Believe it or not, medications are recalled on a daily basis and due to numerous reasons. Medication recalls can range from minor to life-threatening incidents if not immediately and appropriately taken care of.
What are these drugs prescribed for?
Who can recall a drug?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recalls a particular medication.
A small number of cartons containing cyclobenzaprine 5 mg tablets may potentially be mislabeled as amantadine 100 mg capsules. The blister pack inside the carton is correctly labeled as cyclobenzaprine 5 mg, though.
Taking the wrong medication may potentially cause severe adverse effects like dangerous drug interactions, sudden worsening of your disease, allergic reaction or death.
Which products were recalled?
The recall will affect the following:
- Drug: Cyclobenzaprine 5 mg tablets (50 unit dose) and amantadine 100 mg capsules (50 unit dose)
- Manufacturer: AvKare, Inc
- Packager: Apace Packaging, LLC
- National Drug Code (NDC)
What has Apace Packaging LLC done to alert those who may be affected?
Apace Packaging LLC has notified its distributors and customers by email and is arranging for return of all recalled product.
Distributors that have any of the product which is being recalled should contact Customer Service at AvKARE, Inc. at 931-292-6222 to arrange for its return.
What do I do if I think I have a recalled package of Eliquis?
If you have questions regarding this recall you can contact Apace Packaging LLC by calling 270-434-2722 Monday-Friday from 8am–4pm Central Standard Time. You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using these drug products.
Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch Reporting Program as they can conduct further necessary investigations.
Last month, the Food and Drug Administration (FDA) requested that Endo Pharmaceuticals remove their opioid pain medication Opana ER over concerns that the benefit of the medication may no longer outweigh its risks. You can read more about this request here.
Endo Pharmaceuticals has officially responded to the FDA’s request. On July 6th, 2017, Endo said that they would comply with the removal request of Opana ER, and would work with the FDA to ensure that this does not cause a problem for patients currently taking Opana ER. Despite this removal, Endo Pharmaceuticals still believe in the safety and efficacy of Opana ER.
What do I do if I am currently taking Opana ER?
If you are currently taking Opana ER, contact your doctor or healthcare provider to determine what your next step should be. You can work with your care provider to find another medication to help treat your chronic pain.
When will Opana ER no longer be available?
At this time, there has not been a determined date for Opana ER removal. Stay tuned, and GoodRx will keep you updated.
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.
With concerns over opioid use at an all-time high in the US, the FDA has started re-evaulating the risks vs benefits of some pain relief medications.
Now, the FDA is asking the manufacturer of Opana ER, Endo Pharmaceuticals, to remove Opana ER from the market due to concerns that the benefit of the medication may no longer outweigh its risks.
What is Opana ER?
Opana ER (oxymorphone) is a narcotic pain medication used for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic (pain reliever) is needed for an extended period of time.
When was Opana ER approved by the FDA?
The original approval of Opana ER was in 2006, but Opana ER was reformulated by the manufacturer in 2011.
Why was Opana ER reformulated?
In 2011, Endo Pharmaceuticals replaced the original formulation of Opana ER by adding INTAC technology with the hope of making it more resistant to potential abuse.
The reformulation was intended to make the drug more resistant to physical and chemical manipulation for abuse by snorting or injecting. However, it was determined by the FDA that the reformulation did not meaningfully reduce abuse, and therefore could not be labeled as abuse-deterrent.
Why is the FDA asking for Opana ER to be taken off of the market now?
The FDA has evaluated Opana ER, and expressed concern that its benefits may no longer outweigh its risks.
How did the FDA come to this conclusion?
The FDA’s decision is based on a review of all available post-marketing data, which showed a significant shift in the route of abuse of Opana ER, from snorting nasally to injection, following the product’s reformulation.
This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18 – 8 that the benefits of reformulated Opana ER no longer outweigh its risks.
Have there been consequences of the increased Opana ER injection abuse?
Injection abuse of reformulated Opana ER has been associated with an outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).
What is the intended result of the FDA taking Opana ER off the market?
The removal of Opana ER from the market will protect the public from further potential for misuse and abuse of this product.
What if Endo Pharmaceuticals does not want to remove Opana ER from the market?
If Endo Pharmaceuticals does not agree to remove Opana ER from the market, the FDA will formally require removal by withdrawing its approval.
Is the FDA going to start targeting other pain medications and requesting their removal from the market?
The FDA has stated that they will continue to examine the risk-benefit profile of all approved opioid analgesic products, and take further actions as appropriate. It’s possible that other medications may receive a similar evaluation in the future.