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.
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: email@example.com
• 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.
A pharmaceutical company can decide to discontinue a medication for many reason reasons. Just like any other business, if a product does not sell as expected, the company can decide to stop making it—and this just what happened with Vertex Pharmaceuticals’s hepatitis C med Incivek.
What is Incivek used for?
Incivek is indicated for the treatment of adults with genotype 1 hepatitis C to be used in combination with peginterferon alfa and ribavirin. Hepatitis C is a viral infection that affects the liver and causes swelling and inflammation. It is contracted through the contact of blood from another person who is infected with the Hepatitis C virus.
Why was Incivek discontinued?
In the past few months the market for hepatitis medications has drastically changed with the introduction of new medications such as Sovaldi, Olysio, and the recently approved Harvoni. All three drugs have changed the way we treat the majority of patients with hepatitis C—specifically, these new options mean the use of fewer medications.
With that being said, Incivek was ultimately discontinued due to the alternative treatments that are available which have lead to a decrease in demand for older treatments.
When will the discontinuation take place?
The official discontinuation of Incivek was to take place by October 16, 2014.
However, Vertex Pharmaceuticals has instructed pharmacies to continue to fill prescriptions for patients who need to complete their course of therapy, and to call the prescribing doctor for any new prescriptions received to inform them of the discontinuation of Incivek. Courses of treatment are typically 12 weeks, so if you have been receiving Incivek, you should still be able to finish your treatment.
Coughing brings many of you to the doctor. Most of this is acute bronchitis, an inflammation of the bronchi (airways) due to upper airway infection. For almost all of you, it is self-limited and will go away on its own. It may surprise you to know this respiratory condition is generally caused by a virus, but reports indicate that more than 60 to 90 percent of patients with acute bronchitis who come to the doctor are given antibiotics. A startling 75 percent of all antibiotic prescriptions are written for upper respiratory infections. Most of these, you don’t need. We should all care about this because in addition to promoting antibiotic resistance, antibiotic use accounts for over 19 percent of all emergency department visits for adverse drug events.
Here are 10 things that will reassure you that supportive care may be all you need:
- What to expect. With an acute bronchitis you may have a cough lasting more than five days, typically one to three weeks, and you may cough up sputum. Cough goes along with other viral upper respiratory infections but if you have a cough that persists more than five days you likely have acute bronchitis.
- What about antibiotics? This has been well studied and doing nothing (placebo) or taking ibuprofen, compared to either Augmentin or amoxicillin, did not significantly decrease the number of days with cough or the probability of cough resolution. Multiple studies indicate that people with acute bronchitis do not experience significant benefit from antibiotic therapy.
- How do I know I have bronchitis and not pneumonia? Pneumonia, unlike acute bronchitis, does require antibiotic therapy. Fever is an unusual sign in patients with acute bronchitis and suggests instead either influenza or pneumonia. If you have the combination of cough, fever, sputum production, and constitutional symptoms (body ache, headache, fatigue, nausea, no appetite) you are more likely to have influenza or pneumonia.
- With acute bronchitis you will have few systemic symptoms (nausea, body aches, etc) though you may have chest wall tenderness related to muscle strain from coughing. Wheezing may also occur.
- But I’m still coughing, is that ok? Cough in patients with acute bronchitis usually lasts from 10 to 20 days. Cough disappeared by day 14 in three-quarters of patients with viral bronchitis in one study, but in other studies it’s longer with an average of 24 days. Yes, I know that is LONG.
- If I cough up green or yellow sputum doesn’t it mean I need an antibiotic? No. Purulent sputum is reported in 50 percent of patients with acute bronchitis (viral). This usually represents sloughing of cells from the trachea and airways, along with inflammatory cells. Purulence does not signify bacterial infection, contrary to what many of you think.
- Do I need blood tests or chest x-ray? For most patients with acute bronchitis, the diagnosis is based upon the history and physical examination, and further testing is not needed. A chest x-ray may be done if you have abnormal vital signs (pulse faster than 100 beats/minute, respiratory rate greater than 24 breaths/minute, or temperature higher than 100.4 degrees). This is different for patients over 75 who may have pneumonia without mounting a significant fever so fast breathing, decreased oxygen saturation, and decreased mental status with cough should still lead to a chest x-ray.
- But, I’m also wheezing. Yes, this is common with acute bronchitis where your cough may be accompanied by bronchospasm. Mild shortness of breath may also be present in some patients. Physical examination of the chest may reveal wheezing and if you are short of breath you should check in with your doctor.
- What should I take for my acute bronchitis? You may benefit from symptomatic treatment using a nonsteroidal anti-inflammatory drug: ibuprofen (Motrin, Advil), aspirin or acetaminophen (Tylenol). Routine use of inhalers like albuterol (Proventil, Proair) for the treatment of acute bronchitis is not helpful either and no significant differences were noted in daily cough scores or persistence of coughing at seven days.
- What does work for my cough? Many cough suppressants don’t work well to suppress the cough from acute bronchitis. Prescription cough suppressants like Tessalon (benzonatate) capsules or codeine cough syrups work but not very well. A review of over-the-counter (OTC) medications for acute cough found variable results for effectiveness of guaifenesin (Mucinex) or antihistamine-decongestants (Dimetapp, Delsym, Theraflu) and concluded that there is no evidence for or against the effectiveness of OTC preparations for acute cough. Honey suppresses cough better than over the counter meds in children (and possibly adults) by forming a soothing film over irritated mucous membranes.
What has worked for you?