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FDA has approved a subcutaneous (SC) formulation of abatacept (Orencia, Bristol-Myers Squibb) for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA). It is the first biologic available in both SC and intravenous formulations for the treatment of RA.

FDA has issued a 90-day extension of the action date for Pfizer?s Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults 50 years of age and older.

While Medicare and Medicaid were exempted from budget cuts in the initial debt agreement reached by the U.S. House and Senate this week, they could be up for cuts later this year.

The Independent Specialty Pharmacy Coalition, a group of community-based specialty pharmacies, called on the Federal Trade Commission to block Express Scripts? proposed acquisition of Medco.

A new white paper examines the costs of medication nonadherence and suggests solutions.

Johnson and Johnson has announced plans for new dosing instructions that lower the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the United States from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg).

Federal regulators should take the lead in creating a national system to keep tabs on chronic diseases and provide guidance for stakeholders across the country, the Institute of Medicine (IOM) announced.

The significant decrease in the death rate from the varicella virus, or chickenpox, can be attributed to the effectiveness of the chickenpox vaccine, according to a new study in a recent issue of Pediatrics.

As a result of combined investigations by FDA, the IRS Criminal Division, and the U.S. Department of Justice, Elisane Garcia was sentenced on July 25 for disguising controlled substances as "Brazilian diet pills" and smuggling them into the United States with intent to distribute. She was also convicted of 1 count of money-laundering.

If the U.S. Congress fails to reach a consensus on the deficit issue by August 2, there could be significant impact on Medicare and other federal programs, the National Association of Chain Drug Stores announced today.

Opponents of a controversial Change Request initiated by the Centers for Medicare and Medicaid Services aired their views to CMS officials earlier this week.

FDA has received reports of serious central nervous system reactions when methylene blue is given to patients taking serotonergic psychiatric medications.

A new report from the Institute of Medicine (IOM) recommends that 8 preventive health services for women be added to the services that health plans will cover at no cost to patients under the Patient Protection and Affordable Care Act of 2010.

Patients treated with belatacept (Nulojix, Bristol-Myers-Squibb) are at increased risk of developing 2 potentially fatal complications: post-transplant lymphoproliferative disorder (PTLD), which predominantly involves the central nervous system, and progressive multifocal leukoencephalopathy, according to a recent FDA Safety Alert. The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV) and therefore is indicated for use only in transplant patients who are EBV seropositive.

Improved glycemic control may help prevent heart failure, according to a study recently published in The Lancet.

CVS Caremark, the National Community Pharmacists Association, and several healthcare groups are supporting a new bill that would allow patients to purchase OTC medications through flexible spending accounts (FSAs) and health savings accounts (HSAs).

The National Community Pharmacists Association (NCPA) and Cardinal Health are encouraging female pharmacy students to consider community pharmacy ownership.

FDA has approved the Risk Evaluation and Mitigation Strategy (REMS) for Fentora (fentanyl buccal tablet) [C-II] and Actiq (oral transmucosal fentanyl citrate) [C-II]. Both products, manufactured by Cephalon, are indicated for management of breakthrough pain in opioid-tolerant patients with cancer.

On June 15, 2011, FDA published an online safety communication informing prescribers and patients that pioglitazone (Actos, Takeda Pharmaceuticals America Inc) use may be associated with a 20% to 40% increased hazard of new bladder cancer.

The merger of 2 of the biggest pharmacy benefit managers (PBMs), Express Scripts and Medco Health Solutions, has been top of mind with industry stakeholders who are wondering how the PBM space will shake out moving forward.

FDA has approved ticagrelor (Brilinta, AstraZeneca) tablets to reduce the rate of heart attack and cardiovascular death in adult patients with acute coronary syndrome.

Over the past 3 decades, pharmacists have become integrated members of multidisciplinary teams. To recognize the value of the role of pharmacists in improving patient outcomes and safety in cardiac care, the American Heart Association (AHA) will offer pharmacists a session devoted specifically to them at this year?s AHA Scientific Sessions in Orlando, Fla.

An increase in methicillin-resistant Staphylococcus aureus (MRSA) has led to a significant increase in cases of children?s pneumonia, a new study has reported.

FDA has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the 6 manufacturers licensed to produce and distribute influenza vaccine for the United States.

The CDC is concerned about the increasing potential in gonorrhea patients for resistance to cephalosporin.

After the North Dakota legislature defeated a bill to overturn the state?s Pharmacy Ownership Law this year, a group is working to get the issue on the 2012 general election ballot.

The US Centers for Disease Control and Prevention has released revised recommendations for postpartum contraceptive use based on an assessment of new evidence, announced an article published in the July 8 issue of Morbidity and Mortality Weekly Report.

Potential Medicare budget cuts made through a new board are likely to significantly reduce healthcare access for beneficiaries, according to testimony presented to the U.S. House Energy and Commerce health subcommittee.

The concentration of the influenza drug oseltamivir phosphate (Tamiflu, Genentech) for oral suspension has been reduced from 12 mg/mL to 6 mg/mL to reduce the possibility of prescribing and dosing confusion that can lead to medication errors, FDA announced.

In this section we showcase products and product news that ran up against space limitations or fell outside the parameters of recently featured categories in the print edition. Look for more OTC Product News in upcoming issues of the Drug Topics e-newsletter.