The asthma drug Xolair (omalizumab) for children and adults 12 years of age and older can cause problems with the heart and blood vessels supplying the brain, the Food and Drug Administration (FDA) announced after a review of safety studies. As a result, new warnings of an elevated risk of serious cardiovascular and cerebrovascular adverse events will be added to the drug’s label. The review also investigated rates of cancer between patients using Xolar and found no difference compared to patients not being treated with Xolair. However, due to limitations in the five-year study, the agency cannot rule out the ... Read More
Pharmaceutical 3263 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.
Nearly 3 percent of American men aged 40 and older – about two million men – received prescriptions for testosterone replacement treatments in 2011 – three times more than a decade earlier, raising concerns that the drugs may be overprescribed. Testosterone therapy is intended for men who suffer from low testosterone levels, a condition known as hypogonadism, caused by damage or disease in their testes or other parts of the endocrine system. This can cause symptoms such as low sex drive, muscle loss, weight gain and fatigue. Testosterone levels typically drop as a man ages. But many middle-aged and older ... Read More
When Sabrina Nixon’s son started developing breasts, his pediatrician said it was normal for a boy going through puberty. But at 16, Nixon began to wonder if it was something more serious. A visit with his primary care doctor confirmed her hunch. Her son has gynecomastia, a condition in which boys and men develop breast tissue. Gynecomastia can be embarrassing for boys, causing emotional scars. But it can also be physically painful. Breasts can become tender and even lactate. The condition can impede male reproduction and increase the risk of beast cancer. Gynecomastia typically goes away in time but for ... Read More
Frustrated by the Food and Drug Administration’s approval of potent opioid medications during a nationwide epidemic of prescription drug abuse, anti-addiction activists are calling for the resignation of the agency’s top official. More than a dozen groups have banded together and are appealing to the Obama administration to replace FDA Commissioner Dr. Margaret Hamburg, who has headed up the agency since 2009. Activists have been vocal about their disappointment with the agency for its approval of Zohydro, the only single-ingredient hydrocodone on the market. Hydrocodone is in a class of narcotics known as opioids, which are known for their euphoric effects. ... Read More
Attorneys for a woman who was poisoned by an allegedly defective hip implant grilled an executive at Johnson & Johnson’s DePuy Orthopaedics unit over what studies the company performed on its Pinnacle metal-on-metal hip replacement system in an attempt to show jurors that the company was negligent in proofing the device’s safety before they were approved by the Food and Drug Administration (FDA) in 2000. Plaintiff Kathy Herlihy-Paoli’s lawsuit is the first of more than 6,000 lawsuits claiming DePuy’s Pinnacle hip implants caused injuries from premature failures and corrosion of the metal parts causing a type of blood poisoning known ... Read More
Sprout Pharmaceuticals says it will resubmit an application for Food and Drug Administration (FDA) approval for its “female Viagra” pill by the end of the year in hopes of having the first marketed pill to treat hypoactive sexual desire disorder, or HSDD, in women. HSDD is the most commonly reported female complaint and is characterized by a decreased libido that causes personal distress or personal difficulties. An estimated 1 in 10 women are affected by the disorder. Filbanserin is a 5-HT1A receptor agonist and 5-HT2A receptor antagonist that was initially investigated as an antidepressant. Preclinical studies suggest that fibanserin targets ... Read More
Shire Pharmaceuticals has agreed to pay the U.S. $56.5 million to settle two whistleblower lawsuits filed by former employees of the company who alleged the company illegally marketed several drugs for unapproved, off-label purposes and then billed Medicare, Medicaid, and other taxpayer-funded health care programs for them. Dublin, Ireland-based Shire operates in the U.S. out of its facility in Wayne, Penn. The company makes and markets Adderall XR, Vyvanse, and Daytrana, which are approved for the treatment of attention deficit hyperactivity disorder (ADHD), and Pentasa and Lialda, which are approved for the treatment of mild to moderate ulcerative colitis. The ... Read More
Cholesterol-lowering statin medications, such as the widely prescribed Lipitor, may protect diabetics against diabetes-related damage to small blood vessels that can cause to blindness and neuropathy, which can lead to amputations, a new study suggests. However, the drugs may cause non-diabetics to develop the disease. Statins are used to lower the risk of heart attacks and strokes in people with elevated cholesterol levels. Statin side effects, which include muscle injury and liver damage, also include increased blood sugar levels, which can increase the risk for type 2 diabetes. It is this adverse event, however, that researchers focused in on for ... Read More
Makers of testosterone replacement drugs should collect data on heart attacks and strokes in men who use their products, and the labels on the treatments should have stronger language to restrict intended uses to reduce over-prescribing, a Food and Drug Administration (FDA) advisory panel recommended. The FDA asked an outside panel of experts to address whether there is a risk of major cardiovascular events such as stroke, heart attack and death in men who used testosterone replacement therapies. The agency also asked the panel whether current evidence still supports the use of the drugs in certain patients. The FDA is ... Read More
In 2013, nearly 23,000 procedures – including liposuction and mastectomies – were performed on men to remove enlarged breast tissue, a condition known as gynecomastia. The procedure is the third most common cosmetic surgery performed for men behind rhinoplasty (nose reshaping) and blepharoplasty (eye lift). Gynecomastia can be embarrassing leaving lingering emotional scars. It can also be painful, causing breasts to become swollen and tender. In some cases, the breasts can lactate. The condition may go away after a few months or years, or symptoms may persist for a lifetime, in which case surgical intervention may be considered. “Surgical treatment ... Read More