Medicare Program to Limit Insulin Costs to $35/month.
5/12/2023 Things to Know about Medicare Insulin Costs
- As of January 1, 2023, your Medicare drug plan can’t charge you more than $35 for a one-month supply of each Part-D covered insulin product, and you don’t have to pay a deductible for your insulin. You’ll pay $35 (or less) for a one-month supply of each Part-D covered insulin product, even if you get Extra Help to lower your prescription drug costs.
- If you get a 2- or 3-m2.onth supply of Part D-covered insulin, your costs can’t be more than $35 for each month’s supply. For example, if you get a 2-month supply of a Part D-covered insulin, you won’t pay more than $70 for that 2-month supply.
- If you get a Part D-covered insulin product and pay more than $35 for any month’s supply between January 1, 2023 and March 31, 2023, your Part D plan must reimburse you within 30 calendar days for the amount you paid that’s over $35 per month’s supply. (Part D plans have until March 31, 2023, to update their systems to make sure you’re charged the correct amount.) If you haven’t received reimbursement within 30 days, contact your plan.
- If you use a covered insulin product and decide you’d like to be in a different Part D plan for 2023, you can add, drop, or change your Part D coverage one time between now and December 31, 2023. If you change plans mid-year, your True Out-of-Pocket (TrOOP) costs will carry over from your old plan to your new one. Call 1-800-MEDICARE (1-800-633-4227) if you take insulin and want to change your plan. TTY users can call 1-877-486-2048.
- If you use a disposable insulin patch pump, you’ll continue to get your insulin through your Part D plan, and the insulin for your pump won’t cost more than $35 for a month’s supply of each covered insulin product. If your Part D plan covers disposable insulin patch pumps, the pump is considered an insulin supply. Because it isn’t an insulin product, the pump isn’t subject to the $35 cap and might cost more than $35.
Why is my medicine so expensive? What can I do about it? Jan. 7, 2020.
This is how it works; pharmacy benefit managers (PDMs) create formularies of “covered or preferred drugs”. To get on the covered formulary, drug manufacturers must give the PDM a discount (kickback). The pharmacy benefit managers then create a high 
deductible and a high copay, so the patient ends up with huge out of pocket expenses. PDM’s are discouraged from listing lower priced drugs on their formularies because there is less opportunity for a discount. Follow the $.
Everybody’s talks about the price of insulin but hardly anybody is doing anything about it. A bipartisan bill was introduced in July known as Insulin Price Reduction Act. It was endorsed by the American Diabetes Association and JDRF. The bill provides incentives for manufacturers to reduce the list price of all insulin products to their 2006 list price. Importantly, these lower-priced products would not be subject to deductibles or PDM rebates. It was read twice in the Senate and referred to the Finance Committee and hasn’t been heard from since. In December the House passed a bill that would require Medicare to negotiate the price of 50 to 250 prescription drugs they say would lower consumer drug spending by 55% and save the federal government nearly $400 billion. The FDA now fast tracks approval for generics. Generics have been approved for lispro (Humalog), aspart (Novolog) and dapagliflozin (Farxiga). Should be available soon.
What can you do?
Regular commercial insurance
Use manufacturer discount cards. Be sure to request these from your prescriber.
Shop pharmacy prices, they can vary quite a bit.
Request generics when available.
Consider cash price with discount card. NeedyMeds offers a drug discount card that provides a savings up to 80% on many medicines. The card is free and available to everyone. There is no registration 
and your entire family can use the same card. GoodRx offers multiple discounts with its prescription discount card including prescription coupons on a prescription-by-prescription basis. Get even deeper discounts for around $5.99 per month with GoodRx Gold. Freestyle Libre retails for $142 at CVS with GoodRx Gold $112.79.
I searched GoodRx for cash price of GENERIC Novolog (FDA approved): 5 Flexpens $123.9 Walgreens; $262.20 CVS; $258.98 Walmart.
