Alerts, warnings, recalls
Prescribing information for Exubera (insulin human rDNA origin) was updated to reflect new reports of lung cancer in patients who used the inhaled insulin product. Six of 4,740 Exubera patients in clinical trials were diagnosed with lung cancer, compared with one of 4,292 patients treated with a comparator drug. In October, Pfizer said it would stop marketing Exubera due to slow sales; providers should find other means of maintaining patients' glycemic control.
Prescribing information for zanamivir (Relenza) now reflects a warning about delirium and abnormal behavior in patients taking the drug. The events occurred mostly in Japan among pediatric patients, and had abrupt onset and rapid resolution. Providers should monitor patients closely for signs of abnormal behavior, and weigh the risks/benefits of continuing treatment with zanamivir if symptoms occur.
Thirty-two lots of Covidien's Heparin Sodium USP are being recalled because two lots contain a heparin-like contaminant. No adverse events have been associated with the recalled lots. Physicians and patients should stop using the lots immediately.
A list of affected lots is online.
Twelve dietary supplements containing ephedra, aristolochic acid or human placenta were recalled due to potential health hazards. Ephedra has been linked to heart attacks and stroke; aristolochic acid can cause kidney damage; placenta can transmit disease. The products are made by Herbal Science International. A list is online.
Doctors should warn patients not to use Blue Steel or Hero products marketed as supplements for erectile dysfunction because they are unapproved and contain undeclared ingredients that may dangerously affect blood pressure level.
Tropical Orange and Peach Nectar flavors of Total Body Formula, and Orange/Tangerine flavor of Total Body Mega Formula, were recalled due to hazardous levels of selenium. Dozens of people had adverse reactions including hair loss, muscle cramps, diarrhea, joint pain, fatigue and deformed fingernails.
FDA is investigating a potential association between progressive multifocal leukoencephalopathy (PML) and the use of CellCept and Myfortic to prevent organ rejection. Providers should be alert to the possibility of PML with use of these drugs while the review is ongoing.
The Spectra MRSA test detects nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) within 24 hours. It has a positive predictive value of 98.1%, and shows MRSA as dark blue colonies against a white background.
The Yulex Patient Examination Glove, made of a new form of natural rubber latex that data indicate is less likely to stimulate allergic reactions during short-term exposure. Long-term exposure effects aren't yet known, and will be studied.
Certolizumab pegol (Cimzia) for adults with moderate to severe Crohn's disease who haven't responded to conventional therapies. Providers should closely monitor patients because they are at higher risk for serious infections, as well as lymphomas and other malignancies. They should also educate patients on how to identify an infection.
Treximet, which combines 85 mg sumatriptan and 500 mg naproxen sodium, for acute treatment of migraine attacks. In trials, the combination drug was more successful at relieving pain at two and four hours than placebo or either drug alone, with relief maintained from two to 24 hours.
The FDA has teamed up with academics to develop a post-market real-time drug surveillance system that will track drug interactions and clinical outcomes. In early 2009, insurer WellPoint will start to scan data from members to look for patterns or problems that could be linked to certain drugs. Other insurers are expected to follow suit.
Generic bupropion XL is just as effective as brand-name Wellbutrin XL. An FDA review of the two drugs was prompted by patient reports that the generic was less effective and led to new or worse side effects.
Carbenicillin indanyl sodium (Geocillin) was discontinued by Pfizer, the drug's only manufacturer.