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Weekly Drug News Round Up - May 30, 2012

Counterfeit Adderall 30 mg Tablets Contain Wrong Active Ingredient

The counterfeit Adderall is white, round, with no markings on the tablet; real Adderall tablets are peach, scored with markings Read More...

Consumers and healthcare providers should be aware that counterfeit versions of Adderall by Teva Pharmaceuticals are available for purchase on the Internet. Adderall is a prescription controlled substance drug used to treat attention deficit hyperactivity disorder and narcolepsy. The counterfeit Adderall 30 mg tablets contain tramadol and acetaminophen for pain relief instead of a mixture of amphetamine salts. The counterfeit Adderall is a white, round tablet, with no markings or scoring, and comes in a blister pack. The real Adderall appears as a round, scored, peach tablet with “dp” embossed on one side and “30” on the other, and only comes in a 100-count bottle. Consumers should be cautious when purchasing medication online and only use the most reputable pharmacies.

Dosing Error Recall: Abacus Total Parenteral Nutrition Calculation Software

Dosing errors may occur with salt-based or ion-based electrolyte doses and templates used in total parenteral nutrition (TPN) Read More...

The U.S. Food and Drug Administration (FDA) issued a Class 1 recall of the Abacus Total Parenteral Nutrition (TPN) calculation software manufactured by Baxa Corporation. Class 1 recalls are the most serious type of recall that may involve serious adverse health consequences or death. Abacus TPN Calculation Software is designed to allow the ordering of TPN electrolytes in only one of two ways: as a salt (for example, calcium gluconate) or as an elemental ion (for example, calcium). However, if a dosage is entered into the system based on one method, when the template is set up for the other method, a TPN dosing error can occur. This recall originally occurred in 2009, and over 90 percent of Abacus users have already made corrections.

Expanded Recall: Franck’s Pharmacy Sterile Compounded Products

Clean room investigation at Franck’s Pharmacy reveals fungal microorganism growth Read More...

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating Franck’s Compounding Pharmacy of Ocala, FL. Currently, there is a nationwide recall of all sterile compounded products sold by Franck’s from November 21, 2011 through May 21, 2012. In March of 2012, the FDA received reports of fungal endophthalmitis (eye infections) in patients who received Brilliant Blue G (BBG), and in April of 2012 more infections were reported in patients who received ophthalmic injections containing triamcinolone. Healthcare providers in possession of any sterile compounded product should destroy the preparation and notify Franck’s Pharmacy.

FDA Urges Healthcare Providers to Review Hemodialysis Dialysate Concentrates

Metabolic alkalosis associated with a higher risk of death in hemodialysis patients Read More...

Dialysate is a solution used in the treatment of renal failure during the hemodialysis procedure to remove wastes from the blood. The U.S. Food and Drug Administration is urging healthcare providers to review the specific labels and consider the presence and quantity of acetate, citrate and/or acetic acid in dialysate concentrates when determining the dialysate prescription. Acetate, citrate and/or acetic acid are sources of alkali and can contribute to elevated bicarbonate levels and metabolic alkalosis. Metabolic alkalosis is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.

New FDA Database Details Drug Safety and Dosing For Children

New database allows parents, healthcare providers to search for new dose, safety, or use information Read More...

In response to pediatric legislative initiatives passed in Congress, the U.S. Food and Drug Administration (FDA) has released a database that details more than 440 entries of pediatric drug information. The database was developed based on legislation that required manufacturers to supply more studies in children for newly approved drugs, as drugs often affect children differently than adults. Users can search by brand or generic drug name, such as Intuniv or guanfacine, or they can search by condition, such as ADHD. The pediatric labeling date, trade or generic name, therapeutic category, studied indication, and label changes are summarized in the database. A separate safety database details adverse events reported to the Pediatric Advisory Committee.