Warning on parenteral syringes with translucent caps used for oral medication administration.
Caps on parenteral syringes, if left intact by mistake, pose choking hazard for young children when medications are administered orally.
http://findarticles.com/p/articles/mi_qa3689/is_200111/ai_n8984855
http://www.ismp.org/hazardalerts/Hypodermic.asp
http://www.bd.com/injection/pdfs/hypodermic_syringe_tipcaps_white_paper_0502.pdf
Sunday, September 9, 2007
Diabetes News
Stronger FDA warning on thiazolidinediones and heart failure
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html
Avandia (rosiglitazone maleate) Tablets
Actos (pioglitazone hydrochloride) Tablets
Avandaryl (rosiglitazone maleate and glimepiride) Tablets
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets
Duetact (pioglitazone hydrochloride and glimepride) Tablets
Audience: Endocrinologists, other healthcare professionals, consumers[Posted 08/14/2007]
After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Manufacturers of certain drugs have agreed to the upgraded warning. The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments. [August 14, 2007 - Press Release - FDA] [August 14, 2007 - Rosiglitazone maleate - Information for Healthcare Professionals - FDA] [August 14, 2007 - Pioglitazone HCl - Information for Healthcare Professionals - FDA]
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html
Avandia (rosiglitazone maleate) Tablets
Actos (pioglitazone hydrochloride) Tablets
Avandaryl (rosiglitazone maleate and glimepiride) Tablets
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets
Duetact (pioglitazone hydrochloride and glimepride) Tablets
Audience: Endocrinologists, other healthcare professionals, consumers[Posted 08/14/2007]
After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Manufacturers of certain drugs have agreed to the upgraded warning. The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments. [August 14, 2007 - Press Release - FDA] [August 14, 2007 - Rosiglitazone maleate - Information for Healthcare Professionals - FDA] [August 14, 2007 - Pioglitazone HCl - Information for Healthcare Professionals - FDA]
Motherhood And Drugs
Nursing mothers on codeine could be putting their infants at risk
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01685.html
Codeine Products Used By Nursing Mothers
Audience: Obstetricians, pediatricians, other healthcare professionals, consumers[Posted 08/17/2007] FDA issued a Public Health Advisory with important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. When codeine enters the body and is metabolized, it changes to morphine, which relieves pain. Many factors affect codeine metabolism, including a person’s genetic make-up. Some people have a variation in a liver enzyme and may change codeine to morphine more rapidly and completely than other people. Nursing mothers taking codeine may also have higher morphine levels in their breast milk. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. When prescribing codeine-containing drugs to nursing mothers, physicians should choose the lowest effective dose for the shortest period of time and should closely monitor mother-infant pairs. There is an FDA cleared test for determining a patient’s CYP2D6 genotype. The test is not routinely used in clinical practice but is available through a number of different laboratories. The results of this test predict that a person can convert codeine to morphine at a faster rate than average, resulting in higher morphine levels in the blood. When levels of morphine are too high, patients have an increased risk of adverse events. [August 17, 2007 - Public Health Advisory - FDA] [August 17, 2007 - Drug Information Page - FDA]
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01685.html
Codeine Products Used By Nursing Mothers
Audience: Obstetricians, pediatricians, other healthcare professionals, consumers[Posted 08/17/2007] FDA issued a Public Health Advisory with important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. When codeine enters the body and is metabolized, it changes to morphine, which relieves pain. Many factors affect codeine metabolism, including a person’s genetic make-up. Some people have a variation in a liver enzyme and may change codeine to morphine more rapidly and completely than other people. Nursing mothers taking codeine may also have higher morphine levels in their breast milk. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. When prescribing codeine-containing drugs to nursing mothers, physicians should choose the lowest effective dose for the shortest period of time and should closely monitor mother-infant pairs. There is an FDA cleared test for determining a patient’s CYP2D6 genotype. The test is not routinely used in clinical practice but is available through a number of different laboratories. The results of this test predict that a person can convert codeine to morphine at a faster rate than average, resulting in higher morphine levels in the blood. When levels of morphine are too high, patients have an increased risk of adverse events. [August 17, 2007 - Public Health Advisory - FDA] [August 17, 2007 - Drug Information Page - FDA]
Subscribe to:
Posts (Atom)