Evidence from a large study in New Zealand for bacterial meningitis revealed an interesting finding – the meningitis B vaccine may help protect against gonorrhea. These findings are just observational though, and extensive clinical trials will need to be performed to ensure the effectiveness and safety of the vaccine.
Gonorrhea is a sexually transmitted infection caused by unprotected vaginal, anal or oral sex. It can be cured if properly treated, however, gonorrhea can cause complications like infertility, sepsis or arthritis if not treated.
On July 7th of this year, the World Health Organization (WHO) issued a news release that antibiotic-resistant gonorrhea is on the rise. With this resistance developing, it is expected that pharmaceutical companies will begin to explore forms of treatment such as vaccinations. Unfortunately, the vaccine that showed positive results for gonorrhea, MeNZB, is no longer available in the UK and has never been used in the United States.
It is too early to make assumptions about the use of the meningitis B vaccine, but this could be a step in the right direction towards preventing gonorrhea, especially amidst the emergence of bacterial resistance.
What is meningitis?
Meningitis is a life threatening infection that can cause inflammation of the brain and spinal cord membranes. Symptoms usually arise one week after exposure to the bacteria and include muscle pain, fever, lethargy, loss of appetite, nausea or vomiting. Currently, in the United States, there are three common forms of meningitis – B, Y, and C.
How can I protect myself against gonorrhea?
For now, the most effective way to prevent gonorrhea is to always use a condom during sex, even during oral or anal sex.
Are there any vaccinations available for sexually transmitted infections?
Yes. HPV is the most common sexually transmitted infection in the United States. The HPV vaccine can protect against disease (including cancer) caused by HPV, when given at the appropriate time. You can read more about the HPV vaccine, Gardasil, here.
Every three months, the FDA reviews and publishes reports of adverse reactions from medications they’ve received through the FDA Adverse Event Reporting System (FAERS). The FDA has been posting these quarterly updates since 2007, due to an update to the Food and Drug Administration Amendments Act that requires the FDA to publish a new list of potential signals of serious risks/new safety information identified every 3 months (see our overview of the previous list here).
Should I be worried if my prescription is on the list?
The FDA does emphasize that just because a medication appears this list, it doesn’t mean that the they have determined that the drug actually carries a risk. Following the quarterly update, the FDA will complete an evaluation of each potential safety issue and make additional announcements if they find anything further.
At the end of June 2017, the FDA released the list of medications for the first quarter (January – March) that potentially carry serious risks.
So which prescriptions is the FDA monitoring this quarter?
- Alli and Xenical (orlistat) are prescribed for weight loss. They are on the list due to reports of neuropsychiatric side effects (like mild cognitive impairment).
- Cubicin and Cubicin RF (daptomycin) are antibacterials (antibiotics) that appear on the list because of reports that confusion around the similar names causes prescribing and filling errors. To resolve the issue, the external package labeling has been updated, and the “Dosage and Administration” section of the labeling was updated to better differentiate the two formulations.
- Exjade and Jadenu (deferasirox) are prescribed for chronic iron overload, and they are on the list due to reports of fever and dehydration in children.
- Lupron (leuprolide), Lupron Depot PED (leuprolide), Supprelin LA (histrelin), and Synarel (nafarelin) are all used to treat central precocious puberty (CPP), a condition where girls under 8 years old and boys under 9 begin puberty too early. These prescriptions appear on the list due to reports of musculoskeletal and connective tissue pain and discomfort.
- Keppra (levetiracetam) products are typically used to treat seizures. They appear on the list due to reports of acute kidney injury and interstitial nephritis—a kidney condition characterized by swelling inside of the kidney. The “Adverse Reactions; Postmarketing Experience” section of the labeling for Keppra and Keppra XR was updated to include acute kidney injury.
- Keytruda (pembrolizumab), Opdivo (nivolumab), and Yervoy (ipilimumab) are used to treat certain cancers, and are on the list because of reports of adverse effects on the eye, including vision loss and retinal detachment.
- Kybella (deoxycholic acid) treats double chin by destroying fat cells under the chin. It’s on the list due to reports of injection site reactions and tissue death.
- Methimazole is typically used to treat overactive thyroid. It’s on the list due to reports of rhabdomyolysis, the breakdown of muscle tissue which can lead to kidney damage. The FDA decided no action is necessary at this time, based on available information.
- Neulasta (pegfilgrastim) is typically used the day after chemotherapy to boost your white blood cell count and help lower your risk for infection. It appears on the list for reports of device failure—the delivery device is applied to your skin at your chemo appointment and is designed to deliver Neulasta automatically the next day.
- Ofev (nintedanib) is used to treat a lung disease called pulmonary fibrosis, and it appears on the list due to reports of liver dysfunction.
- Farxiga (dapagliflozin), Glyxambi (empagliflozin/linagliptin), Invokana (canagliflozin), Invokamet (canagliflozin/metformin), Invokamet XR (canagliflozin/metformin), Jardiance (empagliflozin), Synjardy (empagliflozin/metformin), Synjardy XR (empagliflozin/metformin), and Xigduo XR (dapagliflozin/
metformin) are all prescribed for the treatment of type 2 diabetes. Reports of kidney stones landed these diabetes meds on the list, but the FDA decided no action is necessary at this time, based on available information.
