Category Archives: New Drugs

What You Should Know about the New Shingles Vaccine, Shingrix.

Last week a new vaccine for prevention of shingles was not only approved by the FDA, but the CDC recommended vaccination of everyone over age 50 with Shingrix, revaccination with Shingrix if you have previously received the older shingles vaccine Zostrix, and expressed preference for Shingrix over Zostavax.  Shingrix has approval and recommendation for use in patients age 50 or older, vs. age 60 for the older Zostavax, presumably because it is expected to last longer and has a higher efficacy.

Here are the key take home details that I can find out about the new vaccine:

  1. Shingrix is non-live vaccine vs. the older Zostavax which is a live attenuated vaccine.  This means that Shingrix should  be able to be  used in people with a suppressed immune system like HIV patients, chemotherapy patients, organ transplant recipients etc.
  2. Shingrix requires two doses, separated by two months to get the desired immunity, unlike the one-dose regimen for Zostavax. This raises concern about patients getting the first dose but forgetting or otherwise not being compliant with getting the second dose.
  3. The immunity from Shingrix seems to be both stronger and longer lasting than immunity from Zostavax.
    1. Zostavax confers about 50% immunity from shingles, but the immunity wanes fairly quickly, so that by years 7-10 the efficacy is only about 20%, and it is likely that by 10-12 years the immune benefit is gone.
    2. Initial data about Shingrix shows about 97% reduction in the risk of shingles initially, with 85% risk reduction persisting at 4 years. Longer term benefits are TBD.
  4. Minor side effects seem pretty common from Shingrix, including:
    1. Most patients had some degree of pain redness and swelling of the injection site, and about 10% had fairly severe pain, and about 2% had at least 10 cm of redness or swelling.
    2. Other common side effects seem slightly more common in patients age 50-69 that in patients age >70. These include:
      1. Myalgia, fatigue, and or headache in about half of patients.
      2. Shivering, fever and or gastrointestinal side effects in about a quarter of patients.

My initial take on Shingrix is that it is a pretty major improvement over Zostavax, and that although it is likely to cost about $280 for the 2-dose regimen, and the chance of moderate side effects it pretty high, it will be well worth it for me to have an effective and long-lasting immunization for shingles which I (and others over age 50) have a 1:3 chance of getting if not immunized.

The remaining questions are when will Shingrix be available at your pharmacy or doctors office and will your insurance cover getting Shingrix.  My guess is Shingrix will be available within the next few months, and that within a few months after that will be covered by Medicare and other insurers since it has the endorsement of the CDC.

Generic Boniva: A Welcome Addition to our Generic Drug Options

The bisphosphonates have been very popular for treatment of osteoporosis. On March 19th the FDA approved several manufacturers to sell generic Boniva, ibandronate, at the 150 mg monthly dosage that is commonly used. Unlike many drugs that go generic Boniva has been approved for several manufacturers from the start, so we should expect prices to… Continue Reading

Vesicare: When is it Better than Generic Oxybutynin?

Vesicare is one of the older of the second generation medications for urge incontinence. Vesicare has been around long enough that its earliest patent expiration is anticipated in Dec. 2015. You may not hear much about urge incontinence now, because the more popular term for this is overactive bladder. Overactive bladder is a medical condition… Continue Reading

Gabapentin Recreational Use

When I first heard about gabapentin recreational use at first it seemed bizarre, but recently there have been more reports of the diversion of prescriptions for gabapentin recreational use.  This makes some sense because the one of the primary problems with the use of gabapentin for neuropathic pain is that most people need to start… Continue Reading

Duexis: An Example of a Combination Drug Designed Primarily for Profit

Deuxis®  was brought to market by Horizon Pharma as yet one more combination drug offering.  The argument for taking a second drug to reduce the incidence of the most common serious ibuprofen side effects, namely dyspepsia, symptomatic and asymptomatic gastric ulcers, and gastrointestinal bleeding is fairly convincing. It is especially a valid approach in moderate… Continue Reading

Nosocomial Infections

Nosocomial infections are infections which develop in a hospital setting. In the United States the CDC estimates about 1.7 million nosocomial infections from various types of organisms occur annually. Nearly 100,000 deaths occur each year related to these infections. Over the course of most of my medical career nosocomial infections have been primarily related to… Continue Reading

Victoza and the Incretin System Modulator Medications for Diabetes

Victoza is among what is becoming an increasingly crowded market for drugs that affect the incretin system of pancreatic beta cell function and control of insulin release.  The whole incretin system has been a bit more confusing to me than it needs to be primarily because of the nearly unpronounceable terms and similar acronyms.  I’ve… Continue Reading