The names (and active ingredients) of Renagel and Renvela are almost identical and can be extremely confusing. These medications both treat high phosphate levels, but they have varying insurance coverage, and can’t be substituted for one another without your prescriber’s approval.
Sevelamer hydrochloride and sevelamer carbonate are used to treat hyperphosphatemia, also known as high phosphate levels. High phosphate levels may be caused by the consumption of phosphate-rich foods (like dairy products), or the result of kidney failure.
Your kidneys help filter waste products in your body, and kidney failure is due to the build-up of waste products not properly being excreted. Some types of kidney failure can be reversed, though others are irreversible.
It is especially important to take care of yourself if you have a disease such as diabetes or high blood pressure which can potentially lead to kidney failure if not appropriately controlled. Keeping up with your sugar readings and keeping your blood pressure numbers under control can help prevent the progression of chronic kidney disease to kidney failure.
What dosage forms are sevelamer hydrochloride and sevelamer carbonate available in?
Sevelamer hydrochloride (Renagel) is available as a tablet, in both 400 mg and 800 mg strengths.
Sevelamer carbonate (Renvela) is also available as an 800 mg tablet, and in 0.8 g or 2.4 g powder packets.
What is are the advantages and disadvantages of using sevelamer hydrochloride (Renagel)?
Sevelamer hydrochloride is a calcium-free, metal-free, nonabsorbed phosphate binder that has proven effective in controlling serum phosphorous levels in patients with chronic kidney disease.
However, some patients cannot tolerate it due to stomach side effects.
What are advantages and disadvantages of using sevelamer carbonate (Renvela)?
Sevelamer carbonate offers the same exact advantages as sevelamer hydrochloride, with the additional benefit of a carbonate acid buffer.
Sevelamer carbonate is also available in powder packets for oral suspension. The powder packets are sprinkled into a prescribed amount of water depending on the strength. The powder packets are a great advantage for those patients who have a hard time swallowing tablets or capsules.
Sevelamer carbonate might help reduce the risk of acidosis (too much acid in the bodily fluids), but also has the potential for stomach side effects.
The 800 mg tablet is also available as an authorized generic, which may be less expensive and/or more likely to be covered by your insurance.
Which medication will my insurance cover?
Unfortunately each prescription insurance plan differs so it’s hard to make a blanket statement about which medication is most likely to be covered by your individual plan.
More than likely only Renagel or Renvela will be covered by your insurance since the cost is similar and sevelamer hydrochloride and sevelamer carbonate are almost identical in efficacy. The main differences are a result of their side effect profiles.
Benzodiazepines are great for anxiety but used long term there are downsides. Long-term use of benzodiazepines can be habit forming and oh—put you at increased risk of Alzheimer disease.
Common benzodiazepines like Xanax (alprazolam), Ativan (lorazepam) and Valium (diazepam) are used to treat anxiety symptoms, panic disorder and social anxiety disorder and have been associated with cognitive impairment in some older adults. These effects were presumed to be short-lived and reversible until the results of a new study, so pay attention. Long-term exposure to benzodiazepines might increase the risk of Alzheimer disease.
In a study of nearly 2000 older adults in Canada, use of benzodiazepines for more than 180 days was associated with a 1.5-fold increase in risk of Alzheimer disease. What is important to note is that longer exposure and longer-half life benzos (like Klonopin/clonazepam) were associated with increased risk.
This study should reinforce that benzos are only a short term solution. Studies show that when either lorazepam or alprazolam are used for more than one month, dependence will occur in 47% of those taking them. Now we know there is also an increased risk of Alzheimer disease. Benzos shouldn’t be used long term and treatment for more than 4 months should be re-evaluated to determine the continued need for the drug.
During pregnancy, women not only consider their own well-being, but also the welfare of their developing child. It is crucial to take into account what you are putting into your body during your pregnancy—and following pregnancy for those who decide to breast feed—and medications are no exception.
Recently the FDA published a final rule setting standards for how information about the risks using medications during pregnancy and breast-feeding is presented in the labeling of all prescription drug products.
What are the current classifications of risk, and what do they mean?
The lettered categories for the risk associated with using a medication while pregnant are currently designated by the U.S. Department of Health and Human Services. Here’s a break down of the current categories, what they mean, and examples of medications in each category:
- Category A. Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Example: prenatal vitamins
- Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Example: Tylenol (acetaminophen), Claritin (loratadine)
- Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Example: Sudafed (pseudoephedrine)
- Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Example: tetracycline, aspirin
- Category X. Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. Example: Coumadin (warfarin), Accutane (isotretinoin)
Why is this change taking place?
The new labeling for pregnancy and lactation is meant to help healthcare providers in making informed decisions about the benefits versus the risks of prescribing medications.
The new labeling will also help inform and educate pregnant and nursing mothers so that they can make responsible decisions for themselves and their children.
What will the new labeling be like?
The current letter categories will ultimately be replaced by three detailed subsections describing the potential risks.
The three subsections will be:
- Females and Males of Reproductive Potential
And both the pregnancy and lactation subsections will be broken down even further into:
- • Risk summary
- • Clinical considerations
- • Data
When are these new standards expected to be in place?
The new standards will go into effect on June 30, 2015.
Will this change how over-the-counter (OTC) medications are labeled?
No. OTC medications are not affected by the final ruling from the FDA.
Want to find out more?
For more information regarding the Pregnancy and Lactation Labeling Final Rule from the FDA click here.
