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boxed warning 44 articles

FDA requires makers of generic opioids to develop abuse-deterrent versions

The Food and Drug Administration (FDA) is pressuring manufacturers of generic opioid painkillers to reformulate their meds to make them more difficult to tamper with and abuse, the latest step in the agency’s fight to curb the national prescription drug abuse epidemic. The draft guidance encourages generic drug makers to develop their pain medications with abuse-deterrent properties to help prevent certain types of abuse, such as crushing a tablet in order to snort, or dissolving a capsule in order to inject its contents. Abuse-deterrent formulations do not prevent abuse, addiction, overdose or death, the agency pointed out, but they could have ... 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

Five new black box warnings added to long-acting, extended-release opioid painkillers

Five new black box warnings are being added to the safety labels of extended-release and long-acting opioid painkillers, warning that the drugs are addictive, can cause life-threatening problems, and are easily abused and misused, the Food and Drug Administration (FDA) announced. Opioids are a potent class of painkillers that also give patients a feeling of euphoria, making them choice recreational drugs. The following brand-name drugs and their generic counterparts have updated labels reflecting the new warnings: Avinza (morphine sulfate) Extended-Release Capsules,
 Butrans (buprenorphine) Transdermal System, 
Dolophine (methadone hydrochloride) Tablets,
 Duragesic (fentanyl transdermal system), 
Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release ... Read More

New black box warning for birth defects, infant death added to hypertension meds

Women of childbearing age using the hypertension drugs Hyzaar or Cozaar should be counseled about the consequences of using the medication if they become pregnant, and women who become pregnant while taking the drug should discontinue it as soon as possible due to new studies that show the drugs may put developing fetuses at risk for birth defects and death. Hyzaar (losartan potassium hydrochlorothiazide) and Cozaar (losartan potassium) are drugs that work directly on the renin-angiotensin system, a hormone system in the body that regulates blood pressure and water or fluid balance. They are in a class of drugs known ... 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

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

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