Reason for label change: NovoLog, a rapid-acting insulin that can be injected or used in insulin pumps, was originally approved by the FDA to be kept in pumps for no more than two days at a time. The FDA’s labeling change for NovoLog allows the insulin to be stored in pump reservoirs for six full days. The new approval also extends the length of time between pump infusion set changes from two days to three.
Product: Metoclopramide (Reglan, Maxolon, Octamide)
Manufacturer: various
Reason for label change: The drug metoclopramide, which can be used to treat gastroparesis (slowed stomach emptying caused by nerve damage), now must carry a stronger warning to alert doctors and users that people who take the drug for longer than recommended are at risk of developing the neurological disorder tardive dyskinesia. Symptoms of the disorder include repetitive and involuntary movements of the hands, feet, and face, such as lip smacking, excess blinking, and grimacing — these symptoms may persist even after the drug is stopped. Metoclopramide had already carried a warning about the risk of tardive dyskinesia, but the FDA has chosen to intensify that warning in light of continued reports of the disorder associated with its use.
Product: Repaglinide (Prandin)
Manufacturer: Novo Nordisk
(800) 727-6500
www.novonordisk.com
Reason for label change: The FDA found that gemfibrozil (Lopid, Jezil, Gen-Fibro) and drugs that block the activity of the protein OATP1B1, such as cyclosporine, decrease the rate at which the body metabolizes Prandin, potentially resulting in too-high levels of the drug in the bloodstream. Prandin’s labels have been updated to indicate that these drugs should not be taken in combination with it.
Discontinuations
Product: Deltec Cozmo
Manufacturer: Smiths Medical
(800) 826-9703
www.smiths-medical.com
Details: Smiths Medical suspended manufacture and sales of the Deltec Cozmo insulin pump in March. The company is honoring warranties for existing pumps (including replacement pumps, if necessary), and providing clinical and customer support. Smiths Medical is no longer directly filling orders of Deltec Cozmo insulin cartridges, infusion sets, and other pump accessories, but these items will continue to be available through distributors.
Product: Humulin 50/50 insulin
Manufacturer: Eli Lilly and Company
(800) LillyRx (800 545-5979)
www.lilly.com
Details: According to Eli Lilly and Company, because use of Humulin 50/50 (a premixed insulin consisting of 50% human insulin isophane suspension and 50% human insulin injection) has been steadily declining, the product was discontinued in August. The existing stock of Humulin 50/50 will be sold with a notice on the packaging warning customers of the discontinuation; Lilly expects this supply to last until the end of April 2010.
