The Food and Drug Administration has granted the ‘Breakthrough Therapy’ designation to the treatment of major depression disorder (MDD) using psilocybin, the psychoactive compound found in many mushrooms collectively referred to as ‘magic mushrooms.’ The designation was granted to Usona Institute, enabling it to proceed with an investigation into psilocybin-based treatment for MDD.
Public health officials with the FDA and CDC have linked a hepatitis A outbreak to the consumption of blackberries purchased from a natural food marketplace with stores in the Midwest. Federal experts have been working with public health officials from three states on investigating a hepatitis A outbreak currently involving 11 cases and six hospitalizations.
In a statement published on Friday, the Food and Drug Administration warned the public to avoid all vaping products that are sold privately, including homemade offerings, which it collectively refers to as 'street' vapes. As well, officials are warning the public to avoid vaping products that contain THC, the compound in marijuana that causes one to become 'high.'
Public health officials in Georgia and Florida reported two vaping deaths this week, bringing the nationwide total to 11. Both cases involved individuals suffering from the severe lung condition that has appeared in hundreds of people who reported recent use of electronic cigarettes or other vaping products. In at least one of these newly disclosed fatal cases, the victim is said to have used nicotine products.
The FDA has advised consumers that Torrent Pharmaceuticals is voluntarily expanding its blood pressure medication recall over the presence of an impurity that may trigger the development of cancer in some patients. The expansion covers another two lots of Losartan Potassium / Hydrochlorothiazide tablets USP, as well as three lots of Losartan Potassium tablets USP.
As anticipated, the FDA has proposed a new rule detailing the steps tobacco companies will be required to take in order to sell electronic cigarettes and similar vaping products. The FDA will evaluate applications for marketing approval across a variety of categories, including the product's potential impact on public health. The agency aims to 'clear the market' of all unauthorized flavored electronic cigarettes.
The CDC has published its latest update on the vaping lung injury outbreak, revealing that the number of cases has increased to at least 530 people, the majority of whom are between the ages of 18 and 34. In addition to the new numbers, officials have also revealed that the FDA's Office of Criminal Investigations has been probing the matter alongside the ongoing public health investigation.
Since last year, the FDA has been looking into the presence of impurities in various types of medication, leading to multiple drug recalls over past months. In the latest announcement on this matter, the agency reports that some units of a popular heartburn and antihistamine drug called ranitidine may contain low levels of a cancer-causing impurity, though it isn't ordering a recall of the products at this time.
The FDA has taken a major step toward approving Palforzia, a treatment for peanut allergy that may reduce both the number and severity of allergic reactions. The treatment, assuming it ultimately gets approval, would be for allergy sufferers ages 4 to 17 who have been diagnosed with peanut allergy. Palforzia is a biologic oral immunotherapy (OIT) that received Fast Track Designation from the FDA in 2014.
The FDA is taking steps to ban the sale of flavored electronic cigarettes amid ongoing reports of a serious lung condition that has caused at least six deaths and more than 450 cases, including hospitalizations. The announcement was made today by Department of Health and Human Services Secretary Alex Azar, who said in a statement that these devices are paving the way for a new generation of nicotine addicts.
In addition to the Salmonella outbreak linked to the growing trend of keeping backyard chickens is another Salmonella outbreak previously linked to dried pig ears sold as dog treats. The CDC previously issued an advisory about the matter, though it didn't have any information about the source of the potentially contaminated treats. In a new update, the agency is warning that people should avoid all pig ear treats, including ones that have already been purchased.
The Food and Drug Administration (FDA) has teamed with the Centers for Disease Control and Prevention (CDC) to issue an update on their ongoing investigation into cases of severe lung injury linked to vaping. The agency says that 215 'possible' cases of this condition had been identified in 25 states as of August 27. The cases all have one thing in common: the use of vapes with nicotine and THC.