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seizure 11 articles

Mislabeled ibuprofen, seizure drugs recalled

American Health Packaging (AHP) is recalling packages of the anti-inflammatory drug ibuprofen and the anti-seizure drug oxcarbazepine because the individual blister packs may be mislabeled and contain the wrong drug. Thus, patients prescribed oxcarbazepine may inadvertently take a dose of ibuprofen, and patients prescribed ibuprofen may inadvertently receive oxcarbazepine. Patients who miss a scheduled dose of oxcarbazepine are at an increased risk of having a seizure. And, inadvertent consumption of ibuprofen may cause side effects in patients for which the medication is contraindicated. The recall involves Lot #142588, Expiration Date, 01/2016 of ibuprofen tablets USP, 600 mg, in a hospital ... Read More

Children given flu shot, Prevnar 13 together more likely to suffer fever side effect

Children and infants who are given both the flu vaccine along with the Prevnar 13 vaccine for specific bacterial infections are likely to develop a fever, according to a new study in JAMA Pediatrics. Fever is a common side effect following either vaccination. Researchers set out to find if giving children both vaccines at the same time increased this risk. For the study, researchers asked the parents of 530 children to check their child’s temperature the evening after they were vaccinated and text the results. Researchers assessed the likelihood of children developing a fever of 100.4 after receiving either the ... Read More

Fresenius receives FDA warning letter regarding another dialysis product

Fresenius Medical Care North America, a division of Fresenius Medical Care, the world’s largest provider of dialysis products and services, received a warning letter from the Food and Drug Administration (FDA) alleging the company’s Optiflux Polysulfone Dialyzers, a dialysis product, did not go through adequate design verification studies and thus the products are considered unadulterated. The Optifulx Polysulfone is like an artificial kidney. It is used during hemodialysis to process blood and remove molecules that would otherwise build up when the kidneys are not functioning normally. The devices are the No. 1 prescribed dialyzer brand in the country. The FDA ... Read More

Brain injury from 2005 motorcycle crash may have caused snowboard champ’s death

A traumatic brain injury from a motorcycle crash years ago has been blamed for the death of Chelone “Chilly” Miller, a 29-year-old snowboarding champion and the younger brother of Olympic gold medalist alpine skier Bode Miller. Chelone Miller, a resident of Mammoth Lakes, California, had been staying at a friend’s house in the area when he passed away. ABC News reports that the friend found Mr. Miller unresponsive in his van and called 911. The call was relayed to paramedics, the fire department, and the Mono County Sheriff’s office around 12:45 p.m. Sunday. Responders determined Mr. Miller to be deceased ... Read More

Brain monitoring device for epileptics recalled due to dangerous defect

A serious injury to a patient using a medical device that temporarily (less than 30 days) records, monitors and stimulates electrical signals on the surface of the brain of epileptics has prompted a Class 1 recall. These recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the products will cause serious adverse health consequences or death. Ad-Tech Medical Instrument Corporation is recalling Macro Micro Subdural Electrodes because of a defect that may cause injury to the brain, including scraping (abrasion) of brain tissue and broken pieces remaining in ... Read More

Tainted dietary supplements seized by federal agents

Tainted dietary supplements made by Globe All Wellness (Globe All), in Hollywood, Fla., were seized by U.S. Marshals acting on behalf of the Food and Drug Administration (FDA) because the products contain an undisclosed active pharmaceutical ingredient and may be unsafe. Several of the seized products contain sibutramine hydrochloride (sibutramine), the active ingredient in the obesity drug Merida. In December 2010, the FDA pulled Meridia from the U.S. market after clinical data showed the drug increased the risk for heart attacks and strokes. Globe All claims its products can lower blood pressure and cholesterol, as well as improve other health ... Read More

Smoking cessation drug Aplenzin carries risk of suicidal thoughts, mental problems

A new black box warning has been added to the antidepressant Aplenzin informing  patients of suicidal thoughts and neuropsychiatric reactions in those who use the drug to help them stop smoking. Aplenzin contains the active ingredient bupropion hydrobromide, which is also found in the brand-name drugs Budeprion, Buproban, Forfivo, Wellbutrin and Zyban. Aplenzin and Wellbutrin are indicated for depression. Some dosages of Wellbutrin are also used to treat seasonal affective disorder. Zyban is prescribed to help people quit smoking. Doctors have the discretion to prescribe drugs for uses other than those on the drug’s label. The new boxed warning for ... Read More

FDA warning: Antibiotic cefepime dosage should be altered in patients with kidney problems

The Food and Drug Administration (FDA) is reminding doctors that the dosage for the drug cefepime used to treat bacterial infections should be adjusted in patients with kidney impairment because inappropriate dosages can cause seizures in patients with renal problems. Cefepime is a cephalosporin antibiotic used to treat pneumonia, urinary tract, skin, and intra-abdominal infections. It is often used in hospital settings and given intravenously through a vein or by injection into a large muscle. Some patients may continue to use cefepime after they have been discharged from the hospital. The FDA noted that there have been cases of a ... Read More

SSRIs during pregnancy linked to newborn seizures

Babies born to mothers who used antidepressants during their pregnancy are more likely to be born premature or suffer a seizure shortly after birth, according to a new study published in the American Journal of Obstetrics & Gynecology. The new study backs up concerns raised by previous studies that antidepressant use among pregnant women is dangerous to developing fetuses despite what drug companies claim on their safety labels. The new study found that among nearly 229,000 babies born in Tennessee, those born to women who used antidepressants during their second trimester were more likely to be born an average of ... Read More

Abbott to pay $1.5 billion for marketing Depakote for unapproved uses

Abbott Laboratories has admitted to promoting its anti-seizure drug Depakote for uses that were not approved by the Food and Drug Administration (FDA), and has agreed to pay $1.5 billion in criminal fines and civil settlement fees. Deputy Attorney General James Cole said the settlement shows the government’s determination to “hold accountable those who commit fraud.” Depakote is approved by the FDA to treat seizures as well as bipolar disorder. However, the company was found guilty of marketing the drug for unapproved uses including as a treatment for schizophrenia, agitated dementia, and autism. Abbott admitted that it trained its sales ... Read More