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Pharmaceutical 6438 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.

‘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

Axiron safety label updated

Axiron

The Patient Counseling Information/Patient Information/Medication Guide for the topical testosterone gel Axiron has been updated to include clarifications such as ensuring patients know how to administer the correct dosage as well as understanding that they should not drink the product. Axiron is a testosterone supplement intended for men with low levels of the male hormone due to injury or disease. It is a topical gel that is applied to the armpits. Patients are advised to wash their hands right away with soap and water after applying the gel and, once the solution has dried, to cover the area with clothing to ... Read More

Supplement maker slapped with FDA warning letter

dietary supplements - pills, probiotics

The Food and Drug Administration (FDA) came down on a manufacturer of dietary supplements for promoting its products to treat, cure or prevent diseases, which renders them unapproved drugs as defined by federal law. In a warning letter to Dr. Carolyn Dean, who runs the website www.rnareset.com and takes orders for the products ReMyte, ReAline, ReMag, ReStructure, and ReCalcia Pico Meter Calcium, the FDA said it found that some of the website claims and testimonials “provide evidence that your products are intended for use as drugs.” For example, the company’s ReMyte boasts protection against cancer, claims to treat arthritis, to ... Read More

FDA finds hidden drugs in sexual enhancement supplements

ucm567230

The Food and Drug Administration (FDA) is advising consumers not to purchase or use specific dietary supplements marketed for sexual enhancement because they contain hidden drugs that could cause serious health risks. FDA laboratory analysis found that Platinum 500 contains sildenafil, the active ingredient in the erectile dysfunction drug Viagra; and Kingdom Honey for Her, Kingdom Honey for Him, and Royal Honey VIP, contain tadalafil, the active ingredient in the erectile dysfunction drug Cialis. Undeclared Viagra and Cialis in these dietary supplements may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to ... Read More

Testosterone heart risk not worth benefit

Low T

Jesse Mitchell was in his mid 40s when he was stricken with lethargy, anxiousness and depression. He started taking AndroGel testosterone replacement therapy, lured by the aggressive marketing campaigns geared directly to consumers informing them that AndroGel could cure so-called Low T. Mitchell said the gel did boost his energy and he continued to use the hormone treatment, Law360 reported. But in 2012, after using the medication for about two years off and on, Mitchell suffered a heart attack. He learned that testosterone treatments had been linked to cardiovascular risks including heart attacks, strokes, blood clots and death, and in ... Read More

Diet pill pusher gets 18 months in prison

bathroom scale, diet, weight

A Fort Myers, Florida, dietary supplement marketer received an 18-month prison sentence in federal court after pleading guilty for selling diet pills and supplements to boost attention deficit containing an illegal and potentially dangerous ingredient. The distributor Derek Vest also forfeited $2.5 million to federal officials he reportedly made selling Phen Tabz, Add Tabz and Phen Tabz Teen from April 2013 to November 2014. He also testified in other investigations as part of his plea deal. The adulterated dietary supplements were made by Fort Myers-based Gentech Pharmaceuticals. Laboratory testing conducted on Phen Tabz, Add Tabz and Phen Tabz Teen detected hidden ... Read More

New test detects Viagra hidden in supplements

Viagra single pack

Korean scientists have devised a sensitive, rapid and efficient test to detect the erectile dysfunction drug Viagra in dietary supplements, according to SeparationNow.com. The process involves combining solid-phase extraction with dispersive liquid-liquid microextraction. The result of this is liquid chromatography-UV detection method is that it sniffs out sildenafil almost as well as more sophisticated methods based on liquid chromatography-mass spectrometry (LC-MS). “Up to now, LC-MS has proved to be the most effective method for detecting sildenafil, but Korean scientists led by Sung Won Kwon at Seoul National University wanted to try to develop an equally effective LC-UV detection method,” SeparationsNow.com ... Read More

Diet doesn’t affect Xarelto effectiveness

xarelto

A cross-study analysis of Xarelto indicates that neither the timing nor the content of a meal appear to clinically change the level or effectiveness of the blood thinner, according to a study published in The Journal of Clinical Pharmacology. The highly selective oral direct factor Xa inhibitor is approved by the Food and Drug Administration (FDA) to prevent strokes in patients with the heart condition atrial fibrillation. It is also used to treat or prevent deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery. Xarelto, which contains ... Read More

Doctor testifies about testosterone heart risks

Low T

There is plenty of evidence to show that testosterone replacement therapy increases the risk for hear attacks, a cardiologist told an Illinois federal jury during the first trial among thousands in a multi district litigation alleging Abbie’s AndroGel causes heart risks, Law360 reports. Dr. Hossein Ardehali, a cardiologist at Northwestern University’s Feinberg School of Medicine, is an expert witness testifying for plaintiff Jesse Mitchell. Dr. Ardehali told jurors that he reviewed several studies involving men who took AndroGel and concluded that there was sufficient evidence to show the testosterone treatment increases cardiovascular risks. For example, he pointed to a 2010 ... Read More