Another indication

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FRIDAY, Feb. 29 (HealthDay News) -- The U.S. Food and Drug Administration has approved Abilify (aripiprazole) to treat manic and mixed episodes in children aged 10 to 17 with bipolar 1 disorder, makers Otsuka Pharmaceutical Co. and Bristol-Myers Squibb Inc. said Friday.The drug has been approved for this and other uses in adults for several years.The new approval was based on results from a four-week study involving children in this age group. The trial demonstrated the drug's effectiveness compared to a placebo, the drug companies said in a statement. Abilify was first approved in November 2002, and nearly 15 million prescriptions had been written through December 2007, the statement said.

Baxter Recalls Heparin Products

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Baxter International recently announced a voluntary recall of all remaining lots and doses of its heparin sodium injection multidose and single-dose vials and HEP-LOCK heparin flush products.
The FDA has received 448 reports of adverse events associated with heparin products, but some of these may be duplicate reports. In 389 of these cases, Baxter was named as the source of the product. The reports included 215 “events of interest” and 21 deaths. Most of the events occurred last year.

The FDA has launched a “far-reaching investigation” of a Chinese firm, Changzhou SPL, which made the active pharmaceutical ingredient (API) for Baxter, Michael Rogers, director of the FDA’s Division of Field Investigations, said. Two FDA inspectors were sent to China to carry out that investigation and related investigations of two “consolidators” associated with the API manufacturer. They also may inspect workshops and farms associated with the manufacture of the product, which uses pig intestines.

The agency has posted on its website a redacted version of the Form 483 observations that its investigators issued after inspecting the API plant. It can be accessed at www.fda.gov/ora/frequent/483s/Changzhouspl_heparin_20080226_483.html.

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It's the backdoor method of the Chinese trying to kill us.  Just kidding.  Seriously though this recall does affect the hospitals where I work pretty severely.  When do you think we'll stop relying on foreign countries to make a medicine that can be trusted?

Baseball and steroids

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I don't know if Roger Clemens is guilty or not of using steroids.  If you look at old clips of him pitching the years that the Mitchell reports claims, maybe he looks puffier?  I don't know.  Part of me feels bad for the guy because wonder if he is INNOCENT?  Either way, it seems to me that steroids are NOT going to just go away.  HGH and steroids can make an athlete stronger and younger which equals more money. I just got a kick out of the interview with Clemens because he was talking about how he was taking Vioxx like "eating Skittles."  Are you serious?  Are you kidding me?  He then went on to discuss how if he did go before a senate hearing committee, that he would have to bring up the Vioxx question...  why was this drug on the market if it had the potential to harm?

Does he and the rest of the pill popping Americans not KNOW that every drug has some potential (some more than others) to harm?  You can KILL yourself with an overdose on acetaminophen just as one example.

It's just that I'm surprised he was eating Vioxx like candy with very specific dosing limits spelled out, etc...

They all want to be smart and in the know when on their meds but then later when the med is taken off the market, they want to play the dumb card.  For Roger, the dumb card would be not to find out the max daily dose of Vioxx prior to taking it?  Perhaps?  I mean eating Vioxx like candy means more than 1-2 day obviously!

Brain Shivers... Brain Zaps... Brain Shocks...

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I do not know if many in the medical community are aware of this term that is thrown out there for such offenders as venlafaxine (Effexor), duloxetine (Cymbalta), paroxetine (Paxil), fluoxetine (Prozac), sertraline (Zoloft), fluvoxamine (Luvox), citalopram (Celexa), and escitalopram (Lexapro), but it is a very real phenomenon. Unfortunately, though many in the medical community have not had to rely on any of these meds in their own personal lives, I had a 2-3 year stint with venlafaxine from 2002-03. Basically, I presented with the inability to sleep due to anxiety of some personal issues (which we all have from time to time), and did not want a controlled substance. I tried paroxetine first and absolutely despised the drug. I quit cold turkey. Very smart for a pharmacist, right? (You can't just stop cold turkey and expect to not endure some uncomfortable sensory disturbances.) I found venlafaxine, at 75 mg extended release, to be a very good drug for its purpose of 9 to 12 months. However, what I didn't expect was that weaning from the drug would be so uncomfortable. 75 mg in itself is not even a moderate dose, falling more into the lower dose category. I've seen higher doses much more than the lower doses.

To explain what I felt, I will do my best to try to break down into words the feelings. Initially, there was a sinking feeling in my brain. If you've ever been to the Grand Canyon or a very tall building and looked down, there is a falling feeling that your brain sometimes throws at you though you are not falling at all. That feeling would happen for very short bursts, 2-3 seconds, enough to disrupt my thoughts, my work, and my being. I would just think, "What was that?" If I tapered over the recommended taper schedule (usually a week at a time step down, but keep in mind there's only one strength lower than the 75 mg XR - the 37.5 mg XR. Then where do I go? Literally it didn't matter. The big divide between the 75 mg and the 37.5 mg was enough to cause the "shivers" in my brain - a disorientation, falling, weird, and uncomfortable feeling.

"Brain zaps" are said to defy description for whomever has not experienced them, but the most common themes are of a sudden "jolt," likened to an electric shock, apparently occurring or originating within the brain itself, with associated disorientation for a few seconds. The phenomenon is most often reported as a brief, wave-like electrical pulse that quickly travels across the surface of (or through) the brain. Some people experience these "waves" through the rest of their body, but the sensation dissipates quickly. They are sometimes accompanied by brief tinnitus and vertigo like feelings. Immediately following this shock is a light-headedness that may last for up to ten seconds. The sensation has also be described by many as a flashbulb going off inside the head or brain. Moving one's eyes from side to side quickly while open has also been known to trigger these zaps and sometimes causing them to come in rapid succession. It is thought to be a form of neuro-epileptiform activity.