Medicare Part D
Consider cash price with discount card. GoodRx has a coupon that can be used with Medicare if paying cash. Sometimes the discounted cash price is less than the copay. The pharmacist MUST not file the prescription with Medicare in this instance.
Gabapentin for nerve pain - safe or not?
Gabapentin is often the first line of treatment for diabetic neuropathy pain. It has been around since 1993, originally approved for the treatment of epilepsy. The FDA warns that serious life-threatening and fatal respiratory problems may occur from the drug, especially if used at the same time as opioids or antidepressant/anxiety medications. Gabapentin is not an opioid and is not a controlled substance but requires a prescription. The nonopioid feature makes it a good starting point for diabetic polyneuropathy and other nerve related pain. The main treatment for diabetic neuropathy, however is control of the diabetes. Gabapentin and Lyrica work by reducing the excitement of nerves, one of the mechanisms of pain. The problem is that it works anywhere there are nerves including the brain. The most common reported side effects are dizziness, somnolence and swelling of the legs and feet. Only 20% of patients reported improvement in a study of patients taking gabapentin for diabetic neuropathy.
PROS
Generally safe when compared to other pain medications and opioids.
Generic formation available, generally cheap.
CONS
Should be used very carefully in patients with chronic obstructive lung disease COPD and elderly patients.
Should not be used with central nervous system depressions e.g. opioids, anti-anxiety medications such as benzodiazepine drugs e.g. Xanax, Valium
Coronavirus
The coronavirus is coming. As of 1/26/2020, cases were positively identified in Washington, Illinois and California. This morning there is a report of a suspected case in North Carolina. There is no doubt, it will be here. There are 50 suspected cases still under investigation as of January 24, 2020.
1/26/2020
Do you remember SARS (Severe acute respiratory syndrome)? SARS (SARS-CoV) is a coronavirus. The current virus, 2019-nCoV, also known as MARS-CoV, is a new coronavirus in the same class. Illness from 2019-nCoV was first detected in Wuhan, China. Several confirmed cases have been identified in the US with over 60 suspected ones still under investigation.
SYMPTOMS: Patients with confirmed infection had a mild respiratory illness much like a common cold. It progresses to fever, cough and shortness of breath. A good number of patients advanced to pneumonia with a high fatality rate.
TRANSMISSION: Coronal viruses spread primarily from mouth and lung droplets produced when an infected person coughs or sneezes. Influenza spreads in a similar manner. It can likely be passed by an infected person who coughs in the hand then shakes the hand of a susceptible person. The virus infects the second person when she/he scratches the nose or somehow gets infected material in the respiratory tract.
PREVENTION:
- Wash hands often with soap and water for at least 20 seconds. If soap and water are not available, use an alcohol-based hand sanitizer.
- Avoid touching eyes, nose, and mouth with unwashed hands.
- Avoid close contact with people who are sick.
- Stay home when sick.
- Cover your cough or sneeze with a tissue, then throw the tissue in the trash.
- Clean and disinfect frequently touched objects and surfaces.
- Bump fists rather than shake hands (my idea).
- There are no approved drugs for the treatment of coronavirus infections. There is no vaccine. Source CDC.
Tips to keep your sugar from going off the chain over the Holidays.
- Check sugar more often than usual, especially if driving or adjusting insulin or medication.
- Be party smart. At a party, try the vegetable-based appetizers 1st then carbohydrates and/or fat. Place your appetizers on a napkin instead of a plate, that limits the amount you can get at one time😊.
- Be careful with alcohol. Moderate alcohol can reduce your blood sugar, don’t drink on an empty stomach. A recommendation for alcohol intake with diabetes is “have no more than 1 drink per day for women and no more than 2 for men.” Generally, 1 drink equals 4 ounces of wine, 12 ounces of beer or 1 ounce of whiskey.
- Eat smart. You may not be able to control what food you’re served, and you’re going to see other people eating tempting treats. If you have a high carb treat, cut back on other carbs (like potatoes and bread) during the meal. If you slip up, get right back to healthy eating with your next meal.
