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NEW WARNING
The Food and Drug Administration added a “Boxed Warning” to propylthiouracil prescribing information after reports of severe liver injury and acute liver failure in patients receiving the drug. Propylthiouracil is indicated for treatment of hyperthyroidism. The warning recommends reserving the drug for patients who are unable to tolerate other treatments such as methimazole (Tapazole), radioactive iodine, or surgery. Patients taking the drug should be advised to notify their health care provider if they develop fever, anorexia, nausea, vomiting, tiredness, pruritis, jaundice, or dark-colored urine.

Brought to you by Lippincott Williams & Wilkins.

gonadotropin-releasing hormone agonists
Various GnRH trade names

NEW WARNING
The Food and Drug Administration (FDA) issued a safety announcement about an ongoing review of the following gonadotropin-releasing hormone (GnRH) agonists:

* goserelin acetate (Zoladex) marketed by Astra Zeneca
* histrelin acetate (Vantas) marketed by Endo Pharmaceuticals
* leuprolide acetate (Eligard) marketed by Sanofi-Aventis
* leuprolide acetate (Lupron, Lupron Depot) marketed by Abbott Laboratories
* nafarelin acetate (Synarel) marketed by Pfizer
* triptorelin pamoate (Trelstar) marketed by Watson Pharma, Inc.

The FDA is evaluating whether these drugs increase the risk of diabetes and cardiovascular diseases such as MI, sudden cardiac death, and stroke in men receiving these drugs for treatment of prostate cancer. GnRH agonists lower male hormone levels, slowing growth of prostate tumors or causing them to shrink.
The FDA issued the following recommendations:

* Health care providers should be aware of these safety issues when considering treatment options.
* Patients receiving these drugs should be monitored closely for diabetes and cardiovascular disease.
* Health care providers should address patient risk factors such as obesity, smoking, hypertension, and elevated cholesterol and blood glucose levels.
* Patients shouldn’t discontinue treatment without consulting with their health care provider.

Brought to you by Lippincott Williams & Wilkins.

simvastatin
Zocor
Pharmaceutical company:
Merck & Co., Inc.
www.merck.com

NEW WARNING
The Food and Drug Administration (FDA) issued a warning to patients and health care providers about an increased risk of muscle injury, including rhabdomyolysis, in patients taking the highest approved dose (80 mg) of simvastatin (Zocor) when compared to patients taking lower doses of simvastatin and, possibly, other statins in higher doses. Rhabdomyolysis, the most serious form of muscle injury, can lead to kidney failure and sometimes death. The FDA reviewed clinical trials, observational studies, adverse event reports, and prescription data to gain this new information.
Simvastatin, indicated for lowering cholesterol levels, is also available in combinations with ezetimibe or niacin (marketed under the brand names Vytorin and Simcor, respectively). Health care professionals should consider the risks and benefits of simvastatin before prescribing the drug.

Brought to you by Lippincott Williams & Wilkins.

Rho(D) immune globulin I.V.
WinRho SDF
Pharmaceutical company:
Baxter Healthcare Corporation
www.baxter.com

NEW WARNING
Cangene Corporation and Baxter Healthcare Corporation issued a “Dear Healthcare Professional” letter after cases of intravascular hemolysis (IVH) (and its complications) were reported when RhoD immune globulin I.V. (WinRho SDF) was prescribed for treatment of immune thrombocytopenic purpura (ITP). Some of the reported cases were fatal. In response, Cangene Corporation added a “Boxed Warning” to the prescribing information. The “Boxed Warning” warns of the risk for IVH leading to death in patients treated for ITP with WinRho. It warns that IVH can lead to clinically compromising anemia and multiple-organ-dysfunction syndrome, including acute respiratory distress syndrome. Moreover serious complications, such as severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation, may also occur.
Follow these precautions when administering WinRho:

* Monitor patients closely for at least 8 hours after WinRho administration.
* Perform a dipstick urinalysis at baseline and at 2 and 4 hours after administration, and then immediately before the monitoring period ends.
* Advise the patient to report signs and symptoms of IVH, including back pain, chills, fever, and discolored urine or hematuria.
* Obtain plasma hemoglobin, microscopic and dipstick urinalysis, haptoglobin, LDH, and bilirubin levels, if IVH is suspected.

For questions regarding WinRho use, contact Baxter Medical Affairs at 1-866-424-6724.

Brought to you by Lippincott Williams & Wilkins.

” FOCUS ON DIABETES CARE Charles D. Ponte, Section Advisor
Treatment of gestational diabetes lowers risk of perinatal complications

Key point: In a systematic review and meta-analysis, women with gestational diabetes who were treated with specific interventions versus usual care were at a lower risk for preeclampsia, and their infants were at a lower risk for shoulder dystocia or being large for gestational age.

Finer points: Results of a systematic review and meta-analysis of 18 trials evaluating the effects of different treatments in women with gestational diabetes were published online in BMJ. The researchers conducted two analyses: the first analysis of five trials (n = 2,999) compared specific treatments for gestational diabetes, such as dietary modifications and insulin, to usual care, and the second analysis of 13 trials (n = 1,934) compared different treatments of varying intensities (e.g., insulin twice daily vs. four times daily). The majority of trials diagnosed women with gestational diabetes using a two-step screening process involving a 50-g glucose challenge test or assessing for risk factors followed by a 75-g to 100-g oral glucose tolerance test.

