FDA Approves Ragwitek... Ragweed Allergy Tablet by Mouth (Instead of Allergy Shots)

The FDA formally approved Ragwitek, the third new sublingual allergy tablet to be sold in the United States this year that works the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Ragwitek is the first sublingual allergy tablet to treat ragweed. Although Oralair and Grastek are two other sublingual tablets that have already been approved by the FDA, they treat grass allergies rather than ragweed.

Ragwitek is a tablet made by Merck and treats patients aged 18-65 years who are allergic to only short ragweed. Ragwitek has a simple regimen of 1 sublingual tablet daily starting 12 weeks before the ragweed season and continued until the end of the ragweed pollen season. As with Oralair and Grastek, the first dose is given in a medical office to ensure safety with all other doses are taken at home. The tablet dissolves in less than 10 seconds.

Although in next few weeks US physicians should be able to start prescribing Ragwitek, treatment needs to actually begin in early summer thru the fall for full effectiveness.

As with Oralair and Grastek, epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

The wholesale price of both Grastek and Ragwitek will be $8.25 per pill, or $247.50 for a 30-day supply. The wholesale price of Oralair will be $10 per pill, or $300 for a 30-day supply.

Sources:
FDA approves Ragwitek for short ragweed pollen allergies. FDA 4/17/14

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FDA Approves Grastek... Grass Allergy Tablet by Mouth (Instead of Allergy Shots)

Today, the FDA formally approved Grastek, the second new sublingual allergy tablet to be sold in the United States that works the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Although this tablet has been available in Europe for some time, only now has sale/distribution in the United States been allowed under prescription.

Just 2 weeks ago, FDA approved Oralair which also treats grass allergies.

Grastek (aka Grazax in Europe) is a tablet made by ALK-Abello and Merck and treats patients aged 5-65 years who are allergic to only Timothy Grass. Grastek has a simple regimen of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the grass pollen season. As with Oralair, the first dose is given in a medical office to ensure safety with all other doses are taken at home. The tablet dissolves in less than 10 seconds.

Although in next few weeks US physicians should be able to start prescribing Oralair, it really won't do much good for this year's grass allergies because in order for this tablet to be fully effective in the treatment of grass pollen allergies, treatment needs to actually begin in December but no later than January and continue through August. Grass pollen season begins in April/May, so for at least this year, it may be too late.

For both Oralair and Grastek, epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Sources:
Merck's grass pollen allergy drug wins U.S. approval. Reuters 4.14.14

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FDA Approves Oralair... Grass Allergy Tablet by Mouth (Instead of Allergy Shots)

Today, the FDA formally approved Oralair, the first new sublingual allergy tablet to be sold in the United States that works the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Although this tablet has been available in Europe for some time, only now has sale/distribution in the United States been allowed under prescription.

Oralair is made by a French pharmaceutical company Stallergenes (Greer is US distributor partner) and treats patients aged 10-65 years who are allergic to 5 different grasses: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Treatment is composed of a buildup and maintenance phase. Starting 4 months prior to the grass pollen season, a 100 IR tablet is administered under the tongue in a medical office to ensure no significant side effects. At home on day 2, two 100 IR tablets are administered. On day three and daily thereafter, a 300 IR tablet is placed under the tongue until the end of the grass pollen season. The tablets take about 1 minute to dissolve.

Although in next few weeks US physicians should be able to start prescribing Oralair, it really won't do much good for this year's grass allergies because in order for this tablet to be fully effective in the treatment of grass pollen allergies, treatment needs to actually begin in December but no later than January and continue through August. Grass pollen season begins in April/May, so for at least this year, it may be too late.

Another grass tablet will soon receive FDA approval called Grastek (aka Grazax in Europe). This tablet is made by ALK-Abello and Merck and treats patients aged 5-65 years who are allergic to only Timothy Grass. Grastek has a simpler regimen of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the grass pollen season. As with Oralair, the first dose is given in a medical office to ensure safety with all other doses are taken at home. The tablet dissolves in less than 10 seconds.

