A pair of letters sent out in March by the FDA suggest that Novo Nordisk and AstraZeneca include black box warnings on the labels of their diabetes drugs, Victoza and Bydureon. The letters refer to previous notices sent by the FDA suggesting that the pharmaceutical companies include information about “the risk of medullary thyroid carcinoma” posed by the drugs. Accordingly, both Victoza and Bydureon ...
FDA Suggests Black Box Warnings for Victoza and Bydureon
Posted May 14, 2015 in Product News and Recalls
FDA Panel Recommends Heart Warning for Onglyza
Posted May 5, 2015 in Product News and Recalls
The FDA is recommending that the pharmaceutical giant AstraZeneca include information about increased risk of heart failure on the label of its diabetes drug Onglyza.
An FDA advisory panel met on April 14 to discuss data linking AstraZeneca’s Onglyza, as well as Takeda’s diabetes drug, Nesina, to increased risk of hospitalization due to heart failure. According to Bloomberg, 14 of 15 panel members voted in favor of recommending that AstraZeneca ...
continue reading...FDA Taking Legal Action after Hospital-Acquired Infections in Texas
Posted April 29, 2015 in Drug and Medical Device Lawsuits | Product News and Recalls
The FDA is taking legal action against a compounding pharmacy after 17 hospital patients acquired infections from contaminated injectable drugs.
In August 2013, Specialty Compounding, LLC, issued a nationwide voluntary recall of all lots of its unexpired sterile products. The recall came after 17 cases of hospital-acquired infection were linked to injectable drug products supplied by the company. Patients were reported to have ...
continue reading...FDA: AstraZeneca’s Diabetes Drug Onglyza May Pose Increased Risk of Death
Posted April 27, 2015 in Drug and Medical Device Lawsuits | Product News and Recalls
A new FDA report has concluded that AstraZeneca’s new diabetes drug Onglyza may be associated with an increased risk of death, Reuters reports.
This is not the first time AstraZeneca has come under scrutiny for its anti-diabetic drugs. As early as 2008, the FDA began receiving reports of hemorrhagic and necrotizing pancreatitis developing in patients taking AstraZeneca’s incretin mimetic drug Byetta, used ...
continue reading...FDA Drug Approvals Hit 18 Year High
Posted March 25, 2015 in Drug and Medical Device Lawsuits | Product News and Recalls
In 2014, the FDA Center for Drug Evaluation and Research approved the most drugs since 1996. The FDA approved 41 novel medications last year, 62% more than the 27 approved in 2013. The only year that topped 2014 was 1996, when 53 new drugs were approved.
The new drug approvals consisted mostly of innovative, expensive treatments where competition is limited and costs of treatment can often exceed $100,000 per patient per year. Infectious ...
continue reading...FDA Launches Project to Check Pharmaceutical Quality
Posted March 6, 2015 in Product News and Recalls
The United States Food and Drug Administration (FDA) has recently announced efforts to improve pharmaceutical quality and to establish an Office of Pharmaceutical Quality. A recent Reuters’ article looks at the FDA’s push to address lapses in quality control by pharmaceutical manufacturers, saying “the FDA has only had a general sense of the state of manufacturing quality at the country’s drugmakers.” According to the story, the FDA aims to have full quantitative information. The new ...
