FDA approves J&J drug-resistant tuberculosis treatment
WASHINGTON — The U.S. Food and Drug Administration has approved a new drug from Johnson & Johnson for patients with tuberculosis who do not respond to other treatments, the company announced.
Tuberculosis is an air-spread infection that usually attacks the lungs, but also affect the brain, the spine and the kidneys. The drug blocks an energy-producing enzyme the tuberculosis bacteria needs to survive and is the first drug in 40 years to attempt to cure the disease using this type of treatment.
Following a positive review by an advisory panel last month, the FDA on Monday approved the drug, chemically known as bedaquiline and to be marketed as Sirturo.
In 2011, nearly 9 million people around the world became sick with TB, according to the Centers for Disease Control and Prevention, and there were 1.4 million TB-related deaths. The disease requires six to nine months of drug treatment.
Pharmacists employ grassroots efforts to officially recognize pharmacists as healthcare providers
NEW YORK — A St. John’s University College of Pharmacy and Health Sciences Doctor of Pharmacy Candidate last week picked up on a petition to recognize pharmacists as healthcare providers and filed the petition on the Obama Administration’s "We the People" web site, according to a report published online by The Pharmacopedia.
The petition, filed by Steve Soman, is a replication of a similar charge started Dec. 11, 2011 on Change.org by pharmacist Sandra Leal. The movement even has its own Facebook page.
To date, the Change.org petition has garnered 21,951 signatures, 3,049 shy of a 25,000 signature goal. The "We the People" site has generated 1,052 signatures to date. That petition needs to reach 25,000 signatures by the end of January in order to qualify for an official White House response.
Both petitions are seeking to qualify pharmacists as healthcare professionals under the Social Security Act. "Despite overwhelming evidence of the positive impact pharmacists can have on patient health, pharmacists are not recognized as healthcare providers under the Social Security Act and therefore cannot be paid by Medicare for therapy management and patient consultation services," the petition reads. "The Social Security Act does recognize other healthcare professionals such as dieticians, nurse practitioners, physician assistants, nurse midwives and clinical social workers."
For the full Pharmacopedia report, click here.
FDA approves Bristol-Myers Squibb’s Eliquis to reduce risk of stroke, blood clots
PRINCETON, N.J. — The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.
Atrial fibrillation — one of the most common types of abnormal heart rhythm — is an abnormal, irregular and rapid beating of the heart in which the heart’s two upper chambers (i.e., atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body.
“Blood clots in the heart can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming.”
The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial of more than 18,000 patients that compared Eliquis with the anti-clotting drug warfarin. In the trial, patients taking Eliquis had fewer strokes than those who took warfarin.