Manufacturer PharmaTech and distributor Rugby Laboratories have issued a voluntary recall of all unexpired Diocto (docusate sodium). Diocto is a over-the-counter stool softener, used to relieve constipation.
This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.
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 recall a particular medication. In this case, the manufacturer has voluntarily recalled all lots of Diocto liquid.
Why has Diocto been recalled?
The recall was initiated because of a risk of product contamination with Burkholderia cepacia (B. cepacia). B. cepacia can cause serious or even life-threatening infections in anyone with a compromised immune system, or those with chronic lung conditions like cystic fibrosis.
When was the recall initiated?
All lots of Diocto were recalled by the manufacturer on July 12, 2016.
Are patients who have taken this medication being notified?
Yes. Rugby Laboratories is working with PharmaTech to notify customers using recall letters. They are arranging for the return of all recalled Diocto.
You can also call the Customer Support Department for Rugby Laboratories directly at 1-800-645-2158. They have representatives available Monday through Friday 8:00am – 8:00pm EST.
Which products were affected?
In this recall, all lots and the only strength of Diocto are affected.
Drug: Diocto liquid, /mL, 473 mL bottle
National Drug Code (NDC): 00536-0590-85
If you have any trouble finding information on your medication, please check with your pharmacist.
Have there been any reports of people getting sick?
Yes. The CDC has reported outbreaks in 5 states with a total of 49 cases so far.
What are the FDA and CDC recommendations?
Both the FDA and CDC are recommending that you do not use any docusate sodium liquid products for the time being.
Are all docusate sodium medications affected?
Not at this time. There is currently no evidence to suggest docusate sodium capsules or enema products have been affected.
More and more new hepatitis C medications are being approved at a faster rate than ever thanks to the FDA’s Priority Review program. New approvals over the past few years include Sovaldi, Harvoni, Viekira Pak.
This is great news, as it means there are more effective options than ever out there to treat hepatitis C—and the most recent addition, Epclusa (sofosbuvir/velpatasvir), is another first of its kind treatment.
How is Epclusa taken?
The recommended dose of Epclusa is one tablet, taken once daily with or without food.
What are the side effects of Epclusa?
The most common side effects associated with Epclusa include headache and fatigue.
Is there anything unique about Epclusa?
Yes. Epclusa is the first medication approved to treat all 6 genotypes of Hepatitis C with one single tablet. Epclusa is also the first single-tablet regimen for genotypes 2 and 3 without the need of ribavirin—meaning you only need to take a single pill.
Who will benefit most from using Epclusa?
Patients with genotypes 2 or 3. Again, these types of hepatitis C have traditionally required ribavirin or multiple other drugs.
Will Epclusa be a specialty medication like other hepatitis C medications?
For more information on what a specialty medication is please see our previous articles Specialty Pharmacy and Specialty Medications: What You Should Know and What Makes Specialty Drugs Special?
How much will Epclusa cost?
Gilead has priced a 12-week regimen of Epclusa to cost $74,760. The cost of Epclusa is in-line with, if not a little less than, the other 12-week Hepatitis C medication regimens currently on the market such as Sovaldi and Harvoni which cost $84,000 and $94,500 respectively.
Want more information on Epclusa?
Check out the press release from the manufacturer Gilead here.
You can also find the announcement from the FDA here.
Do your ears feel like they’re under water, or plugged? Often related to allergies or upper respiratory infection, eustachian tube dysfunction is a common cause of congested ears and brings many of you to the doctor. While you are waiting to get an appointment, there are some good non-prescription options you can start off with.
So what’s happening, why and what can you do about it?
Why do my ears feel like I’m under water?
The eustachian tube runs from the middle ear, the air filled chamber, to the back of your nose. The mantra of ENT (ear, nose and throat) doctors is that “the ears are always tied to the nose” so a congested nose often results in congested ears—feeling like your ears are popped and you can’t un pop them.
What does the eustachian tube do?
This is important to know if you have ear congestion. The eustachian tube’s main function—equalizing pressure in your ear—is controlled by opening and closing of the tube. Equalizing pressure across the eardrum or “gas pressure equalization” is essential for proper hearing.
Super cool fact: the eustachian tube normally opens with swallowing and yawning approximately 84 times per hour in the daytime. When the tube isn’t opening or closing properly due to inflammation or infection—meaning it can’t equalize pressure—you aren’t able to hear well and will have the sensation of fullness in the ears.
How do I know if I have eustachian tube dysfunction?
