A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary). Despite these driving and other problems, patients were often unaware they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day.
FDA
Drug Safety Labeling Changes – February 2014
Safety Information > February 2014.
Get to Know an Enzyme: CYP3A4.
I routinely check the FDA drug safety information for personal reasons. One thing led to another, thus the reason for the CYP3A4 link. If you like puzzles, try to figure out why I’m reading up on CYP3A4. My son the molecular biochemist soon to be MD would have no problem figuring this out.
FDA Drug Safety Labeling Changes – December 2013
Safety Information > December 2013.
Memory permitting I will link to this FDA webpage on a regular basis. From my perspective the adverse reactions are the most interesting nuggets of information.
Safety Alerts for Human Medical Products > Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage
ISSUE: FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.
Acetaminophen: Drug Safety Communication – Association with Risk of Serious Skin Reactions
FDA notified healthcare professionals and patients that acetaminophen has been associated with a risk of rare but serious skin reactions. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal.
via Safety Alerts for Human Medical Products > Acetaminophen: Drug Safety Communication – Association
Yikes!
Olmesartan Medoxomil – Watch for These Side Effects
FDA is warning that the blood pressure drug Olmesartan Medoxomil marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. FDA has approved changes to the labels of these drugs to include this concern. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan
Azithromycin (Zithromax or Zmax) – Risk of Potentially Fatal Heart Rhythms
ISSUE: FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. FDA has issued a Drug Safety Communication today as a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.
FDA Panel Says Yes to Home HIV Test
If marketed, the test would likely be sold in a similar manner to some cough medicines, according to a company spokesman. At checkout, the cashier would ask to see the purchaser’s ID to confirm he or she is at least 17.
via Medical News: FDA Panel Says Yes to Home HIV Test – in HIV/AIDS, HIV/AIDS from MedPage Today.
Might be time to review your application and exam question.
I’d take a hard look at my non-medical limits too.
Meridia (sibutramine hydrochloride) – Update
Oops.
Sibutramine is not to be used in patients with a history of cardiovascular disease, including:
* History of coronary artery disease (e.g., heart attack, angina)
* History of stroke or transient ischemic attack (TIA)
* History of heart arrhythmias
* History of congestive heart failure
* History of peripheral arterial disease
* Uncontrolled hypertension (e.g., > 145/90 mmHg)
Bye Bye Byetta?
The FDA just updated their safety information on Byetta to reflect the reports of 6 cases of hemorrhagic necrotizing pancreatitis in people taking the drug. All six required hospitalization and two have died. If you know any diabetics taking this drug, please advise them of this information. Sooner, not later. I’ve added a link to the FDA MedWatch page on the sidebar under drug abuse.
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