OsmoPrep increases chances of acute kidney injuries

The FDA issued an alert on December 11th, 2008 stating that it had become aware of reports of acute kidney injury associated with the use of OsmoPrep. This type of kidney injury is known as Acute Phosphate Nephropathy. OsmoPrep is a type of oral sodium phosphate products (OSP) and it is used for bowel cleansing prior to colonoscopy or other procedures. In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSPs or they did not drink sufficient fluids after ingesting OSP.

Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of OsmoPrep. The occurrence of these events was previously described in an Information for Healthcare Professionals sheet and an FDA Science Paper issued in May 2006. Additional cases of acute phosphate nephropathy have been reported to FDA and described in the literature since these were issued.

Individuals who appear to have an increased risk of acute phosphate nephropathy following the use of OsmoPrep include persons: who are over age 55; who are hypovolemic or have decreased intravascular volume; who have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]).

As a result of new safety information received, FDA is requiring the manufacturer of OsmoPrep, Salix Pharmaceuticals, Inc. to add a Boxed Warning to the labeling for this product. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of OsmoPrep outweighs the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of OsmoPrep.

Visicol is causing kidney injuries

The FDA issued an alert on December 11th, 2008 stating that it had become aware of reports of acute kidney injury associated with the use of Visicol. This type of kidney injury is known as Acute Phosphate Nephropathy. Visicol is a type of oral sodium phosphate products (OSP) and it is used for bowel cleansing prior to colonoscopy or other procedures. In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSPs or they did not drink sufficient fluids after ingesting OSP.

Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of Visicol. The occurrence of these events was previously described in an Information for Healthcare Professionals sheet and an FDA Science Paper issued in May 2006. Additional cases of acute phosphate nephropathy have been reported to FDA and described in the literature since these were issued.

Individuals who appear to have an increased risk of acute phosphate nephropathy following the use of Visicol include persons: who are over age 55; who are hypovolemic or have decreased intravascular volume; who have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]).

As a result of new safety information received, FDA is requiring the manufacturer of Visicol, Salix Pharmaceuticals, Inc. to add a Boxed Warning to the labeling for this product. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of Visicol outweighs the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of Visicol.

Byetta health risks and concerns.

Eli Lilly & Co. and Amylin Pharmaceuticals, Inc. notified the FDA about four more deaths from pancreatitis among users of their diabetes drug Byetta. These four cases are in addition to two other Byetta pancreatitis deaths the FDA cited in their notice to healthcare providers last week. Byetta is an injection given twice a day to patients with Type-2 diabetes to lower their blood sugar levels. Concerns have grown recently among users and prescribers about the life threatening side effect.

On August 18, 2008, the FDA posted an alert on their website to notify doctors that the agency had received reports of at least six cases of necrotizing pancreatitis or hemorrhagic pancreatitis associated with Byetta. The FDA indicated that two of those six had died as a result of the severe cases of acute pancreatitis, and the other four were recovering. Despite this data, Eli Lily and Amylin do not believe there is any definite relationship between the drug and the deaths. The manufacturers and the FDA are in talks now for giving Byetta a "black box" warning for the risks of pancreatitis.

The first known Byetta pancreatitis lawsuit has already been filed in San Diego Superior Court on August 20, 2008. The diabetic patient was hospitalized back in December of 2007 with pancreatitis after using Byetta. The Byetta lawsuit alleges that Amylin and Eli Lily failed to test and monitor the side effects of the drug and did not issue warnings on the label about the potentially life threatening condition of pancreatitis.

Fentanyl Patches could cause you to overdose.

The Johnson & Johnson Corporation voluntarily recalled 32 million of their Fentanyl Patches on February 12 th , 2008 . Of these 32 million, an estimated 2 million of the Fentanyl Patches could possibly have a defect that can lead to an accidental overdose. The Duragesic Pain patch, which is sold by PriCara and the Fentanyl Transdermal System Patch, sold by Sandoz were involved in this Pain Patch Recall.

This Fentanyl Patch Recall involves all 25-microgram-per-hour patches that are sold in the U.S. by J&J's PriCara unit and Sandoz; made by another J&J unit, Alza Corp. All of the patches affected in the recall are only sold in the United States and they all have expiration dates set on or before December of 2009.

The defect that has caused this recall is a possible cut along one side of the drug reservoir within the patch. If the fentanyl patch does have a cut in it the fentanyl gel within can leak into the pouch the patch is packaged in and easily be transferred to the patient or caregiver when opened. Direct exposure to fentanyl gel can cause serious harm, including an accidental overdose. Anyone who believes they may have a damaged fentanyl patch should immediately properly dispose of the patch to eliminate the risk of accidental overdose.

Pain Pumps may be more painful than you thought.

Intraarticluar Pain Pumps are often used after shoulder surgery to help aid in pain management. These pumps are implanted in the shoulder joint and are used to dispense pain medication. These pumps were believed to be a better way to manage pain after surgery, but recently it has been found that this may be incorrect and the Intraarticular Pain Pumps could be doing more damage than good.

In 2006, the American Academy of Orthopedic Surgeons studied the medical charts of 152 patients who had arthroscopic surgeries. Of these 152 patients, 12 were found to have a condition known as Postarthroscopic glenohumeral chondrolysis or PAGCL. A study was also published by the American Journal of Sports Medicine in July stating that these pain pumps were a likely cause of PAGCL. This condition causes increased pain and stiffness in the shoulder, constant need for pain management, reduced strength, a limited range of motion and a probable need for continual pain management. Patients who suffer from PAGCL also need to undergo more surgery, and there is a chance that the injured shoulder will never fully recover.