Saturday, June 27, 2009
A spoonful of sugar not needed, just a straw
Tuesday, June 23, 2009
Mom vs. RPh: the Inner Struggle
Tuesday, June 16, 2009
Safe contact lens use: advice from the FDA
Intranasal Zicam linked to loss of smell - throw out!
Loss of Sense of Smell with Intranasal Cold Remedies Containing Zinc
June 16, 2009
FDA is alerting consumers that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size, a discontinued product that consumers may still have in their homes, have all been associated with long lasting or permanent loss of smell (referred to as anosmia). These products, marketed by Matrixx Initiatives, are zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms. However, these products have not been shown to be effective in the reduction of the duration and severity of cold symptoms.
This advisory does not concern oral zinc tablets and lozenges taken by mouth.
FDA recommends that consumers stop using these products and throw them away. See the FDA website for How to Dispose of Unused Medicines.
For treating symptoms of the common cold, consumers can take a number of other over-the-counter drugs. However, the common cold goes away without treatment, usually within seven to ten days.
Since the introduction of Zicam Cold Remedy Nasal Gel to the market in 1999, FDA has received more than 130 reports of anosmia associated with the use of Zicam zinc-containing intranasal products. The reports vary. Many people state that the loss of sense of smell occurred with the first dose of the Zicam product, although some people report it happened after later doses. The loss of sense of smell may be long-lasting or even permanent in some people.
Loss of the sense of smell may cause serious problems, such as failing to smell smoke, a gas leak, or spoiled food. Also, loss of the sense of smell is often linked with a loss of the sense of taste. People who cannot taste could unintentionally eat spoiled food and not appreciate flavors, and lose much of the pleasure of eating.
FDA recommends that consumers contact their healthcare provider if they experience loss of the sense of smell or taste, or experience other problems after using any zinc-containing nasal products.
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.
Monday, June 15, 2009
Following the label, the label, the label
Speaking of ibuprofen, it is exciting that the FDA also recently approved an injectable formulation of the pain and fever reliever. The brand name is Caldolor. Although its use will be limited to hospital use only, it will be an important addition for pain treatment algorithms, especially for children with acute painful crises, such as those with sickle cell disease, and can't tolerate medication by mouth and need the combination of an opioid and a nonsteroidal antiinflammatory drug (ibuprofen). For postpartum pain, I preferred moderate doses of ibuprofen over opioids; the former was effective to control my pain after vaginal delivery and, surprisingly, after the c-section years later.
“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”Although pain is subjective, no one, not even a young child, should suffer from it.
Caldolor will be available for hospital use only. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.
In a clinical trial of 319 women who had undergone an elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when administered Caldolor.
Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots and those who have a prior history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.
The most common adverse reactions reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.
Caldolor is manufactured by Cumberland Pharmaceuticals Inc., Nashville, Tenn."