Manufacturer Unichem Pharmaceuticals has issued a voluntary recall of divalproex, used to treat certain types of seizures, bipolar disorder, and migraine headaches.
This is a class II recall, the most common type of recall, which means that there is a situation where the 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.
Why was Divalproex recalled?
The manufacturer, Unichem Pharmaceuticals, has issued a nationwide voluntary recall of divalproex, with the knowledge of the FDA, due to possible contamination with another medication, metronidazole.
Metronidazole is an anti-fungal medication. Taking a contaminated medication can cause severe adverse effects.
What is affected by this recall?
The recall will affect the following:
- Drug: Divalproex delayed-release 500 mg tablets
- Manufacturer: Unichem Pharmaceuticals
- Bottle size: 100 count bottle
- National Drug Code (NDC) and Lot(s): NDC: 29300-140-01, Lot: ZDPH17040
Unichem Pharmaceuticals is notifying distributors and customers by letter and is arranging for return of all recalled products.
What should I do if I think I may have the affected product?
You should contact your physician or healthcare provider if you have experienced any problems that you think may be related to taking this medication.
You should not stop taking divalproex without talking to your prescribing physician.
If you’ve watched the news or heard anything about the flu this season than you’ve probably heard that it hasn’t been going so well. According to the Journal of Family Practice, the 2017-2018 flu vaccine has been reported to only be about 34% effective against influenza A and 56% for influenza B.
Because the flu virus is constantly changing, scientists are challenged with reviewing the vaccine each year. The flu vaccines are then updated as needed based on which influenza viruses are making people sick, the extent to which those viruses are spreading, and how well the previous season’s vaccine protects against those viruses.
We have some exciting news, though. Although we’re aren’t quite there yet, a universal flu vaccine is in the works. A company in the UK, Vaccitech, is currently conducting a clinical trial of what could become the first universal flu vaccine in the world. In the United States, Inovio Pharmaceuticals is conducting their own research for a universal vaccine.
The launch of a universal flu vaccine would be extremely beneficial for global public health and eliminate the need for annual injections. Additional benefits of a universal flu vaccine may include the following:
- Targets flu viruses in a different way.
- Reduce flu transmission more effectively than conventional flu vaccines.
- Slow the development of new strains of flu virus.
- Strengthen the immunity of a population, allowing protection against the emergence of dangerous pandemic strains.
On September 21, 2017, the FDA issued a drug safety communication for the medication, Ocaliva. The communication highlighted the increased risk of serious liver injury due to being incorrectly dosed in some patients with moderate to severe decreases in liver function.
In response to this safety communication, on February 1st, the FDA added a boxed warning to Ocaliva to highlight the dosage issues.
What is Ocaliva indicated for?
Ocaliva is indicated for the treatment of primary biliary cholangitis (PBC), a chronic liver disease resulting from progressive destruction of the bile ducts in the liver. PCB primarily affects women, as approximately 1 in 1,000 women have this condition. Bile in your liver aids in the digestion of fat and fat-soluble vitamins. When the ducts are destroyed, bile builds up and can lead to inflammation and scarring.
What confusion has Ocaliva dosing caused?
Ocaliva continues to be incorrectly dosed daily instead of weekly, which has led to liver decompensation, liver failure, and death. Healthcare professionals should follow the Ocaliva dosing regimen in the drug label.
Contact your prescriber immediately if you develop any of the following symptoms that may be signs of worsening liver problems: stomach swelling, yellow eyes or skin, bloody or black stool, coughing or vomiting up blood, or mental changes.
Does the FDA require Intercept Pharmaceuticals to do anything else at this time?
Yes. As a condition of approval, the FDA requires Intercept Pharmaceuticals to continue studying the medicine in patients with advanced PBC.
These clinical trials are currently ongoing and FDA expects to receive results in 2023.
The number of people who have asthma continues to grow – an estimated 24.6 million Americans are currently suffering from the disease. Things that can trigger asthma include allergies, exercise, acid reflux, and irritants like smoke or perfumes. But did you know that prescription and over-the-counter medications can also cause problems with asthma?
Here are some medications that can make your asthma worse, or even cause an asthma attack. If you have asthma and are taking any of these, you may want to consider speaking with your doctor.
Blood pressure medications
It’s important to take your medication if you have high blood pressure, but some of these could be making your asthma worse. If you have both high blood pressure and asthma, you may want to avoid the following:
- Beta Blockers: carvedilol, propranolol, timolol, labetalol, or nadolol.
- ACE-inhibitors: lisinopril, enalapril, or captopril.
There are several different types of medication that can be used for pain. Prescription and over-the-counter anti-inflammatory medications are used to treat inflammation for problems like rheumatoid arthritis, fever, or generalized pain.
You may be wondering how or why over-the-counter anti-inflammatory medications could cause a problem. After all, you can get it without a prescription – right? Keep in mind that just because you’re able to buy something over-the-counter, without a prescription, doesn’t mean it can’t cause problems or is consequence-free given the perfect storm scenario.
The following are examples of anti-inflammatories that could cause problems with your asthma:
- Prescription anti-inflammatories: ibuprofen, indomethacin, sulindac, naproxen, ketorolac, etodolac, oxaprozin, diclofenac, piroxicam, nabumetone.
- Over the counter anti-inflammatories: ibuprofen, naproxen, and aspirin.
What if I am taking one of the medications listed and have asthma?
If you’re taking one of the medications listed above and have asthma that is uncontrolled or worsening, you will want to talk to your doctor. Never stop taking a medication without first speaking with your doctor. It can be extremely dangerous to abruptly stop certain medications.
Also, keep in mind that sometimes the benefits of certain medications may outweigh the risks and your doctor’s professional and clinical judgment will be used to determine if you should remain on a medication or be taken off it.
The drug business is booming, especially when it comes to medications used to treat type 2 diabetes. With each passing year, drug companies are making product improvements by developing medications that are easier to take, use and store. The newest drug getting an upgrade is a once-weekly injectable Bydureon. The medication will now be available, in addition to the current Bydureon products, in an easy-to-use device known as Bydureon BCise.
How is Bydureon BCise to be used?
The recommended dose of Bydureon BCise is 2 mg injected under the skin every 7 days (once weekly). Bydureon BCise can be given with or without food.
Bydureon will be available as a 2mg/ml single-dose autoinjector.
What are some of the main differences between the Bydureon Pen and Bydureon BCise?
The main differences between the old Bydureon Pen and the new Bydureon BCise are as follows:
- The Bydureon BCise injector is a pre-filled device with a pre-attached hidden needle.
- You cannot see the needle with the Bydureon BCise injector.
- Bydureon BCise is designed for patient ease and convenience as it’s administered in 3 simple steps- mix, unlock, inject.
- Bydureon BCise only needs to be mixed for 15 seconds compared to the Bydureon Pen which must be tapped 80 times or more to make sure the medicine is well mixed.
Are there any serious side effects that may occur with Bydureon BCise?
Yes. Bydureon BCise, as well as all other formulations of Bydureon, have a Boxed Warning regarding the risk of thyroid tumors. A Boxed Warning is the strictest warning the FDA can give to a medication in order to warn patients and health care providers of the possible serious risks associated with a medication.
Does AstraZeneca have any cost savings programs for Bydureon BCise?
Yes. AstraZeneca is committed to supporting patient access to Bydureon BCise. Eligible commercially insured patients may pay as low as $0 for Bydureon BCise every month. Make sure to read the fine print, as cash-paying patients are limited to $150 maximum savings per 28-day supply.
For more information on Bydureon BCise, check out the manufacturer website here.