Anyone who is currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis. Posted 11/21/2017
The use of this product in patients with uncontrolled diarrhea due to chronic medical conditions may predispose the patient to toxicity from either the diphenoxylate or atropine components. Posted 11/17/2017
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.
Preliminary safety trial results in over 6,000 patients with gout being evaluated.
Silicone, when injected into areas with many blood vessels, can travel to other parts of the body and block blood vessels in the lungs, heart, or brain. This can result in permanent damage to those tissues and lead to stroke or death.
Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences.
If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.
Risk of decreased quality and consistency (i.e., the safety, identity, strength, quality and purity)
Suspend further administration of octagam 10% from production lots K724B8541 and K725A8541.
Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. Posted 10/21/2017
UPDATED 10/19/2017. St. Jude Medical notified physicians of the Battery Performance Alert (BPA), a new tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion.
Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
When subjected to freezing, emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation/lead to serious adverse health consequences that can be life-threatening.
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.
FDA reminding parents and caregivers not to put babies in sleep positioners. These products, sometimes also called “nests” or “anti-roll” products, can cause suffocation that can lead to death.
Type III endoleak may require treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. Interventions to address endoleaks carry added risks for impacted patients.
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.
UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening.
Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label.