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Medication errors with risperidone still a problem despite warnings, action steps

Despite warnings from the Food and Drug Administration (FDA) and action steps to avoid confusion, the Institute for Safe Medication Practices (ISMP) continues to receive reports of mix-ups between the prescription drugs risperidone (Risperdal) and ropinirole (Requip). Risperidone is an antipsychotic medication used to treat both children and adults with bipolar disorder, schizophrenia and irritability associated with autism. Ropinirole treats symptoms of Parkinson’s disease and restless leg syndrome. In 2011, the FDA alerted the public that the ISMP and FDA had received more than 200 reports of medication errors, some of which resulted in patients being hospitalized. The agency said ... Read More

More drugs in development to treat ailments of an increasing aging population

Americans are living longer and as a result, the number of people 65 years of age and older with serious chronic conditions is also increasing. Pharmaceutical companies are rushing to cash in by developing drugs to treat the nearly 50 million Medicare beneficiaries who are battling conditions such as diabetes, high cholesterol, high blood pressure, and osteoarthritis. Currently, about 435 drugs primarily targeting seniors are either in clinical trials or under review by the Food and Drug Administration (FDA), according to a report by the Pharmaceutical Research and Manufacturers of America. Among them, 110 are designed to treat diabetes, 68 ... Read More

Another recall issued for Hospira injectable anesthetic drug

Hospira is recalling one lot of 0.5% Marcaine (Bupivacaine Injection) after a customer reported seeing particles embedded in the glass vial as well as floating within the solution. Marcaine is an injectable anesthetic used to deaden feeling in the body prior to surgeries, childbirth and dental procedures. This is the fourth injectable anesthetic Hospira has recall in recent months due to vials contaminated with particle matter, and one of numerous products recalls the company has issued in the past six months. The latest recall involves one lot of 0.5 % Marcaine Bupivacaine Injection, 30 mL, single-dose vial – preservative free ... Read More

Surgeon: Metal hip implant failures led to ‘severe patient wreckage’

“I’d seen patients coming into the clinic complaining of groin pain. I saw it once and then again and then again and again,” Surgeon Antoni Nargol told Four Corners, an investigative news program for ABC News Australia. Nargol was referring to patients who had received ASR metal-on-metal hip replacement systems made by Johnson & Johnson subsidiary DePuy Orthopaedics. The devices were recalled in 2010 after mounting reports of premature failures and infections caused by heavy metal blood poisoning. New research shows that Johnson & Johnson knew the devices were defectively designed as early as 2006 – four years before the ... Read More

North Carolina senate supports measure to shield drug makers from personal injury claims

The North Carolina Senate has approved an amendment to a bill that would give pharmaceutical companies protection against litigation regarding adverse effects from their drugs if they have previously warned of specific side effects and followed all Food and Drug Administration (FDA) rules. If the legislation becomes law, North Carolina consumers would likely have a more difficult time suing drug companies for injuries caused by their products. Supporters say the measure will put drug companies on equal footing with consumers. Opponents disagree, saying the move could hurt people who hare harmed by side effects that emerge after a drug is ... Read More

FDA lifts clinical hold on experimental pancreatic cancer treatment

The Food and Drug Administration (FDA) has removed a clinical hold on patient enrollment and dosing of PEGPH20 in a Phase 2 trial evaluating the drug in patients with pancreatic cancer. The study will resume under a revised protocol. In April, the FDA placed the clinical hold following Halozyme Therapeutics’ decision to temporarily halt enrollment and dosing of the drug in order assess thromboembolic event risks in patients treated with the drug. “Pancreatic cancer has one of the lowest survival rates of any cancer,” Dr. Helen Torley, President and CEO of Halozyme, said at the time. “We remain committed to ... Read More

Drug to treat rare disorders recalled for third time since August

Alexion Pharmaceuticals has issued the third recall since August of its sole approved drug Soliris after visible particles were seen in some vials during periodic testing. If injected, the particles could pose safety risks to patients in two general areas – first it could cause immune reaction and blood clots. Secondly, particles could cause blockage of blood flow in vessels, which could be life threatening. Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare, acquired, potentially life-threatening blood disease; and patients with atypical hemolytic uremic syndrome, (aHUS), a rare disease in children that causes ... Read More

Drug company anticipates launch of new oral testosterone treatment

Clarus Therapeutics, an emerging men’s health specialty pharmaceutical company, filed with the Securities and Exchange Commission (SEC) this week to raise up to $86 million in an initial public offering. The biotech company is preparing for the commercial launch of REXTORO, an oral testosterone replacement therapy for which the company has submitted a New Drug Application with the Food and Drug Administration (FDA). If approved, REXTORO will be the first oral testosterone treatment available in the United States. The drug is intended to boost testosterone levels in men with low testosterone levels, also known as hypogonadism. The term “Low T” ... Read More

Drug companies plan to market OTC version of ED drug Cialis

Drug companies are devising a plan to market a nonprescription version of the erectile dysfunction drug Cialis (tadalafil) in major markets, however they will have an uphill battle with regulators to get the impotence drugs on store shelves. Drug makers Eli Lilly & Co. and Sanofi SA have struck a licensing deal to sell the blockbuster prescription drug as an over-the-counter product. Cialis generated as much as $2.2 billion in sales last year, overtaking its rival Viagra, which drummed up $1.9 billion in revenue last year. The drug makers are targeting the United States, Canada and Australia for exclusive rights ... Read More

Newer type 2 diabetes drugs carry serious side effects, pancreatic cancer risks

The newest classes of type 2 diabetes drugs may help diabetics manage their disease, but it can come at a great price. Diabetes drugs known as GLP-1, DPP-4, and SLGT2 have been associated with serious side effects including acute pancreatitis, pancreatic cancer, thyroid cancer, urinary tract infections, gastrointestinal issues, and renal and gallbladder problems, according to AdverseEvents (AE), a company that analyzes post-market side effects data. According to DrugWatch.com, Glucagon-like peptide-1 receptor (GLP-1) agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors both affect levels of the incretin hormone, which helps to control blood sugar. Sodium-glucose co-transporter 2 (SGLT2) inhibitors (glucuretics) block glucose reabsorption ... Read More