Medication Monitor

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  • June 28, 2013

    Baxter International announced that FDA has approved recombinant coagulation factor IX for routine prophylactic treatment, control of bleeding episodes, and perioperative management in patients 16 years and older with hemophilia B.

    A purified protein made with recombinant DNA technology, the drug is the first new recombinant factor IX (rFIX) approved for hemophilia B in more than 15 years.

    The drug's efficacy was assessed in a late-stage trial that included 73 male patients between the ages of 12 to 65 years. Patients who received recombinant coagulation factor IX for routine prophylaxis experienced a significant reduction in annual bleeding: 75% lower compared with those who received other treatment options.

    Common and less severe adverse effects include dysgeusia (distorted taste), atypical blood results, and pain in an extremity. Serious and uncommon adverse effects of the drug include life-threatening allergic reactions.

  • April 11, 2012

    FDA has released an updated drug safety communication regarding the risk of venous thromboembolic events (VTEs) associated with the use of oral contraceptive tablets containing drospirenone. Previous alerts were released in May, September, and October of last year. The agency reported that it has completed its review of recent observational studies and concluded that drospirenone-containing tablets may be associated with a higher risk for VTEs than other progestin-containing pills. This new information will be added to the labels of drospirenone-containing products.

    The revised drug labels will report that some epidemiologic studies reported as much as a threefold increase in the risk of VTEs for drospirenone-containing products compared with products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of VTEs with drospirenone-containing products.

    FDA advised health professionals to consider the risks and benefits of drospirenone-containing oral contraceptives and a woman’s risk for developing a blood clot before prescribing these drugs.

  • April 30, 2014

    FDA is advising people with diabetes and health professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels. During a recent inspection of Shasta Technologies, FDA found extensive violations of federal regulations intended to ensure the quality of products in the manufacturing of GenStrip Test Strips. FDA recommends the use of alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.

    The test strips are "third-party" blood glucose monitoring test strips—this means that the test strips are not made by the same company as the meter with which they are used. The strips are used in the home and in health care facilities to measure blood glucose levels in diabetes care and management. Shasta’s GenStrips are advertised for use with the LifeScan OneTouch family of glucose meters (e.g., Ultra, Ultra 2, and Ultra Mini).

    The affected test strips have been manufactured and distributed since March 2013 and are available through online retailers and retail pharmacies.

    To date, the company has been unwilling to voluntarily recall their test strips, resulting in their continued availability.

    The test strips may be packaged in green-and-white packaging with the GenStrip name on top.

  • January 9, 2014

    FDA is warning that using more than one dose in 24 hours of OTC sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and possibly even death. 

    FDA has become aware of reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose of OTC sodium phosphate products, resulting in serious adverse effects on organs, such as the kidneys and heart, and in some cases resulting in death. These serum electrolytes include calcium, sodium, and phosphate. According to the reports, most cases of serious harm occurred with a single dose of sodium phosphate that was larger than recommended or with more than one dose in a day.

    OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally. The products are marketed under the trade name Fleet and as store brands and generic products. They are available as single-ingredient drug products containing either sodium biphosphate or sodium phosphate, and as combination drug products containing both ingredients.

    Patients and health professionals should always read the Drug Facts label for OTC sodium phosphate drugs, use these products as recommended on the label, and not exceed the labeled dose. Caregivers should not give the oral products to children 5 years and younger without first discussing with a health professional. Health professionals should use caution when recommending an oral dose of these products for children 5 years and younger. The rectal form of these products should never be given to children younger than 2 years.

  • October 24, 2013

    FDA and Codman & Shurtleff, Inc., announced a class 1 recall of MedStream Programmable Pump and MedStream Refill Kit due to air in the pump reservoir, which may release a higher dosage of drug than expected, leading to drug overdose. This product may cause serious adverse health consequences, including low blood pressure, an abnormally slow heart rate, loss of consciousness, and/or death.

    The MedStream Programmable Infusion Pump is an implanted drug delivery system used in the U.S. for the chronic delivery of baclofen to treat muscle symptoms and used in Europe, Middle East, and Africa (EMEA) for the chronic delivery of morphine or baclofen. Refill kits are used in filling and refilling of the MedStream pump reservoir. On August 13, 2013, Codman & Shurtleff sent a Medical Device Field Safety Notice Letter to U.S. and international customers. The affected products were manufactured from March 2009 to September 2012 and distributed from January 8, 2010, to July 19, 2013.

    Contact Codman Representative or Codman Neuro Clinical Support at 800-660-2660 for questions about the recall. Report any malfunctions or adverse events related to the MedStream Programmable Infusion Pumps and refill kits to 866-491-0974 (choose option 2).