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black box warning 220 articles

Mortality rates lower in older men with moderate testosterone levels, study finds

Older men with testosterone levels in the middle range tend to live longer than men with levels of the hormone that are either too low or too high, a new Australian study has found. The study, published in The Endocrine Society’s Journal of Clinical Endocrinology & Metabolism (JCEM), underscores some of the dangers men may face when they use testosterone replacement drugs to boost hormone levels that aren’t chronically low. According to the study’s lead author Dr. Bu Beng Yeap of the University of Western Australia, when testosterone is metabolized by the body, it produces dihydrotestosterone (DHT), a natural chemical linked to ... Read More

Adverse health reports for testosterone drugs could fuel advertising

Earlier this month, the Journal of the American Medical Association (JAMA) published a report that cast doubts about the safety of testosterone-replacement drugs for men who take them to boost their levels of the hormone. But with so many pharmaceutical drug companies vying for a larger share of the extremely lucrative but fiercely competitive testosterone drug market, don’t expect all the “Low-T” advertising to slow down until more is understood about the drugs. Indeed, reports of adverse events linked to the drugs may fuel the need for some manufacturers relying on testosterone sales to ramp up advertising campaigns. The latest ... Read More

New blood clot warning with NuvaRing contraceptive device

A new warning has been added to the safety label of the NuvaRing contraceptive vaginal ring, alerting health care providers and women that the birth control method should be discontinued if symptoms of blood clots are experienced. Symptoms of blood clots include chest pain; shortness of breath; upper body discomfort such as in the arms, back, neck or jaw; redness, warmth or swelling in the lower leg; headaches; speech changes; paralysis, dizziness; or trouble speaking. “Stop NuvaRing use if an arterial thrombotic or venous thromboembolic event (VTE) occurs,” the warning reads. “Stop NuvaRing use if there is unexplained loss of ... Read More

Combination birth control pills discouraged for older women who smoke

A new black box warning will be added to the safety labels of several brands of estrogen-plus-progestin birth control pills urging women who are older than 35 years of age who smoke not to use the medication because it greatly increases their chances of having a heart attack or stroke. Black box warnings, or boxed warnings, are the strongest warning the Food and Drug Administration (FDA) requires, and signifies that medical studies indicate that using a drug carries a significant risk of serious or even deadly adverse effects. The warnings will be placed on the following oral contraceptives: Modicon (norethindrone/ethinyl ... Read More

FDA warns health care providers to carefully consider spinal catheters in patients using blood thinners

Physicians should carefully consider the timing of spinal catheter placement and removal in patients taking blood thinners such as Lovenox (enoxaparin), and delay dosing of the drugs for some time interval after the catheter is removed to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures, the Food and Drug Administration (FDA) advised. The new recommendations will be added to the labels of all anticoagulants known as low molecular weight heparins, which include the brand name Lovenox as well as generic versions of enoxaparin and similar products. Spinal column bleeding, ... Read More

FDA orders sales of leukemia drug Iclusig stopped due to blood clot risk

Less than a year after the Food and Drug Administration (FDA) approved Ariad Pharmaceutical’s leukemia drug Iclusig (ponatinib), the drug company announced it was suspending sales of the drug because of a greater risk for blood clots. Iclusig was approved to treat two rare types of leukemia, chronic myeloid leukemia and acute myeloid leukemia. About 5,000 people are diagnosed with chronic myeloid leukemia each year. When the FDA approved the drug late last year, the agency required that the drug’s label include a black box warning for potentially serious side effects including blood clots and liver toxicity. The FDA had ... Read More

Study looks at safety of Reglan as treatment for morning sickness

The acid reflux drug metoclopramide may be a safe and effective morning sickness treatment for pregnant women, a new study suggest. Metoclopramide, also known by the brand name Reglan, is used to treat esophageal reflux disease (GERD), nausea, vomiting and diabetic gastroparesis, a condition in which the stomach digests food too slowly. Researchers looked at data from more than 40,000 women who were given metoclopramide while pregnant and found they were no more likely to have a miscarriage or have a baby with birth defects than women who did not take the drug. About half of all pregnant women experience nausea ... Read More

FDA investigates life-threatening blood clots associated with leukemia chemotherapy drug

An increasing number of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) in patients taking the leukemia chemotherapy drug Inclusig (Ponatinib) has prompted an investigation by the Food and Drug Administration (FDA). Data from clinical trials and adverse event reports after the drug was approved in December 2012 show that serious health problems have occurred in patients who were treated with Iclusig, including fatal heart attacks, worsening coronary artery disease, narrowing of the large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to ... Read More

FDA approves Pfizer’s new hormone treatment for hot flashes, prevention of osteoporosis

The Food and Drug Administration (FDA) has approved Duavee, Pfizer’s new hormone treatment for menopause-related hot flashes in women who have not had a hysterectomy, and to prevent osteoporosis in post-menopausal women. Duavee is the first FDA-approved drug that combines a mixture of estrogens with another compound, bazedoxifene, which acts like estrogen to protect bone density. The FDA rejected bazedoxifene as an osteoporosis treatment in 2009 after numerous delays based on concerns that the drug could increase the risk for strokes and blood clots. Duavee enters a profitable market that already includes Hisamitsu Pharmaceutical Co.’s Brisdelle and Eli Lilly & ... Read More

Antibiotic Tygacyl gets new black box warning for increased risk of death

The Food and Drug Administration (FDA) is ordering the intravenous antibiotic Tygacyl (tigecycline) include on its safety label a new black box warning for increased risk of death compared to other antibacterial drugs. Tygacyl was given a fast-track approval by the FDA in 2005. The drug was developed in response to the growing prevalence of antibiotic resistance in bacteria such as Staphylococcus aureus and Acinetobacter baumannii. The drug was approved to treat complicated skin and soft tissue infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. Tygacil is not approved for the treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia. ... Read More