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U.S. Food and Drug Administration

Good News: FDA Committee Approves Peanut Allergy Treatment; Bad News: It’s $10,000

A new treatment for people with severe peanut allergies just became one step closer to becoming available.

Last week,  an advisory committee of the U.S. Food and Drug Administration voted 7-2 to approve Palforzia, a standardized peanut powder product, to help reduce allergic reactions to peanuts for patients ages 4 to 17 as part of oral immunotherapy protocol.

Pharmaceutical company Aimmune Therapeutics developed the treatment.

An estimated 2.2% children in the U.S. are allergic to peanuts and while pills via oral immunotherapy don’t cure these allergies, they do make the symptoms more manageable.

The therapy involves gradual incremental daily exposure to tiny amounts of peanut powder which over the course of several months, has been shown to reduce the incidence and severity of allergic reactions to small amounts of peanuts in many patients.

Palforzia is essentially a standardized, medical-grade version of the treatment some doctors already offer using peanut flour.

The drug is controversial because research shows that some patients have a tripling of the risk (9.4% compared with 3.8% for placebo) of anaphylactic reaction during the time a patient is building tolerance to reach maintenance dose, and  some members of the Allergenic Products Advisory Committee expressed concern that the data omitted the outcomes of many patients who had dropped out of the trial because of adverse effects.

“To be consistent with your primary analysis, where people who don’t make it are considered failures, I think to be consistent, you can’t censor them. I think this might be a bit misleading,” said Erica Brittain, mathematical statistician and deputy branch chief at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Md.

Another concern is treatment can be costly, from $5,000 to $10,000 for the first six months of treatment to cost $5,000 to $10,000 and $300 to $400 a month after that.

 

 

FDA Issues New Fish Guidelines for Kids and Pregnant Women

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A new U.S. government guideline classifies fish into three categories of safety to help pregnant women, breast-feeding mothers and parents of young children make healthy choices.

The 62 types of fish and shellfish included in the guideline are sorted into: best choices: eat two to three servings a week; good choices: eat one serving a week; and fish to avoid.

Nearly 90 percent of fish eaten in the United States fall into the best choices category, according to the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency.

Fifty percent of pregnant women eat fewer than 2 ounces of fish a week, which is far less than the recommended amount, the FDA said. Fish offers nutritional benefits important for growth and development during pregnancy and early childhood, the agency said.

The FDA and EPA recommend two to three servings of lower-mercury fish per week, or 8 to 12 ounces total. Twelve ounces is the recommended maximum weekly consumption, according to the new guidelines.

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Study links Prozac, Paxil use with birth defects

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A sweeping government study of thousands of women has found links between the older antidepressants Prozac and Paxil and birth defects, but has cleared other popular treatments in the class, including Celexa, Lexapro and Pfizer’s Zoloft, which is the subject of a major lawsuit over birth defect claims.

Earlier studies had raised questions about antidepressants in a class of drugs known as Selective Serotonin Reuptake Inhibitors or SSRIs, prompting the U.S. Food and Drug Administration in 2005 to issue a safety warning about use of the treatments during pregnancy.

In the current study, published on Wednesday in the British Medical Journal, researchers at the U.S. Centers for Disease Control and Prevention wanted to see if the birth defect risk affected the entire class of drugs, or only select treatments.

For the study, the researchers asked nearly 28,000 women if they took Celexa, Lexapro, Prozac, Paxil or Zoloft any time from one month before conception through the third month of pregnancy and analyzed which women bore children with birth defects.

They found that many popular antidepressants – Celexa, Lexapro or Zoloft – are not associated with birth defects. Only two in the study, Prozac, sold generically as fluoxetine, and Paxil, sold generically as paroxetine, were implicated.

In women who took those two drugs early in pregnancy, birth defects occurred 2 to 3.5 times more frequently compared with women who did not take them.

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