Gilead Sciences has immediately halted the continuation of six clinical trials. The US Food and Drug Administration (FDA) says that the use of Idelaslisib (Zydelig) has led to serious adverse events and several deaths in clinical trial participants. Continue reading “Six Gilead Sciences Trials Halted Following Deaths Involving Idelalisib (Zydelig) Drug”
Benicar, also known as olmesartan, has been linked to dangerous side effects in patients nationwide. The drug is manufactured by Daiichi Sankyo and Forest Laboratories. Daiichi Sankyo is based in Japan. The serious side effects were experienced while maintaining proper dosages of the drug. Continue reading “Benicar Warning: Medication Causes Dangerous and Undisclosed Side Effects”
Following findings that eight patients experienced significant, non-life threatening heart incidents, Teva Pharmaceutical Industries Ltd. And Active Biotech AB have ceased phase-2 and phase-3 clinical trial studies of Laquinimod. Laquinimod is used for the treatment of multiple sclerosis and Huntington Disease. The U.S. Food and Drug Administration (FDA) requires phase 3 clinical trial completion before a drug can obtain approval for distribution on a large scale. Continue reading “MS Drug Laquinimod Linked to 8 Non-Fatal Cardiovascular Events”
Harman Law is investigating complaints of serious injuries and deaths resulting from severe dehydration in patients taking the MS drug Tecfidera (dimethyl fumarate). Severe dehydration may lead to blood-clotting or thrombosis, stroke, renal failure, seizure, and shock, among other things. Continue reading “Tecfidera May Cause Dangerous Dehydration”
Anti-diabetic SGLT2 inhibitors may predispose to ketoacidosis
Manufactured by Janssen Pharmaceuticals, type II diabetes drug Invokana is a SGLT2 inhibitor that increases urinary excretion of glucose, thereby improving glycemic control and promoting weight loss. Continue reading “INVOKANA May Result in Serious Condition”
On March 9, 2015, the FDA updated the safety label for Chantix to include how the drug (1) could change the way users react to alcohol and (2) be associated with seizures.
Chantix (varenicline) is an FDA-approved prescription drug manufactured by Pfizer, used to help adults quit smoking. Chantix works by reducing cravings for and decreasing the pleasurable effects of cigarettes and other tobacco products. Continue reading “Chantix (varenicline): FDA Issues Drug Safety Communication Regarding Update to Label”
The U.S. Food and Drug Administration (FDA) recently announced that it added new information to the label for Tecfidera (dimethyl fumarate) regarding progressive multifocal leukoencephalopathy (PML). The FDA based its decision on a report of a multiple sclerosis (MS) patient who, while being treated with Tecfidera, developed PML then died.
The patient was a 54 year-old woman with MS. She had been using it for four and a half years and was not taking other drugs that affected her immune system. She had no medical conditions that would predispose her to PML. Continue reading “Tecfidera Label Change and FDA Drug Safety Communication Regarding PML”
Following up on an earlier blog post, Harman Law LLC is following a story about a 45-year-old man who took Tecfidera (dimethyl fumarate) for three weeks. He experienced extensive bilateral deep venous thrombosis extending from calf veins to deep femoral veins. Fortunately, the man’s DVT abated after receiving anticoagulation treatment. Continue reading “Medical Journal Article Raises Possible Association Between Tecfidera MS Drug and Deep Venous Thrombosis”
Asthma Drug Under Scrutiny
The Food and Drug Administration issued a Safety Announcement warning that the asthma drug Xolair® increases the risk of heart attack, stroke, chest pain, and blood clots, among other serious problems.
Xolair® is an injectable drug that was approved in 2003 to treat moderate to severe asthma in adults and children 12 and over whose condition could not be controlled by inhaled steroids alone. Xolair is also approved in the treatment of chronic idiopathic urticaria, a form of chronic hives, in adults and adolescents. Continue reading “Asthma Drug Xolair Increases Chances for Heart Attack”
The FDA issued a drug safety alert that the agency is requiring the manufacturer of the antibiotic Levaquin (levofloxacin) and Avelox (moxifloxacin) to revise the labeling to warn patients of the risk of serious side effects including antibiotic nerve damage. Previously, these drugs were implicated in tendon tears and ruptures in the arms and legs, also serious injuries. Continue reading “Levaquin and Avelox Antibiotics Linked to Peripheral Neuropathy”