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Weekly Drug News Round-Up: April 26, 2017

Renflexis: Second Remicade Biosimilar Gains FDA Approval

Merck will market Renflexis in the US

The US Food and Drug Administration (FDA) has approved Renflexis (infliximab-abda), a tumor necrosis factor (TNF) blocker from Samsung Bioepis that is biosimilar to Remicade (infliximab). Renflexis, given as an intravenous infusion, is indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The biosimilar must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product Remicade. Only minor differences in clinically inactive components are allowable in biosimilar products. The first biosimilar to Remicade, Pfizer’s Inflectra (infliximab-dyyb) was approved by the FDA in April, 2016.

FDA: Codeine and Tramadol Updates in Children, Breastfeeding

Single-ingredient codeine and all tramadol-containing products are FDA-approved only for adult use Read More...

The FDA is adding additional label Warnings and Contraindications to the use of codeine and tramadol in children and in breastfeeding. This goes beyond the 2013 FDA contraindication of codeine use under 18 years to treat pain after surgery to remove the tonsils and/or adenoids. FDA is now requiring these label updates:

  • Codeine and tramadol are contraindicated in children under 12 years.
  • Tramadol is contraindicated in children under 18 for pain after surgery to remove the tonsils and/or adenoids (in addition to the previous contraindication for codeine).
  • Codeine and tramadol warnings against use in adolescents 12 to 18 years who are obese, have obstructive sleep apnea or severe lung disease.
  • Codeine and tramadol use is not recommended in breastfeeding due to the risk of serious adverse in infants.

Beware of Fake Cancer Treatments and False Claims of 'Cures'

Products are usually for sale online, but can be seen in stores, too Read More...

If you see these common phrases on products claiming to treat cancer, steer clear, warns the FDA this week: "treats all forms of cancer," "miraculously kills cancer cells and tumors," "shrinks malignant tumors," "selectively kills cancer cells," "more effective than chemotherapy," "attacks cancer cells, leaving healthy cells intact," and "cures cancer." The FDA has sent warnings to 14 fraudulent companies that are selling more than 65 fake cancer treatments, often on the Internet. These unsafe products may prevent a patient from seeking approved medical care that could be life-saving. Unproven cancer treatments for pets are also common, according to the FDA.

Children Who Receive Donated Organs at Elevated Cancer Risk

Experts agreed that this study shouldn't prevent parents from seeking an organ transplant for their child Read More…

A U.S. National Cancer Institute (NCI) study of almost 18,000 pediatric transplant patients has found that the risk for cancer was 19 times higher than in the general population. In some cases the cancer risk was 200-fold, for example with non-Hodgkin's lymphoma. In fact, 71% of those who developed cancer after a pediatric organ transplant had non-Hodgkin's lymphoma, according to the study published in Pediatrics. However, the numbers and risk are small - only 400 out of 18,000 transplant recipients developed cancer over 4 years of follow-up, on average. Researchers state that two factors were likely to blame: immunosuppressant drugs used after organ transplants and the Epstein-Barr virus.

Rheumatoid Arthritis Outcomes Fare Better With Early Treatment: Study

Early treatment translated into a notably lower mortality risk Read More...

Treatment algorithms today suggest that early treatment in rheumatoid arthritis (RA) can improve outcomes and lower disease progression. Now a study shows that is actually the case over the long-term. A 20-year British study that tracked 600 rheumatoid arthritis (RA) patients found that the earlier RA treatment is started, the better the outcomes. Investigators assessed key symptoms of RA, such as swollen and/or tender joints and indicators of disability. They also looked at death rates. Patients treated within 6 months of their first symptoms did better in the long-run and were less likely to suffer early death.