For both tablets, epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Sources:
Stallergenes wins U.S. go-ahead for Oralair allergy pill. Reuters 4/2/14

Grastek Recommended by FDA Panel for Timothy Grass Allergy. Medscape 12/12/13

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Nasacort AQ Steroid Nasal Spray NOW Available OTC!

Sanofi announced in 2013 that the FDA had approved Nasacort steroid nasal spray to be made available over-the-counter (OTC) starting sometime spring 2014.

Well... It's now available for about $20. Here's where you can get it on Amazon.com.

Nasacort is a steroid nasal spray used to treat allergies in patients starting from the age of 2 years old. It is similar to prescription steroid nasal sprays like flonase, nasonex, etc. It is also the very first steroid nasal spray made OTC in the United States which can be both a blessing as well as a curse.

Why?

With Nasacort going OTC which will certainly make it more convenient for patients, I also anticipate that the other prescription steroid nasal sprays including flonase, nasonex, qnasl, zetonna, veramyst, etc will become much harder to prescribe due to insurance requiring patients to use OTC Nasacort first. Worst case, insurance may even simply stop paying for the prescription steroid nasal sprays.

After all, this is exactly what happened with prescription reflux and anti-histamine medications.

Source:
FDA Approves Sanofi's Nasacort(R) Allergy 24HR for Over-the-Counter Use. Wall Street Journal 10/11/13

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New Ragweed Under the Tongue Pill Instead of Allergy Shots Recommended by FDA Panel

Yesterday, the FDA Allergenic Products Advisory Committee supported approval for a new sublingual allergy tablets (Ragwitek) that work the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Given this is only a panel recommendation, final "official" FDA approval may not occur for another year or so for sale/distribution under prescription in the United States.

Ragwitek is made by ALK-Abello and Merck and treats patients aged 18-65 years who are allergic to only short ragweed pollen. The way Ragwitek is taken is placement of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the ragweed pollen season. The first dose is given in a medical office to ensure safety with all other doses taken at home. The tablet dissolves in less than 10 seconds.

Epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Ragwitek is similar to Oralair and Grastek which treat only grass allergy. Oralair and Grastek were both recommended by the FDA panel last year.

Source:
Sublingual Ragwitek Backed FDA Panel for Ragweed Allergy. Medscape 1/28/14

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Two New Sublingual Allergy Tablets Approved by FDA Advisory Committee

This week, the FDA Allergenic Products Advisory Committee unanimously supported approval for two new sublingual allergy tablets (Oralair and Grastek) that work the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Although both tablets have been available in Europe for some time, final "official" FDA approval may not occur until end of 2014 (or later) for sale/distribution under prescription in the United States.

Oralair is made by a French pharmaceutical company Stallergenes and treats patients aged 10-65 years who are allergic to 5 different grasses: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Treatment is composed of a buildup and maintenance phase. Starting 4 months prior to the grass pollen season, a 100 IR tablet is administered under the tongue in a medical office to ensure no significant side effects. At home on day 2, two 100 IR tablets are administered. On day three and daily thereafter, a 300 IR tablet is placed under the tongue until the end of the grass pollen season. The tablets take about 1 minute to dissolve.

Grastek (aka Grazax in Europe) is made by ALK-Abello and Merck and treats patients aged 5-65 years who are allergic to only Timothy Grass. Grastek has a simpler regimen of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the grass pollen season. As with Oralair, the first dose is given in a medical office to ensure safety with all other doses are taken at home. The tablet dissolves in less than 10 seconds.

For both tablets, epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Sources:
Grastek Recommended by FDA Panel for Timothy Grass Allergy. Medscape 12/12/13

Sublingual Oralair Recommended for Grass Pollen Allergy. Medscape 12/11/13

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Nasacort Steroid Nasal Spray to be Available Over-The-Counter!

Sanofi announced today that the FDA has approved Nasacort steroid nasal spray to be made available over-the-counter (OTC) starting sometime spring 2014.

Nasacort is a steroid nasal spray used to treat allergies in patients start from the age of 2 years old. It will also be the very first steroid nasal spray made OTC in the United States which can be both a blessing as well as a curse.

Why?