- Be kind to yourself. Have fun. It’s okay to make mistakes, to forget things, and fall off track sometimes. It’s part of life and life isn’t perfect. Be gentle with yourself and remember that doing your best is all you can ask of yourself. The most important thing about this time of year is that you can enjoy the festivities and the company of your loved ones. Believe in yourself and show yourself the unconditional love, self-care, and nourishment you deserve! (CDC)
Do you just HATE shots? With type 2 diabetes there is something new.
The newly available drug is called Rybelsus. It is in a class called GLP1 receptor agonist. There are several of these available on the market for injection. Examples include Victoza, Bydureon, Trulicity and Ozempic. Rybelsus Is the first one to be taken by mouth.
Rybelsus must be taken once daily in the morning, at least 30 minutes before food or other medications and followed by a full glass of water. It has the same warnings as the injectable GLP1 products including the potential increased risk of thyroid c-cell tumors. People who have had medullary thyroid carcinoma (MTC) or who have a family member who has had MTC are advised not to use Rybelsus or any GLP1 product. There are also has warnings about pancreatitis (inflammation of the pancreas), diabetic retinopathy (damage to the eye’s retina), hypoglycemia (low blood sugar), acute kidney injury and hypersensitivity reactions.
Rybelsus may be slightly less effective than the injection GLP1 products. It comes in 3, 7 and 14 milligram sizes. It is recommended that a patient take the lower dose for a full month before advancing to in the higher doses.
Should I take Cinnamon to help my blood sugar?
One study shows that cinnamon reduces fasting blood glucose, but 
only by small amounts. Cinnamon in these studies reduced blood sugar by approximately 8.6 MG/DL with a range +/- 3 MG/DL. Therefore, taking cinnamon might reduce your morning fasting blood sugar by 11.6 or 5.6 MG/ DL. If morning sugar 220, at best to 208 or at worse to 214. Not much bang for the Buck$.
Another study from Pakistan showed that several grams of cinnamon per day could lower the fasting blood sugar as well as cholesterol and other fats but strangely enough there was no effect on A1C. In an analysis of several studies on cinnamon with either type 1 or type 2 diabetes did not show any significant changes in A1C, fasting blood sugar or blood fats in comparison to patients receiving placebo.
The bottom line is that cinnamon will not cause problems if one does not have severe liver disease but taking it is probably not worth the trouble.
We all would like something natural, cheap, without the need for prescription and easy to use to reduce blood sugar. However, 
nothing beats plain old diet and exercise☹
Genteel Lancet Device
If you just can’t stand the pain of picking your finger, this device may be for you. It can also check sugar on sites other than the fingertip. Remember blood from some alternate sites may give a result several minutes behind the actual blood sugar, especially if it is changing rapidly. The same is true for continuous glucose monitors such as the Dexcom and Abbott Freestyle Libre System. It uses regular lancets and creates a vacuum to draw blood when activated. Downsides: it is larger and heavier than of the devices. Cost is $129 but on sale for $99 on Amazon and eBay. It is not likely to be covered by insurance.
Medtronic pump "recalls".
Recall number one involves older Medtronic products including 508, 511, 512, 515, 522, 523, 712, 722, 72
3K, 712 the, 554 and 754. “The FDA has become aware that an unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially connect wirelessly to a nearby MiniMed insulin pump with cybersecurity vulnerabilities. This person could change the pump’s settings to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis.” This is more of a warning that pumps in this class have the potential for cyber security risk. According to the FDA “Patients with diabetes using these models should switch their insulin pump to models that are better equipped to protect against these potential risks.”
My understanding is these pumps are designed to communicate by radio waves. Therefore, a cyber attacker would need to be reasonably close to hack your pump. There is a good chance the hacker would need to have the serial number of your pump to hack.
FDA Recommendations:
Keep your insulin pump and the devices that are connected to your pump within your control at all times whenever possible.
