Pharmaceutical 4051 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.

Black box warning for bleeding risks added to antiplatelet Brilinta

blood cells

The safety label for the oral antiplatelet drug Brilinta (ticagrelor) has been updated to include a new boxed warning for serious bleeding risks and a lessening of effectiveness when taken with maintenance doses of aspirin above 100 mg. Brilinta, made by AstraZeneca, is used with low-dose aspirin to help prevent heart attacks and stokes in people with heart problems such as unstable angina or previous heart attack, as well as in patients with acute coronary syndrome (ACS). It is also used to reduce the risk of stent thrombosis in patients who have been stented for the treatment of ACS. Like ... Read More

Xarelto safety label updated to include details of major bleeds


The ADVERSE REACTIONS section of the safety label for the blood thinner Xarelto (rivaroxaban) has been updated to include more detailed information about bleeding risks. Xarelto, made by Bayer and Johnson & Johnson unit Janssen Pharmaceuticals, was first approved by the Food and Drug Administration (FDA) in 2011. It is used to prevent strokes in patients with an irregular heart rhythm called atrial fibrillation, to treat and prevent blood clots of the deep veins and lungs, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery. Xarelto was designed to go head-to-head with the ... Read More

Erectile dysfunction drugs update safety label to include new contraindication


Drugs to treat erectile dysfunction have updated their safety labels to include an increased risk of low blood pressure when used in patients also taking pulmonary hypertension drugs known as guanylate cyclase (GC) stimulators, such as Riociguat. The new contraindication will be added to the safety labels of Cialis (tadalafil), Levitra and Staxyn (vardenafil), Stendra (avanafil), and Viagra (sildenafil citrate). The drugs are in a class of medications known as PDE5 inhibitors. The drugs help men get and maintain erections by relaxing the smooth muscles of the penis and increasing blood flow. They also work through the same genetic pathways ... Read More

Type 2 diabetes added to list of statin side effects


Cholesterol-lowering statin drugs are widely prescribed to lower levels of LDL – the so-called “bad” cholesterol – that builds up in the arteries in order to prevent cardiovascular events. However, studies have found the drugs can increase blood sugar levels and put users at risk of developing type 2 diabetes. Statins work by preventing the liver from producing LDL cholesterol. They also stabilize the lining of the blood vessels, which helps to prevent strokes and heart attacks. How statins effect glucose metabolism is unclear. Some studies suggest that statins may cause hyperglycemia – or high blood sugar – by increasing ... Read More

FDA orders duodenoscope makers to conduct studies on devices


The Food and Drug Administration (FDA) is ordering three manufacturers of specialized endoscopes called duodenoscopes, blamed for spreading drug resistant superbugs at several hospitals in the United States, to conduct studies to evaluate how the devices work and what can be done to stop the spread of more infections. Duodenoscopes are flexible tubes that are fed down a patient’s esophagus to treat or diagnose various gastrointestinal conditions. The surgical tools, considered key in illness detection and treatment, are used in about a half million procedures each year. The devices have small crevasses that researchers say can harbor bacteria. These spaces are difficult ... Read More

Talc linked to increased risk of lung diseases, ovarian cancer

baby powder contains talc

Manufacturers of talcum powder products have convinced consumers that their body and baby powders are safe even for infants. However, national health agencies, including the Food and Drug Administration (FDA) and the American Cancer Society, acknowledge there are safety concerns related to talc. Talc is a naturally occurring mineral that contains elements such as magnesium, silicon and oxygen. It can also contain asbestos, though many manufacturers claim that their talc-containing products do not contain detectable amounts of the carcinogen. Regardless, talcum powder has been linked to serious health problems including an inflammation in the lungs known as talcosis, mesothelioma, and ... Read More

New black box warnings added to HIV drugs


Abacavir, a type of drug used to slow the progression of the human immunodeficiency virus (HIV) infection carries updated black box warnings, the most serious warning issued by the Food and Drug Administration (FDA) reserved for drugs in which there is a reasonable probability that the medication can cause serious health consequences or death. One of the boxed warnings involves serious and sometimes hypersensitivity reactions with multiple organ involvement. The listing warns “NEVER restart (brand name drug) or any other abacavir-containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following ... Read More

Consider side effects with meds for autism-related irritability


Parents of children with autism are faced with tough decisions when considering antipsychotic medication to treat irritability. Weight gain is perhaps the most cited side effect associated with antipsychotics, but other adverse reactions should be taken into consideration as well. “It’s important to remember that if a medication is powerful enough to relieve symptoms, it is powerful enough to cause side effects,” said Dr. Christopher McDougle, director of Massachusetts General Hospital’s Lurie Center for Autism, a member of Autism Speaks Autism Treatment Network. “This is certainly true of the medications used to treat irritability and related behavioral challenges in individuals ... Read More

New OTC Poise product offers alternative for incontinence treatment

Poise Impressa

Women who suffer from stress urinary incontinence have a new, nonprescription and nonsurgical option for symptom relief. Stress urinary incontinence affects millions of women. It occurs when muscles and tissues that support the bladder weaken. This can cause the leaking of urine in situations such as coughing, laughing, running or lifting heavy objects. The risk of developing stress urinary incontinence increases with age, obesity and childbirth. Treatment can involve surgeries such as the implantation of transvaginal mesh. However, this procedure has been linked to serious health complications including the mesh eroding into tissue and protruding into organs causing pain, inflammation, ... Read More

NY new advertising campaign promotes IUD for birth control

mirena IUD

The New York Health Department is hoping a new advertising campaign will encourage women to consider getting intrauterine devices, or IUDs. The ads, which feature all five boroughs, are produced in English and Spanish. They feature bright colors with eye-catching designs. One of the ads reads, “You spent the night in Brooklyn. But you left your birth control in Staten Island. Maybe the IUD is right for you.” The ads will run for three months citywide, with 1,000 appearing on subway stations and 20 big posters at bus stations. They also feature the social-media hashtag, #MaybeTheIUD. IUDs are small devices ... Read More