Tag Archives: FDA alerts

Stop Marketing E-Cigarettes Without Approval Says FDA

The FDA has sent warning letters to five manufacturers of e-cigarettes telling them that they cannot market the devices as a way to quit smoking without FDA approval. If manufacturers claim that e-cigarettes treat a disease — in this case, nicotine addiction — they have to prove to the FDA that the product is both safe and effective for its intended use.  All five manufactures say that the products help users to stop smoking, but none have sought FDA approval. In addition, FDA intends to regulate e-cigarettes under its new powers from the Family Smoking Prevention and Tobacco Control Act.  In a letter to the Electronic Cigarette Association, the FDA

FDA: Don't Use Vita Breath Because of High Lead Levels

The FDA has warned consumers not to take Vita Breath dietary supplements.  Some samples tested with more than 10,000 times FDA safe recommended levels for candy. Although the Vita Breath website suggests use of the supplement for asthma, the Symptom-Formula Index on that site lists Vita Breath for a wide range of ailments including some common to people living with colon and rectal cancer.

New Black Box Warning for Promethazine

The Food and Drug Administration has warned health care professionals that intravenous administration of promethazine can lead to serious tissue damage including gangrene that requires amputation.  Deep intramuscular injections are the preferred method of giving the drug, and injections just under the skin or injections into an artery are contraindicated. The FDA is requiring that manufacturers of promethazine place a boxed warning on its label and revise the label content and organization to stress the importance of avoiding IV administration.  If IV administration is required, the drug should not exceed a maximum concentration or speed of IV drip.

FDA Warns: Remove Transdermal Drug Patches Before MRI

Some drug patches that deliver medicine through the skin have metals in their outer layer that can overheat and cause burns during MRI exams. The Food and Drug Administration is reviewing labeling for medicated transdermal patches to be sure that any with aluminum or other metals include warnings to remove them before MRIs.  Until their safety review is complete, the FDA is advising physicians to check patients before an MRI to be sure they are not wearing a transdermal patch.  Patients with patches should be told how to remove them safely before their MRI and replace them afterwards.