There is a huge need for rapidly acting antidepressants. Suicide is a leading cause of death in young adults in the United States and currently available antidepressants often take weeks to kick in. There is great interest in glutamate mechanisms in major depression as a promising new target. One of the drugs that works on glutamate you may know as an illegally obtained illicit drug called ketamine or Special-K. Ketamine is used rarely for anesthesia in people and more commonly in animals.
Try to wrap your mind around the use of ketamine in depression and remember that SSRI antidepressants like citalopram (Celexa) improve depression only about 28% of the time and take 3 – 4 weeks for any effect.
Let’s look at the science. In studies on people with depression, one intravenous dose of ketamine can alleviate depressive symptoms in patients within hours, and its effects last up to 14 days. If someone is suicidal this may present a better solution than taking an antidepressant for 3 weeks before you may feel improvement.
How does ketamine work for depression? The answer lies in the NMDA glutamate receptor, and ketamine is an NMDA receptor antagonist (which means it blocks the effects). While we don’t know the true role of glutamate in major depression, ketamine causes an increase in glutamate release which may be the mechanism of its antidepressant effect.
How is ketamine used? In studies on depression and bipolar disorder, ketamine is given as an infusion over 40 minutes. Many studies are now looking at repeated infusions which have a more sustained effect than a single dose.
Does it work? Yes. The response rate in people with major depression is 20 – 90%. In people given repeat infusions it’s better, and after the 6th ketamine infusion one study showed significant improvement in 85% of folks with depression. In those who have received Ketamine infusions for 5 days, the improvement in their symptoms lasted for 12 months after use.
What’s the downside? Well, the psychotomimetic effects of Ketamine are impressive. Psychotomimetic effects mean Ketamine causes psychosis, delusions, delirium, and hallucinations. It also causes dissociative effects meaning users feel detached from reality.
What other drugs work like ketamine and can be used for depression? GLYX-13 (this will get a new name if it’s FDA approved) is a new NMDA receptor partial agonist that has completed trials and been shown to be effective for major depressive disorder. GLYX-13 does not cause those dissociative effects like Ketamine with less visual and auditory distortions among other things.
Stay tuned because there appears to be a role for ketamine in bipolar disorder as well.
Believe it or not medication recalls happen on a daily basis, for all kinds of reasons. The severity of recalls can range from very minor to potentially life-threatening incidents if they aren’t immediately taken care of.
Are there different types of drug recalls?
Yes. Drug recalls are broken down into the following classes:
- Class I
- Class II
- Class III
What is a Class I recall?
A Class I recall is the most serious type of recall. The FDA defines a Class I recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
What is a Class II recall?
A Class II recall is the most common type of recall, and not as serious as a Class I. According to the FDA, a Class II recall is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Example: In 2010 the recall of various lots of injectable ketorolac due to the possibility of tiny particles in the vial.
What is a Class III recall?
Class III recalls are the least serious, and Class III recalled products aren’t likely to cause adverse consequences.
Who can recall a drug?
A manufacturer can voluntarily initiate a recall, or the Food and Drug Administration (FDA) can either request or require that a manufacturer recall a particular medication.
The majority of recalls are voluntary. The FDA rarely requests a recall but they do play a supervisory role to make sure the company does everything properly to ensure the safety of those affected by the recall.
What type of medication recalls is the FDA involved in?
The FDA has control over recalls ranging from human drugs, vaccines, medical devices, and biological products; to cosmetics and food; to food and drugs intended for animals.
What is the significance of recalls?
The use of a recalled medication, depending on the recalled reason, may result in physical harm.
To use the recent gabapentin recall as an example, a medication that has empty capsules in the batch can lead to missed doses—which could result in decreased effectiveness, short-term withdrawal, and seizures if you are using this medication to prevent them.
However, not all recalls are this serious. Another example of a recent but less dangerous recall is the over-the-counter lubricant eye drop Oasis TEARS. This product was recalled because in one particular lot, the actual bottle wasn’t labeled in the packaging. Even if the medication inside the bottle is correct, it can be scary if you receive an unlabeled product.
How are patients notified if their medication is recalled?
You may be notified by telephone, mail, fax, or email if your medication or medical device has been recalled.
Recall information may also be posted on the manufacturer website, however, this isn’t the primary means of providing notification to patients.
Who notifies a patient if their medication is recalled?
You may be notified by the FDA, the manufacturer, or the dispensing pharmacy.
Sometimes the FDA will publically announce a recall via news and other media to reach more people; however, not all recalls are announced in the media.
In July 2011, the FDA began a program to notify people of drug recalls before they are grouped into classes I, II, or III as mentioned above. The unclassified recalls are published every Wednesday in the Enforcement Report titled Human Drug Product Recalls Pending Classification, which can be found here.
What should I do if I have questions about a recalled product?
You can contact the manufacturer of the product via telephone, email, or through their website. Contact information is also typically included in the recall announcements.
You may also contact the FDA with any questions or concerns:
• Toll free phone numbers: (855) 543-3784 or (301) 796-3400
• Email: firstname.lastname@example.org
• Drug Recalls webpage
Where can I find more information on animal & veterinary recalls?
Check out the FDA webpage for Recalls & Withdrawals for animal & veterinary products here.
Where can I find out more information on biologic recalls?
Check out the FDA webpage for Recalls on Biologic products here.
How can I find out more information on medical device recalls?
Check out the FDA webpage for Recalls on Medical Devices here.