- Stelara (ustekinumab) is used to treat plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Interstitial pneumonia (a form of lung disease) has been reported by patients using Stelara.
- Tanzeum (albuglutide) and Trulicity (dulaglutide) are used for the treatment of type 2 diabetes, and appear on the list due to reports of serious hypersensitivity reactions.
- Uloric (febuxostat) is prescribed to treat gout. It appears on the list due to reports of reactions to the drug, including an increase in disease-fighting white blood cells, eosinophils, as well as various symptoms in other parts of the body.
What is the FDA doing about all of these reports?
Unless otherwise noted, the FDA is currently evaluating the need for further action on all of the medications on the list.
What should I do if I take one of these medications?
First, don’t stop taking your prescription without speaking to your doctor—this can cause more problems than it solves. If you have any concerns or if you think you’re experiencing one of these side effects, talk to your prescriber or pharmacist.
How can I report a problem with a drug to the FDA?
If you need to report a serious problem with a medication to the FDA, you can do so through their MedWatch website. The MedWatch website allows you to voluntarily report a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can report suspected counterfeit medical products here as well.
Medications are a common offender when it comes to lower extremity edema, either as the cause or as a factor that can make it worse. Swelling in the lower legs from fluid in the tissues—lower extremity edema—is a familiar complaint among patients. Imprints from your socks, puffy legs and feet so you can’t put your shoes on, or swelling so that you can make an indent with your thumb (pitting edema) may lead you to wonder what’s going on.
One clue that your medication could be the cause: you have edema on both sides (it’s bilateral). Swelling from a clot in the leg, a “DVT” or deep venous thromboembolism, is usually on one side not both. Other causes of bilateral lower extremity edema is dependent edema (your legs have been in a dependent position for a while—sitting or standing for long periods of time), or more complex conditions like chronic venous disease, lymphedema, or heart failure.
If you do start to have lower extremity edema on both sides of your body, look at this list and make sure you aren’t taking one of these seven medications.
- Amlodipine (Norvasc) is a medication used to lower blood pressure. The higher the dose, the more likely you are to have swelling in both of your legs and feet. Edema occurs in 1.8% of folks taking 2.5 mg, 3% of folks taking 5 mg, and almost 11% of those taking 10 mg of amlodipine. So one in ten of you will have swelling when taking amlodipine 10 mg daily. More women taking amlodipine experience edema in their lower extremities: 15% of women compared to 5.6% of men. Other options exist for lowering blood pressure that don’t cause swelling in the legs, so if this is a problem for you, ask your doctor about switching up.
- Gabapentin (Neurontin) is used for the treatment of neuropathic pain—pain after a shingles outbreak (postherpetic neuralgia) or pain in the legs from diabetes (diabetic peripheral neuropathy). Gabapentin is also used for patients with fibromyalgia, epilepsy and restless leg syndrome. Gabapentin is a known cause of lower extremity edema. In postherpetic neuralgia trials, edema occurred in 8% of the gabapentin group.
- Pregabalin (Lyrica) may also cause swelling in the feet and legs. Lyrica, similar to gabapentin, is prescribed for neuropathic (nerve) pain, also associated with diabetic peripheral neuropathy and postherpetic neuralgia, as well as from spinal cord injury. Lyrica may also be prescribed for seizures and the treatment of fibromyalgia. It’s known to cause lower extremity edema.
- Ibuprofen (Motrin, Advil), naproxen (Aleve) and other nonsteroidal anti-inflammatory drugs (NSAIDs) are common over the counter medications used for pain and inflammation and are a well described cause of edema. In this case, it’s typically mild and reversible, caused by sodium retention.
- Oral contraceptives. This is tricky because the estrogen in many oral contraceptives increases your risk of clot in the leg (DVT) which would cause one-sided leg swelling and is an urgent medical issue. However, swelling of both legs may occur—without a DVT—from the estrogen component in oral contraceptives. If you do have edema, a progesterone-only option is worth looking into, after your doctor has ruled out a DVT.
- Oral steroids, like prednisone, are often prescribed for asthma or COPD exacerbation, severe rash or allergic reactions, and many autoimmune diseases. Prednisone causes sodium retention and may lead to lower extremity edema.
- Pioglitazone (Actos) and rosiglitazone (Avandia) are medications used in the treatment of diabetes. Lower extremity swelling is a well described side effect of these two diabetes meds so if you are experiencing lower leg edema, ask about a change to another newer medication for diabetes.
Hope this helps
Have you been told that you have borderline diabetes or prediabetes, but you’re not quite sure what that means? If so, you are not alone!
Many people are diagnosed with prediabetes, often times without being educated or given any additional information about the disease. According to the Centers for Disease Control and Prevention (CDC), more than 86 million American adults have prediabetes. Ultimately, 15-30% of people with prediabetes will go on to develop type 2 diabetes within five years.
What is prediabetes?
