News

Prenatal exposure to valproate significantly increased the risk of autism spectrum disorder and childhood autism in the offspring of mothers who took the anti-epileptic agent, according to a study published in the April 24 issue of the Journal of the American Medical Association.

A draft bill that hopes to address regulatory gaps in oversight of pharmaceutical compounding would give the FDA authority to regulate compounding manufacturers that make sterile products without, or in advance of, a prescription and sell them across state lines, according to a statement by the Senate Health, Education, Labor, and Pensions (HELP) Committee.

FDA has issued a Drug Safety Communication indicating that the drug tolvaptan (Samsca, Otsuka American Pharmaceuticals), used in the treatment of electrolyte disturbances, can cause irreversible liver injury with the potential to result in liver transplant or death.

FDA issued a warning April 26 that the anti-seizure drug, ezogabine (Potiga) may cause pigment changes in the retina as well as blue skin discoloration. It is not known if the changes are permanent, according to an FDA drug safety communication.

The US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has halted a phase 2b clinical trial, HVTN 505, evaluating a sequential regimen of 2 HIV vaccine candidates.

Actavis will be able to sell defined quantities of a generic version or an authorized generic version of reformulated OxyContin as early as next year, according to a prepared statement from Purdue Pharma L.P., the manufacturer of the opioid analgesic

Patients who fail to fill a new prescription for statin therapy have a number of reasons, including negative perceptions about the medication, a preference for lifestyle modifications, concerns about side effects, drug interactions, polypharmacy, and a perception that they do not need the drug, according to a study published by The American Journal of Managed Care.

Global progress has been made since the introduction of pneumococcal conjugate vaccines (PCVs) 13 years ago, according to a report published in the April 26 Morbidity and Mortality Weekly Report (MMWR).

FDA approved a new fixed-dose combination ophthalmic suspension of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%), which is indicated for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

FDA has approved a supplemental new drug application (sNDA) for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda Pharmaceuticals) 24 ?g twice daily as the first oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, noncancer pain.

As FDA takes an increased interest in the prescribing of narcotic medications, due to higher levels of prescribing and increased overdoses over the recent years, the American Society of Health-System Pharmacists (ASHP) stressed the importance of understanding the causes of pain and issues of patient access to appropriate drug therapy.

Healthcare providers believe that the pharmaceutical industry could play an important role in helping value-based healthcare providers such as accountable care organizations to deliver better care at lower cost. But pharma companies currently do a poor job of delivering the kind of data needed to accomplish that goal, according to a survey of physicians in value-based delivery models, conducted by Oliver Wyman, a New York-based management consulting firm.

Guideline-directed medical therapy for heart failure (HF) is highly cost-effective and able to produce significant health gains for individuals with mild to moderate disease, according a study published April 2 in the Journal of the American College of Cardiology.

On April 5, a US District Court judge ruled that the emergency contraception (EC) pill Plan B One-Step must be made available over-the-counter to all girls and women, regardless of their age. This ruling, made by Judge Edward R. Korman, was in response to a 2011 move by Health and Human Services Secretary Kathleen Sebelius.

PCPs must consider the whole patient with type 2 diabetes, not just the blood glucose, noting that patient weight loss, weight maintenance, and exercise are huge challenges