A new Avandia and Actos study published in the medical journal Circulation: Cardiovascular Quality and Outcomes, on August 24, 2010 reveals Takeda Pharmaceuticals Actos and GlaxoSmithKlines Avandia raised the risk of heart problems by 4%.

The study consisted of 36,000 diabetes patients who used Avandia or Actos to treat the chronic condition diabetes. Of the 36,000 diabetes patients, 602 who took Avandia suffered heart problems or died, while 599 of those taking Actos had heart problems or died.

Avandia (Rosiglitazone) and Actos (Pioglitazone) is used to treat Type 2 Diabetes (a condition in which the body does not use insulin normally and, therefore cannot control the amount of sugar in the blood). Unfortunately, these medications may also cause some side effects, such as water retention, swelling of the ankles, weight gain, muscle weakness, and fatigue.

As a health educator working with clinical pharmacists, we commonly see patients who use these types of medications, and need answers for their medicine questions. As always, make sure you carefully read the ‘Drug Facts Label’ on the back of all medications, and consult a health care professional when it comes to managing your medications.

In our effort to make medicine simple, and educate the public on the type of medication errors/problems, which injure 1.5 million people, every year, we wanted to pass along some quick information regarding a recent FDA alert. Individuals taking Lamictal or Healthcare professionals who prescribe Lamictal should be aware the FDA issued a “drug safety communication,” indicating the Warnings and Precautions section on the drug label will be updated to list “aseptic meningitis” as a potential side effect.

For those not aware, aseptic meningitis is an inflammation of the protective membranes covering the brain and spinal cord that is not caused by any detectable bacteria. In addition, Meningitis is considered a medical emergency due to its proximity to the brain. Research shows if this condition remains untreated, it can result in deafness, cognitive problems, and epilepsy.

Lamictal is prescribed to more than 46 million people every year for treatment of epilepsy and bipolar disorder. The FDA recommends, those taking Lamictal, who experience symptoms such as headaches, neck stiffness, fever, confusion, vomiting, or light sensitivity to contact their healthcare professional. If you are looking for general medicine questions, do not hesitate to contact our clinical pharmacists.

Tylenol (Brand Name), otherwise known as acetaminophen, is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds, sore throats, toothaches, backaches, and reactions to vaccinations (shots).  In addition, this particular medication is sometimes used to relieve the pain of osteoarthritis.

In a recent study, published in the American Journal of Respiratory and Critical Care Medicine, acetaminophen, is said to be linked to higher risks of asthma, allergic nasal conditions, and eczema.

The study consisted of roughly 320,000 kids ages 13 and 14 in 50 countries who take acetaminophen. Clinical trials revealed, children who take acetaminophen are more than twice as likely to have asthma as teens the same age and who have never taken the common over-the-counter medication.

More detailed results reveal, those who participated in the study, and took acetaminophen at least once per year were 43% more likely to have asthma. In addition, those who took acetaminophen at least monthly were 2.5 times as likely to suffer from the condition.  The FDA has not yet released a statement in response to this data. 

As a clinical pharmacist, we commonly see patients who use these types of medications.  It is a reality that we have needs that require self-medication and over-the-counter medications can be a big relief.  As always, make sure you carefully read the ‘Drug Facts Label’ on the back of all over-the-counter medications.  Pay attention to the active ingredient, directions for use, and warnings.  In addition, always discuss any over-the-counter medication use with your health care professional.

Another recall, and interestingly enough, is similar to the recall of another sexual performance drug located here. Prolatis’, a dietary supplement, is advertised on various websites as a “fast acting sexual performance enhancer.”

This particular dietary supplement is aimed towards men who are “experiencing a premature decline in sexual function.” However, Prolatis’ is currently issuing a voluntary nationwide recall of their product after being informed by the Food and Drug Administration (FDA) “that lab analysis has found Prolatis’ to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making Prolatis’ an unapproved drug.

As stated in our previous posting, the threat to consumers is based on the fact this undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to danger levels.

This is extremely possible for high-risk population groups such as those with diabetes, high blood pressure, high cholesterol, or heart diseases, since usually, these high-risk population groups are often taking nitrates.

A recent FDA lab analysis of Revivexxx Extra Strength was found to contain undeclared tadalafil. For those not aware, Tadalafil is an FDA approved drug for the treatment of male Erectile Dysfunction (ED) making Revivexxx Extra Strength an unapproved drug.

The threat to consumers is based on the fact tadalafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to danger levels. This is extremely possible for high-risk population groups such as those with diabetes, high blood pressure, high cholesterol, or heart diseases, since usually, these high-risk population groups are often taking nitrates.

