Medication Safety - Formulary

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Medication Safety

FDA finds no increased cardiovascular risk in patients using tiotropium

February 1, 2010

After completing a review of available tiotropium bromide inhalation powder (Spiriva HandiHaler, Pfizer) data, FDA released an updated communication, stating that in the regulatory body's opinion, available data does not support an association between the use of tiotropium, a commonly prescribed daily treatment for chronic obstructive pulmonary disease, and an increased risk of stroke, heart attack, or cardiovascular death.

Exenatide drug label to include information on post-marketing surveillance of altered kidney function

January 1, 2010

In early November 2009, FDA approved revisions to the drug label for exenatide (Byetta, Amylin Pharmaceuticals), an injectable glucagon-like peptide-1 agonist for the treatment of type 2 diabetes mellitus.

FDA's Safe Use Initiative to address preventable harm due to medication misuse, errors, and other related problems

January 1, 2010

Towards the end of 2009, FDA launched a new medication safety initiative.

Bloodstream infections and contaminated prefilled syringes: issues of medication safety

November 1, 2009

An investigation into a multistate outbreak of Serratia marcescens bloodstream infections (BSIs) published in the Archives of Internal Medicine found an association between the BSIs and contamination of prefilled syringes.

Two antimalaria drugs are tolerated regimens in regions with resistance

November 1, 2009

In a review published in The Cochrane Library, researchers determined that atovaquone-proguanil and doxycycline were well tolerated by most travelers and are less likely than mefloquine to cause adverse neuropsychiatric outcomes.

Thiopurines increase lymphoproliferative disorder risk in IBD patients

November 1, 2009

Patients with inflammatory bowel disease receiving thiopurines are at increased risk of developing lymphoproliferative disorder, according to a French prospective observational cohort study, which was published online in The Lancet.

Specialty pharmacy's role in REMS, FDA's new drug safety program

October 1, 2009

Specialty pharmacies are uniquely positioned to play a key role in the implementation of Risk Evaluation and Mitigation Strategies (REMS).

FDA issues early communication about ongoing safety review of orlistat

September 14, 2009

FDA is reviewing reports of liver injury in patients treated with orlistat (prescription drug, Xenical; OTC drug, Alli) for obesity management or weight loss.

Mycophenolic acid associated with increased risk of pure red cell aplasia

September 14, 2009

Novartis has issued a Dear Healthcare Professional letter regarding a risk of pure red cell aplasia (PRCA) in patients treated with mycophenolic acid (Myfortic).

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