Most of these insulins have been designed for use in adults. However, a new short-acting insulin has been approved for use in children—Humalog Junior KwikPen.
What is Humalog prescribed for?
Humalog is indicated for the treatment of diabetes type 1 and diabetes type 2. Humalog Junior KwikPen is specifically indicated for use in children, who require smaller doses of insulin compared to adults.
What’s unique about the Humalog Junior KwikPen?
The Humalog Junior Kiwkpen can dose in half unit increments. This precise dosing is a benefit for children with diabetes who require smaller doses of insulin.
The Junior Kwikpen is also prefilled, and disposable so you can toss it when you’re done.
Can I share my KwikPen?
No. All Humalog products should not be shared even if a new needle is used.
The main difference is the number of units a patient can receive. The Humalog KwikPen can give up to 60 units per injection whereas the Humalog Junior KwikPen can only give up to 30 units per injection.
Both the Humalog and Humalog Junior KwikPens are the same strength which is 100 units per mL. Each Humalog Junior KwikPen contains 300 units of insulin.
Do any other short-acting insulins have a ‘Junior’ product?
Sort of. Novolog has the NovoPen Echo, a device that allows for half-unit dosings. Novolog used to make a NovoPen Junior, however, it was discontinued in March of 2013 and replaced by the NovoPen Echo.
The FDA (Food and Drug Administration) may seem like it’s been around forever, but it was only just over 100 years ago. It was created as a result of the Pure Food and Drug Act of 1906, which prohibited the sale of adulterated or misbranded drugs. At that time though, the law did not yet require that drugs be approved by the FDA.
It wasn’t until 1938 that the Federal Food, Drug, and Cosmetic Act was passed, requiring that new drugs be found safe. It took another 24 years after that for amendments to be made to the law stating that drugs must be both safe and effective in order to be approved.
What does this have to do with the prescriptions you take today? Well, believe it or not, some prescription drugs still on the market today have been in use since the early 1900s. When the law was changed in 1962, the drugs that were approved in that 24 year gap (between 1938 and 1962) were reviewed by the FDA for effectiveness, in addition to safety.
However, that still left drugs approved before 1938 in a bit of a grey area. These “unapproved” medications haven’t had the thorough evaluation required by the FDA today, but they were “grandfathered” in under the law, meaning they were not required to go through the same approval process as new drugs.
Are generic medications considered unapproved?
No. Generic medications and the companies that make them go through an extensive process in order to be approved by the FDA. Generic drugs must be proven bioequivalent (that they work the same) as the brand name medication.
Many unapproved drugs are marketed without brand names and have been available for many years, causing people to often assume that these unapproved drugs are generic drugs; however, this is not correct.
How do I know if my medication is FDA approved?
If you want to double check and make sure your medication is FDA approved, you can use the FDA Approved Drug Products tool.
If you don’t see your drug, it may be unapproved. Keep in mind though, some other types of specialty or biologic medications may also not return results—those are approved through a different process with the FDA.
Is the FDA doing anything about these unapproved medications?
Yes. In 2006, the FDA started an initiative to remove these unapproved medications from the market. Basically, the FDA is telling companies who manufacture these unapproved medications to get their medication approved or remove it from the market.
The FDA also came up with a final guidance document that outlines how they plan to put all unapproved medications through the approval process, starting with those medications that pose the greatest health risk to the public.
The following medications are given the highest priority:
- Drugs with potential safety risks
- Drugs that lack evidence of effectiveness
- Health fraud drugs
- Drugs that present direct challenges to the new drug approval and OTC drug monograph systems
- Unapproved new drugs that are also violative of the Act in other ways
- Drugs that are reformulated to evade an FDA enforcement action
Since this initiative began in 2006 the FDA has removed around 550 unapproved drugs from the market—and worked with manufacturers to get the approval process started for others.
What are examples of some unapproved medications?
A few current (and some previously) unapproved medications include:
- nitroglycerin tablets
- morphine concentrated solution
- morphine sulfate solution
- chloral hydrate
- pheniramine maleate and dexbrompheniramine maleate (in cough and cold combination drugs)
Are there any downsides to unapproved medications getting FDA approval?
For the most part, it’s a good thing—it means the medication you’re taking has been evaluated and approved under modern standards.
However, the approval process can be very expensive, and it can mean that a drug that was previously very inexpensive might increase in price. Colchicine, for example, is a gout medication that was unapproved until 2009. It was only available as brand-name Colcrys for some time after that, at a much higher price.
Now, there is an authorized generic available—but even the new generic colchicine still costs over $100 for a 30-day supply at most pharmacies.
I’m taking an unapproved medication—should I be worried?
If you find out you are on an unapproved medication, don’t stop taking it without talking to your health care provider! Your doctor or pharmacist will be the best person to answer any questions you might have about your prescription.
