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FDA Adds More Drugs to Watch List

Details: Published: Tuesday, 18 December 2012 23:52

The US Food and Drug Administration (FDA) has added several drugs to its list of products to monitor because of possible signs of serious risks or new safety information. The drugs treat conditions that include cancer, epilepsy, hypertension, and malaria.

The agency spotted yellow flags for these drugs in the FDA Adverse Event Reporting System (FAERS) database during April, May, and June 2012.

Making the FDA's watch list does not mean that the agency has concluded that the drug actually poses the health risk reported through FAERS, formerly known as AERS. Rather, the agency will study the drug to determine whether there is truly a causal link. If it establishes a link, the FDA then would consider a regulatory response such as gathering more data to better characterize the risk, revising the drug's label, or requiring a risk-evaluation and mitigation strategy.

The FDA also is not suggesting that clinicians should stop prescribing watch-list drugs, or that patients should stop taking them, according to an agency press release.

Grapefruit Interferes With Drug Levels

Details: Published: Monday, 03 December 2012 13:09

The following information piece was recently sent to medical toxicology physicians regarding the effect of grapefruits on medication metabolism and blood levels. It is worth noting.

New Guidelines on Carbon Monoxide Poisoning

Details: Published: Tuesday, 27 November 2012 13:44

The first consensus guidelines on how to evaluate, treat, and prevent carbon monoxide poisoning has recently been released and published in the American Journal of Repiratory and Critical Care Medicine. These guidelines standardize management of carbon monoxide poisoning for clinician, toxicologist, and public health worker, and offer a road map to attorneys prosecuting or defending a carbon monoxide exposure legal action. You can read more about these guidelines by obtaining the actual article from the journal. The citation is Hampson et al, Am J Respir Crit Care Med. 2012, October 18. epub, (ahead of print). The title of the article is: Practice Recommendation in the Diagnosis, Management, and Prevention of Carbon Monoxide Poisoning.

FDA Adds 8 Drugs to Watch List

Details: Published: Thursday, 08 November 2012 11:14

The US Food and Drug Administration (FDA) has added 8 drugs to its list of products to monitor because of possible signs of serious risks or new safety information. The drugs treat conditions that include cancer, epilepsy, hypertension, and malaria.

The agency spotted yellow flags for the 8 drugs in the FDA Adverse Event Reporting System (FAERS) database during April, May, and June 2012.

Death Caused by Oxymorphone Narcotics

Details: Published: Thursday, 08 November 2012 11:12

Deaths due to narcotic abuse typically occur by overdose, and consequent respiratory failure. New data demonstrates a novel cause of death associated with narcotic abuse. On October 12, 2012 the US Food and Drug Administration (FDA) warned that individuals who abuse the prescription pain medication oxymorphone hydrochloride extended-release tablets (Opana ER, Endo Pharmaceuticals) are at serious risk of developing thrombotic thrombocytopenic purpura (TTP), a blood disorder that can result in kidney failure and death.

According to the FDA, cases of TTP linked to Opana appear to occur only when the drug is injected intravenously.

The FDA notes that in TTP, blood clots form in small blood vessels throughout the body. The clots can limit or block blood flow to the body’s organs, such as the kidneys, brain, and heart.

Platelets help the blood to clot. In TTP, as platelets form blood clots, fewer of them are available to assist with clotting in other parts of the body. This can lead to bleeding under the skin and internal bleeding.

TTP can cause death or lead to other complications with permanent damage, such as kidney failure, brain damage, or stroke.

FDA Targets 8 drugs that have potential adverses health effects

Details: Published: Wednesday, 24 October 2012 12:06

FDA Adds 8 Drugs to Watch List

The agency spotted yellow flags for the 8 drugs in the FDA Adverse Event Reporting System (FAERS) database during April, May, and June 2012.

CT scans Linked to Leukemia and Brain Tumors

Details: Published: Monday, 23 July 2012 00:25

Ultrasound Gel Contaminated With Bacteria

Details: Published: Monday, 07 May 2012 22:24

Bacteria has a proclivity for finding any medium that can support its growth. That includes the gel that is used by ultrasonographers to perform routine ultrasounds. Normally the skin acts as a decent barrier against microbials but not always. Klebsiella and Pseudmonal organisms have a tendency to find their way through the skin barriers and can cause superficial or deep skin infections. Sterile technique and good habits are necessary to prevent contamination of these biologic media. The following FDA information as reported in MedScape details the recently discovered contamination of ultrasound gel.

Overdoses of Opioid Pain Relievers in the U.S.

Details: Published: Sunday, 06 May 2012 19:44

A recent study published in the CDC's Morbidity and Mortality weekly report, 2011; 60:1487 addresses the epidemic of overdoses associated with prescription narcotic medication. Physicians unwittingly prescribe too much opioid medications and often turn their patients into narcotic addicts. The abstract follows: