto, ... Read More

Jardiance stealing Invokana market share

Invokana

Johnson & Johnson’s first-in-class diabetes drug Invokana is losing ground to its biggest competitor in the market, FiercePharma reported. The company reported that sales of Invokana fells short of second-quarter forecasts, coming in a tad more than 20 percent below consensus estimates of $371 million. “And that was in a quarter when the overall market expanded by 3.5 percent,” the media source said, referencing the drug company’s projections. Eli Lilly and Co. and Boehiringer Ingelheim’s diabetes medication competitor Jardiance, meanwhile, is gaining ground on the heels of promising cardiovascular data and fewer warnings than Invokana or others in the SGLT2 ... Read More

Osteoporosis drug rejected over heart risks

osteoporosis - bone scan microstructure - Wikimedia Commons

The Food and Drug Administration (FDA) has rejected the Biologics License Application (BLA) of Amgen and UCB’s osteoporosis drug Evenity, raising concerns about serious cardiac side effects seen in late-stage clinical trials, according to Genetic Engineering & Biotechnology News. Evenity, which contains the acrive ingredient romosozumb, was being tested as an osteoporosis treatment in postmenopausal women. The drug companies’ original submission to the FDA included data from a Phase III trial. The FDA says that it would like to see efficacy and safety data from other studies in the company’s resubmission of the drug, including a Phase II clinical trial ... Read More

Supplement maker slapped with warning

contract, arbitration agreement - Pixabay image

Significant violations of Current Good Manufacturing Practice (CGMP) regulations were identified during an inspection of dietary supplement maker Black Seed Herb Inc.’s facility in Liberty, New York, resulting in a Food and Drug Administration (FDA) warning letter. “These violations cause your dietary supplement products, including but not limited to Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim with pure Hoodia Gordonii Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules, Black Seed w/ Olive Leaf/Garlic Capsules, Black Seed Honey Booster, Sweet Excitement Her Honey, Revive Honey Herbal Elixir, Flax Seed Oil, Black Seed Oil, and Black Cumin Seed Oil, to ... Read More

Same equipment used to make Car polish, mouthwash

mouthwash - Wikimedia Commons

During a rather unappetizing inspection of Wisconsin-based ChemRite CoPac Inc.’s facility, the Food and Drug Administration (FDA) found concerning manufacturing practices such as using the same equipment to make its over-the-counter and other oral products as it used to make industrial car polishes and other nonpharmaceutical products. The car polishes are paraffin-based and have warning labels that state “harmful or fatal if swallowed” and “keep out of reach of children.” “The ingredients in your non-pharmaceutical products are extremely difficult to remove from manufacturing equipment, and could contaminate the drug products that you manufacture on shared equipment, such as the various ... Read More

Lawsuit over Merck’s shingles vaccine

syringe, vials, pills, injectable

A group of consumers across the country claim they have suffered a persistent strain of shingles after receiving Merck & Co.’s shingles vaccine Zostavax, and have launched a product liability action against the drug maker in New Jersey state court for not adequately warning about the risks associated with the vaccine, Law360 reported. Some consumers claim to have developed a condition called postherpetic neuralgia, resulting in nerve damage and pain. One victim says her symptoms were accompanied by scarring. The lawsuit was filed July 11 in Middlesex County Superior Court by 18 plaintiffs from Louisiana, South Carolina, Tennessee, Kentucky, Mississippi, ... Read More

ED drug in coffee prompts recall

ucm567303

Bestherbs Coffee LLC is recalling its New Kopi Jantan Tradisional Natural Herbs Coffee because the product packs far more than caffeine. A laboratory analysis conducted by the Food and Drug Administration (FDA) found that the coffee contains hidden desmethyl carbodenafil, an ingredient structurally similar to sildenafil, the active ingredient in the erectile dysfunction drug Viagra. New Kopi Jantan Tradisional Natural Herbs Coffee also contains undeclared milk. Both undeclared ED drugs and milk in this product pose health risks to some consumers. Desmethyl carbodenafil, like Viagra, may interact with nitrates found in some prescription drugs, like nitroglycerin, and may lower blood ... Read More

‘Is there something wrong with Invokana?’

Invokana

“Is there something wrong with Invokana?” The Motley Fool posed this question as part of a roundup of elements leading up to Johnson & Johnson’s quarterly report, which the media source says “often sets the tone for the pharmaceutical industry.” Johnson & Johnson is expected to produce $18.97 billion in sales – a growth of 2.6 percent over last year’s quarter. But, The Motley Fool says, “there is so much more to pay attention to than just a single sales and profit-per-share figure.” This includes the status of Johnson & Johnson’s top selling diabetes drug Invokana, which is manufactured by subsidiary ... Read More

Egg donation center slapped with FDA warning

Pregnant Girl

The Food and Drug Administration (FDA) has cracked down on a fertility clinic for not properly screening its egg donors for exposure to Zika, HIV, syphilis and other diseases. The agency issued Illinois-based Center for Reproductive Health a warning letter for deeming at least four women eligible to be egg donors before receiving the results of communicable disease tests. The FDA also found other concerning violations such as donor records with multiple or altered assessment dates. Medical history forms also had confusing dates and didn’t include questions related to conditions such as West Nile virus and syphilis or behaviors that ... Read More