RapidRx

September 04, 2015
The Advisory Committee on Immunization Practices (ACIP) has revised its interval recommendations for the pneumococcal polysaccharide vaccine (PPSV23) and pneumococcal conjugate vaccine (PCV13) in older healthy adults.

Specifically, immunocompetent adults older than 65 years who have not previously been vaccinated with pneumococcal vaccine should receive a dose of PCV13, followed at least 1 year later by a dose of PPSV23, according to the updated guidelines, published in the September 4 issue of the Morbidity and Mortality Weekly Report. If PPSV23 is given earlier than the recommended interval, the dose need not be repeated, the guidelines specify.

“No clinical studies evaluating efficacy of the two vaccines given in series are available. Therefore, current recommendations are based on best available evidence from immunogenicity studies,” the authors write.

In its previous guidelines published in 2014, the ACIP recommended routine use of a dose of PCV13 followed 6 to 12 months later by a dose of PPSV23. The change harmonizes the vaccine interval in this patient population with that recommended for immunocompetent adults older than 65 years who already received a dose of PPSV23. For adults in the latter group, the guidelines are unchanged: They should receive a dose of PCV13 at least 1 year after receiving the PPSV23, according to the report.

The revision is supported by studies of PCV–PPSV23 sequence among immunocompetent adults suggesting that shorter between-dose intervals may be associated with increased local reactogenicity when compared with longer intervals, whereas intervals of at least 1 year may lead to an improved immune response against serotypes in both vaccines compared with a single dose of either, the authors write.

The vaccine interval recommendations for other patient populations remain unchanged from the existing guidelines. In particular, a dose of PPSV23 should be given at least 8 weeks after a dose of PCV13 in children and adults at high risk for pneumococcal disease, including those with an immunocompromising condition, functional or anatomic asplenia, cerebrospinal fluid leak, or cochlear implant.

“The currently recommended 8-week interval minimizes the risk window for invasive pneumococcal disease caused by serotypes unique to PPSV23 in these highly vulnerable groups,” the authors write.

Children with an immunocompromising condition or functional or anatomic asplenia should receive a second dose of PPSV23 5 years after the first PPSV23, according to the guidelines.

August 28, 2015
Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes may cause joint pain so intense it is disabling, the US Food and Drug Administration (FDA) warned today.

Fortunately, the pain goes away, usually in less than a month, once patients stop taking the medicine.

The agency said it identified 33 cases of severe arthralgia associated with DPP-4 inhibitors from October 16, 2006, through December 31, 2013, in its FDA Adverse Event Reporting System database. Twenty-eight of the cases involved sitagliptin (Januvia, Merck & Co, Inc). Sitagliptin accounts for more than 80% of all DPP-4 prescriptions in the country, according to a spokesperson for Merck.

Patients began experiencing joint pain anywhere from 1 day to years after they started taking the drugs. For 10 patients, disabling pain required hospitalization.

Clinicians prescribe DPP-4 inhibitors in conjunction with diet and exercise to reduce blood sugar levels in patients with type 2 diabetes. They are either combined with other diabetes drugs such as metformin or dispensed as stand-alone products.

The US Food and Drug Administration (FDA) yesterday approved a topical gel combination of adapalene 0.3% and benzoyl peroxide 2.5% (Epiduo Forte, Galderma) for the treatment of acne vulgaris, the company has announced.

The approval was based on a phase 3 randomized double-blind study involving 217 patients, all aged 12 years and older, with an average patient age of 20 years. In the study, Epiduo Forte gel was superior to vehicle control gel in the overall study population of patients with moderate to severe acne at week 12 for the Investigator’s Global Assessment Success Rate and for changes in inflammatory and noninflammatory lesion count, the company notes in a news release announcing the approval.

In addition, half of the patients had severe acne at baseline, and more than half of this group (50.5%) saw marked improvement during the study, with results seen as early as 1 week, with continued improvement through week 12, according to the company.

“Acne is a challenging condition to manage. It can vary greatly from patient to patient, can have a significant physical and psychosocial impact on sufferers, and patients can find treatment adherence difficult to maintain,” Jonathan Weiss, MD, a board-certified dermatologist at Gwinnett Dermatology, PC, and lead investigator on the study, said in the news release.

“For many patients, rapid results are especially important, and some acne treatments take time to show effect. We were very excited to see in the clinical trial that people using Epiduo Forte gel saw results as early as 1 week, with efficacy continually improving through week 12,” Dr Weiss added.

Erythema, scaling, dryness, stinging/burning, and irritant and allergic contact dermatitis may occur with Epiduo Forte, requiring discontinuation in some cases.

Patients using Epiduo Forte gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided, the company said.

Epiduo Forte gel will be available by prescription beginning in September.

The formulation of adapalene 0.1% and benzoyl peroxide 2.5% (Epiduo) was approved by the FDA in 2009 for use in patients 12 and older.

The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.

Entresto was studied in a clinical trial of more than 8,000 adults and was shown to reduce the rate of cardiovascular death and hospitalizations related to heart failure compared to another drug, enalapril. Most patients were also receiving currently approved heart failure treatments, including beta-blockers, diuretics, and mineralocorticoid antagonists.

The most common side effects in clinical trial participants being treated with Entresto were low blood pressure (hypotension), high blood potassium levels (hyperkalemia), and poor function of the kidneys (renal impairment).

Angioedema (an allergic reaction usually appearing as swelling of the lips or face) was also reported with Entresto; black patients and patients with a prior history of angioedema have a higher risk. Patients should be advised to get emergency medical help right away if they have symptoms of angioedema or trouble breathing while on Entresto. Health care professionals should advise patients not to use Entresto with any drug from the angiotensin converting enzyme (ACE) inhibitor class because the risk of angioedema is increased. When switching between Entresto and an ACE inhibitor, use of the two drugs should be separated by 36 hours.

Health care professionals should counsel patients about the risk of harm to an unborn baby. If pregnancy is detected, use of Entresto should be discontinued as soon as possible.

The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.

Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor.

“It is important that the use of Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.”
Avycaz is the fifth approved antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP). This designation is given to antibacterial products to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.
The most common side effects include vomiting, nausea, constipation and anxiety. Health care professionals should inform patients of these risks and also advise that decreased efficacy, seizures and other neurologic events were seen in patients with poor kidney function (renal impairment). Serious skin reactions and anaphylaxis may occur in patients with penicillin allergies.