During this Halloween season, the FDA is reminding people that candy can have side effects too. They’re looking at you, black licorice lovers. According to the agency, eating just 2 ounces of black licorice a day for at least 2 weeks could cause you to end up in the hospital with an irregular heart rhythm (arrhythmia), particularly if you’re 40 or older. This root contains glycyrrhizin, the sweetening compound derived from licorice root, which can cause potassium levels in the body to fall. Once those levels decline, some people can experience abnormal heart rhythms, high blood pressure, swelling, lethargy and…

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Switching from metformin – the standard drug treatment for type 2 diabetes – to sulfonylureas – a second-line treatment for diabetes – can increase the risk of major side effects, such as heart attack and stroke, a new study suggests. Common sulfonylureas include Amaryl (glimepiride), Glucotrol (glipizide) and DiaBeta (glyburide). Researchers examined data from more than 77,000 patients with type 2 diabetes. The patients started metformin treatment and during an average follow-up period of just over 1 year, researchers found that switching from metformin to a sulfonylurea or taking a sulfonylurea and metformin together increased the risk of heart attack, death…

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Multivitamins and mineral supplements (MVMs) don’t help to prevent heart attack or stroke, or have any cardiovascular benefits, according to a meta-analysis. Researchers examined the results from 18 individual published studies with more than 2 million participants. Results showed that MVMs had no effect in reducing the risk of heart attacks, strokes or cardiovascular death. However, MVMs were associated with a slightly lower risk of coronary heart disease incidence in the overall analysis. The findings, published in the journal Circulation, support current guidelines that don’t use MVMs to promote cardiovascular health. According to the research team, eating a proper diet,…

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Many drugs approved through the FDA’s Breakthrough Therapy designation had clinical trials that enrolled fewer patients and lacked randomization, compared to drugs approved under the traditional pathway. This can potentially increase the risk for patient harm as side effects and adverse events may be missed, according to a research letter. Researchers reviewed all FDA approvals granted Breakthrough Therapy designation– a process designed to expedite the development and review of drugs that are intended for serious and life-threatening conditions. They wanted to assess the pivotal trials that served as the basis of FDA approval as well as premarket development and review…

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Acupuncture is effective in relieving joint pain, a common side effect seen in a class of drugs used to treat breast cancer, according to a new study. Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors and can be so severe that they cause some women to stop using the treatment altogether. Over the course of 6 years, researchers analyzed 226 postmenopausal women with early-stage breast cancer. All were taking aromatase inhibitors and experiencing joint pain. Common aromatase inhibitors include Arimidex (anastrozole), Aromasin (exemestane) and Femara (letrozole). Participants were divided into 3 groups: acupuncture, sham acupuncture and control.…

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If new guidelines on high blood pressure are adopted, many more people would likely be put on hypertension drugs, a new study argues. Last year, the American College of Cardiology (ACC) and the American Heart Association (AHA) released proposed updated guidelines that would lower the values for determining high blood pressure, which would label millions more people as having hypertension. Researchers from the Yale School of Medicine examined adults aged 45 to 75 years from the US and China who would have a diagnosis of hypertension and be candidates for treatment based on the updated ACC/AHA guidelines, compared with current…

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The FDA has again mandated labeling changes for fluoroquinolones, a class of antibiotics, this time to warn of potentially life-threatening low blood sugar levels (hypoglycemia) and mental health side effects with their use. Fluoroquinolones are used to treat serious bacterial infections. Common ones include Levaquin (levofloxacin), Cipro (ciprofloxacin), Avelox (moxifloxacin), Factive (gemifloxacin) and Ocuflox (ofloxacin). The labeling changes came after the FDA conducted a comprehensive review of adverse event reports and case reports published in medical literature. It found instances of hypoglycemic coma in cases where patients — particularly older ones — on fluoroquinolones experienced hypoglycemia. As a result, a…

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The percentage of men using testosterone therapy has drastically decreased in recent years as the treatment has been linked to an increased risk of heart attack and stroke. Testosterone therapy, which is mainly used in the treatment of “low T” – a condition characterized by low sex drive or excessive fatigue  — tripled from 2001 through 2011, though mostly in men without a clear indication. During that time, “low T” treatments were heavily marketed by drug companies to consumers as youthful products. However, in late 2013 and early 2014, 2 studies reportedthat testosterone use was associated with an increased myocardial…

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The FDA has issued new guidance for drug companies in an effort to provide better information on the “indications and usage” part of a drug’s labeling. The potential changes are to help health care providers select the best treatment option for their patients. The agency is aiming to provide more-understandable information – such as clearer descriptions on a drug’s labeling — on which conditions a drug is approved to treat as well as for whom. The guidance details instances in which an indication can be narrower or broader than what was studied in a clinical trial that supported a product’s…

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Four safety trials have concluded that popular combination inhalers — like Advair (fluticasone/salmeterol) and Symbicort (budesonide/formoterol) — are not associated with an increased risk of asthma-related hospitalizations or deaths, undermining previous findings. LABAs (long-acting beta agonists) such as salmeterol and formoterol, and combination products containing them, received a boxed warning in 2003 because findings at the time suggested that LABAs were associated with serious adverse outcomes, including asthma-related hospitalization, intubation and death. In 2011, the FDA required the manufacturers of the combination inhalers to perform studies where they compared an inhaled glucocorticoid (corticosteroid) – such as fluticasone or budesonide – plus…

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