Not through fancy tests—this diagnosis is based on history and physical examination. Your doctor will hear your story and look in your ears. An ENT doctor is only needed to confirm the diagnosis with nasal endoscopy and audiology (hearing tests) if your symptoms aren’t improving with standard treatment.
Other than my ears feeling “plugged” what other symptoms might I have?
Ear pain, a sensation of ear fullness or pressure, hearing loss, and ringing in your ears (tinnitus) are all signs of eustachian tube dysfunction. Hearing popping and snapping noises is also common and occurs with the opening of the eustachian tube against an unusually large change of pressure. You may have vertigo or dizziness.
Remember that TMJ (temporomandibular joint dysfunction) also produces ear blockage symptoms that are commonly mistaken for eustachian tube dysfunction. With TMJ though, there is often pain deep in the ear, and tenderness within the joint space that occurs with mouth opening.
How did I get eustachian tube dysfunction?
- Allergies: If you’ve had itchy runny nose or sneezing, those may be symptoms of allergy.
- Upper respiratory infections: Colored (yellow, green) discharge from the nose, sore throat and cough are a good sign your eustachian tube dysfunction was a result of infection.
- Heartburn and reflux can do it.
- Smoking and secondhand smoke are also contributing factors.
The treatment of eustachian tube dysfunction should be directed at the underlying cause so start here:
- Decongestants. Sudafed (pseudoephedrine) may be helpful for the ear fullness and pressure.
- Nasal steroid sprays. Flonase, Nasacort, Nasonex, and others will help if your symptoms are due to allergies and nasal congestion.
- Non sedating antihistamines. Again, if you have allergies, adding Claritin, Zyrtec, or Allegra may help.
- Oral steroids like prednisone or methylprednisolone. Oral steroids may be used for persistent symptoms when other options have failed.
Atrial fibrillation and atrial flutter are two common types of abnormal heartbeat that are often treated with the same medications, as many people experience both together. Atrial fibrillation is an irregular, often rapid heart rate that commonly causes poor blood flow. Atrial flutter is similar to atrial fibrillation but it causes the heart to beat in a fast, regular rhythm.
How is dofetilide be available?
What are the side effects of dofetilide?
The most common side effects associated with dofetilide capsules include headache, chest pain, and dizziness.
What if I want to keep taking brand name Tikosyn?
If you would like to continue on brand Tikosyn, make sure your doctor handwrites BRAND MEDICALLY NECESSARY on your next prescription. This means the pharmacy is not permitted to substitute and give you the generic product.
Otherwise, you can still request that your pharmacist fills the brand medication for you—just make sure to ask before your prescription is filled.
Keep in mind that because the generic is now available your insurance company may not be willing to cover the cost of the brand medication. You may want to call your prescription insurance company to find out the potential cost (or if it’s covered at all) before wasting a trip to the pharmacy.
Are there any other ways to save if I keep taking the brand?
Eligible patients will get their Tikosyn for as little as $4 a month. The offer is not available for patients eligible for Medicare, Medicaid, or any other federal or state healthcare programs.
Differin has been a popular prescription treatment, and you’ll now be able to find it on the shelves of your local pharmacy without a visit to your doctor.
Is there anything unique about the OTC approval of Differin Gel 0.1%?
Yes. The approval of Differin Gel 0.1% for sale without a prescription marks the first new FDA-approved product to be introduced to the OTC acne category in over 30 years.
It’s also the first and only OTC acne product containing a full prescription-strength retinoid (a strong acne fighter).
Are there any other strengths of prescription Differin?
Are there any other dosage forms of prescription Differin?
- 0.1% cream
- 0.1% lotion
- 0.3% gel
What is an advantage of using OTC Differin Gel?
Convenience, first and foremost. Because Differin gel 0.1% will available without a prescription you will no longer be required to see your doctor to get refill.
The second advantage is that you get the same prescription strength as the original Differin—this isn’t a different medication with the same active ingredient.
What is a disadvantage of using OTC Differin Gel?
Cost. Because generic Differin (adapalene) is available by prescription it can be billed to your prescription insurance. Your co-pay will typically be lower than the cash price of OTC Differin.
And, because Differin is the only OTC product of its kind, the manufacturer may be able to set the price higher than other OTC acne treatments.
What other options are available OTC for acne?
There are also a bunch of “natural” products that can be used for acne, including tea tree oil, witch hazel, green tea extract, masks and exfoliants, and more.
Want more information?
Check out the news release from the FDA here.