Weekly Digest: FDA mandates species-specific livestock antibiotic reports; New malaria vaccine success

A new graphic on the CDDEP website shows new molecular entity (NME) antibiotic approvals by the U.S. Food and Drug Administration from 1981–2015. The graphic presents an updated version of an often-plotted chart of FDA antibiotic approvals since 1981, and differentiates antibiotics still marketed from antibiotics that were later withdrawn from the market for safety or business reasons. Unlike other depictions of this trend, in this more complete version, approvals do not appear to be on a precipitous decline. [CDDEP]

Pharmaceutical companies selling antibiotics for use in livestock in the United States will be required to report on species-specific sales, beginning with the 2016 calendar year. The U.S. FDA announced the new rule, which was originally proposed in May 2015, on Wednesday. Until now, animal antimicrobial sales were reported for all animals combined. The new rule requires reporting separately for cattle, swine, chickens, and turkeys. [CIDRAP, FDA]

A new treatment regimen for multidrug-resistant tuberculosis (MDRTB) recommended by WHO is significantly shorter and less expensive than previous regimens. The new approach relies on rapid diagnostic tests to determine second-line drug resistance, and would reduce treatment for susceptible infections to 9-12 months, from the current 18 to 24 months. The treatment would still be expensive at about $1000, but only one-third of the current cost. WHO estimates that nearly half a million people globally have MDR-TB, only 20 percent of whom are currently being properly treated. [The Wall Street Journal]

A malaria vaccine long in development provided 55 percent protection against infection with the parasite in a small trial. The vaccine, produced by Sanaria, is composed of live malaria parasites that have been attenuated (weakened) via radiation, to stimulate an immune response, but not an infection. Of the 55 study participants, those who got the highest dose (270,000 parasites) responded best. Results of the study were published in Nature Medicine. [New York Times, Nature Medicine]

Without improved vaccination rates in Angola, yellow fever may be the next global health infectious disease emergency, write Daniel Lucey and Lawrence Ostin in a JAMA viewpoint. Lucey and Ostin write that the World Health Organization needs to urgently mobilize funds, spur vaccine production and coordinate an international response to the ongoing outbreak in Angola. The country has recorded more than 2000 suspected cases as of April 26. Vaccination campaigns there and in the Democratic Republic of the Congo have exhausted most of the available resources to contain the spread of the disease. Lucey and Ostin argue that WHO should utilize Emergency Use Assessment and Listing (EUAL) procedures, developed during the Ebola epidemic, to authorize using a reduced dose of the vaccine, in order to reach more individuals and bolster herd immunity. [JAMA]

The U.S. FDA has issued a safety warning for fluoroquinolone antibiotics about harmful side effects that can outweigh the benefits. This echoed FDA statements in 2008 and 2013 about potentially dangerous or disabling side effects of fluoroquinolones, which can affect muscles, joints, tendons, nerves and the central nervous system. Physicians are advised to use the drugs only when no other treatment options exist, and FDA will require all medication guides and drug labels to include the new safety information. [CIDRAP, FDA]

Conflict-related injuries in the Middle East are increasingly complicated by antibiotic-resistant infections. Dr. Rasheed Fakhri, a physician with Médecins Sans Frontières (MSF), said that he is “not optimistic that there is a significant strategy to tackle [antibiotic resistance] in these countries.” Fakhri and other MSF clinicians noted, in particular, the difficulty of treating antibiotic-resistant osteomyelitis, a serious bone infection. MSF’s executive director in the UAE named drug resistance as one of the biggest medical humanitarian challenges in the region, and called for raising awareness about antibiotic resistance and restricting over-the-counter antibiotic sales. [The National]

“The clear statements from WHO that there should be no restrictions on travel and trade means there is no justification for cancelling, delaying, postponing or moving the Rio Games,” announced International Olympic Committee medical director Richard Budgett on Wednesday. Budgett was responding to a call from Canadian health professor Amir Attaran for the IOC to postpone or move the Games because of the Zika virus epidemic. Attaran claims that if WHO and the IOC do not delay the games to avoid serious Zika-related birth defects, “they’re among the cruelest institutions in the world.” The Brazilian health ministry announced Wednesday that the total number of confirmed and suspected microcephaly cases in the country is 4759, down from an estimate of 5200 in March. The first suspected cases of Zika-related microcephaly in both Puerto Rico and Honduras were reported this week. [BBC, Reuters, Reuters, Washington Post]