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Painkiller recalled due to improper expiration dates on label

Syringe - Insulin - Diabetis

Sagent Pharmaceuticals has issued a nationwide recall on a painkiller. Three lots of Ketorolac Tromethamine Injection, a nonsteroidial anti-inflammatory drug, were recalled because the medications were printed with the incorrect expiration date. The labeled date is longer than the known stability of the drug. Ketorolac Tromethamine is used short-term in postoperative patients to treat moderately severe acute pain that requires analgesia in patients already using opioid painkillers. The affected lots include 30mg/mL single-dose vials with the NDC numbers 25021-701-01 and 25021-701-02. Affected lot numbers include MP5021, MP5024, and MP5025 and were distributed to hospitals, wholesalers and distributors across the country ... Read More

Women should not be treated with testosterone therapy, Endocrine Society advises

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Low testosterone is not a valid diagnosis in healthy women, and most women with low amounts of the hormone should not use testosterone-replacement drugs, the Endocrine Society said in a new guideline. “Although limited research suggests testosterone therapy in menopausal women may be linked to improved sexual function, there are too many unanswered questions to justify prescribing testosterone therapy to otherwise healthy women,” guideline task force chair Dr. Margaret Wierman, of the University of Colorado, said in news release. Dr. Wierman said that in a review of past studies, women who had low testosterone levels did not exhibit any signs ... Read More

Merck’s once-weekly diabetes drug as effective as Januvia

januvia - sitagliptin

Merck’s new, once-weekly experimental type 2 diabetes treatment was found in recent clinical trials to have a similar safety and efficacy profile compared to Merck’s sitagliptin, marketed under the brand name Januvia. The study involving the new omarigliptin randomly assigned participants with type 2 diabetes into one of three groups – once-weekly omarigliptin 25 mg; once-daily Januvia 50 mg; or placebo. A mixed-meal tolerance test was performed the day before the study drugs were administered and again at 24 weeks, 1 day after the last dose of Januvia, or 7 days after the last dose of omargliptin. Researchers found that ... Read More

Plaintiffs want information on cases of pancreatic cancer associated with type 2 diabetes drugs

byetta

A federal judge denied plaintiffs’ motion to gather drug companies’ analysis of pancreatic cancer cases among users of their type 2 diabetes drugs; however, his decision is still pending regarding plaintiffs’ request to gather adverse event reports involving those drugs submitted to the U.S. Food and Drug Administration (FDA). U.S. District Judge Anthony Battaglia is presiding over a multidistrict litigation (MDL) involving about 460 plaintiffs who allege they developed pancreatic cancer after taking one of four drugs in a class of type 2 diabetes drugs known as incretin mimetics. The lawsuits name Amylin Pharmaceuticals and Eli Lilly & Co., for the drug Byetta; Merck ... Read More

First-in-class cholesterol drug faring well in clinical trials

lipitor

A first-in-its-class cholesterol-lowering drug is plowing through clinical trials and appears to lower LDL levels significantly more than Merck & Co’s Zetia. ETC-1002 is an oral pill made by Esperion Therapeutics. It is the first in a new class of cholesterol-lowering drugs known as ACL inhibitors. They work by reducing cholesterol synthesis in the liver and increasing LDL receptors that remove cholesterol from the blood. ETC-1002 was pitted against Zetia in a 12-week study involving 348 patients with high LDL, considered the “bad” cholesterol. ETC-1002 reduced LDL an average of 30 percent in patients who received a 180-milligram dose and ... Read More

New drug information database aims to help consumers understand risks and benefits

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Last week, former Wired editor Thomas Goetz and Google engineer Matt Mohebbi introduced health care leaders to their new health information resource, which offers an easy-to-use database of drug information by combining the worlds of technology and health. Their company, called Iodine, seeks to serve the public by offering “better information about thousands of drugs, built from clinical research and real life experience from people like you.” Iodine’s database allows users to enter drugs of interest into a search engine, then presents basic information about the searched drug, its purpose, how it works, reported side effects, warnings, upsides and downsides ... Read More

Asthma drug linked to serious cardiovascular, cerebrovascular events

brain

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

Drug company to seek FDA approval for first ‘female Viagra’

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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

Panel recommends more studies on cardiovascular risks with testosterone drugs

Low T

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

Breast reduction third most common cosmetic surgery for men

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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