Tagged Articles

black box warning 220 articles

Boxed warning, patient checklist to come with Essure permanent birth control

The controversial permanent birth control device Essure will now come with an updated safety label that includes a boxed warning about potential injuries and a patient decision checklist to ensure that women who are considering being implanted with the device are aware of the potential risks associated with it. Essure, manufactured by Bayer, was approved by the Food and Drug Administration (FDA) in 2002. It consists of two nickel alloy coils that are inserted into each of the fallopian tubes. Scar tissue builds up around the coils forming a permanent barrier preventing sperm from reaching the egg. In recent years, ... Read More

FDA recommends black box warning for Essure birth control method

The Food and Drug Administration (FDA) fell short of ordering a ban of the controversial Essure permanent birth control method, instead recommending a black box warning be placed on the device and a patient checklist included in the packaging that informs of possible risks including perforation of the uterus or fallopian tubes, coil migration, hypersensitivity reactions, and chronic pain. The agency also ordered Bayer Healthcare, maker of the contraceptive device, to perform a postmarket data to compare adverse events with Essure compared to bilateral tubal ligation. The agency said that despite the risks, the product should remain on the market ... Read More

Schizophrenia drugs’ label includes black box warning for blood condition

The safety labels of the schizophrenia drug clozapine have been updated to include a new black box warning for a serious blood condition known as severe neutropenia. The new labels also include updated requirements for monitoring, prescribing, dispensing and receiving the drug. The updated black box warning was added to the safety labels of brand-name clozapine, which include Clozaril, FazaClo, Zaponex, and Clopine. The medication is used to treat borderline personality disorder, paranoid disorder, and schizophrenia. Clozapine is also used to treat recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder. Neutropenia is a condition in which there is a ... Read More

Black box warning for bleeding risks added to antiplatelet Brilinta

The safety label for the oral antiplatelet drug Brilinta (ticagrelor) has been updated to include a new boxed warning for serious bleeding risks and a lessening of effectiveness when taken with maintenance doses of aspirin above 100 mg. Brilinta, made by AstraZeneca, is used with low-dose aspirin to help prevent heart attacks and stokes in people with heart problems such as unstable angina or previous heart attack, as well as in patients with acute coronary syndrome (ACS). It is also used to reduce the risk of stent thrombosis in patients who have been stented for the treatment of ACS. Like ... Read More

New black box warnings added to HIV drugs

Abacavir, a type of drug used to slow the progression of the human immunodeficiency virus (HIV) infection carries updated black box warnings, the most serious warning issued by the Food and Drug Administration (FDA) reserved for drugs in which there is a reasonable probability that the medication can cause serious health consequences or death. One of the boxed warnings involves serious and sometimes hypersensitivity reactions with multiple organ involvement. The listing warns “NEVER restart (brand name drug) or any other abacavir-containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following ... Read More

Black box warning added to skin cancer treatment

The safety label of the skin cancer drug Erivedge has been updated with a new black box warning that use of the drug by pregnant women could cause embryo-fetal death or severe birth defects. Men who use the drug can also pass along medication in their semen and cause birth defects in the offspring. Erivedge, containing the active ingredient vismodegib, is a capsule used to treat metastatic or locally advanced basal cell carcinoma. The drug has been found to be embryotoxic, fetotoxic and teratogenic (causing birth defects) in laboratory animals who were exposed to the drug in doses lower than the ... Read More

FDA warns of deadly allergic reactions with anemia drug Feraheme

Stronger warnings were added to the safety label of the anemia drug Feraheme (ferumoxytol) regarding serious and potentially deadly allergic reactions, the Food and Drug Administration (FDA) announced. Prescribing instructions have also been changed and a new Contraindication has been added warning against use of the drug in patients who have had an allergic reaction to any intravenous (IV) iron replacement product. All IV iron products can cause potentially life threatening allergic reactions. When Feraheme was approved in 2009, this risk was described in the Warnings and Precautions section of the drug’s label. Since then, serious reactions, including deaths, have ... Read More

FDA adds strongest warning to power morcellators for hysterectomies, myomectomies

The Food and Drug Administration (FDA) has slapped its most serious warning possible on a surgical tool used to perform hysterectomies and remove uterine fibroids because the devices can spread undetected cancer throughout the abdomen and worsen long-term survival. The warning was applied to laparoscopic power morcellators, surgical tools that are used to grind away uterine growths or entire uteruses inside the body and remove the bits through small incisions in the abdomen. Morcellation is often preferred for hysterectomies or myomectomies (removal of uterine fibroids) over open surgery because it is less invasive, offers less recovery time, and is less scarring. ... Read More

Label of Estring menopause treatment updated to include estrogen-class standards

The black box warning and other warnings and precautions on the hormonal postmenopausal symptom reliever Estring have been updated to reflect current recommended estrogen-class labeling standards which include risk of uterine cancer, breast cancer, heart attack, stroke, blood clots and dementia. Estring is a vaginal ring made by Pfizer that contains estradiol, a synthetic estrogen. It is inserted into the vagina and should be removed after 90 days of continuous use. Estring is used after menopause to treat moderate to severe vaginal itching, burning and dryness, painful intercourse, urinary urgency and painful urination due to urogenital atrophy. Hormone replacement therapy, ... Read More

New black box warning added to blood thinner Eliquis

The blood thinner Eliquis (apixaban) has a new black box warning that prematurely discontinuing therapy for reasons other than pathological bleeding or completion of a course of therapy increases the risk of blood clots. If therapy is prematurely discontinued, it is advised that patients be given another anticoagulant to prevent this risk. Eliquis is used to reduce the risk of strokes or blood clots in patients with a common heart rhythm abnormality known as atrial fibrillation, not caused by a heart valve problem. It is also approved to prevent and treat blood clots in the veins of the legs, known ... Read More