Data from the first analysis showed no differences between treatment groups in terms of maternal or perinatal/neonatal mortality, birth trauma, being in the neonatal intensive care unit, or maternal development of diabetes later in life. Although one trial reported a significant reduction in cesarean sections in women in the intervention group (27% vs. 34%, P = 0.02), a pooled analysis of data from four of the five trials resulted in an odds ratio (OR) of 0.86 (95% CI 0.72–1.02, P = NS). Preeclampsia was only assessed in one trial; according to results from that study, women in the intervention group had a significantly lower risk for developing preeclampsia (2.5% vs. 5.5%. P = 0.02). Other significant differences in favor of the intervention group were shoulder dystocia (OR 0.40 [95% CI 0.21–0.75], pooled data from two trials) and large for gestational age (0.48 [0.38–0.62], pooled data from four trials). In the second analysis, a significant difference in favor of more intensive treatment was only seen for shoulder dystocia (0.31 [0.14–0.70], P = 0.005). The investigators concluded that compared with usual care, specific interventions such as daily self-management, diet, and/or pharmacotherapy are beneficial in reducing some perinatal complications.

What you need to know: Gestational diabetes affects approximately 5% to 9% of pregnant women in the United States, and its prevalence is rising. In addition to the current analysis, other studies have shown that neonatal outcomes such as death, shoulder dystocia, bone fracture, and nerve palsy were reduced when specific interventions were used to manage gestational diabetes. First-line therapies include dietary modifications, such as carbohydrate counting with meal-specific recommendations, and moderate exercise. If these interventions fail to meet glycemic goals, insulin is initiated in the majority of women. Recent data suggest that glyburide or metformin may also be safe and effective to use in this patient population. Women with gestational diabetes are also at higher risk of developing diabetes in the future; therefore, lifestyle modifications should be continued and they should be screened more regularly.

What your patients need to know: Counsel women with gestational diabetes on the importance of maintaining euglycemia. Educate them on specific measures such as dietary modifications, exercise, and appropriate use of prescribed medications.

Sources:

* Horvath K et al. Effects of treatment in women with gestational diabetes mellitus: systematic review and meta-analysis [posted online April 1, 2010]. BMJ.
* Meltzer SJ. Treatment of gestational diabetes [posted online April 1, 2010]. BMJ.

Related resource on www.pharmacist.com:

* Pharmacy Today, February 2010: Counseling pearls for pregnant, breastfeeding women.

Posted by Alex Egervary (aegervary@aphanet.org) on http://www.pharmacist.com
May 17, 2010, 9:15 am “

Philadelphia, PA (May 3, 2010) – Teaching parents about the importance of continued breast-feeding may help to lower the risk of death from brain disease (encephalopathy) related to Shigella infection in developing countries, reports a study in the May issue of The Pediatric Infectious Disease Journal. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.

Other risk factors for Shigella encephalopathy include dehydration and having an illiterate father, according to a study of Bangladeshi children with Shigella infection (shigellosis). The study was led by Dr. Mohammod Jobayer Chisti of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B) in Dhaka, Bangladesh.

Stopping Breast-Feeding Early Is Key Risk Factor
Infections with Shigella bacteria are a major cause of death in poor countries, especially among children. Shigellosis most often causes diarrhea or dysentery. Some children also develop Shigella encephalopathy, which can lead to confusion, seizures, and coma and greatly increases the risk of death.

To identify the characteristics associated with this serious complication, Dr. Chisti and colleagues compared 29 children with Shigella encephalopathy to 87 children who had shigellosis without encephalopathy. Both groups were treated at the ICDDR, B’s Dhaka Hospital, which specializes in the treatment of diarrhea and other infectious diseases.

Seven percent of the children with Shigella encephalopathy died, compared to none of those who had shigellosis without encephalopathy. With adjustment for other factors, the risk of death was four times higher for children with encephalopathy.

The strongest risk factor for Shigella encephalopathy was stopping breast-feeding early. Children whose mothers stopped breast-feeding during the newborn period were 40 times more likely to develop encephalopathy. Breast-feeding has been shown to reduce the risk of diarrhea and other serious infections in infants.

Dehydration and Illiteracy Also Affect Risk
Encephalopathy was more likely to develop in children who had dehydration caused by diarrhea, as well as those who had had diarrhea for less than one day. Risk was also increased for children with severely stunted growth, which results from malnutrition and causes reduced ability to fight infections.

Children who had an illiterate father were also at higher risk: five times higher than those whose fathers could read. “In Bangladeshi culture, the father is the dominant decision maker in the family,” the researchers explain. “This influence in the family on proper child care might play a role for this association.”

The study highlights the need to educate parents about the importance of breast-feeding to boost the infant’s developing immune system, especially in poor countries like Bangladesh. Current World Health Organization recommendations state that “[I]nfants should be exclusively breast-fed for the first six months of life to achieve optimal growth, development and health.”

