Reporting Pediatric Medical Product Issues

In 2012, the FDA received almost 900,000 adverse event and medical error reports from consumers—but only 5 per cent of those reports concerned children less than 18 years of age. However, reporting adverse effects in pediatrics can help shed important light on these products, especially since most pediatric clinical trials only contain a small number of patients. In addition, a product may be studied in one age group and approved for widespread use but affect another age group in a different way.
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Californian Drug and Dietary Supplement Manufacturer Closed

According to the FDA, a federal judge declared that a Californian company must stop manufacturing drugs and dietary supplements for domestic commerce—at least until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act. Titan Medical Enterprises, Inc. continuously failed to comply with Good Manufacturing Practice for drugs or Good Manufacturing Practice for dietary supplements. In addition, the company violated the Act by distributing unapproved new drugs.
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Recall of Fisher & Paykel Healthcare Reusable Breathing Circuit

Apnea in Greek means “without breath”. When a person has sleep apnea their breathing involuntarily stops while they are sleeping. This stopping can happen hundreds of times up to a minute or longer at a time. Most of the time the person is not aware of their breathing stopping hence making death a quiet inevitable occurrence when not treated.
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FDA: Iron Supplement Recall

Recently, Natural Standard posted an article stating that Rugby Natural Ferrous Sulfate Iron Supplements have been recalled. The U.S. Food and Drug Administration (FDA) have issued a consumer warning for the iron supplement listed above, which is manufactured by Advance Pharmaceutical Inc.
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FDA Recall for St. Jude Medical’s Amplatzer TorqVue FX

According to a recent article published by, St. Jude’s has recalled their Amplatzer TorqVue FX delivery system because of concerns about fractures in the core wire. The FDA has issued the highest-risk label on the recall of the delivery system produced by St. Jude Medical.
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Doctor Says New Medical Device May Not Be Safe

The new lead free implantable heart defibrillator, invented by Boston Scientific Corp, should not be used on a regular basis until more data is available, according to a story in the Chicago Tribune. Defibrillator leads have often caused problems for device makers.
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Sleep Aids Using Zolpidem Now Require Lower Dosage

The FDA is now requiring sleep aids such as Ambien, Ambien CR, Edluar and Zolpimist to lower their dosage. Zolpidem, an ingredient in these brands, may remain in the blood the next morning in high enough levels to impair certain activities that require alertness. Zolpidem is eliminated slower from women’s bloodstreams, so the FDA is notifying manufacturers to lower the recommended dose for women—and they suggest lowering it for men as well. Especially in the extended-release form, zolpidem can cause problems the following morning for some activities, such as driving.
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Man sues diabetes medication manufacturer

Doyle Swafford ended up filing a lawsuit against the manufacturer of his type 2 diabetes medication called Actos after he suffered from severe side effects. Swafford took the case to Cook County Circuit Court, saying that there is a link between the use of Actos medication and the development of baldder cancer, which is one of the side effects recognized for the medication.
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL