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Pharmaceutical 3315 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.

Label of Estring menopause treatment updated to include estrogen-class standards

Estring black box warning

The black box warning and other warnings and precautions on the hormonal postmenopausal symptom reliever Estring have been updated to reflect current recommended estrogen-class labeling standards which include risk of uterine cancer, breast cancer, heart attack, stroke, blood clots and dementia. Estring is a vaginal ring made by Pfizer that contains estradiol, a synthetic estrogen. It is inserted into the vagina and should be removed after 90 days of continuous use. Estring is used after menopause to treat moderate to severe vaginal itching, burning and dryness, painful intercourse, urinary urgency and painful urination due to urogenital atrophy. Hormone replacement therapy, ... Read More

New black box warning added to blood thinner Eliquis

blood cells

The blood thinner Eliquis (apixaban) has a new black box warning that prematurely discontinuing therapy for reasons other than pathological bleeding or completion of a course of therapy increases the risk of blood clots. If therapy is prematurely discontinued, it is advised that patients be given another anticoagulant to prevent this risk. Eliquis is used to reduce the risk of strokes or blood clots in patients with a common heart rhythm abnormality known as atrial fibrillation, not caused by a heart valve problem. It is also approved to prevent and treat blood clots in the veins of the legs, known ... Read More

Makers of generic Reglan hoping federal law preempts lower court’s ruling

Reglan

Drug companies Pliva Inc., Actavis Elizabeth LLC, and Teva Pharmaceuticals USA Inc., hope the New Jersey Appellate Division will find that federal law overrides a lower court’s ruling that consumers can sue makers of generic versions of the heartburn drug Reglan (metoclopramide) who they claim failed to update their labels to include new warnings on the brand name drug’s label. Reglan, known generically as metoclopramide, is used to treat gastric esophageal reflux disease (GERD). It is also used to treat nausea and vomiting, and heartburn caused by a stomach problem known as gastroparesis in diabetic patients. The issue stems from a ... Read More

Naproxen recall issued due to packaging mix-up

Assured brand naproxen sodium tablets recalled

Thousands of boxes of the over-the-counter painkiller Naproxen Sodium are being recalled because some cartons actually contain bottles of ibuprofen, a different pain reliever. The naproxen recall, initiated by Contract Packaging Resources, involves 11,640 boxes of Assured brand Naproxen Sodium Tablets 220mg, 15 count with the Lot #FH4102A and SKU #122368/UPC #639277223685. The boxes contain bottles of ibuprofen softgels in 200mg. The mix-up could cause problems for consumers who intentionally avoid using ibuprofen due to allergies or other medical conditions. Allergic reactions can range from mild irritation or hives to serious reactions such as anaphylaxes that may be life-threatening. Contract ... Read More

Diabetes drug Farxiga label updated to include new warnings for bladder cancer risk

Actos (pioglitazone) Type 2 diabetes medication

The safety labels of the new type 2 diabetes drug Farxiga (dapagliflozin) have been updated to advise patients and health care professionals not to monitor glycemic control with urine glucose tests in patients taking Farxiga or similar drugs in the class because the drugs increase urinary glucose excretion and will lead to positive glucose tests. Alternative methods are advised to monitor glucose control. Farxiga was approved by the Food and Drug Administration (FDA) in January to help lower blood sugar levels in patients with type 2 diabetes. Manufactured by AstraZeneca and Bristol-Myers Squibb, Farxiga had been previously rejected because of ... Read More

New Ovarian Cancer Test May Offer Hope for Women

baby powder contains talc

Scientists claim that a new test developed by the University of Leuven and Imperial College London can help doctors identify ovarian cancer more accurately and cut down on unnecessary surgeries. Ovarian cancer is a devastating yet hard to diagnose disease, ranking fifth in cancer deaths among women. About 1 in 73 women will be diagnosed with ovarian cancer in her lifetime, and her chance of dying as a result of the cancer is about 1 in 100. The American Cancer Society estimates that in 2014, about 21,980 women will receive a new diagnosis of ovarian cancer and about 14,270 will ... Read More

UNC researchers investigate Drug Induced Liver Injuries in connection with diabetes drugs

januvia - sitagliptin

When life-threatening side effects are linked to pharmaceuticals already on the market, it can lead to black box warnings or even market withdrawal. When this potential for injury is found during clinical trials before the medication has been approved, it can stop development in its tracks resulting in a waste of time and resources. “We’re trying to be smarter in our approach to drug development,” says Kim Brouwer, a researcher with the University of North Carolina. Brouwer and colleagues have partnered with the Drug Induced Liver Injury (DILI)-sim Initiative, a group of life science companies led by the Hamner Institutes ... Read More

Statins linked to weight gain, increased blood sugar, type 2 diabetes

lipitor

Statins were once considered the holy grail of medications, lowering cholesterol levels and promising protection against heart attacks, strokes and premature death. But decades later, with millions of user side effect reports filed away, the ugly truth comes out – statins can make you resist exercise, gain weight, increase your blood sugar levels, and raise your chances of developing type 2 diabetes. Statins, including the widely prescribed Lipitor, are one of the most prescribed drugs in the world. New guidelines offered by the American Heart Association and other organizations are recommending wider use of the drugs, which means even millions ... Read More

Researchers work to develop diabetes drugs with fewer side effects

Actos (pioglitazone) Type 2 diabetes medication

Researchers with the Department of Medicine at Imperial College London and LMU Munich in Germany are developing a type 2 diabetes drug that can be switched off and on with a blue light, potentially improving treatment. Many type 2 diabetes drugs encourage the pancreas to release insulin to control blood sugar levels, but they can also cause side effects to other organs. Other drugs encourage too much insulin release, causing blood sugar levels to drop to dangerously low levels. The prototype drug, called JB253, is designed to stimulate insulin release from pancreatic cells only when it is exposed to blue ... Read More

Defibrillator maker issues Field Safety Alert after incident reports, patient death

defibrillator

Medical device maker Covidien has issued a Field Safety Alert for a defibrillator, involving connector compatability issues involving some types of electrodes with certain automatic external defibrillators (AED). The issue involves Medi-Trace Cadence and Kenall Multi-function Defibrillation Electrodes when used with Phillips FR3 and FRx Defibrillators. Covidien has received two reports where customers attempted to use a Covidien electrode with a Phillips FR3 AED unit. The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the death of another patient. AEDs are portable electronic devices used to treat life-threatening cardiac dysrhythmias, ventricular fibrillation and pulseless ... Read More