The FDA has required manufacturers of propoxyphene-containing products (Darvon, and others) to strengthen boxed warnings to include the potential for overdose.1 This action followed disclosure of fatal overdoses linked to propoxyphene-containing products taken alone or concurrently with other CNS depressants, including alcohol. Many of the overdoses occurred in patients with a history of emotional instability or suicide attempts. Accumulation of metabolites of propoxyphene can lead to central nervous system, cardiac and respiratory depression; convulsions and cardiotoxicity have occurred.

A Schedule IV controlled substance, propoxyphene is a weak full agonist opioid indicated for relief of mild to moderate pain.2 It is often prescribed in combination with acetaminophen (Darvocet, and others). One reasonable alternative would be codeine with acetaminophen; 32 mg of codeine has an analgesic effect similar to that of 65 mg of propoxyphene. Another would be 400 mg of ibuprofen, which may be more effective than either propoxyphene or codeine combined with acetaminophen.

1. FDA News Release. FDA takes actions on Darvon, other pain medications containing propoxyphene. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170769.html. Accessed August 23, 2010.

2. Drugs for pain. Treat Guidel Med Lett 2010; 92:25.

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The FDA has approved prasugrel (Effient - Lilly/Daiichi Sankyo), an oral antiplatelet drug, for use with aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention (PCI). It will compete with clopidogrel (Plavix) for such use.

The bisphosphonate risedronate (Actonel - Procter & Gamble) was recently approved by the FDA in a 150- mg once-monthly oral tablet for prevention and treatment of postmenopausal osteoporosis. The drug is also available for the same indication in 5-mg daily, 35-mg weekly and 75-mg twice-monthly tablets.

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.1

Given by subcutaneous injection, exenatide is a synthetic peptide that stimulates release of insulin from pancreatic beta cells.2 It is FDA-approved as adjunctive therapy in patients with type 2 diabetes. In addition to potentiating insulin release, exenatide slows gastric emptying, which may cause nausea and sometimes vomiting. The presenting symptoms of acute pancreatitis typically are nausea, vomiting and severe upper abdominal pain. Severe abdominal pain is not a usual side effect of exenatide. If pancreatitis is suspected in a patient taking exenatide, the drug should be discontinued promptly, and should not be restarted after recovery.

1. SR Ahmad and J Swann. Exenatide and rare adverse events. N Engl J Med 2008; 358:1970.
2. Exenatide (Byetta) for type 2 diabetes. Med Lett Drugs Ther 2005; 47:45.

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Rotigotine (Neupro - Schwarz Pharma), a nonergot dopamine agonist in a transdermal patch formulation, was recently approved by the FDA for treatment of early Parkinson's disease (PD).