The FDA has approved the 5-HT4 receptor agonist prucalopride (Motegrity – Shire) for treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride is the only drug currently approved in the US for treatment of CIC that stimulates colonic peristalsis. It has been available in Europe and Canada for several years.

The FDA has removed prescribing and dispensing restrictions placed on rosiglitazone (Avandia, and others) in 2010 because of concerns about its cardiovascular safety.1 The removal of restrictions was based on the results of an independent reevaluation of the RECORD trial, which found no significant difference between rosiglitazone and metformin/sulfonylurea in the risk of cardiovascular (or unknown cause) death, myocardial infarction, or stroke.21. FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes...

Ifosfamide (Ifex - Mead Johnson), a synthetic analog of cyclophosphamide (Cytoxan; and others), has been approved by the US Food and Drug Administration (FDA) for concurrent use with other drugs in third-line chemotherapy of metastatic germ-cell testicular cancer. Given concomitantly, a synthetic sulfhydryl compound known as mesna (Mesnex - Asta) acts in the urine to detoxify metabolites of ifosfamide that cause hemorrhagic cystitis (H Burkert, Cancer Treat Rev, 10 suppl A:175, 1983). Ifosfamide and mesna are available together from Bristol-Myers Oncology Division.

Gallium nitrate (Ganite - Fujisawa, USA), originally an anticancer drug, was recently marketed for treatment of cancer-associated hypercalcemia that has not responded to hydration. Other drugs used for treatment of hypercalcemia include furosemide (Lasix, and others), the bisphosphonate etidronate (Didronel IV), calcitonin (Calcimar), and plicamycin (Mithracin, formerly mithramycin) (RAB Schaiff et al, Clin Pharm, 8:108, 1989). Newer bisphosphonates are available in Europe.

Atovaquone (Mepron - Burroughs Wellcome), a hydroxynaphthoquinone, was recently approved by the US Food and Drug Administration (FDA) for oral treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in patients who cannot tolerate trimethoprim-sulfamethoxazole (Septra, Bactrim, and others). PCP is a common opportunistic infection and frequent cause of death in patients with AIDS.

The US Food and Drug Administration (FDA) recently approved the marketing of clarithromycin (Biaxin - Abbott), a macrolide antibiotic, and omeprazole (Prilosec - Astra Merck), a proton pump inhibitor, for concurrent use in treatment of duodenal ulcers associated with Helicobacter pylori.

Clonidine, an Alpha2-selective adrenergic agonist marketed in the USA only for treatment of hypertension, has also been used in recent years to treat children with attention-deficit/hyperactivity disorder (ADHD).

S-adenosyl-methionine (SAM; SAMe; ademetionine; adomet), an endogenous compound synthesized from methionine and adenosine-triphosphate (ATP), has been marketed in stores and on the internet as a dietary supplement to promote "emotional well being."

Genetic Test for Carbamazepine-Induced Stevens-Johnson Syndrome Carbamazepine (Tegretol, Carbatrol, Equetro, and others), which is now used to treat not only epilepsy but also trigeminal neuralgia and manic episodes in patients with bipolar disorder,1 is a known cause of Stevens-Johnson syndrome (SJS). The incidence of carbamazepine-induced SJS in countries with mainly white populations is 1 to 6 per 10,000 new users of the drug, but Asian patients have a 10-fold higher incidence of this reaction. An association has been found between the human leukocyte antigen (HLA)-B*1502 allele and...

The FDA has issued an update (August 18, 2008; www.fda.gov) on occurrences of acute pancreatitis in patients with diabetes taking exenatide (Byetta – Amylin/Lilly). The latest update, which follows an FDA Alert in October 2007, reports 6 cases of hemorrhagic or necrotizing pancreatitis with 2 deaths in patients taking the drug. Whether pancreatitis occurs more often in patients taking exenatide than in patients with diabetes not taking exenatide is not clear.1Given by subcutaneous injection, exenatide is a synthetic peptide that stimulates release of insulin from pancreatic beta cells.2 It...