Do not share your pump serial number.
- Be attentive to pump notifications, alarms, and alerts.
- Monitor your blood glucose levels closely and act appropriately.
- Immediately cancel any unintended boluses.
- Connect your Medtronic insulin pump to other Medtronic devices and software only.
- Disconnect the USB device from your computer when you are not using it to download data from your pump.
Get medical help right away if you:
- Have symptoms of severe hypoglycemia (such as excessive sweating, feeling very tired, dizzy and weak, being pale, and a sudden feeling of hunger).
- Have symptoms of diabetic ketoacidosis (such as excessive thirst, frequent urination, nausea and vomiting, feeling very tired and weak, shortness of breath).
- Think your insulin pump settings or insulin delivery changed unexpectedly.
The 600 series “recall” is a safety notification involving the 670G, 640G, 632 and 630G 
Medtronic insulin pumps. In this case, the keypad buttons may become unresponsive when atmospheric pressure goes up or down quickly such as takeoff and landing during air travel. A letter sent to patients indicates “If this happens, in most cases you may not even notice because the pump will resolve this on its own”. In case the problem occurs, buttons on the pump will become temporarily unresponsive. We believe that all patients with using insulin pumps should have backup insulin and pens or syringes when traveling.
In a related item, Medtronic has launched a clinical trial of the 780g advanced hybrid closed loop system. The system is designed to automate bolus deliveries based on “user experiences, or is predicted to experience” or prolonged high glucose levels based on sensor readings.
Another medicine hits the dust because of (probable) cancer causing contamination. This time it’s ranitidine (Zantac), designed to decrease stomach acid. The problem is the same contaminant 
(NDMA)) that caused recalls in several blood pressure medicines over the past couple of years.
This medication Is taken by millions of people to treat heartburn, GERD, ulcers etc. NDMA (N-Nitrosodimethylamine) has been found in many common products including cooked meats. It can be found in bacon. The FDA has stated it is reasonably safe to consume as much as 1 microgram of NDMA daily. According to Bloomberg, blood pressure pills were recalled for containing as much as 17 micrograms . One set of testing found as much as 3000 micrograms in Zantac pills and ranitidine generics.
What to do, stop taking Zantac or ranitidine. Contact your healthcare professional for a substitute if you need it. It is probably not a good idea to continually take these stomach acid tablets of any sort because they decrease the absorption of calcium which can lead to several problems.
Blood Pressure Medicine Recalls
3/3/2019
2018 – 2019 seem to be the years of blood pressure medicine recalls. The “SARTAN” group were hardest hit. These are a group of medicines called angiotensin II receptor blockers (ARBs). Recalls include losartan, Irbesartan and valsartan. They are used for blood pressure control. Somewhere in the range of 70 – 75% of patients with diabetes also have high blood pressure. Most guidelines recommend either ACE inhibitors (all end in “pril” e.g. quinapril) or ARBs for kidney protection. A good number of diabetes patients are therefore likely taking an ARB.
New as of 6/12/2019:
- Two lots of 50 mg strength losartan potassium tablets USP 50 mg. The tablets are green, film-coated, oval-shaped biconvex tablets with “LK 50” on one side and “>” on the other side.
- Four lots losartan potassium tablets, USP 100 mg. The tablets are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and “>” on the other side.
So, what’s all the fuss about? Traces of NDMA (n-Nitrosodimethylamine) was found in the recalled drugs. It is classified as a probable human cancer-causing agent. It is associated with cancer in test animals. NDMA was used to make rocket fuel but was discontinued after unusually high levels were found in air, water, and soil samples near a rocket fuel manufacturing plant. NDMA is, however, unintentionally formed during various manufacturing processes. “The primary sources of human exposure to NDMA are tobacco smoke, chewing tobacco, diet (cured meats [particularly bacon], beer, fish, cheese, and other food items), toiletry and cosmetic products (for example, shampoos and cleansers), interior air of cars, and various other household goods, such as detergents and pesticides. In addition, NDMA can form in the stomach during digestion of alkylamine containing foods. Alkylamines are naturally occurring compounds which are found in some drugs and in a variety of foods.” This, according to the CDC.