If you are worried, bring up your concerns, and they can take into consideration your response to the drug, the benefits and risks, and whether any FDA-approved alternatives are available.
Where can I find more information on unapproved medications?
Here are a few references to get you started:
- What are unapproved drugs and why are they on the market?
- Unapproved Drugs Initiative
- FDA Issues Revised Guidance on Marketed Unapproved Drugs
- Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval
- Unapproved Prescription Cough, Cold, and Allergy Products
- Questions & Answers: FDA’s Removal of Unapproved Prescription Drug Products Containing Codeine and Dihydrocodeine from the Market
- Do You Take Unapproved Drugs?
It’s not being overly dramatic to say that abnormal levels of potassium may actually kill you. Serum (bloodstream) potassium is an electrolyte, and imbalances are called hyperkalemia (when too high) and hypokalemia (when too low). Cardiac arrhythmias are a known serious outcome of both hypo- and hyperkalemia, and national statistics indicate that almost half of 1% of emergency department visits and 2% of hospitalizations for high potassium end in death.
High or low potassium may occur as a result of your medications—and older folks and women are more likely to be affected. Here’s what you need to know.
What are electrolytes?
Electrolytes like sodium, calcium, and potassium control the fluid balance in the body and are important for muscle contraction. You may not have any symptoms when electrolytes are abnormal so your doctor needs to check a basic metabolic panel blood test when you are on medications that may alter these.
What might happen with LOW potassium (hypokalemia)?
Muscle weakness that begins in your lower extremities then moves to your trunk and upper extremities, decreased appetite and nausea, and a variety of heart arrhythmias are seen in patients with hypokalemia. While it’s hard to say how low your potassium has to be to contribute to heart arrhythmias—generally speaking potassium levels lower than 3.0 (normal is 3.5-5.0) put you at much greater risk.
What might happen with HIGH potassium (hyperkalemia)?
The scary truth is high potassium, at levels over 5.5, may present with life-threatening complications that go unrecognized (there are few symptoms) prior to cardiac arrest. Non-cardiac related signs and symptoms include altered mental status, confusion, muscle cramps, and weakness.
Which medications may lower your potassium (hypokalemia)?
- Diuretics are water pills with two familiar forms: loop diuretics (furosemide/Lasix, bumetanide/Bumex) and thiazide diuretics (hydrochlorothiazide or HCTZ, chlorthalidone). Used to treat blood pressure, heart failure, and lower extremity swelling, diuretics are the main cause of low potassium. Think of potassium as following water out of the kidneys—so increased urination from diuretics may lower your potassium.
- Albuterol (Proair, Proventil) inhalers used in the treatment of asthma may lower your potassium. Albuterol stimulates the release of insulin which “pushes” potassium into the cells, thus lowering the amount of potassium in your blood. This may cause hypokalemia. Know that nebulizer treatments lower potassium more than inhalers.
- Sudafed (pseudoephedrine) is available over the counter as a decongestant. It also pushes potassium into the cells, lowering your blood/serum level of potassium.
- Insulin at high doses also may lower potassium in the blood by shifting potassium into the cells.
- Laxatives and enemas at large doses can cause loss of potassium in the stool. Intestinal loss of potassium due to diarrhea may occur if you are using high doses of laxatives or enemas.
- Risperdal (risperidone) and Seroquel (quetiapine) are antipsychotic meds that may cause hypokalemia, but it’s a rare complication.
Which medications may raise your potassium (hyperkalemia)?
- The ARBs (angiotensin II receptor blockers): losartan, telmisartan, valsartan, irbesartan used to lower high blood pressure may raise your potassium. Simply put, these medications decrease aldosterone, which impairs release of potassium from the kidneys. As many as 10% of patients taking these meds may experience at least mild hyperkalemia, and your electrolytes need to be checked after you are started your prescription.
- ACE Inhibitors are blood pressure lowering medications ending in -il like lisinopril, enalapril, quinapril. They also raise potassium similar to ARBs.
- Important to note: many combination pills exist with ACE inhibitors or ARBs and HCTZ (lisinopril/HCTZ, valsartan/HCTZ). Those two medications together in one pill help normalize potassium—one raises it and one lowers it. The upshot is that the combinations carry less risk of potassium abnormalities.
- Aldactone (spironolactone) is a “potassium-sparing diuretic” that may raise potassium by inhibiting the effects of aldosterone. Spironolactone may be prescribed for acne, cirrhosis, PCOS (polycystic ovary syndrome), and heart failure.
- NSAIDs. Ibuprofen (Motrin, Advil) and naproxen (Aleve) may raise potassium by inhibiting the hormone renin, which impairs the release of potassium by the kidneys.
