The Food and Drug Administration is warning doctors and patients that a widely used antibiotic from Pfizer can cause rare but deadly heart rhythms in some patients.
The agency is adding new warnings to the label of Zithromax, which is commonly used to treat bronchitis, pneumonia and other infections.
Doctors should consider prescribing other antibiotics to patients at risk of heart problems, including those with irregular heartbeats or low levels of potassium or magnesium in their blood.
In the medical device industry, labeling errors can lead to costly consequences. Both the industry and federal regulators require specific information about each medical device and its packaging to travel with each item in order to provide full traceability up and down the supply chain.
Pharmaceutical and medical device manufacturers alike are gearing up to include more product information in labeling. Many of these products will need to carry item-level serialization or other variable information, and some products must bear detailed warnings to convey product risks. And for manufacturers serving a global market, they must accommodate the 20-plus languages spoken within the European Union (EU), along with new outer packaging requirements under the Falsified Medicines Directive.
AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider, welcomed the news today the boxed warning label (also called the ‘black box warning’) on Gilead Sciences’ blockbuster AIDS treatment Truvada for use as a form of an HIV prevention pill appears much stronger than proposed versions of the label earlier this year.
Datalogic S.p.A. (Borsa Italiana S.p.A.: DAL), a global leader in Automatic Identification and total solutions provider of bar code readers, data collection mobile computers, RFID and vision systems, is enhancing processes in the healthcare sector by meeting high demands in patient safety and inventory tracking solutions.
Weber Packaging Solutions (formerly Weber Marking Systems), founded in 1932 as a small addressing machine company, has achieved worldwide status as a manufacturer of labels and labeling systems as it approaches its 80th anniversary in July 2012.
“We’re proud to be a company with eight decades of experience in product identification and labeling,” said Glenn Gilly, Weber’s president and CEO. “But getting older doesn’t mean we’re getting stale. We continue to be a company that strives to remain fresh.”
Amneal Pharmaceuticals, LLC today announced significant formulation and labeling changes to its generic Metformin products, offering substantial improvements in these medications for both pharmacists and their patients.
LITTLE ROCK, Arkansas — A Johnson & Johnson subsidiary downplayed and hid risks associated with the antipsychotic drug Risperdal, a jury determined Tuesday in Arkansas' billion-dollar lawsuit against Janssen Pharmaceuticals Inc.
Attorney General Dustin McDaniel's office is seeking fines of at least $1.2 billion for the 250,000 Risperdal prescriptions a state health coverage program paid over more than three years. The penalty will be decided Wednesday.
Wayne, NJ,- In agreement with the U.S. Food and Drug Administration (FDA), Bayer HealthCare Pharmaceuticals Inc. today announced that it has updated the labels for its drospirenonecontaining combination oral contraceptives (COCs) in the United States.