Posted today in FDA Alerts

Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children

[Posted 09/30/2016] ISSUE: The FDA is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about...

Posted today in Medical

Hormone Therapy for Prostate Cancer Less Safe for Men With Prior Heart Attack

Men diagnosed with prostate cancer often receive hormone-depleting therapy to help fight the tumor. But a new study suggests that the treatment may pose a risk to men who've previously suffered a heart attack. "Patient age, cardiac risk, and disease recurrence risk should be considered when selecting candidates for hormone therapy in this patient population,"...

Posted today in Medical

It May Be Time to Punt on Your Favorite Football Fare

Fried foods and free-flowing beer may be the norm at many football or tailgate parties, but the American Heart Association (AHA) says there are many healthier options. When it comes to meats for the grill, they recommend choosing lean or extra-lean beef burgers and keeping the patties to the size of a deck of cards. Or try turkey or salmon burgers....

Posted 3 days ago in New Drug Approvals

FDA Approves Orkambi (lumacaftor/ivacaftor) for Use in Children with Cystic Fibrosis Ages 6 through 11 who have Two Copies of the F508del Mutation

(BUSINESS WIRE) September 28, 2016 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Orkambi (lumacaftor/ivacaftor) for use in children with cystic fibrosis (CF) ages 6 through 11 who have two copies of the F508del mutation. People with this mutation represent the largest...

Posted 2 days ago in Pharma Industry News

Monthly News Roundup - September 2016

Amjevita, a Biosimilar to Humira, Wins FDA Approval Amgen’s Amjevita (adalimumab-atto) is the first adalimumab (Humira) biosimilar approved by the U.S. Food and Drug Administration (FDA) and is used for the treatment of seven inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. Amjevita is an anti-TNF-α monoclonal...

Posted today in Medical

1 in 10 Stroke Rehab Interruptions May Be Preventable

Interruptions in inpatient rehabilitation occur for some stroke survivors and patients with brain and spinal cord injuries, a new study finds. But at least one-tenth of these treatment breaks could be prevented, resulting in improved patient outcomes and lower health care costs, the researchers said. The findings indicate that inpatient rehabilitation...

Posted 2 days ago in Medical

Study Links Pot Use to Relapse in Psychosis Patients

A British study says it provides new evidence that marijuana use may boost the risk that people who struggle with psychosis will relapse. But critics said the effect seems to be small, and they questioned the validity of the research. A study co-author stands by the work, however. "We show that pot use causes an increase in the risk of relapse in...

Posted 2 days ago in Medical

FDA Asks Public: What Is 'Healthy Food'?

The U.S. Food and Drug Administration wants Americans to help it clarify the meaning of "healthy" on food labels. The agency is seeking this public input as it redefines nutritional claims on food labeling. The effort is part of an overall plan to help consumers quickly make healthy food choices and to encourage the food industry to develop healthier...

Posted 2 days ago in Medical

'Artificial Pancreas' Approved for Type 1 Diabetes

The first automated insulin delivery device for type 1 diabetes has been approved by the U.S. Food and Drug Administration for people aged 14 and older. Often called an "artificial pancreas," the MiniMed 670G hybrid closed loop system automatically monitors blood sugar levels every five minutes and delivers insulin when needed with little or no input...

Posted 2 days ago in Medical

Congress Agrees to More Zika Funding: Reports

Long-delayed funding to combat the Zika virus is included in an emergency spending bill designed to keep the U.S. government running through mid-December, according to published reports on Wednesday. The bill would provide $1.1 billion to combat the Zika virus and develop a vaccine and improved tests to detect it, the Associated Press reported. Zika,...

Recently added consumer and prescribing information: Yosprala, Troxyca ER, Adlyxin, Xiidra, Epclusa, Byvalson, Zinbryta, Probuphine, Tecentriq, Bevespi Aerosphere

Posted in Blog

REMS@FDA: An Upgraded Patient Safety Program

REMS Overview Fact: Prescription drugs are complicated, and they are getting more complicated every day. Issues with complex drugs and side effects is not just a concern for the healthcare provider, it directly impacts the patient and caregiver, too. We’ve all heard the long list of adverse effects and warnings that unfold during a primetime […]

Posted in Blog

Drugs.com the First Major Consumer Health Publisher to Implement Full HTTPS Encryption

Drugs.com is pleased to announce the introduction of full HTTPS encryption for all web site visitors. With this significant and important change, nearly 70 million monthly visitors will have access to critical health and medicine information in a safe, secure and private environment. Why HTTPS Encryption? Almost everything you do on the Internet leaves a digital […]

Posted in Blog

Off-Label or Off-Limits? Should You Use A Drug For An Unapproved Use?

Off-Label Drug Use: What Is It? You may be surprised to learn that you have probably been prescribed a medication “off-label” at one point or another by your doctor. Maybe you’ve heard of “off-label” drug use in the news, but what does this really mean? “Off-label” use of a drug refers to prescribing a medication […]