Formulary Watch |

FDA lopinavir/ritonavir label change warns of serious health risks in premature babies

FDA notified healthcare professionals of serious health risks that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra, Abbott) oral solution.

Formulary Digital Edition April 2011

Metastatic breast cancer: a review of current and novel pharmacotherapy; Focus on belimumab; Agents in late-stage development for the treatment of type 1 diabetes mellitus

Drug Watch: Type 1 diabetes (PDF) (April 2011)

Agents in late-stage development for the treatment of type 1 diabetes.

FDA continues its review of abacavir: Evidence does not suggest an increased risk of myocardial infarction

Available evidence reviewed by FDA does not suggest abacavir is associated with an increased risk of myocardial infarction, according to an updated safety communication released March 2011.

Lopinavir/ritonavir label change warns of serious risks in premature babies

FDA notified healthcare professionals of serious health risks that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra, Abbott) oral solution.

First-time generic approvals April 2011

Generic drugs approved by FDA (through March 2011): Docetaxel and Zidovudine

For now FDA will continue to allow pharmacies to provide compounded hydroxyprogesterone caproate

FDA "...does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products," according to a statement.

FDA warns of risks associated with the use of antipsychotic medications in pregnancy

FDA recently announced that the 'Pregnancy' sections of labeling for all antipsychotic medications will now have to include wording about the potential risk for extrapyramidal side effects and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

Health reform controversies pose new challenges for drug plans and healthcare providers

There's growing uncertainty about how the Obama healthcare reform program will be implemented, and how proposed changes will affect biomedical product development and coverage of prescription drugs.

Ambulatory blood pressure lowering efficacy of hydrochlorothiazide inferior to other drug classes

Investigators question whether the thiazide diuretic, hydrochlorothiazide, should be used as commonly as it is for treating hypertension, according to a report published in a recent edition of the Journal of the American College of Cardiology.

FDA Actions in Brief April 2011 (Benlysta, Yervoy, Zostavax, Banzel Oral Suspension, Intuniv, Promacta, Gadavist)

Recent FDA Approvals (through March 2011) related to Benlysta, Yervoy, Zostavax, Banzel Oral Suspension, Intuniv, Promacta, Gadavist

Belimumab: A B-lymphocyte stimulator inhibitor for-systemic lupus erythematosus

Belimumab is a monoclonal antibody that inhibits B-lymphocyte stimulator that has been FDA approved for the treatment of systemic lupus erythematosus. It is the first new drug for the treatment of SLE approved in more than 50 years.

Brand-name, generic antidepressants share similar discontinuation rates and healthcare costs during 6 months of treatment

Patients using brand-name or generic antidepressant medications to treat major depressive disorder have similar drug discontinuation rates and accrue comparable healthcare costs during the first 6 months of treatment, according to a study published in March 2011 in the Journal of Managed Care Pharmacy.

FDA Pipeline Preview, April 2011 (Salix, Protalix, Amyvid, indacaterol, Istodax, Mucin 1 targeting peptide GO-203-2c, Intercept plasma, Lomitapide, Liver cell therapy)

Recent FDA action (through, March 2011) related to Salix, Protalix, Amyvid, indacaterol, Istodax, Mucin 1 targeting peptide GO-203-2c, Intercept plasma, Lomitapide, Liver cell therapy.

Meningococcal oligosaccharide diphtheria CRM197 conjugate vaccine (Menveo): A vaccine indicated for active immunization to prevent invasive meningococcal disease

New molecular entity: Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine was approved by FDA to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons aged 2 to 55 years.

Cost of heart failure drugs impacts medication adherence

In a new study published ahead of print on the Mayo Clinic Proceedings website, researchers demonstrated that the cost of medications was a factor influencing the proportion of patients with heart failure who had poor medication adherence to beta-blockers, angiotensin converting-enzyme inhibitors or receptor blockers, and statins.

Intensive glycemic management leads to higher mortality in type 2 diabetes mellitus patients

The management of type 2 diabetes mellitus needs to change in response to the evolving evidence base now available. Research from the ADVANCE and the ACCORD trials was presented during the American Diabetes Association 58th annual advanced postgraduate course in New York City.

Too early to predict impact of biosimilars on utilization of hematopoietic growth factors

Overall, it would not appear that the new erythropoiesis-stimulating agents for treatment of cytopenia will add substantially to pharmacy budgets. As they are approved by FDA, each medication will need to be reviewed to understand its complete clinical advantage, and the safety profile will need to be completely understood.

Hydroxyprogesterone caproate injection (Makena): A synthetic progestin, hydroxyprogesterone caproate intramuscular injection to reduce the risk of preterm birth

New indication: Hydroxyprogesterone caproate injection was approved by FDA in February to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of at least 1 spontaneous preterm birth.

New guidelines for atrial fibrillation management incorporate dabigatran

An update on the management of atrial fibrillation issued by a task force consisting of the American College of Cardiology Foundation, the American Heart Association, and the Heart Rhythm Society has incorporated dabigatran into its recommendations.

Metastatic breast cancer: A review of current and novel pharmacotherapy

Despite advancements, treatment of metastatic breast cancer hinges on multifarious factors and numerous unanswered questions about therapy linger. Agents that are highly active in heavily pretreated patients are needed to optimize outcomes in patients with metastatic disease. This article reviews current and novel treatment options for metastatic breast cancer.

FDA approves first new drug for lupus in 56 years

FDA approved belimumab (Benlysta, Human Genome Sciences and GlaxoSmithKline) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus who are receiving standard therapy.

FDA approves new treatment for late-stage skin cancer

FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

FDA expands approval of shingles vaccine

FDA has approved an expanded age indication for Zoster Vaccine Live, (Zostavax, Merck) for the prevention of herpes zoster, commonly known as shingles, in adults ages 50 years and older.

New meta-analysis argues against a link between ARB use and increased cancer risk

The use of angiotensin-receptor blockers alone are not associated with increased odds of cancer or cancer-related death, according to a meta-analysis published in a recent edition of Lancet Oncology.

FDA, EMA announce pilot for parallel assessment of Quality by Design applications

FDA and the European Medicines Agency have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design, of new drug marketing applications that are submitted to both agencies.

Pradaxa gains preferred formulary status with 2 key PBMs

Dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) capsules have received tier 2 formulary status with 2 key pharmacy benefit managers.

FDA update: ongoing safety review of insulin glargine and cancer risk

FDA released a safety communication to update prescribers and patients about the ongoing review of insulin glargine (Lantus) that was initiated in July 2009.

Resistance testing should guide initial treatment choice in HIV

A substantial portion of antiretroviral-naïve patients are infected with transmitted drug-resistant HIV with one or more drug-resistant mutations, and they are much more likely to experience treatment failure, according to research published in The Lancet Infectious Diseases.

Anti-tumor necrosis factor-α effective in psoriatic arthritis

Patients with psoriatic arthritis undergoing their first treatment with tumor necrosis factor-? inhibitor showed a high adherence to therapy and a good response, according to a recent Danish study published in Arthritis & Rheumatism.