FDA Warns Against High-Dose Acetaminophen : severe liver injury with acetaminophen

TGI: Thrive Health

The U.S. Food and Drug Administration (FDA) is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit.

“Limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant and death.”

Cases of severe liver injury with acetaminophen have occurred in patients who:
  • took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;
  • took more than one acetaminophen-containing product at the same time; or
  • drank alcohol while taking acetaminophen products.


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Helping keep pharmaceuticals safe:metal detection overview and guidelines

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New Drug Approvals


105826-92-4 (HCl)

 ICF 205-930, Navoban™
Molecular Formula: C17H20N2O2   Molecular Weight: 284.3529

Novartis (Originator)

Tropisetron (INN) is a serotonin 5-HT3 receptor antagonist used mainly as an antiemetic to treat nausea and vomiting following chemotherapy, although it has been used experimentally as an analgesic in cases of fibromyalgia.[1] The drug is available in a 5 mg oral preparation or in 2 mg intravenous form. It is marketed by Novartis in Europe, Australia, New Zealand, Japan, South Korea and the Philippines as Navoban, but is not available in the U.S. It is also available from Novell Pharmaceutical Laboratories and marketed in several Asian countries as Setrovel

Tropisetron is a 5-hydroxytryptamine receptor 3 (5-HT3) antagonist that was launched in 1992 by Novartis for the oral and injection treatment of chemotherapy-induced emesis. The drug has also been approved for the prophylaxis and treatment…

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