Consumers in possession and/or currently consuming Revivexxx are instructed to return the product immediately to the place of purchase for a full refund. For those who used Revivexxx and are experiencing any problems, which may be related to taking this product, please contact your physician. If you are looking for additional information, do not hesitate to contact our clinical pharmacists.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA’s MedWatch Safety Information and Adverse Event Reporting program:

Complete and submit the report Online here.

Some interesting information just passed our hands and we want to make sure we share this information with our readers. If you reside within the state of Louisiana, you may have encountered a recent lawsuit filed by two residents regarding the generic medication Reglan.

For those not aware, Reglan (metoclopramide) is used to relieve heartburn and speed the healing of ulcers and sores in the esophagus. As always, for more information, please contact our clinical pharmacist hotline. The residents in question claim taking this particular medication caused the development of abnormal movements as part of a disorder known as tardive dyskinesia.

Research shows tardive dyskinesia as a disorder which involves involuntary movements, especially of the lower face. Some of these features may include grimacing, tongue protrusion, lip smacking, puckering, pursing, and rapid eye blinking. Although over the years, this side effect continues to be documented, the residents claim manufacturers of this particular medication are failing to adequately warn that Reglan can cause tardive dyskinesia when used over long periods.

Our questions for those who are currently taking Reglan, know of someone taking Reglan, or have seen the bottle of Reglan; Are you being sufficiently warned of the side effects of Reglan?

Miracle Mineral Solution is an oral liquid solution, also known as “Miracle Mineral Supplement” or “MMS.” Those who have came across this particular supplement may find claims of this particular solution treating multiple unrelated diseases including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer and other conditions. Unfortunately, on July 30, 2010, the Food and Drug Administration is warning consumers not to use Miracle Mineral Solution, and emphasize if this particular solution is used as directed an individual’s health will deteriorate.

The proposed use is for consumers to mix 28 percent sodium chlorite solution with an acid such as citrus juice, but unfortunately, this mixture produces chlorine dioxide, which is a potent bleach used for stripping textiles, and industrial water treatment. The FDA indicates high oral doses of this bleach may cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

 You may find MMS on many Internet Sites, and online auctions by multiple independent distributors, and it is strongly encouraged for those consumers who are currently using MMS to stop using it immediately. Are you taking Miracle Mineral Solution or have you found this oral liquid advertised on a site you recently visited?

The US Food and Drug Administration (FDA) has approved a once-weekly buprenorphine transdermal system (Butans; Purdue Pharma LP) for the management of moderate to severe chronic pain in patients requiring a continuous, around-the –clock opiod analgesic for an extended period. The patches are available in 5, 10, and 20ug/hour strengths.

For those not aware, and looking for a technical definition, Buprenorphine is a schedule III controlled substance with partial agonist activity at the u-opiod receptor and competitive antagonist activity at the kappa opiod receptor. The patch represents a new formulation for the opiod, which was previously available as an intramuscular/intravenous injection for the relief of moderate and severe pain. Those looking for a simpler explanation, please contact one of our clinical pharmacists for more information.

Please take the time to learn more about Buprenorphine, along with the side effects. Do you have additional questions regarding buprenorphine, prescribing buprenorphine, or just want to get more information on this particular patch?

A study reported online on June 24, 2010 in the Journal of the American Society is linking digoxin use to mortality in patients with end-stage renal disease. Kevin E. Chan, MD, MSci from Fresenius Medical Care North America in Waltham, Massachusetts states, “We were surprised to find that digoxin use increased death risk in dialysis patients, especially in patients on higher does.”

Digoxin is frequently prescribed for the management of congestive heart failure and atrial fibrillation. It is derived from leaves of a digitalis plant and it helps make the heat beat stronger and with a more regular rhythm. Are you taking digoxin or planning to take it in the future and have additional medicine questions?

Source:

Journal of the American Society of Nephrology

Medscape

In an effort to share valuable information, individuals using pre-filled ephinephrine syringes should proceed with caution. The National Council on Medication Error Reporting and Prevention issued an alert to healthcare professionals about preventing medication errors when using substitute products. EPINEPHrne syringes are currently on back order. If you have any further questions, feel free to comment, or contact one of our clinical pharmacists. Clinical pharmacists help make medicine simple…

Source:

All Sites Nursing News | Daily News: Epinephrine Shortage Leads to Medication Error Warning

http://www.medscape.com/viewarticle/723878