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Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, in those who have allergies to diclofenac, or those with underlying illnesses. Consumption of undeclared dexamethasone may lead to severe and serious adverse events such as adrenal suppression, a disorder in which the adrenal glands do not produce enough hormones, and adverse consequences can range from limited adverse consequences to death.
Read MoreWashington, D.C. (Updated June 13, 2022) – Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, released the following statement in advance of the Senate HELP Committee’s June 14th Executive Session. “The amendments offered to include foreign drug importation in S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, are a dangerous step toward opening…
Read MoreSo, what does all of this have to do with importing drugs from a friendly nation like Canada? The simple, inarguable fact is that, once we open up our drug supply, we can no longer ensure the safety of the products in it.
Read MoreInstead of wasting time and money on dangerous and faulty importation proposals, Congress should encourage the FDA to speed up the drug approval process and reduce the cost of program and application fees for future drug development. In 2022, the application fee for a human drug application will cost $1.6 million for drugs that don’t require clinical data and $3.1 million for medicines that do need clinical data.
Read MoreIn this week’s news: A San Diego doctor pays for smuggling hydroxychloroquine to sell fake $4,000 COVID treatment kits; the British Medical Journal writes about black market sales of molnupiravir; Canadians warn about fake Xanax made with flualprazolam; and 14 more stories in 11 states.
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