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FDA approves new diet pill Contrave

A new prescription diet pill has been given clearance by the Food and Drug Administration (FDA) for marketing in the United States. Contrave, made by Orexigen Therapeutics, is a combination of bupropion, an antidepressant that is also used for smoking cessation, and naltrexone, a drug used to treat drug and alcohol dependence. Contrave is approved for overweight or obese patients with a body mass index (BMI) of 30 or higher, as well as people with a BMI of 27 or higher with at least one other health issue such as diabetes. Patients treated with Contrave lost an average of 4.2 ... Read More

FDA to reassess appropriateness, usefulness of testosterone replacement drugs

The U.S. Food and Drug Administration (FDA) will hold an advisory panel meeting Sept. 17 on the safety and usefulness of testosterone replacement drugs, which a number of pharmaceutical manufacturers are promoting and selling aggressively to men who may be stricken with low testosterone levels, or “Low T.” FDA officials added briefing documents to the agency website earlier this month, acknowledging that while testosterone levels commonly drop in men as they age, studies indicate that lower levels of the hormone do not necessarily lead to serious health problems, such as testicular and pituitary disease. Still, as the agency notes, testosterone ... Read More

Hospira recalls heparin vials due to contamination with human hair

Hospira, Inc., is recalling one lot of its blood thinner Heparin after confirming that a piece of human hair was found floating in a sealed vial. The nationwide user-level recall involves one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL) in 0.9 percent Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. The injection of particulate material, such as human hair, may cause local inflammation, phlebitis, and/or low-level allergic response. Capillaries, which may be as small as the size of a red blood cell, approximately seven microns in diameter, ... Read More

FDA to consider new single-dose anti-viral drug to fight seasonal flu

Peramivir, a new once-daily injectable drug, appears to be a safe and effective at alleviating most flu symptoms if taken within 48 hours of the onset of symptoms, according to Dr. Rich Whitley, the University of Alabama at Birmingham (UAB) researcher who led the study on the new drug. “If we don’t get immunized and we get influenza or if we get immunized and we still get influenza, we need to have anti-viral drugs available for the purposes of therapy and the goal is to keep people out of the hospital and to keep people from dying,” Whitley said. Each year ... Read More

British Columbia refuses to cover some type 2 diabetes drugs

The British Columbia Medical Beneficiary and Pharmaceutical Services Division has delisted all sitagliptin drugs, including Januvia and Janumet, from its Pharmacare Benefits Program and will adjust its coverage of all other diabetes drugs in the class by February 2015. The agencies gave no reason for this action but experts speculate that it may be because sitagliptin has been linked to serious pancreatic side effects. Merck, maker of Januvia and Janumet, is fighting the action, saying the move limits therapeutic options for patients. Januvia works by enhancing the body’s own ability to control blood sugar levels by increasing insulin production when ... Read More

Statin side effects may not be worth the benefits for some people

Kailash Chand admitted he dismissed complaints of muscle pains, weakness, fatigue and memory problems he heard from patients he put on cholesterol-lowering statins. Then his own doctor discovered he had high cholesterol, and put him on statins to lower his risk of heart attacks, strokes and death. It wasn’t long before Chand, too, started experiencing problems. “My regular exercise was curtailed. I was feeling tired and exhausted,” Chand, deputy chairman of the British Medical Association, told Web MD. A stabbing pain in his back sent him to a specialist. When blood tests, X-rays and MRI scans showed no signs of ... Read More

Antipsychotic drugs considered as alternative treatment for MS

The antipsychotic drugs clozapine and risperidone may help improve symptoms in patients with multiple sclerosis, according to a study conducted by researchers with Victoria University of Wellington in New Zealand. Multiple sclerosis, or MS, is an autoimmune disease that affects the brain and spinal cord. It is unpredictable and often disabling, leading to impaired vision and coordination and paralysis. Medications approved to treat symptoms of the disease work through traditional immune pathways and don’t work on all populations of patients with MS. Researchers found that clozapine and risperidone target a very different set of pathways that work to reduce inflammation ... Read More

FDA orders recall of mole, wart and skin tag remover

Dermatend Original and Dermatend Ultra, products used to remove moles, warts and skin tags, are being recalled by the manufacturer, Solace International, because the products are not approved by the Food and Drug Administration (FDA) and thus have not been shown to be safe and effective. Moles should be removed under the supervision of a dermatologist, the FDA warned, and using these products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer. Dermatend Original and Dermatend Ultra are sold online and at retail stores. They are packaged in flexible plastic tubes with the product’s ... Read More

Generic drug makers failed to warn about side effects from heartburn drug Reglan

A Missouri appeals court upheld claims by two women that makers of generic versions of the heartburn drug Reglan failed to update their safety labels to warn about side effects associated with long-term use of the medication. Reglan, which is sold generically under the name metoclopramide, has been linked to a movement disorder known as tardive dyskinesia. In 2004, manufacturers of brand-name Reglan updated its safety label with the approval of the Food and Drug Administration (FDA) to warn that “Therapy should not exceed 12 weeks in duration.” Generic manufacturers were required to update their safety labels as well but ... Read More

Experimental testosterone therapy outperforms leading testosterone gel in studies

The experimental testosterone treatment Androxal performed better than a leading testosterone gel and placebo in the first of two studies, Repros Therapeutics Inc. announced. Data from the clinical trials showed that men treated with Androxal had more sperm concentration compared to men who were treated with AndroGel testosterone supplement. Androxal is being developed as an oral therapy to boost testosterone levels in men of reproductive age. Androxal a single isomer of clomiphene citrate, a drug currently marketed as Clomid to induce ovulation in women. It has been used off-label as a treatment for secondary low testosterone in men though, until ... Read More