Articles related to FDA

According to a press release from April 2021, “the FDA is working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars.” Acting Commissioner Janet Woodcock, MD, said the agency had now “accumulated sufficient evidence establishing the addictiveness and harm from menthol,” which provides a “trajectory” toward ending tobacco-related disease and death.

The investigational new drug (IND) application is for GDX012, which also received an FDA orphan drug designation for the treatment of acute myeloid leukemia (AML). The drug’s manufacturer, GammaDelta Therapeutics, is developing the T-cell platform in partnership with Takeda and will initiate a phase I study in late 2021 that will evaluate the treatment’s safety and activity in patients with measurable residual disease-positive AML.

The action comes after observational evidence associating the HeartWare left ventricular assist device (LVAD) with increased neurological adverse events and mortality, as well as more than 100 complaints involving delay or failure to restart. First approved in November 2012, the LVAD has been implanted in approximately 2,000 US patients experiencing end-stage heart failure.

Despite the pandemic interrupting trials and drug development in 2020, the US Food and Drug Administration (FDA) claims it is “full speed ahead” on the approval of novel cancer drug therapies. The authors of this Journal of the American Medical Association (JAMA) study wanted to verify these remarks, reviewing the FDA Hematology/Oncology Approvals website to ascertain all hematology/oncology drugs approved in 2020.

This article dives into information and the causes of five drug-induced diseases (DIDs) including hyponatremia/SIADH, pulmonary disease, GI bleeding, QT prolongation/Torsades de pointes, and hypoglycemia. Because research reviewed by the FDA for drug approval does not always include DIDs, it is the physician’s responsibility to monitor for DIDs and think twice about prescribing agents that could lead to DIDs.

This article from the American College of Physicians (ACP) provides a deeper dive into the pause of the J&J vaccine, which was recommended by the FDA and CDC on April 13, 2021, after six cases of cerebral venous sinus thrombosis (CVST) among patients who had received the vaccine was reported. The pause is being done to determine whether the vaccine is associated with any other types of thrombosis and to develop more specific recommendations for its use, possibly based on age.