Parents also need information on the importance of replacing fluids to prevent dehydration—particularly in children who are losing body fluids because of severe diarrhea. “Education of parents about the value of exclusive breast-feeding and of prompt hydration in children with Shigella is critical to minimize morbidity and deaths,” Dr. Chisti and co-authors conclude.

Access the full-text article Characteristics of Children With Shigella Encephalopathy: Experience From a Large Urban Diarrhea Treatment Center in Bangladesh at http://www.pidj.com.

About The Pediatric Infectious Disease Journal
The Pediatric Infectious Disease Journal® (http://www.pidj.com) is a peer-reviewed, multidisciplinary journal directed to physicians and other health care professionals who manage infectious diseases of childhood. The journal delivers the latest insights on all aspects of infectious disease in children, from state-of-art diagnostic techniques to the most effective drug therapies and other essential treatment protocols. The Pediatric Infectious Disease Journal is official journal of the Pediatric Infectious Diseases Society and the European Society for Paediatric Infectious Diseases.

About Lippincott Williams & Wilkins
Lippincott Williams & Wilkins (LWW) is a leading international publisher for healthcare professionals and students with nearly 300 periodicals and 1,500 books in more than 100 disciplines publishing under the LWW brand, as well as content-based sites and online corporate and customer services.

AVAILABLE FORMS
Lyophilized powder for injection: 250-mg, 750-mg single-use vials

INDICATIONS AND DOSAGES
Complicated skin and skin-structure infections caused by susceptible gram-positive organisms, such as Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group, or Enterococcus faecalis (vancomycin-susceptible isolates only)—
Adults: 10 mg/kg I.V. infusion every 24 hours for 7 to 14 days.

ADVERSE REACTIONS
CNS: dizziness.
GI: abdominal pain, decreased appetite, diarrhea, nausea, taste disturbance, vomiting.
GU: foamy urine.
Skin: generalized pruritus, infusion site pain, infusion site erythema, rash.
Other: rigors.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING.
www.vibativ.com

acetaminophen (Tylenol Arthritis Pain Caplet)
Recall announced for various 100-count bottles due to “uncharacteristic smell”

clevidipine butyrate (Cleviprex)
Recall of 11 lots announced due to visual particulate matter

diclofenac sodium, topical gel (Voltaren Gel)
Prescribing information revised to address risk associated with liver test results

valproic acid (Depakene, Stavzor), valproate sodium (Depacon),
divalproex sodium (Depakote, Depakote CP, Depakote ER)
Labeling to be revised to reinforce risk of birth defects in neonates
exposed to these drugs during pregnancy

orlistat
Alli
Pharmaceutical company:
GlaxoSmithKline
www.gsk.com

NEW WARNING
The Food and Drug Administration is warning consumers about a counterfeit, possibly harmful version of the OTC weight-loss product Alli 60 mg capsules. Preliminary laboratory tests conducted by GlaxoSmithKline (GSK), the product’s manufacturer, revealed that the counterfeit product didn’t contain orlistat, the active ingredient in Alli. The counterfeit product contained the controlled substance sibutramine instead. Sibutramine is a drug that shouldn’t be used in certain patient populations or without physician supervision. Sibutramine can also interact dangerously with other medications the consumer may be taking.
Beginning early December 2009, consumers began reporting suspected counterfeit Alli, which was sold over the Internet, to GSK. There is no evidence that this product was sold in retail stores. The counterfeit product has a similar appearance to the authentic product with a few notable differences, including:

* The “Lot” code is missing from the outside cardboard package.
* The expiration date contains the month, day, and year. (The authentic product contains only the month and year.)
* Plain foil seals the plastic bottle. (The foil sealing the authentic bottle contains the printing “SEALED for YOUR PROTECTION.”)
* The plastic container is taller and has a wider cap with coarser ribbing than the authentic product.
* The capsules are larger and contain a white powder. (The authentic product contains small white pellets.)

If you believe you have received the counterfeit product, contact the FDA’s Office of Criminal Investigations (OCI) by calling 800-551-3989.
Health care professionals and consumers should report adverse events that may be associated with the use of these counterfeit products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online, by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

sibutramine hydrochloride
Meridia
Pharmaceutical company:
Abbott Laboratories
www.abbott.com

NEW WARNING
After reviewing data, the Food and Drug Administration (FDA) notified health care professionals about an increased risk of MI and stroke in patients with a history of cardiovascular disease who are being treated with sibutramine (Meridia). Sibutramine is indicated for treatment of obesity in conjunction with a reduced-calorie diet. The FDA requested that the manufacturer add a new contraindication to prescribing information stating that the drug shouldn’t be used in patients with a history of cardiovascular disease, including coronary artery disease, stroke, transient ischemic attack, arrhythmias, heart failure, peripheral arterial disease and uncontrolled hypertension. Patients currently prescribed sibutramine should consult with their health care provider to determine when they should continue treatment with the drug.

Brought to you by Lippincott Williams & Wilkins.