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...The FDA announced in a Drug Safety Communication that it is strengthening warnings that the anemia drug Feraheme can lead to serious and sometimes fatal allergic reactions. The agency has also changed the prescribing instructions for Feraheme and added a Black Box Warning—the FDA’s strongest warning—to the drug’s packaging. The new warning strongly recommends against using Feraheme in any patient who has had an allergic ...
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...The FDA will enforce stricter guidelines for reusable medical instruments in an attempt to reduce the spread of hospital-acquired infections, the AP reports. Federal health officials hope to prevent more hospital-based outbreaks like those that occurred recently at the Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in LA.
Although the FDA began working on the new guidelines in 2011, it has accelerated its pace due to the ...
continue reading...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 ...
The U.S. Food and Drug Administration (FDA) has approved a total of four prescription drugs for obesity since 2012. In a population where two-thirds of the adults are considered overweight or obese, it is not surprising that there is such a demand for the medications. The most recent drug to gain FDA approval is called Saxenda. The drug was approved in December, 2014, and insurance companies have already stated that they will not ...