And the beat goes on. February 28, 2019 recall of losartan. Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg. The U.S. Food and Drug Administration released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China. It is confusing because not all these products have been recalled, just some from certain manufacturers, frequently overseas.
So, what to do?
What NOT to do is abruptly stop taking your medicines.
If you are taking losartan, valsartan or Irbesartan alone or in combination with other drugs such as hydrochlorothiazide or amlodipine there may be some risk.
- Check with your pharmacist to see if your prescription is in the recalled lot number. Your physician or NP is not likely to know.
- Request a change in medicine.
ARB drugs NOT YET involved with a recall (as far as I know) are:
Azilsartan (Edarbi)
Candesartan (Atacand)
Olmesartan (Benicar)
Telmisartan (Micardis)
Some “sartan” products a not recalled. FDA has a web site listing valsartan agents NOT recalled. See list.
11/16/2018
Losartan recall. Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg manufactured in Ljubljana, Slovenia. The recall is because of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen.
The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020. This product was distributed nationwide to distributors. The affected product was not distributed prior to October 8, 2018. RECOMMENDATION: If you have had a refill or new prescription for Losartan HCT in since October 8, 2018, check the lot number (JB8912) or call your pharmacist. Patients with questions regarding this recall can contact Sandoz Inc. at 1-800-525-8747 Monday-Friday 8:30 AM – 5:00 PM (EST) or email usdrugsafety.operations@novartis.com
Prescription drug prices diving you mad??
This information was researched from web sites of various plans. It is subject to change and I cannot guarantee accuracy.
Commercial Prescription Plan Deductibles
The most popular prescription plans in South Carolina are Blue Cross Blue Shield; South Carolina PEBA, Cigna and Express Scripts.
Deductibles for Blue Cross Blue Shield PEBA $490 individual and $980 family +$14 for physician office or video visit; $175 for emergency care; $105 for outpatient facility services.
Cigna. Deductibles for in-network and out-of-network providers: $2,000/individual or $4,000/family for out-of-network providers: $2,000/individual or $4,000/family Amount your employer contributes to your account: Up to $400/individual or $800/family.
How can I get help with out of pocket expenses with commercial insurance?
Tips for getting help with out of pocket expenses with commercial insurance.
- Ask your medical professional for discount cards.
- Shop around. Pharmacies have different prices Check with GoodRX,com for best prices in your area.
- Check with agencies that can help you with pharmaceutical company discounts. Download list here.
Medicare Part D Deductibles
Deductibles vary between Medicare drug plans. No Medicare drug plan may have a deductible more than $415 in 2019. Some Medicare drug plans don’t have a deductible.
How soon will the 2019 doughnut hole appear? Soon enough!
Initial Coverage Limit (ICL): $3,820
Out-of-Pocket Threshold (or TrOOP): $5,100
You’re in the doughnut after your total cost of medication (to the plan) reaches $3820.
You’re out of the donut hole once you have spent $5100.
TIP: Ask for cash price. Sometimes cash price is lower than Co-pay. If paying cash insist the pharmacy does NOT run it through your insurance. Medicare Part D is a voluntary program, my understanding is you can opt out for specific prescriptions at any time. If you pay cash, the retail cost of the drug doesn’t count toward the doughnut hole.
Check with Medicare.gov
How can I get help with out of pocket expenses with Medicare Part D? Download list here.
Diet soda linked to stroke.
An article published in the Journal Stroke (Feb.14, 2019) indicated an increased risk of stroke and heart disease in women having more than 2 diet drinks per day. Women using the diet drinks were twice as likely to have a stroke or heart problem. On the day the article was released Coca-Cola stock dropped 8.38% and Pepsi 1.34%. This may not be significant when compared to stock price swings. It will be interesting to see what happens over the next several days.
