Why was fluoxetine recalled?
According to the FDA, one of the ingredients used to create the 10 mg fluoxetine tablet was not up to FDA standards. While the use of the product is not likely to have significant adverse health consequences, Teva has pulled certain lots of fluoxetine until they are up to FDA regulations.
Which fluoxetine products were recalled?
According to Teva, the affected products were shipped from March 24th, 2016 to January 4th, 2018. The recall will affect the following:
- Drug: Fluoxetine 10 mg tablets
- Manufacturer: Teva Pharmaceuticals
- National Drug Code (NDC): 00093-7188-56
What has been done to alert those who may be affected?
Teva 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 fluoxetine without talking to your prescribing physician.
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.
After practicing medicine for 20 years, I’ve become adept at “clarifying” to insurance companies why patients are taking certain medications. The same medications appear to trigger red flags for both long-term care and life insurance companies.
Their “concern” makes sense for some medications because they are used for serious chronic illnesses, but for others, the insurance companies are worried about your lifestyle. Most on this list are important medications so do not stop taking them because you’re concerned about rejection and do not omit them from your forms. Instead, along with your physician, you can clarify and appeal their decision.
Here are the ten worst medications to be taking that will trigger a “no” or a further review if applying for life insurance or long-term care insurance.
- Namenda (memantine) or Aricept (donepezil). One of the more obvious red flags, dementia is expensive for Long-term care insurance plans because folks with dementia are often physically healthy and their care is expensive. Pro tip: be careful here because Namenda is also prescribed for migraine prevention and may trigger an unnecessary alarm.
- Hydrocodone, oxycodone, morphine aka “Opioids.” Long-term use of pain medication raises red flags for insurance companies and almost always results in a closer review. Why? Because costs associated with chronic pain patients taking opioids are substantial and range from 560 to 635 billion per year in the U.S. in 2010. Insurance companies run for the hills because of that.
- Xanax (alprazolam), Ativan (lorazepam) and Valium (diazepam) are benzodiazepines that will lead to a closer review of your application. Why? Several studies have shown an association between benzodiazepines and risk of death. In folks 65 years or older benzodiazepines increase the risk of falls and fracture-related mortality. Some studies have found a threefold or higher increase in the risk of all-cause mortality among adult populations using benzodiazepines even for durations shorter than one month.
- Lithium and Divalproex. Life insurance companies love to hate bipolar medications because suicide rates in bipolar patients average approximately 1% annually, or 60 times higher than the international population rate. Pro tip: If you take Valproic acid for migraine prevention or trigeminal neuralgia you will want to clarify if turned away.
- Paxil (paroxetine), Lexapro (escitalopram), Celexa (citalopram), Zoloft (sertraline) aka the “SSRI” antidepressant medications. This is one of the common reasons my patients are turned away, and yes you can appeal and clarify this. Why are life insurance and long-term care insurance plans worried? Because of the risk of suicide and increased use of healthcare resources in folks with depression and anxiety.
- Plavix (clopidogrel). This is another common medication that will often lead to a “no”. Clopidogrel is used for the treatment of coronary artery disease and atherosclerosis – often given to patients who have had stent placement for coronary artery disease. This puts you in a high-risk category and insurance companies don’t like that.
- Arimidex (anastrozole) or tamoxifen. These are medications taken long term to prevent the recurrence of breast cancer. Even though cancer outcomes have been improving dramatically in recent years, life insurance companies continue to see cancer as a high-risk situation. Breast cancer receives quite a bit of scrutiny from insurance companies.
- Naltrexone, Campral or Antabuse (disulfiram) are medications used for the treatment of alcohol abuse and that sends insurance companies running for the hills. Insurance companies don’t like alcohol overuse or abuse to be part of your history and this medication is used to help with alcohol cravings and will trigger a red flag.
- Harvoni, Sovaldi, and Viekira Pak. Medications used for the treatment of Hepatitis C will cause insurance companies to balk at your application. Pro Tip: Here is a perfect example of where you can file an appeal and have your doctor help with clarification especially if you have achieved cure (sustained virologic response) of your Hepatitis C.
- Atripla and Genvoya are commonly prescribed combination HIV medications and will often trigger a “no” for long-term care and life insurance policies.
Has this happened to you?
Last December, not one, but two generic versions of Viagra (sildenafil) became available in pharmacies. As a result, men can now purchase the erectile dysfunction (ED) treatment for as low as $17 with GoodRx, compared to $72 for the brand version. And although Viagra is an extremely popular medication, with more than 60 million men worldwide having used it since 1998, it’s not the answer for everyone.
