Unapproved product leads to death
The FDA has issued a warning against bismacine, also called chromacine, after use of the unapproved product led to one death, one hospitalization, and several injuries. The product contains high concentrations of bismuth and is not a pharmaceutical.
Unapproved product leads to death
The FDA has issued a warning against bismacine, also called chromacine, after use of the unapproved product led to one death, one hospitalization, and several injuries. The product contains high concentrations of bismuth and is not a pharmaceutical. The drug is reportedly mixed by druggists into an injectable form and used to treat Lyme disease by people claiming to be physicians. There are reports of individuals who have experienced serious adverse events, including cardiovascular collapse and kidney failure as a result of treatment with the product. The FDA is advising consumers and healthcare providers not to use bismacine. Meanwhile, the agency will evaluate product suppliers and take additional action if necessary.
To see more Hot off the Press news articles, click here http://www.drugtopics.com/Hot+off+the+Press.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
