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Pharmaceutical 5836 articles

Beasley Allen has one of the largest and most technologically advanced Mass Torts practices in the country. The Mass Torts division represents numerous people in claims against companies that manufacture and/or market defective pharmaceuticals and/or medical devices. The resources devoted to this division allow the firm to competently and conscientiously handle any group of cases, no matter how large, along with particular catastrophic injury cases.

Our firm was recently involved in one of the greatest victories in Mass Torts history, against drug manufacturer Merck regarding the drug Vioxx. After more than five years of hard-fought and difficult litigation, Merck agreed to pay $4.85 billion, the largest pharmaceutical settlement in U.S. history, to resolve certain Vioxx-related claims involving plaintiffs who suffered a heart attack, including sudden cardiac death, or a stroke.

Educate yourself on preventable forms of hair loss

bald woman, Taxotere - Pixabay image

Some forms of hair loss, like male pattern baldness, also known as androgenic alopecia, are caused by hormones and genetics. Others like alopecia areata, an autoimmune disease, can be unexpectedly brought on by great stress. But there are other kinds of hair loss that are completely preventable. Knowridge Science Report says that traction alopecia is one of these, and one-third of African American women is estimated to suffer from this preventable form of hair loss. Researchers recently published results of a review of 19 studies on traction alopecia online in the Journal of the American Academy of Dermatology. They urge ... Read More

Plaque psoriasis drug approved with strong suicidal ideation warning

black box warning graphic - WL

The recently approved anti-inflammatory plaque psoriasis drug Siliq (brodalumab) will hit the market later this year facing major hurdles, including a black box warning, restrictive prescribing protocols, and steep competition. The development of Siliq came out of a partnership between Amgen and AstraZeneca. In 2015, Amgen backed out of the deal after observing suicidal ideation in patients who were treated with the drug during clinical trials. Amgen feared the drug would not only have a difficult road to approval due to the suicide risk, if it were approved, it would come with restrictive labeling. AstraZeneca then struck a deal with ... Read More

China’s regulation of deadly opioid expected to help curb overdose deaths in US

World of Pain

China has listed the deadly opioid carfentanil as a controlled substance, a small battle won in the U.S. war on drugs. Carfentanil is mega-opioid, 10,000 times more potent than morphine and about 100 times more potent than fentanyl, the painkiller that killed pop star Prince. Its only practical use is as an elephant tranquilizer, but drug dealers cut it up and add it to heroin and other drugs to boost profit margins. And their main supplier of carfentanil? China. The emergence of carfentanil and fentanyl have upped the ante in the opioid epidemic that has swept the U.S. Thousands of ... Read More

Dietary supplement maker warned about parasite infestation claims

fda-logo

Dietary supplement manufacturer Humaworm was hit with a Food and Drug Administration (FDA) warning letter for making claims that it’s products could cure, mitigate, treat or prevent diseases or conditions, a direct violation of the Federal Food, Drug and Cosmetic Act, the agency stated. The warning comes following an agency inspection that occurred Aug. 16 and 17, 2016, and an agency review of the company’s website at www.humaworm.com in December 2016. The FDA said that the claims the company made regarding its products rendered them unapproved new drugs. Some of the claims include statements such as “FACT: OVER 90% OF ... Read More

Common drugs’ link to kidney damage should be taken seriously, say study authors

PPI proton pump inhibitor

Last month Knowridge Science Report warned its readers about the serious kidney damage that has been linked to proton pump inhibitors, or PPIs, used to treat heartburn, ulcers and acid reflux. The site reports that more than 15 million Americans are prescribed these drugs, which include the name brands Prevacid, Nexium and Prilosec. They are also available over-the-counter to countless more. Knowridge references two recent studies. One published in February 2016 in the Journal of the American Medical Association by researchers at Johns Hopkins University compared PPIs to another common type of heartburn treatment, H2 receptor blockers such as ranitidine or ... Read More

Melatonin levels vary greatly from bottle to bottle

sleep

The amount of melatonin in dietary supplements promoted to help regulate sleep and wake cycles varies dramatically from 83 percent less than the concentration declared on the product’s label to 478 percent more, with lot-to-lot variations of as much as 465 percent, according to a new study published in the Journal of Clinical Sleep Medicine. “We found that some products have much more melatonin than is indicated on the label,” said study co-author Praveen K. Saxena, PhD, professor in the department of plant agriculture and the Gosling Research Institute for Plant Preservation at the University of Guelph in Ontario, Canada. ... Read More

Metallosis Linked to Metal-on-Metal Hip Implant may lead to Dementia-Like Symptoms

DePuy-ASR-hip-recall

Recently, a Texas jury awarded six plaintiffs with a $1 billion verdict against DePuy Orthopaedics, a subsidiary of Johnson & Johnson, over its metal-on-metal hip implant design that many patients claim has caused them pain, inflammation, bone erosion, tumors and tissue death. The company is facing a total of 8,900 lawsuits from people who say they have experienced adverse effects from the artificial hip. The metal-on-metal hip implant is a design meant for younger patients, or patients who have a more active lifestyle. They were intended to be more sturdy and durable with a longer lifespan than traditional ceramic implants, but have been ... Read More

FDA mum about whether amputation warning will be added to Invokana, Invokamet

Invokana

The Food and Drug Administration (FDA) has not tipped its hand on whether it will require updating of the safety labels of the type 2 diabetes drugs Invokana and Invokamet to include new warnings of lower limb amputations following an announcement earlier this week that European drug authorities were ordering the updates on labels of Invokana and Invokamet as well as others in the same class. Invokana and Invokamet (marketed as Vokanamet in Europe) are in a class of type 2 diabetes medications known as sodium-glucose go-transporter 2 (SGLT2) inhibitors. Other drugs in this class include Forxiga and Jardiance. Both ... Read More

Unapproved HCG weight loss treatment recalled due to sterility concerns

bathroom scale

Concerns about sterility of an unapproved weight loss treatment have prompted Synergy Rx Pharmacy to recall all lots of Human Chorionic Gonadotropin (HCG). Administration of a drug intended to be sterile that is not could result in serious infections that could be life threatening. To date, Synergy Rx Pharmacy has not received any reports of adverse events related to this recall. HCG is a hormone produced by the human placenta and found in the urine of pregnant women. It is FDA-approved for the treatment of select cases of female infertility and hormone treatment in men. The products are only available ... Read More

FDA slaps dietary supplement maker with warning letter over significant violations

dietary supplements - pills, probiotics

California-based dietary supplement manufacturer Herbal Sciences International received a warning letter from the Food and Drug Administration (FDA) following an inspection of the plant during which agency inspectors “identified a number of significant violations of FDA’s Current Good Manufacturing Practices (CGMP) in the Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements Regulations.” The company manufactures dietary supplements under the names Xiao Ke Wan (Diabetic Formula), Ping Ya San (Pressure Reduce Formula), Ruan Jian Xiao Zhen Tang (Tumor, Cancer Fighter #1, 10:1), She Hu Xiao Zhong Wan (Prostate Ease), An He Jian Fei Wan (An Ho Diet Pills); Geng Nian ... Read More