With Nasacort going OTC which will certainly make it more convenient for patients, I also anticipate that the other prescription steroid nasal sprays including nasonex, qnasl, zetonna, veramyst, etc will become much harder to prescribe due to insurance requiring patients to use OTC Nasacort first. Worst case, insurance may even simply stop paying for the prescription steroid nasal sprays.

After all, this is exactly what happened with prescription reflux and anti-histamine medications.

Source:
FDA Approves Sanofi's Nasacort(R) Allergy 24HR for Over-the-Counter Use. Wall Street Journal 10/11/13

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Another Egg-Free Flu Vaccine Approved by FDA

First there was Flucelvax introduced in 2012 and now there is Flublock, both considered egg-free for those concerned with egg allergy in traditional flu vaccines.

Rather than being cultured in eggs, Flucelvax is cultured in mammalian cells and Flublock is grown in caterpillar cells injected by an insect virus containing the flu gene.

Both vaccines are approved for use in people 18 years and older.

Why the concern of egg-allergic patients with the traditional flu vaccine used to defend against both seasonal and pandemic flu virus?

Traditionally, the flu shot vaccine (both H1N1 and seasonal) are grown inside eggs which is where this concern arises. It also doesn't help that the pre-flu shot questionnaire specifically asks about egg allergy. Though egg-based, during vaccine production the egg protein is filtered out such that there should be no egg contaminants in the final vaccine. However, it is theoretically possible that some egg may still be present in the vaccine.

Although there is an infinitesimal possibility of egg contaminants, studies have shown that even patients with life-threatening egg allergy can still safely have the flu vaccine.

In spite of these reassurances, there are still concerns from patients and healthcare professionals which makes the availability of two different egg-free flu vaccines welcome news.

Source:
FDA approves next-generation, bug-based flu vaccine. MSNBC 1/16/13

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Fake Botox Being Sold to US Physicians: FDA Sends Warning

It is not just patients trying to save money when purchasing medications from online pharmacies located in Canada. It's doctors as well when it comes to expensive drugs like Botox made by Allergan which costs a physician practice $550 per vial (2012 price)... but if purchased from Canada, may cost hundreds less.

Unfortunately, just like prescription drugs purchased outside the US, foreign-purchased Botox may be a product that is potentially unapproved, counterfeit, unsafe, or ineffective. Indeed, medical practices that purchase and administer such illegally obtained and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment.

To address this dangerous practice, the FDA has alerted more than 350 medical practices that they may have received unapproved medications, including unapproved versions of Botox from foreign-based suppliers, especially from Canada.

Disclaimer! Our practice has ALWAYS purchased Botox directly from Allergan, the maker of Botox, and have never purchased Botox from a third party supplier, whether US-based or not, past and present.

The ones the FDA specifically listed on a watch-list of sorts under the umbrella of online Canada Drugs include:

• Quality Specialty Products (QSP)
• A+ Health Supplies
• QP Medical
• Bridewater Medical
• Clinical Care

Per the FDA, "many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA. Therefore, FDA cannot confirm that the manufacture and handling of these products follow U.S. regulations or that these medications are safe and effective for their intended uses."

The FDA has also publicly released the names of physicians and physician groups who have purchased from these online sources... public humiliation in order to persuade a change?

However, it may not be just public humiliation, but even jail-time for one physician in a particularly egregious case (Botox not meant for human use was deliberately and knowingly injected).

It's not just doctors, but even medical institutions on the list (ie, University of SW Texas Medical Center).

Source:
Letters to Doctors about Risks of Purchasing Unapproved Versions of Botox and Other Medications from Foreign or Unlicensed Suppliers. FDA 12/19/12

FDA warns doctors of counterfeit Botox. Fox News 12/24/12

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Egg Free Flu Vaccine Approved by FDA

Why the concern of egg-allergic patients with the flu vaccine used to defend against both seasonal and pandemic flu virus?

Traditionally, the flu shot vaccine (both H1N1 and seasonal) are grown inside eggs which is where this concern arises. It also doesn't help that the pre-flu shot questionnaire specifically asks about egg allergy. Though egg-based, during vaccine production the egg protein is filtered out such that there should be no egg contaminants in the final vaccine. However, it is theoretically possible that some egg may still be present in the vaccine.

