Clinical News

FDA has sent MannKind Corp. a complete response letter regarding the company?s New Drug Application for Afrezza (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with types 1 and 2 diabetes for the control of hyperglycemia.

Concern that its drug vorapaxar, in trial for its potential to prevent clots, actually increased the risk of bleeding in stroke victims has prompted Merck & Co. to halt a late-stage study of the drug, the Associated Press reported.

FDA has approved a label update to include a 200-mg formulation of etravirine (Intelence, Tibotec Therapeutics), a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 in adults resistant to an NNRTI and other antiretroviral agents.

The impact of generic drugs ? which now account for more than 70% of all prescriptions dispensed in the United States ? will continue to increase as some of the world?s most-prescribed products lose their patent protection in 2011 and begin facing generic competition.

FDA approved spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% for the treatment of head lice infestation in patients aged 4 years and older. Natroba is a topical drug product and should be applied only to the child's scalp or hair.

Severe liver injury, including 2 cases of acute liver failure leading to liver transplant in patients treated with the medication, has been associated with the use of dronedarone (Multaq), according to an FDA Drug Safety Communication announcement.

FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.

The National Community Pharmacists Association commended BB&T Corporation's recent decision to reemphasize and continue its employees' choice in filling their maintenance prescriptions, including at independent community pharmacies.

The first trial to provide evidence that drugs used to treat HIV can also help to prevent HIV infection among men who have sex with men (when combined with other prevention strategies) was reported late November online in the New England Journal of Medicine.

The Infectious Diseases Society of America is set to release its first guidelines for the treatment of the increasingly common and potentially deadly methicillin resistant Staphylococcus aureus infection.

Compared with conventional 21-day regimens, 24-day oral contraceptive regimens containing a progestogen with a long half-life show higher contraceptive effectiveness under routine medical conditions, according to research published in the January 2011 issue of Obstetrics & Gynecology.

FDA has approved fentanyl (Abstral, ProStraken) transmucosal tablets to manage breakthrough pain for adults with cancer.

Duloxetine (Cymbalta, Eli Lilly), used to treated depression and anxiety, was found to be effective at reducing joint and muscle pain associated with breast cancer treatment.

Bristol-Myers Squibb Co. recently recalled 64 million tablets of Avalide blood pressure medication in the United States and Puerto Rico.

Oncology treatment and benefits are changing. Buy-and-bill, the traditional methodology that had physicians buying chemotherapeutic products, treating in the office, and billing the payer, is going the way of surgery by barbers. But no one is quite sure what will replace the one-time standard of payment.

While there may be some notable breakthroughs to brighten an otherwise bleak pharmaceutical pipeline for 2011, the overall outlook remains grim as the number of new drugs under development continues to shrink, compared to the glory days of just a few short years ago.

Medtronic Inc. in Minneapolis, Minn., recently received FDA approval for its new CareLink Pro 3.0 Therapy Management software.

In October 2010, FDA approved dabigatran etexilate (Pradaxa, Boehringer Ingelheim), the first oral direct thrombin inhibitor for the prevention of thromboembolic stroke in patients with nonvalvular atrial fibrillation.

Under the federal Controlled Substances Act, marijuana is classified as Schedule I, a definition that gives it a high potential for abuse, with no current safe or medical use. Meanwhile, in 14 states, patients have access to medical marijuana upon physican recommendation.

FDA has approved the premix formulation of vancomycin injection, USP (750 mg/150 mL) (Baxter). Vancomycin is an antibiotic used to treat severe infections caused by susceptible strains of methicillin-resistant Staphylococcus aureus and/or treat patients who are penicillin-resistant.

A study released by the Canadian Medical Association Journal reported that the use of acid-suppressive drugs could be linked to an increased risk of pneumonia.

The addition of bortezomib to the standard induction therapy before double autologous stem-cell transplantation for patients with multiple myeloma appears to improve nearly threefold the rates of complete or near-complete response, according to research published online in The Lancet, HealthDay News reported.

Further reductions in LDL cholesterol through more intensive statin regimens safely produce definite further reductions in vascular events, even down to very low LDL levels, lower than current targets, according to the results of 2 meta-analyses, The Lancet reported. There was no evidence of any lower threshold where the benefit is not seen.

Daily aspirin over at least 5 years appears to greatly reduce mortality from gastrointestinal and non-gastrointestinal cancers, according to research published online in The Lancet, HealthDay News reported.

Many serious or potentially fatal adverse reactions associated with new, targeted anti-cancer agents are not reported in the original published research on the drug, and they are not known to oncologists until years later when drug labels are updated, including boxed warnings, according to research published online in the Journal of Clinical Oncology, HealthDay News reported.

Patients who are newly treated with statin-fibrate concurrent therapy are slightly more likely to be hospitalized with rhabdomyolysis than those who take just one of the medications, according to research published in the American Journal of Cardiology, HealthDay News reported.

Daily aspirin over at least 5 years appears to greatly reduce mortality from gastrointestinal and non-gastrointestinal cancers, according to research published online in The Lancet, HealthDay News reported.

Many serious or potentially fatal adverse reactions associated with new, targeted anti-cancer agents are not reported in the original published research on the drug, and they are not known to oncologists until years later when drug labels are updated, including boxed warnings, according to research published online in the Journal of Clinical Oncology, HealthDay News reported.

A higher prescription co-payment, especially among older women, is associated with the early discontinuation and incomplete use of adjuvant aromatase inhibitor therapy, a life-saving therapy for women with hormone-sensitive, early-stage breast cancer, research shows.

Patients who switch statins have lower persistence to therapy compared to those who don?t switch, according to a poster recently presented at the 45th midyear meeting of the American Society of Health-Systems Pharmacists.