The risk of stroke in diabetics (type I or 2) is 1.5 times greater than a similar person without diabetes. It is not known if that is in addition to the risk from diet drinks. People with diabetes tend to use artificially sweetened products. According to the American Diabetes Association the risk of stroke is even greater if you:
- Are older than 55 years.
- Have a family background is African-American.
- Have already had a stroke or TIA.
- Have a family history of stroke.
- Have heart disease.
- Have high blood pressure.
- You are overweight.
- Have high cholesterol.
- Are not physically active.
What’s in diet soda?
A 12 ounce can of diet Pepsi lists the following ingredients: carbonated water, Caramel coloring, phosphoric acid, potassium benzoate, sucralose, acesulfame potassium, caffeine, natural flavor and citric acid.
Note there are 2 sweeteners in this soda. Sucralose is 200 times as sweet as sugar and acesulfame potassium is 650 times sweeter. Some believe that use of highly sweet products dulls the senses to sweetening therefore making people crave sugary, high-calorie foods.
What to do? All things in moderation. A teaspoon of sugar contains about 5 g carbohydrate, a slice of bread contains about 15 g, 12 ounces of regular Pepsi 41 g. If you use 2 teaspoons of sugar in your coffee the effect on your blood sugar will be less than eating a piece of bread.
Glaucoma
Glaucoma. If you are older and or African American or have diabetes you are more likely to have glaucoma. The most common form, open-angle glaucoma, accounts for 19% of all blindness among African Americans compared to 6% in Caucasians. Glaucoma is often treated with eye drops. When you run out of your glaucoma medicine, you run the risk of increased eye pressure and damage your vision. If you’re in a bind and no drops come from the bottle, there are a few tricks for a short-term work around.
- Store your “empty” eye drop bottle upside down (we use a wine glass).
- Place the bottles in the refrigerator.
Often, when you run out of regular drops, these upside-down stored bottles will yield one or two drops. Why the refrigerator? Chemicals breakdown at a lower rate when cold therefore remain effective longer.
Diabetes Pills Action and Side Effects
Medicine | Action | Side effects |
Metformin | Lowers glucose (sugar) released from the liver | Stomach problems, usually diarrhea. |
Sulfonylureas. Glimepiride (Amaryl), glyburide (DiaBeta), glipizide (Glucotrol) | Stimulate the pancreas to release more insulin. | Low blood sugar. Long acting, if sugar is low and corrected it’s likely to go low again in several minutes. Promotes weight gain. |
Meglitinides. Repaglinide (Prandin), nateglinide (Starlix) | Stimulate the pancreas to release more insulin. | Short acting, taken just before meals, less likely to cause low blood sugar. Promotes weight gain. |
Thiazolidinediones TZDs. Pioglitazone (Actos). | Makes insulin work better. Increases carbohydrate uptake by muscle and fat. | Weight gain, swelling, fluid retention. Might make heart failure worse. |
DPP-4s. Sitagliptin (Januvia); saxagliptin (Onglyza) linigliptin (Tradjenta) | Increases insulin level but only if blood sugar is elevated. | Rare. Stomach discomfort, diarrhea |
Alpha-glucosidase Inhibitors. Acarbose (Precose); | Absorbs carbohydrate from the GI tract. | Gas, gas, gas. Rarely diarrhea, upset stomach, abdominal pain. |
Bile acid sequestrants. Colesevelam (WelChol). Pills or powder. | Controversial. It may improve insulin action by decreasing free fatty acids from the liver. Lowers LDL cholesterol | Gas, diarrhea, constipation, rarely nausea. Interferes with other medications, must be taken several hours away from other pills. |
SGLT2 inhibitors. Canagliflozin (Invokana); dapagliflozin (Farxiga); empagliflozin (Jardiance); ertugliflozin (Steglatro) | Blocks reabsorption of sugar in the kidney. This effectively pulls sugar from the blood and places it in urine. | Increased urination, genital yeast infection, urinary tract infections, ketoacidosis, dehydration. Rarely decreased kidney function; Necrotizing fasciitis* |
Bromocriptine, (Cyloset) Rarely used. | Increases brain dopamine D2 and reduces sympathetic nerve action | Nausea, asthenia, constipation, dizziness, weakness. |
*Recently the FDA issued a warning about necrotizing fasciitis of the perineum occurring in patients taking SGLT2 inhibitors. Necrotizing fasciitis, also called Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissues around the genitals. It generally occurs in males between ages 50 and 79 and is estimated to occur in a little over 3 patients per 100,000 taking this class of medication.