Although there is an infinitesimal possibility of egg contaminants, studies have shown that even patients with life-threatening egg allergy can still safely have the flu vaccine.

In spite of these reassurances, there are still concerns from patients and healthcare professionals.

As such, there is now a new FDA-approved flu vaccine called Flucelvax which is guaranteed to be egg-free. Rather than being cultured in eggs, this vaccine is cultured in mammalian cells.

Downside is that latex-allergic patients are unable to safely receive this vaccine.

Made by Novartis, this vaccine is approved for use in people 18 years and older.

For more info.

Source:
FDA approves first seasonal influenza vaccine manufactured using cell culture technology. FDA 11/20/12

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Deaths Associated with Codeine Usage in Young Kids

For decades, surgeons have provided young children with prescriptions for pain control after tonsillectomy and/or adenoidectomy surgery, most commonly tylenol with codeine (otherwise known as tylenol #3). Millions upon millions of such prescriptions have been filled and taken without any problems, but there is now a growing concern that such narcotics may be causing more harm than good in a small percentage of kids and perhaps an even greater percentage where it absolutely does nothing. Furthermore, it has now become the subject of an FDA investigation.

Why the sudden concern?

There has been a small but increasing number of children who have suffered anoxic brain damage and even fatalities due to respiratory suppression associated with codeine use. This association was not figured out until recently as such unfortunate incidences were initially felt to be due to medication overdosage, poor care, and/or surgical error.

But now, it is felt that such adverse events were probably due to the administration of codeine itself.

What's going on?

All of the children who died following codeine administration had extra copies of the liver enzyme CYP2D6 which metabolizes codeine to its more potent form morphine [study]. Referred to as ultra-rapid metabolizers, these children metabolize codeine so rapidly to morphine that it leads to respiratory depression or arrest. Substituting codeine for hydrocodone, oxycodone, or other opioids is also unsafe as such narcotics are also metabolized by CYP2D6 and cause even more problems because the CYP2D6 metabolites of hydrocodone and oxycodone are even more potent than morphine. (Of course, on the flip side, there are patients who have minimal CYP2D6 functionality which leads to minimal if any pain relief with codeine.)

Although rare, there has been an increasing number of case reports describing children who have died after receiving codeine for post-operative pain, particularly after tonsillectomy. The most recent report published in 2012 documented the cases of three children who died after receiving standard treatment with tylenol with codeine after tonsillectomy between 2010 and 2011. However, these are only the known documented cases.

Given how rare, changing prescribing patterns may not be warranted... BUT...

What about the possibility that there may be numerous other cases which are not documented or close-calls? As we all know, for every documented case, there's probably numerous other undocumented cases.

To investigate this possibility, a close proxy would be to look at malpractice lawsuits after tonsillectomy. This report did just that looking closely at lawsuits stemming from tonsillectomy complications between 1984 and 2010 and found that the incidence of codeine-related deaths was much higher than the researchers expected. They found that 18 percent of death claims and 5 percent of injury claims resulted from the use of opioids, largely codeine. Indeed, after bleeding, opioid usage was the second most common cause of death in patients after tonsillectomy.

Additionally, death and anoxic brain injury claims associated with narcotic usage were associated with the greatest indemnity with a median payment of more than $900,000 per case.

Though likely impossible to do retrospectively, it would have been interesting to see whether all these children in these lawsuits had multiple CYP2D6 copies or not.

Alternatives to Narcotics

First, there is the question whether tylenol with codeine even helps with pain. Apparently not according to one study. In fact, children who took tylenol alone resumed a normal diet more quickly than kids who received codeine.

In fact, tylenol with codeine is associated with adverse side effects (nausea, dizziness, vomiting, etc) in up to 79% of children who take it [link].

Ibuprofen may also be given for pain control. Though ibuprofen theoretically can increase risk of bleeding due to its anti-platelet activity, numerous studies have not found this to be true.

Given codeine helps minimally with pain and tylenol alone seems to provide adequate pain control, why even given narcotics, especially given the small but significant risk of death associated with this drug?

Pain Control Protocol

Based on all these findings, we feel that narcotics for pain control after tonsillectomy for kids under 7 years of age is not recommended.