You may or may not feel any symptoms if you have been diagnosed with prediabetes. However, some things to be on the lookout for include extreme thirst, tiredness, blurred vision, gum inflammation, and cuts that don’t heal.
If you are concerned that you may have prediabetes or type 2 diabetes, make sure you contact your doctor to receive an accurate diagnosis. They will be able to tell how advanced your condition is, and if it has progressed.
How can I prevent diabetes?
Prediabetes may seem scary, but knowing how you can prevent type 2 diabetes is the key to success for a healthier future. There are some ways you can reduce your risk of developing diabetes:
1. Eat healthy
Easier said than done, right?! Eating healthy is difficult but is important if you’ve been diagnosed with prediabetes. Just remember, you’re not alone. There are a lot of great resources out there to help you improve your diet!
The CDC has a variety of information on learning how to eat right. Visit their website here for information on healthy food choices, and creating a diabetes meal plan.
Registered dietitians (RD) can also be a great resource for information on eating healthy, as they are experts in food and nutrition. They can help you understand your ideal body weight and dietary needs, create special diet plans, and discuss nutrition topics related to diseases like diabetes.
There are also many lifestyle programs that you can get involved with! Programs like Weight Watchers can support you on your journey to mental, emotional and physical health.
2. Be active
The new Standards of Care from the American Diabetes Association recommend that prediabetics should get at least 150 minutes of moderate-intensity physical activity each week. I know, this sounds like a lot, but it only really means at least 20 minutes of brisk walking per day!
You can also purchase a motivational device like a pedometer or wristband to help you reach your fitness goals. Many of these advanced wearable devices can track your heart rate, level of activity, and sleep patterns to help hold you more accountable.
Finally, check to see if the city you live in has any free programs that can help you be more active. Websites like Cities Changing Diabetes or In My Community can give you more information on healthy events and activities near you.
3. Watch your weight
If you start eating healthy and being more active, your end results should ultimately result in weight loss. According to the American Diabetes Association, prediabetics should aim to maintain a minimum weight loss of 7% of your total body weight. The recommended pace of weight loss is around 1-2 lbs each week.
4. Join a diabetes prevention program
Joining a CDC-led national diabetes prevention program (DPP) is one of the best things you can do to prevent diabetes. The DPP program focuses on improving physical activity, healthy eating, stress management and behavior changes through individual and group work. Joining a DPP program cuts your work of developing type 2 diabetes by more than 50%.
Gabapentin is not considered an addictive drug, although it does have characteristics that offer the potential for abuse. Some individuals describe varying experiences with gabapentin abuse, including euphoria, improved sociability, a marijuana-like high, a sense of calm, as well as ‘zombie-like’ effects.
Because of this potential for abuse, Kentucky has become the 1st state to make gabapentin products schedule 5 controlled substances.
What is Gabapentin prescribed for?
Gabapentin is most notably indicated for neuropathy, also known as nerve pain, caused by a physical injury, alcoholism or certain diseases like diabetes, cancer, or HIV.
Many patients with diabetes will often be prescribed gabapentin products. Diabetic neuropathy is common and is a result of high levels of sugar in the blood that damages the nerves over time. Most diabetics experience nerve pain in the feet and legs that feel like a burning, tingling or numb sensation.
In addition to nerve pain, gabapentin can also be prescribed for restless leg syndrome, shingles, and seizures.
What is a schedule 5 controlled substance?
According to the Diversion Control Division of the DEA, schedule 5 substances contain limited quantities of narcotics and have a low potential for abuse relative to schedule 4 substances.
Schedule 5 controlled substance include Robitussin AC (guaifenesin/codeine), Phenergan With Codeine (promethazine/codeine), Lomotil (diphenoxylate/atropine), Potiga (exogabine), Vimpat (lacosamide), and Lyrica (pregabilin).
Will this happen to other states?
Many healthcare professionals already recognize the dangers of gabapentin abuse. So it is only a matter of time before other states follow in Kentucky’s footsteps.
Many states have already started to keep track of gabapentin products being prescribed and distributed through their prescription drug monitoring programs. In fact, since December 2016, Ohio has been requiring pharmacies, wholesalers, and prescribers to report their dispensing. This is happening in many other states – Minnesota, Virginia, Illinois, Wyoming, and Massachusetts also have rescription-monitoring programs.
I live in Kentucky, what does this mean for me?
If you live in Kentucky, gabapentin’s schedule change may affect you in the following ways:
- Physician assistants (PA) in Kentucky no longer have the authority to prescribe any controlled substances. If your gabapentin prescription is from a PA, it will no longer be valid.
- Existing gabapentin prescriptions will expire after 5 refills, or 6 months, from the date the prescription was issued. This means that you will need to plan ahead as a sudden break from gabapentin can cause seizures.
- You will need to get your gabapentin prescription from a practitioner with a DEA registration.
- You will be unable to transfer any gabapentin prescriptions to other pharmacies that were written before January 1st, 2017.
- You will no longer be able to receive gabapentin samples.
Has this happened to any other medications recently?
Yes. In 2014, a ruling was finalized to move hydrocodone-containing products from a schedule 3 to a schedule 2 controlled substance, thereby eliminating the ability to refill these medications.