Dr. Gustin's Blog

FDA Revises AMBIEN guidelines

Ambien is the most common sleeping medication at the present time.  Unfortunately, although Ambien is usually quite effective at facilitating sleep, it also has been found to have several disturbing side effects, including tolerance, addiction, and somambulism.  Recently the FDA has revised its dosing guidelines on how the medication should be used.  The news brief follows:

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Problems With Ambien

Ambien (zolpidem) is currently the most commonly used sleeping medication on the market. Most physicians believe, unknowingly, that it can be prescribed with impunity.  This is not the case.  Ambien has many side effects that have resulted in a big increase in visits to emergency departments.

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Amitiza for Opioid-induced Constipation

The FDA finally approved a new drug which ameliorates the severe constipation that accompanies the use of Opiates.  Constipation is one of the main side effects that causes individuals to stop Opiate medication prematurely without any other option for their pain.  This addition to treatment with opiates is a notable advancement.

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Zithromax and Sudden Death

At one time or another, most of us have taken the antibiotic, Zithromax.  It is one of the most commonly prescribed medications for conditions including bronchitis, pharyngitis, sinusitis, and others.  The discussion that follows has to do with Zithromax's side-effects, some of which are potentially life-threatening.  Recently, I have seen a case in my emergency room of sudden cardiac arrest secondary to the cardiac effects of Zithromax.  The FDA has recently warned of this phenomenon.

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2013 Review of Food Poisoning

The following article on food poisoning and foodborne outbreak disease was obtained from a recent issue of emedicine #175569.  It is an overview that covers major topics and issues.  It does not address travel medicine.  But it would have direct relevance to community acquired disease, assessments for such diseases, and surveillance.

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2013 Review of Food Poisoning

The following article on food poisoning and foodborne outbreak disease was obtained from a recent issue of emedicine #175569.  It is an overview that covers major topics and issues.  It does not address travel medicine.  But it would have direct relevance to community acquired disease, assessments for such diseases, and surveillance.

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Emergency Medicine Malpractice Defense

A recent article appeared in the Journal of Emergency Medicine that addresses medical malpractice, medical malpractice prevention, improved quality of care and documentation, and medical malpractice defense.  Specific examples are given to illustrate general concepts.  Since the article has particular relevance to the practice of emergency medicine, I include it here on my blog for those who are interested in reading it.

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FDA Warning Regarding Sodium Oxybate for daytime drowsiness

The US Food and Drug Administration (FDA) has issued a warning against use of alcohol and central nervous system depressant drugs (CNS), such as benzodiazepines and opioids, with sodium oxybate ( Xyrem, Jazz Pharmaceuticals) because of the risk for impaired consciousness and respiratory depression.

The drug, used to reduce episodes of cataplexy and treat daytime sleepiness in patients with narcolepsy, is already contraindicated for use with insomnia drugs. The new contraindications are reflected in labeling changes for the drug.

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FDA Adds New Potentially Hazardous Drugs to its Watch List

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.

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