‘Friendly’ Bacteria May Soothe Colic

Daily doses of “friendly” bacteria may help colicky babies cry less, a new study finds. The study included 50 babies, ages 2 to 16 weeks old. All of them were fed only breast milk. On average, they cried about 5 to 6 hours a day. Half of the babies were randomly assigned to receive drops containing Lactobacillus reuteri bacteria. These are known as probiotic bacteria. They may help digestion and also crowd out harmful bacteria in the gut. The other half of the babies received placebo drops. Mothers kept diaries recording how much their babies cried during the 3-week study. By the end, both groups were crying less. But crying time dropped much more in the group that received the probiotic bacteria. Their average crying time was 35 minutes a day, compared with 90 minutes for the placebo group. The journal Pediatrics published the study online.

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Drug Pulled After FDA Threat on Research

Shire PLC has pulled its drug ProAmatine from the U.S. market after regulators threatened to withdraw approval. In a letter posted online August 16, the Food and Drug Administration said Shire had failed to do follow-up research. The FDA approved ProAmatine in 1996 to treat very low blood pressure. It based that decision on early research, but told Shire to do more studies to prove long-term benefits. Shire never submitted them. The FDA letter this week offered to discuss the matter at a hearing. Instead, Shire announced that it would remove the drug by the end of September, the Associated Press (AP) said. The FDA has the power to remove drugs when follow-up studies are not done. However, it has never done so. Shire’s decision does not completely remove the drug from the market. It is also sold as a generic drug, known as midodrine.

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