Eli Lilly and Company announced that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo [teriparatide (rDNA origin) injection] in the United States. The Triad Group is recalling the alcohol prep pads due to potential contamination with the bacteria, Bacillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients. It is important to note that this recall does not affect or involve the Forteo Delivery Device. The starter kits did not contain the Forteo Delivery Device.
Some Forteo starter kits distributed by Eli Lilly and Company between March 2008 and June 2009 may have contained Triad Group alcohol prep pads. The Triad alcohol prep pads should not be used. The Forteo starter kits that contained the Triad alcohol prep pads were black bags and were discontinued in June 2009. The Forteo starter kits have been updated since June 2009. The bags are now blue, do not include Triad alcohol prep pads, nor any other alcohol prep pad.
Lilly has requested that physicians and their staff examine their inventory of Forteo starter kits and remove and appropriately discard the Triad Group alcohol prep pads in the black bags. Lilly has also requested that physicians inform any patients who may have received Forteo starter kits containing Triad Group alcohol prep pads to discontinue use of the pads.
Forteo is used in both men and postmenopausal women with osteoporosis who are at high risk for having fractures. Forteo can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.
Forteo is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures). These include men and women with either a history of broken bones, who have several risk factors for fracture, or who cannot use other osteoporosis treatments.
During the drug testing process, the medicine in Forteo caused some rats to develop a bone cancer called osteosarcoma. Do not use Forteo if you are allergic to any of the ingredients in Forteo. Serious allergic reactions have been reported. Talk to your healthcare provider before taking Forteo.
Forteo can cause serious side effects including a decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking Forteo and goes away within a few hours. For the first few doses, take your injections of Forteo in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking it and call your healthcare provider. It may also cause increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
Common side effects includes nausea, joint aches, pain, leg cramps, and injection site reactions such as redness, swelling, pain, itching, a few drops of blood, and bruising.
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