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black box warning 220 articles

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

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

Newly approved type 2 diabetes drug carries black box warning for thyroid cancer risk

The Food and Drug Administration (FDA) has approved Eli Lilly and Co.’s new Type 2 diabetes treatment Trulicity, but the approval comes with a black box warning about an increased risk of thyroid cancer. Trulicity is an injectable drug in a family of type 2 diabetes medications known as glucagon-like peptide-1, or GLP-1, receptors. These drugs are in class of medications known as incretin mimetics that help control blood sugar levels in patients who do not produce enough insulin. Trulicity can be used as a single treatment or in combination with other commonly prescribed diabetes drugs including metformin, Actos and ... Read More

FDA panel recommends severely limiting testosterone drug prescriptions

A U.S. Food and Drug Administration (FDA) advisory panel voted 20-1 Wednesday to impose strict new limitations on testosterone-replacement drugs, recommending changes to labeling that would limit FDA-approved prescription indications to men who have abnormally low testosterone levels due to injury or disease, but not aging. The changes, triggered by conflicting studies and a lack of evidence showing the efficacy of testosterone drugs for treating common age-related issues, would exclude millions of American men who currently use the drugs as antidotes for low libido, muscle loss, and lack of energy. The panel’s recommendations, which the FDA usually accepts, could also ... 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

Antipsychotic drugs linked to kidney injury in elderly patients

Antipsychotic medications, including risperidone, can cause kidney injury, especially in elderly patients, according to a new study published in the Annals of Internal Medicine. Quetiapine (Seroquel), risperidone (Risperdal), and olanzapine (Zyprexa), are approved by the Food and Drug Administration (FDA) to treat bipolar disorder, schizophrenia and other serious mental disorders. They are also frequently prescribed “off-label” to older adults to treat symptoms such as aggression or agitation associated with Alzheimer’s, dementia, or other neurodegenerative diseases. The study found that older adults taking quetiapine, risperidone or olanzapine were one and a half times more likely to have acute kidney injury compared ... Read More

Mental health groups ask FDA to remove black box warning for suicide risk from antidepressants

Mental health experts are petitioning the Food and Drug Administration (FDA) to remove its severest warning involving suicidal thoughts from the safety labels on all antidepressants because the warning has resulted in a 33 percent increase in suicide attempts, and has scared away some patients who may benefit from the medication. In 2004, the FDA placed a black box warning, its most serious kind, on all categories of antidepressants, indicating that there is an increased suicide risk in children and adolescents treated with the drugs. Two years later, the FDA extended the warning to young adults to age 25 and recommended ... Read More

Canadian regulators warn consumers about cardiovascular risks of testosterone drugs

Canada’s national health regulators have issued a warning to consumers and health care providers about the serious risks associated with the use of testosterone-replacement drugs, which are being prescribed to increasing numbers of men as a treatment for low natural testosterone levels. Health Canada said its safety review of testosterone drugs involved evaluating the currently available studies and reports on the cardiovascular risks the drugs presented. In the course of its safety review, the agency found “a growing body of evidence suggesting a possible association between the use of testosterone replacement products and cardiovascular risk.” As in the U.S., men ... Read More

Acetaminophen as effective as placebo in treating lower back pain

The commonly used painkiller acetaminophen, the same drug in over-the-counter Tylenol, doesn’t relieve lower-back pain any better than a placebo, according to a new study published in the journal The Lancet. Medical guidelines recommend acetaminophen as a first-line treatment for acute lower back pain, however few studies have been conducted to show whether the treatment actually works. Researchers with the University of Sydney in Australia set out to put the painkiller to the test. For the study, researchers randomly assigned more than 1,600 people with sudden, or acute, lower-back pain into three groups. One group took acetaminophen tablets regularly three ... Read More

Pharmacy group wants black box warning added to antibiotic Levaquin

A University of South Carolina pharmacy group is petitioning the Food and Drug Administration (FDA) to put the strongest warning possible on Johnson & Johnson’s antibiotic Levaquin alerting consumers about the potential for cellular damage that could lead to serious diseases. The Southern Network on Adverse Reactions, a project of the South Carolina College of Pharmacy, says the public should be aware that the antibiotic commonly prescribed to treat infections can damage mitochondria that reside in the cells, resulting in mitochondrial toxicity, which is associated with Alzheimer’s disease, Parkinson’s disease, Lou Gehrig’s disease, and liver damage. Levaquin, also known as levofloxacin, ... Read More

FDA rejects consumer group’s request for black box warning on statin drugs

Cholesterol-lowering statin medication will not carry a black box warning for a deadly muscle disorder, the Food and Drug Administration (FDA) announced. The agency was petitioned by the consumer watchdog group Public Citizen, urging the FDA to force drug makers to alert consumers of the risk of rhambdomyolysis, a condition in which muscle cells break down and enter the bloodstream where they can damage the kidneys. Public Citizen filed its petition in 2001, not long after Bayer pulled its statin drug Baycol (cerivastatin) off the market after mounting reports of patients dying from the condition while taking the medication. The ... Read More