- Cyclosporine and Prograf (tacrolimus) are used in organ transplant patients to prevent rejection. High potassium is a common problem in patients treated with these drugs.
- Heparin is a blood thinner given intravenously for blood clots or heart attack, and it may also raise your potassium.
- Propranolol and labetalol are beta blockers that may bump up your potassium a bit, but not significantly. Beta blockers inhibit the uptake of potassium into the cells causing an increase in your serum (bloodstream) potassium. This does not occur with atenolol, another beta blocker.
Bottom line: don’t mess with potassium, make sure you are having it monitored.
Reference: HCUPNet: Healthcare Cost and Utilization Project. Rockville , MD : Agency for Healthcare Research and Quality, 2010.
The United States, Puerto Rico, and many islands in the Carribean have recently faced an immense amount of destruction thanks to mother nature. Several hurricanes and tropical storms have devastated many areas, causing destruction to communities, widespread power-outages, and quite possibly, drug shortages.
How could this cause a shortage?
Around 10% of drugs prescribed in the United States are manufactured in Puerto Rico. Pharmaceutical companies like Eli Lilly, Pfizer, and Baxter are just a few of the many manufacturers that have facilities located in Puerto Rico.
In response to these natural disasters, the FDA Commissioner, Scott Gottlieb, M.D., issued a statement regarding the potential for drug shortages. According to the FDA Commissioner, the pharmaceutical industry is responsible for nearly 90,000 jobs and for 72.4% of Puerto Rico’s 2016 exports totaling $14.5 billion.
You can read more of this statement here.
What drugs have been affected?
The types of medications and medical products produced in Puerto Rico include HIV and cancer drugs, immunosuppressants used by organ transplant patients, diabetes devices, and even hospital IV bags.
What is being done to address the shortages?
In order to address current and future problems, the FDA has been working with pharmaceutical companies to create a task force to prioritize efforts and address the potential for medical product shortages.
According to the American Society of Health-System Pharmacists (ASHP) the FDA is tracking 40 critical medications — 12 that are not produced outside of Puerto Rico — that are at risk of being in short supply because of hurricane-related manufacturing delays.
While there are no shortages yet, a small number may appear in the next couple of weeks. Stay tuned, we will keep you updated!
Asthma can feel different for everyone affected by it. For some people, allergies and various environmental allergens play a major role in the severity of their asthma. For others, triggers like perfume or exercise can lead to breathing problems.
If you have asthma, your doctor will most likely prescribe you a controller inhaler as well as a rescue inhaler. Controller or maintenance inhalers like Symbicort, Advair, and Flovent are used regularly to decrease the inflammation and swelling in the lungs associated with asthma. Rescue inhalers, on the other hand, are used to open your airways immediately when you’re having an asthma attack. These include Proair, Proventil, and Ventolin.
Using your maintenance inhaler regularly can help lessen the frequency and severity of asthma attacks—but many people aren’t using their maintenance inhalers correctly.
To help keep more people on track, a company called Adherium has recently received FDA clearance for their SmartTouch sensor. The sensor will only be used with AstraZeneca’s Symbicort inhaler for now.
What is SmartTouch?
SmartTouch is a device installed onto a an inhaler that will monitor and encourage adherence (taking your prescription as intended) as part of a self-management plan.
What is it meant to do?
According to the press release from Adherium, it’s common for patients with respiratory conditions, like asthma, to take only 30 – 50% of their prescribed medications! And believe it or not, they aren’t alone. The World Health Organization (WHO) notes that on average, 50% of folks suffering from chronic illnesses do not take their medications as prescribed. What’s the downside? It can be outright dangerous, with consequences including (obviously) your condition getting worse, but also increased costs, and even death.
How does SmartTouch work?
The SmartTouch device records the date and time the inhaler is used and automatically sends the info to an app on your phone or tablet.
It stores the history of your usage patterns, which also lets your doctor review the information and help make evidence-based decisions on how to best to meet your needs.
How is the device used?
SmartTouch is placed over the Symbicort inhaler—it’s designed to make installation and removal easy for everyone.
The SmartTouch design includes three buttons that help you easily access the audio-visual reminders, battery monitoring, and bluetooth pairing features.
How will SmartTouch help me?
According to Adherium, the SmartTouch can improve adherence by up to 59% in adults and 180% in children. That increased adherence was also associated with a 60% decrease in severe respiratory episodes in adults.
Is there already anything like SmartTouch out there already?
There are a couple of similar devices made by other companies, including CareTRx (previously known as GeckoCap, and recently purchased by TEVA pharmaceuticals) and Propeller Health (partnered with Boehringer Ingelheim).
Adherium also makes two otherdevices for inhalers (SmartTurbo and SmartTouch AV), but neither have been approved by the FDA for use in the US yet.