Rather, the following protocol is what we will now be implementing:

Tylenol and Ibuprofen over-the-counter as needed to help with pain control. The dosing is weight-based and exact dosing for a given child can be found on the bottle. These medications can be given alternating between Tylenol and ibuprofen every 3-4 hours (Tylenol first, followed by ibuprofen 3-4 hours later, followed by Tylenol 3-4 hours after that, etc). A prescription for a single dose of steroids is also provided which is meant as a one-time dose that can be given anytime 3 days after surgery if the child suddenly seems to have significantly more pain that is not controlled with Tylenol and ibuprofen. Pain in this scenario is often due to inflamed tissues that can be quickly minimized with steroids.

Source:
FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. FDA 8/15/12

Post-Operative Pain in Children Undergoing Tonsillectomy. ENT Today. Sept 2012.

FDA Investigates Codeine Safety After Children’s Deaths. ABC News. 8/15/12

References:
More codeine fatalities after tonsillectomy in North American children. Pediatrics. 2012 May;129(5):e1343-7. Epub 2012 Apr 9.

Preventing opioid-related deaths in children undergoing surgery. Pain Med. 2012 Jul;13(7):982-3; author reply 984. doi: 10.1111/j.1526-4637.2012.01419.x. Epub 2012 Jun 13.

Complications and legal outcomes of tonsillectomy malpractice claims. Laryngoscope. 2012 Jan;122(1):71-4. doi: 10.1002/lary.22438. Epub 2011 Nov 10.

Acetaminophen versus acetaminophen with codeine after pediatric tonsillectomy. Laryngoscope. 2000 Nov;110(11):1824-7.

Non-steroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003591.

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FDA Approves New "Dry" Steroid Nasal Spray

On March 26, 2012, the FDA approved of a new type of steroid nasal spray in the treatment of nasal allergies that puffs powder into the nose rather than a liquid. Liquid formulations such as nasonex, flonase, veramyst, nasacort, and rhinocort has been until now the only delivery medium of administration.

This new spray made by Teva Pharmaceuticals is called QNASL which puffs a steroid beclomethasone dipropionate. For those who know pharmaceuticals, it is the same active ingredient as (liquid) beconase nasal spray.

Just like the other nasal sprays, administration is 2 puffs (sprays) in each nares daily.

This spray does pretty much the same thing (and has similar side effects) as the other established nasal sprays. However, QNASL may be better tolerated in those patients who HATE the drip down the back of the nose after liquid nasal spray use.

Drug should be available for prescription starting in April 2012.

Source:
Teva Announces FDA Approval of QNASLTM (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis. Teva Pharma 3/26/12

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FDA Approves New Surgical Reflux Treatment

On March 22, 2012, the FDA approved the LINX Reflux Management System to treat gastroesophageal reflux disease (GERD). Developed by Torax Medical, the

"LINX system is composed of a series of titanium beads, each with a magnetic core, connected together with independent titanium wires to form a ring shape like a bracelet of beads. It is implanted at the lower esophageal sphincter (LES), a circular band of muscle that closes the last few centimeters of the esophagus and prevents the backward flow of stomach contents. The force of the magnetic beads is designed to provide additional strength to keep a weak LES closed. Upon swallowing, the magnetic force between the beads is overcome by the higher pressures of swallowing forces, and the device expands to accommodate a normal swallow of food or liquid. Once the food passes though the LES, the device returns to its resting state."

Traditionally, surgical management of reflux entailed a stomach wrap called Nissen Fundoplication which is analogous to cinching a belt and is currently the gold standard. Trans-oral incisionless fundoplication is a newer approach to the Nissen fundoplication and is in essence an "internal" stomach wrap.

It is only a matter of time to see whether this new LINX system is as effective if not more effective than fundoplication over a long period of time or whether it will go the way of the Dodo bird.

An immediate disadvantage of this system... Patients can never undergo a MRI scan in the future (LINX uses magnetic beads... MRI which utilizes a strong magnet... Visualization of beads being yanked out of the human body in a MRI machine...)

Reference:
FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease. FDA 3/22/12

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