Metformin recall
New as of May 31, 2020. Apotex and Amneal pharmaceutical manufacturers announced recalls of metformin ER (500 mg for Apotex – 500 + 750 mg for Amneal) on May 29. FDA still has not posted names of the other 3 companies. I suspect the delay is to avoid a run on metformin ER causing shortages.
This is where we stand on the metformin ER recall as I understand it.
- Manufacturers of pharmaceuticals are required by the FDA to test for impurities such as likely cancer-causing nitrosamines (NDMA). Apparently no unacceptable levels were self-reported.
- FDA tested batches of metformin ER and did not find levels of impurities greater than recommended standards.
- An independent pharmacy (Valisure) with its own laboratory tested for NDMA and found many batches containing unacceptable levels. Results were validated by another independent laboratory called Emory.
- In March, Valisure called upon the FDA to recall lots of metformin ER based on their independent results.
- On May 28, FDA announced requests to 5 companies for voluntary recall of metformin ER products. Apotex is the only one listed on the FDA website.
Several things in this situation are important.
1. Regular metformin (non-extended release) is NOT included in this recall.
2. There are many manufacturers of metformin ER not recalled and are listed as passing the independent and FDA laboratory tests. Apotex has not distributed products in the US since 2019. Please do not stop taking your medication without consulting your healthcare provider!!
- One can generally find the name of the manufacturer or an
abbreviation (e.g. APO, Mylan) at the bottom of the prescription label. - The independent laboratory Valisure has a dog in this fight. It is recommending independent testing of batches of generic medications to ensure purity. If this is adopted, it will be good for their business. Currently manufacturers test their own products for impurities and FDA tests samples. To see results of tests performed on metformin on over 20 pharmaceutical companies go to: Https://www.valisure.com/blog/valisure-news/valisure-detects-high-levels-of-ndma-in-metformin/
Gossip, lies, fake news and misconceptions about metformin.
All medicines have the potential for side effects. Any substance must change something in the body to have an effect. What is a good effect for some may be detrimental for others. One must weigh the potential benefits versus possible bad effects for any medication. Metformin, introduced in 1957, has stood the test of time. Since its introduction, several side effects have been observed. The most common complaint we hear about metformin is diarrhea or some other GI problem. Other listed side effects include physical weakness, gas, muscle pain, low blood sugar, abdominal pain, low levels of vitamin B12.
Fallacy #1: Metformin will kill your kidneys
Before 2006, patients with mild kidney problems such as
a creatinine of 1.5 were supposed to avoid metformin. This idea came from experience with the first drug in the class, phenformin (marketed as DBI by Ciba-Geigy). Phenformin caused lactic acidosis and bumped off a lot of folks before it was taken from the market. In the old days, ~50% of folks with Lactic acidosis did not survive. Metformin is different. The newer recommendations state metformin can be taken until the patient has stage 4 or even stage 5 chronic kidney disease.
Fallacy #2: Metformin leads to dementia.
There conflicting studies on this issue. The Alzheimer’s Drug Discovery Foundation has studied the problem. They found 3 studies reporting a decreased risk of dementia in diabetic patients taking metformin. Another study looking at pooled information (meta – analysis) suggested a trend for reduced risk of dementia with metformin. Three other studies reported an increased risk for impaired intellectual performance compared to those taking other medication. Only one study reported that longer metformin use was associated with an increased risk of dementia.
