Archive for January, 2013

FDA targets flu drug claims

The FDA has issued a warning letter to GermBullet, saying the nasal spray’s claim that it is “laboratory tested and shown to reduce illness-causing bacteria, cold and flu viruses” is a “false and misleading promotional statement.” GermBullet is a nasal spray made up of “pure essential oils,” according to its website. The product, sold over the counter, is made by Flu & Cold Defense LLC of Boca Raton, Fla.

Read more about the misleading nasal spray promotional statement…


New study reveals Depakote lowers IQ in children

A new study published in The Lancet has found that exposure to Depakote may directly reduce a child’s IQ by the age of 6. The study looked at mothers who took the antiepileptic drug during pregnancy and exposed their child to valproate, the active ingredient in Depakote.

Read more about the link between Depakote and birth defects…

FDA says metal-on-metal hips can damage soft tissue

The U.S. Food and Drug Administration (FDA) has reported that metal-on-metal hip replacements can cause soft tissue damage and pain that leads to revision surgery. This additional info comes during a review of the agency’s policies regarding all-metal hip implants.

Read more about the complications linked to all-metal hip implants…

Doctor argues SSRI antidepressants are being overprescribed

A doctor’s essay published in the British Medical Journal (BMJ) argues that antidepressants in a class known as selective serotonin reuptake inhibitors (SSRIs) are being overprescribed. Some of the most-prescribed SSRI antidepressants include Zoloft, Paxil, Celexa and Lexapro.

Read more about SSRI antidepressant warnings…

FDA wants hip manufacturers to prove devices are safe before continuing to sell them

The U.S. Food and Drug Administration (FDA) has issued a proposal that would require metal-on-metal hip manufacturers to prove their current devices are safe before continuing to sell them. As many as 500,000 Americans were estimated to have received an all-metal hip implant since they first appeared on the market.

Read more about complications linked to metal hip replacements…

FDA to consider tougher Vicodin restrictions

The U.S. Food and Drug Administration this week will consider a request from federal law enforcement officials to tighten restrictions on Vicodin and similar narcotic painkillers. Beginning Thursday, the FDA will conduct a two-day hearing in Bethesda, Md., on whether hydrocodone products should be more highly controlled, as are narcotics such as OxyContin and Percocet.

Read more about the FDA hydrocodone hearing…

Johnson & Johnson internal analysis shows high DePuy ASR hip failure rate

Newly disclosed court records reveal that a Johnson & Johnson internal analysis from 2011 determined that DePuy ASR hip replacement devices fail within five years in nearly 40 percent of hip implant patients. Johnson & Johnson, the manufacturer of DePuy ASR hip replacements, conducted this internal analysis after issuing a recall of the metal-on-metal hip device in 2010.

Read more about the DePuy hip replacement lawsuits against Johnson & Johnson…


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