The indication for testosterone replacement treatments should be scaled back so that fewer men are prescribed them because the drugs do little to counter the signs of aging, a federal advisory panel announced. The group voted 10-1 to recommend that the prescribing language on testosterone supplements be revised to make it clear that the drugs have not been shown to reverse common symptoms of aging such as low libido, muscle loss, weight gain and fatigue. The new wording would limit the drug only for men who have abnormally low hormone levels due to disease or injury. Testosterone levels typically drop ... Read More
Pharmaceutical 3244 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.
Auxillium and Vivus’ erectile dysfunction drug Strenda has been granted a new designation by the Food and Drug Administration (FDA) that may help it compete against the dominating pills in the market, Pfizer’s Viagra and Eli Lilly’s Cialis. Strenda has been granted “fast-acting” status, allowing the pill to be taken just 15 minutes before sex, instead of 30 minutes as previously stated on its label. Comparatively, Cialis must be taken daily while Viagra must be taken one to two hours before sex. Strendra contains the active ingredient avanafil, which is in a class of drugs called phosphodiesterase inhibitors. Other drugs in ... Read More
African Americans are at an increased risk of kidney disease, and retired videographer Ron Minor wants people to know that lifestyle changes can literally help save lives. Minor, who had a kidney transplant five years ago, created a documentary titled, “I Didn’t Know,” that takes a stark look at the challenges a person with kidney disease faces, from dialysis to kidney transplants, with many people dying while waiting on a kidney. Minor draws a line between the obesity epidemic in America and high rates of related conditions such as diabetes, high blood pressure and heart disease among African Americans – all factors ... Read More
A U.S. Food and Drug Administration (FDA) advisory panel voted 20-1 Wednesday to impose strict new limitations on testosterone-replacement drugs, recommending changes to labeling that would limit FDA-approved prescription indications to men who have abnormally low testosterone levels due to injury or disease, but not aging. The changes, triggered by conflicting studies and a lack of evidence showing the efficacy of testosterone drugs for treating common age-related issues, would exclude millions of American men who currently use the drugs as antidotes for low libido, muscle loss, and lack of energy. The panel’s recommendations, which the FDA usually accepts, could also ... Read More
Using artificial sweeteners may disrupt the way the body handles sugar, increasing the risk of diabetes for some people, according to a new study published in the journal Nature. The research, conducted primarily on laboratory animals, suggests that artificial sweeteners, such as Splenda, Equal and NutraSweet, can change the bacteria that normally resides in the gut. When this happens, it disrupts how the body handles sugar in the diet, which can lead to increased blood sugar levels, a condition called glucose intolerance, which is a precursor to type 2 diabetes. Researchers say that it is too early to caution people ... Read More
Medical safety specialists are concerned at the growing number of young children who are sickened or die from accidentally swallowing a relative’s prescription for a medication used to treat opioid drug addiction. For every 100,000 patients who are prescribed buprenorphine, 200 children are hospitalized – a rate more than four times higher than the second-most accidentally ingested medication, blood pressure mediation. The research is published in the current issue of the journal Pediatrics. Buprenorphine is a narcotic much like the drugs it is designed to help patients wean off, such as heroin or prescription painkillers. While it can produce typical ... Read More
Bayer’s dietary supplement Phillips’ Colon Health is making unsupported claims that it can prevent diarrhea, constipation, gas and bloating but the company does not have reliable scientific evidence to support those claims, according to the Department of Justice. Federal officials took aim at Bayer in a motion filed last week, referencing the company’s multimillion dollar marketing campaigns using both print and television advertisements featuring “the Colon Lady,” who asks people about their colon health. As a result, consumers have spent hundreds of millions of dollars on Phillips’ Colon Health, the motion claims. The government’s crackdown on Bayer stems from a ... Read More
Baxter International, Inc., is recalling one lot of potassium chloride injection because the drug packaging may contain units of gentamicin sulfate instead. Potassium chloride injection is used to treat potassium deficiency. Gentamicin sulfate is an antibacterial drug. This labeling error could result in a medication error or delay in therapy for patients who require high concentration of potassium chloride, the Food and Drug Administration (FDA) warned. The recall involves Lot #P318220, NDC # 0338-079-48 of potassium chloride Injection 10mEq per 100mL, with the product code 2B0826. Shipping cartons labeled for this specific lot number of potassium chloride injection may contain units ... Read More
Pfizer’s testosterone replacement treatment Depo-Testosterone has become the subject of lawsuits questioning the safety and efficacy of the drugs after reports of heart attacks, strokes and blood clots in patients treated with the hormone. The lawsuit filed on behalf of Alvaro Roman Gutierrez alleges that Pfizer and its unit Pharmacia & Upjohn Co. LLC, conducted a “disease mongering” campaign to exaggerate the problem of low testosterone levels in men in order to boost sales of Depo-Testosterone. Gutierrez claims that Pfizer and Pharmacia & Upjohn spent millions of dollars to promote its drug to consumers and, along with other drug companies not ... Read More
Whistleblower lawsuits accusing Merck of mumps vaccine deceptions will proceed to court, judge decides
Two lawsuits accusing Merck & Co. of lying about the efficacy of its mumps vaccines to keep competitors from introducing similar vaccines to the market will be proceed to trial after a federal judge in Pennsylvania refused to dismiss the suits. U.S. District Judge C. Darnell Jones II ruled that one of the lawsuits, filed by a pair of whistleblowers who worked as virologists for Merck, provided enough evidence that the pharmaceutical giant lied about the vaccine’s efficacy to the federal government. The judge also ruled that the other lawsuit, filed by a group of physicians and direct buyers, could ... Read More