Below, Tim Aungst, PharmD and owner of The Digital Apothecary, shares his experience helping patients who are looking for ED treatment outside of Viagra and the class of drugs that work like it (PDE-5 inhibitors).
Consider the case of Mr. Jones, a patient I was helping in an outpatient cardiac clinic. Most of my patients are on multiple medications for their heart conditions and other complicated issues, so I often review their medications to make sure everything is all right. This includes screening labs, checking vitals, reviewing past reports, and conducting drug interaction checks related to therapy. If there are any concerns, I’ll meet with the patient and make recommendations to the healthcare team.
At his last visit, Mr. Jones was prescribed Imdur (isosorbide mononitrate) to help with his heart condition. Reading through the notes, it looked like the Imdur worked. He was feeling better – so much better that he wanted to start having sex with his wife again. And here was the problem: Mr. Jone’s doctor had renewed his Cialis (tadalafil) prescription.
The issue? Well, if you really listen to the advertisements on television for erectile dysfunction (ED) medications, ignoring the jazz from Viagra or the sunsets from Cialis, you may hear the line “Do not take if you take nitrates for chest pain, as it may cause an unsafe drop in blood pressure.” Viagra, Cialis, and Levitra belong to the same drug class called Phosphodiesterase 5 Inhibitors (abbreviated as PDE-5 inhibitors), and they all share the same interaction with nitrates. Many patients wonder how bad can a ‘drop in blood pressure’ be. The answer, as we learned after Viagra came out, is this reaction can lead to heart attack in patients and potentially cause death, leading to a black box warning for the whole class of drugs like Viagra.
Mr. Jones is on a nitrate, specifically Imdur. Fortunately for him, he had not yet used the Cialis. I advised him to avoid the combination, based on his significant cardiac history. But what can patients with ED and taking nitrates do to engage in an active sex life?
There is another drug that came out before Viagra, called alprostadil, available under two brand names: Caverject and Muse. It works by relaxing the penile tissue allowing for easier blood flow leading to an erection. The plus side is it works relatively quickly; the downside is that is not available as a pill.
And there’s the rub. Caverject must be directly injected into the base of the penis to work. Muse is an intraurethral (a fancy way of saying ‘insert via urethra’) version of alprostadil that comes as small pellets that have to be inserted into the urethra by the patient.
For many patients, when I mention there is another option to Viagra and other PDE-5 Inhibitors, their eyes light up, quickly followed by a nervous look as they find that it requires an injection to their penis or inserting something directly into their urethra. At this point, to not completely turn off the patient, I do try to get some information in to help them make a decision.
While both Caverject and Muse share the same active ingredient, there are some pros and cons of each. Caverject tends to work much faster (<10 mins) as it enters the bloodstream quicker, and has been found to work better. The drawback though is that it is an injection that needs to be applied to the base of the penis, and can cause irritation to the surrounding tissue. And let’s be honest, most men don’t want to engage in sex with a bruised member. It has a higher risk of causing priapism (basically an erection lasting for more than 4 hours, which incidentally is named after Greek god Priapus).
Muse, on the other hand, can cause a burning sensation to the penis along the urethra (this happens around 20% of the time) and it takes a little longer to work than the injectable formulation. But for men that don’t want a needle in their penis, it is an alternative. For this reason, I generally recommend starting with Muse prior to moving onto Caverject.
You’re probably wondering why alprostadil can’t just be applied directly to the penis as a topical agent instead of directly injecting or inserting it. A study conducted in 2006 in 1732 patients using a topical formulation did demonstrate some efficacy (though less than Caverject or Muse). Common side effects were burning sensation (for both men and women) though this was relatively low, with only 2.7% of subjects stopping its use. Currently, drug manufacturer Apricus Biosciences is looking to bring this formulation, named Vitaros, to market in the US (it’s currently available in Europe) but FDA approval has been slow. When and if this formulation makes it to the US market, it may be preferred by men who cannot take PDE-5 inhibitors.
Talking to Mr. Jones and those like him about these options takes some time and often requires some trial and error to find what works. At this point, I usually recommend most men to start with Muse and see if they have success with it, and if not they can move on to Caverject (they both run at about $75-$105 a dose). Some men are fine starting with Caverject right away and don’t mind the administration, but I would say it comes down to personal preference on what side effects are manageable for the patient.
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.