This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse effects is remote. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
The 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 one lot of enalapril/HCTZ 10 mg/25 mg tablets, and four lots of losartan 25 mg, 50 mg, and 100 mg tablets.
The recall is based on the discovery that the affected lots of both medications did not meet FDA regulatory requirements for blend uniformity specification. This means that the tablets can differ greatly from each other from one lot to the next, which is not acceptable by either FDA or manufacturing standards.
When was the recall initiated?
How long have the affected products been in pharmacies?
The recalled lot of enalapril/HCTZ 10 mg/25 mg tablets started shipping over a year ago, on February 13, 2014.
The recalled lots of losartan 25 mg, 50 mg, and 100 mg tablets started shipping almost two years ago, on September 20, 2013.
Are patients being notified who have taken either of these medications?
No. These are both class II recalls, which means that notification of patients is not necessary unless your doctor believes it may have an effect on your health.
If you have concerns that your prescription may be affected, contact your doctor or your pharmacist.
Which enalapril/HCTZ products were affected?
In this recall, only one lot and one strength were affected.
Drug: enalapril/HCTZ 10 mg/25 mg tablets, 100-count bottle
Lot: KP4529, expiration 10/2015
National Drug Code (NDC): 60505-0209-01
Which losartan products were affected?
In this recall, four total lots of three different strengths were affected.
Drug: losartan 25mg tablets, 90-count bottle
Lot: KP4726, expiration 09/2015
National Drug Code (NDC): 60505-3160-09
Drug: losartan 50mg tablets
Lot: KN1499, expiration 06/2015
National Drug Code (NDC): 60505-3161-09
Drug: losartan 100mg tablets
Lots: KT3819 and KT3821, expiration 11/2015
National Drug Code (NDC): 60505-3162-09
The most expensive prescriptions are usually the best, right?
That’s what many people think, but it isn’t always the case—not even close. There are many inexpensive drugs out there that work just as well for treating everything from arthritis to depression, and some even have fewer side effects than their high-cost counterparts.
In 2013, pharmacy benefits manager Express Scripts estimated that the United States wasted $418 billion on “bad medication-related decisions”—with $55.8 billion alone on high-priced medications when more affordable drugs could have been used instead.
Expensive is simply not always better.
Here are ten prescriptions that are usually very expensive, even with insurance. All of them have cheaper alternatives that work just as well.
- Vimovo. This is a mixture of the anti-inflammatory naproxen and generic Nexium, which is esomeprazole. Here’s an idea: instead of paying hundreds of dollars for this, get generic naproxen 500 mg tablets and 20 mg tablets of esomeprazole and there you have it: your own Vimovo for just pennies.
- Dexilant. This is a very expensive brand-name proton pump inhibitor (a class of drugs that includes Prilosec and Protonix). A number of studies have compared the various proton pump inhibitors to one another and while some differences have been reported, they have been small and of little clinical importance. Do yourself a favor and give lansoprazole or pantoprazole a try instead.
- Benicar. Used for high blood pressure, this is an expensive brand-name angiotensin receptor blocker (ARB) in a class that has many generic options. Benicar is certainly no better than the cheaper drugs in the class (valsartan and losartan are examples). Plus, Benicar can produce a “sprue-like enteropathy” which gives you severe chronic diarrhea and weight loss, and can occur months to years after starting the drug. Hmmm.
- Vytorin. This is a mixture of simvastatin and Zetia (ezetimibe). Unless you’ve recently had a heart attack, you don’t need to waste money on this and here is why: statins, like the cheap generic simvastatin alone, are the first choice in virtually all patients with high cholesterol in whom the goal is reduction of cardiovascular risk. People have been paying for Vytorin for years and yet it remains “uncertain” whether the combo of simvastatin and Zetia that makes up Vytorin provides additional clinical benefit. A recent study showed benefit in people hospitalized after heart attack but for most people, stick with just the simvastatin part and don’t bother with the combo.
