July update

propylthiouracil
Generic propylthiouracil
Pharmaceutical company:
DAVA Pharmaceuticals, Inc.
www.davapharma.com

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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.

July Update

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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

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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.

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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.

Drug Update

I saw this on American Pharmacist Association, I thought I would share it with you all

” 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 “

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