The causes of intellectual decline are multiple. Diabetes associated with Alzheimer’s has been dubbed “type 3 diabetes”. Long-standing high blood sugar damages blood vessels. The brain does not function well if it doesn’t get an adequate blood supply. This results in something called “vascular dementia”.
Some studies suggest a relation between Alzheimer’s disease and the brain’s ability to get usable insulin. Several small studies show improved brain function with inhaled insulin.
Long-term use of metformin has been associated with low vitamin B12 levels
Fallacy #3 Metformin is bad for your heart.
This rose out of the earlier experience with phenformin which was associated with lactic acidosis and resulted in its removal from the market. The thinking was that decreased oxygenation and changed metabolism would increase the risk of lactic acidosis. Metformin is eliminated by a different mechanism than phenformin. Numerous studies have failed to find that metformin carries a high risk of lactic acidosis.
New natural product for weight loss. Plenity
lI was excited about FDA approval of a new drug for weight loss called PLENITY®. This 
product, taken in capsules, expands with water and fills the stomach (about 25%). It is not a drug but a combination of cellulose and citric acid, natural products. A recent study published in the Journal “Obesity” showed 6.4% weight loss with Plenity over 4.4% for placebo. For someone weighing 210 pounds, that means over 13 pounds weight loss with Plenity Vs 9 pounds for placebo. Both groups were given a dietary and exercise programs for weight loss. The lesson: diet and exercise alone can produce 69% as much weight loss as this prescription product added to diet and exercise 
. Motivation is what’s missing from most weight loss efforts. When we get a pill for that…
The problem with all “artificial” weight loss programs is the effect doesn’t last unless there is also a persistent lifestyle change. We have many patients who had bariatric surgery or took medications like Belviq or phentermine. Most are right back where they started as the weight returned. The problem of obesity is simply consumption of more fuel that is being burned.
Drilling down into the details of Plenity®, enthusiasm decreased.
PROS
- Derived from natural products (cellulose and citric acid)
- No drugs absorbed into the body.
- Effective.
CONS
- User required to take 3 capsules before lunch and dinner with 16 ounces of water before the meal.
- Side effects involve abdominal distention, pain, constipation, diarrhea, flatulence (passing gas), infrequent bowel movements and nausea.
- Requires prescription
- Projected $$$ not published.
- No news on insurance coverage
You can do this without a prescription, but it is recommended that you get approval of your healthcare provider before starting this.
Just like Plenity, fiber expands in the stomach when water is added, the result is stomach filling. The most effective fiber forms are psyllium such as Metamucil®, Fiberall®. etc. you can even purchase generic, organic psyllium husk powder (Amazon, GNC). If one mixes 2 tablespoons of psyllium powder in 8 ounces of water, drink that and follow it with another 8 ounces of water, 20 to 30 minutes before meals, a similar effect as described above occurs. Several years ago, while practicing in Wisconsin, we performed an unofficial study with several patients utilizing this method. Of those who followed the program, 100% lost at least 5 pounds in 2 weeks. We attempted to expand the study but the company marketing the product (Fiberall®), Johnson’s Wax, refused to fund the project. The major drawback: drinking 16 ounces of water before a meal.
Disaster preparedness
Hoping that a disaster will not happen gets us into a lot of trouble. My dad used to say, “there is an inverse relationship between the likelihood of something happening and the level of preparedness for 
it”. In other words, the more prepared you are, the less likely the bad event will happen. The person with no spare tire is most likely to have a flat.
It is a good idea to create a kit for disasters. For those of us with diabetes, small items like extra batteries, supplies to check blood sugar and items to treat low blood sugar are easily forgotten. Insulin should be in a cooler with reusable cold packs but not close to dry ice (might freeze the insulin). The Diabetes Disaster Response Coalition has created a disaster check list.
Diabetes Emergency Kit