- Bystolic. There is no evidence this beta blocker is better than two similar generic options, metoprolol and carvedilol. Bystolic is what is known as a “beta 1 selective” beta blocker used for the treatment of high blood pressure and it does provide a survival benefit in patients with heart failure. Sounds great, right—but wait. In heart failure patients, there are three beta blockers that have shown survival benefit. You guessed it: metoprolol, carvedilol, and Bystolic. Metoprolol and carvedilol are generic and much cheaper so there is no reason to pay money here.
- Zafirlukast (Accolate). Though available as a generic, it is still much pricier than the other option in the same class, montelukast (Singulair). There is no proof that zafirlukast is any better than montelukast for asthma, and in fact, montelukast is usually preferred because it is used once daily and can be taken at any time in relation to meals.
- Celecoxib (Celebrex). Celebrex, used for arthritis, has just recently become available as generic celecoxib so it’s still quite expensive and many folks pay a high price for it. However, meloxicam (Mobic), another Cox-2 inhibitor similar to celecoxib, is much cheaper and also works well for the treatment of osteoarthritis and rheumatoid arthritis.
- Pristiq. This is an expensive brand-name SNRI antidepressant used for depression and fibromyalgia. There is no evidence that Pristiq is any better than the cheaper generic duloxetine (Cymbalta) for fibromyalgia. For depression, there are two generic SNRI options in this class, venlafaxine and duloxetine. You should try those first before paying for Pristiq.
- Pataday. These antihistamine eye drops are used for red, itchy eyes related to allergies. Patanol and Pataday are expensive brand name eye drops in this class which includes azelastine (Optivar) as a good generic option that is much cheaper. Pataday carries the advantage of once daily dosing compared to twice a day but is it worth the cost?
- Avodart. Two 5-alpha-reductase inhibitors are approved in the US for symptoms related to enlarged prostate: Proscar (finasteride) and Avodart (dutasteride). One is cheap, one is not. In a large one-year study, finasteride and the more expensive Avodart worked just as well for reduction in prostate volume, urinary flow rate and urinary symptom scores, and adverse effects were similar. Don’t waste your money on Avodart when you can save on finasteride.
Glatopa, the new generic alternative to multiple sclerosis (MS) treatment Copaxone, was approved earlier this year, and its launch has been anxiously awaited. Now, the time has come, and Glatopa will be available in pharmacies soon!
Manufacturer Sandoz announced last Thursday, June 18, that Glatopa has began shipping following its recent FDA approval.
Is Glatopa an FDA approved generic?
How much will Glatopa cost?
Glatopa is expected to start out about 15% less expensive than Copaxone, but this is an estimate based on the average wholesale price—your cost may vary depending on the pharmacy where you fill and any discounts you may have. Insurance prices may also be lower for Glatopa if your plan places it in a different pricing tier.
Will I get Glatopa from my regular pharmacy?
Possibly. Since Glatopa and Copaxone are specialty medications, only pharmacies that offer specialty medication services will have Glatopa available locally. However, both should be available from most if not all mail-order specialty pharmacies (most specialty medications will be filled from this type of specialty pharmacy).
For more information on specialty medications please see our previous post.
If you are currently taking the Copaxone 20mg/mL injection and wish to switch to generic Glatopa, it would be helpful to reach out to the pharmacy where you are currently filling your Copaxone at and ask them to switch you to Glatopa for your next refill.
Are there any support programs for Glatopa?
Yes. You can enroll in the GlatopaCare program by calling 1-855-GLATOPA (1-855-452-8672). There isn’t currently a program website, but you can also call for more information.
Copaxone is available as a single-dose prefilled syringe in two strengths: 20 mg/mL (equivalent to Glatopa), and 40 mg/mL, which is still brand-only. The 40 mg/mL strength is used only three times per week.
What are the side effects of Glatopa?
Want more information on Glatopa?
Gardasil 9, the new human papillomavirus (HPV) vaccine, targets nine HPV types and became available early in 2015. There’s some confusion surrounding this vaccine so here are 10 points to help clear it up.
- Why do we care? Infection with human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58 is implicated in 90 percent of cervical cancers. Gardasil 9 targets those seven listed above, in addition to the two types associated with genital warts (6 and 11).
- Is Gardasil 9 better than the quadrivalent HPV vaccine (Gardasil) we’ve been using? Immune response to the two vaccines are similar for the HPV types targeted by both (6, 11, 16, and 18). Gardasil 9 is also 97 percent effective for preventing precancerous and cancerous lesions of the cervix and vagina associated with the other targeted HPV types (31, 33, 45, 52, and 58). Hence, the Gardasil 9 is favored for its broader HPV coverage.
- When should you get Gardasil 9? Immunization should be offered to boys and girls ages eleven to twelve, but can be administered as early as nine years of age. Catch-up vaccination should be offered for guys between the ages of 13 to 21 and girls between 13 to 26 years who have not been vaccinated.
- If I had the Gardasil vaccinations already, do I get the new one? No. Re-vaccination with Gardasil 9 is not warranted for those who have completed the series with a different HPV vaccine.
- The girls. To summarize the recommendation for girls: either the quadrivalent or Gardasil 9 HPV vaccine is recommended for the prevention of anal cancer, cervical cancer and its precursor lesions, and genital warts in females. Again, the newer Gardasil 9 is preferred given its greater HPV type coverage.
- I’ve already had HPV infection, will the vaccine help? Neither vaccine treats or accelerates the clearance of pre-existing HPV infections.
- What if I’ve already had an abnormal pap from HPV? Females who are sexually active should still be vaccinated consistent with age-specific recommendations and a history of an abnormal pap, genital warts, or HPV infection is NOT a contraindication to the vaccine. Having said that, Gardasil vaccine is less beneficial for females who have already been infected with one or more of the HPV vaccine types.
- The guys. Gardasil 9 is also recommended over the quadrivalent vaccine (Gardasil) for males given its greater HPV type coverage.
- Why vaccinate the boys if the girls are vaccinated? Several reasons:
- Immunization rates in young girls are generally low so vaccinating males will help prevent infection in unimmunized females.
- Gardasil 9 vaccination will protect against HPV-related infection and disease in men who have sex with men.
- HPV infection is common in males and is readily transmitted, influencing disease infection rates in both males and females.
- Does the Gardasil 9 vaccine prevent HPV related head and neck cancers? We don’t know yet. While the Gardasil 9 works to prevent 93% of oral HPV, whether HPV vaccination can prevent the development of HPV-related head and neck cancer has not yet been evaluated.
Symptoms from an enlarged prostate are a common complaint in older men. While we don’t know exactly what causes it, the changes in male sex hormones that occur with aging appear to play a role.
Urinary symptoms and sleep disturbance from benign prostatic hyperplasia (BPH) may be easily remedied with medications. The prescription options, like tamsulosin (Flomax), finasteride (Proscar), and Rapaflo, among others, do work but may lead to side effects. Because of this, men often opt for a more “natural” remedy first. Do herbal therapies work? What does the evidence show?
Evidence from studies on the safety and efficacy of herbal therapies for BPH is conflicting. Also remember that supplements are unregulated—but if you are going to try them, here is what you should know.
- Saw palmetto. Saw palmetto is widely used for treatment of BPH, but there are few studies to support its use. A 2012 review of 32 studies done on 5,666 men with BPH comparing saw palmetto against a placebo did not find any differences in urinary symptom scores, measures of urinary flow, or prostate size.
- Beta-sitosterol. This is a plant extract often used by men in Europe. A 2011 review of 4 trials found that while evidence suggests that beta-sitosterol improved symptoms in men with BPH, the long-term effectiveness and safety was not known. So, it may work, but safety in the long run is not known.
- Cernilton. Cernilton is a rye-grass pollen extract used by men with symptomatic BPH. Four good studies have been done that suggest cernilton is well-tolerated and modestly improves overall urinary symptoms, including nocturia (getting up at night to pee). While it improved symptoms, it did not affect urinary flow rates, residual urine, or prostate volume.
- Pygeum africanum. The extract of the African prune tree, Pygeum africanum, is another agent men use for the treatment of BPH. In a 2002 meta-analysis of 18 randomized studies, treatment with Pygeum africanum improved symptoms two times more frequently than placebo and increased peak urinary flow rates 23 percent.
Men, have you tried these?