As withdrawal time increases, the frequency of the shocks decreases. At their peak, brain zaps have been associated with severe headaches. They may last for a period of several weeks after the last dose and usually resolve completely within a month or two. However, anecdotal reports of "zaps" during a protracted withdrawal are known to last a year or longer.

My remedy was to open the capsule and to count the tiny beads and literally make capsules with less and less tapering over a 6 week period rather than the usual 2 - 3 weeks at this dose. It did eliminate the feeling, but it definitely helped. One could go as far as asking the physician for a 37.5 mg immediate release tablet and maybe breaking it up into pieces and tapering at the very end that way. Any way you dice it, venlafaxine was a pain and taught me right away a bigger lesson in remembering the side effects than any package insert ever could.

10/31/12 - update and fitting it is Halloween! Guess what? Add Cymbalta (duloxetine) to the list. It has been given approval for pain, both arthritic lower back and cancer. Withdrawal when you miss a dose.

I did take Vitamin B Complex, and maybe it helped.  Others have mentioned other vitamins.  Would love to hear remedies that worked if you can email me at theblondepharmacist@gmail.com

The Wonder Drug

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Study hails heart wonder drug They have been hailed as a wonder drug - the pill of life - a magic bullet in the fight against heart disease, one of the world's biggest killers.

Now new research supports claims by international drug manufacturers that statins, already the world's biggest-selling medication, dramatically reduce the risk of heart attack and death in high-risk middle-aged men. Statins may also provide health benefits up to 10 years after a patient stops using the drug, the research has found.

Statins are a cholesterol-lowering medication taken in pill form that prevents plaque buildup in arteries.

About 10,500 Kiwis die from cardiovascular disease each year.

It is one of the country's biggest killers, accounting for 40 per cent of all deaths.

Nearly 300,000 New Zealanders already consume one million prescriptions annually of the fully subsidised drug, marketed here as Lipex and Lipitor, at a cost to taxpayers of about $50 million.

But a leading Wellington cardiologist is urging calm following the latest findings, warning that statin use is no magic panacea against heart attacks for those most at risk - diabetes sufferers, smokers, Maori men, and people with high blood pressure or high cholesterol levels. Medical experts have just published the results of a 15-year trial in Scotland involving 6500 men aged between 45 and 64 who had not had heart attacks but showed elevated cholesterol levels.

Half were given the drug Pravastatin for five years and the rest given a placebo. Another study then tracked the men's progress for 10 years after the initial trial.

The results show a 25 per cent lower risk of heart attack or death from heart disease among those in the statin group - even though many stopped taking the drug a decade earlier.

Some health experts now suggest the drug - which has little or no side effects - should be prescribed preventively to those who are not high-risk.

Stewart Mann, Wellington School of Medicine Associate Professor of cardiovascular medicine, warned that statins are not a miracle panacea: "There are benefits and I strongly support their use, but particularly in those who are at enough level of risk that it will substantially reduce their risk. It does not guarantee freedom from heart attack."

Pharmac medical director Peter Moodie said people at high risk of heart disease could not substitute healthy living for a magic drug.

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The magic pill that most lazy people are looking for... statins. (after this is the disclaimer warning that the side effects of statins include and are not limited to: Percentages as reported with immediate release tablets; similar adverse reactions seen with extended release tablets.

>10%: Neuromuscular & skeletal: CPK increased (>2x normal) (11%)

1% to 10%:

Central nervous system: Headache (2% to 3%), dizziness (0.5% to 1%)

Dermatologic: Rash (0.8% to 1%)

Gastrointestinal: Abdominal pain (2% to 3%), constipation (2% to 4%), diarrhea (2% to 3%), dyspepsia (1% to 2%), flatulence (4% to 5%), nausea (2% to 3%)

Neuromuscular & skeletal: Myalgia (2% to 3%), weakness (1% to 2%), muscle cramps (0.6% to 1%)

Ocular: Blurred vision (0.8% to 1%)

10x normal), depression, dryness of skin/mucous membranes, dyspnea, eosinophilia, erectile dysfunction, erythema multiforme, ESR increased, facial paresis, fatty liver, fever, flushing, fulminant hepatic necrosis, GGT increased, gynecomastia, hemolytic anemia, hepatitis, hepatoma, hyperbilirubinemia, hypersensitivity reaction, impaired extraocular muscle movement, impotence, leukopenia, libido decreased, malaise, memory loss, myopathy, nail changes, nodules, ophthalmoplegia, pancreatitis, paresthesia, peripheral nerve palsy, peripheral neuropathy, photosensitivity, polymyalgia rheumatica, positive ANA, pruritus, psychic disturbance, purpura, rash, renal failure (secondary to rhabdomyolysis), rhabdomyolysis, skin discoloration, Stevens-Johnson syndrome, systemic lupus erythematosus-like syndrome, thrombocytopenia, thyroid dysfunction, toxic epidermal necrolysis, transaminases increased, tremor, urticaria, vasculitis, vertigo, and vomiting.

Wonder....FUL!

Magic Mouthwash (the vague term for a concoction of ANYTHING)

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When I worked in retail pharmacy, a physician would write a prescription for "Magic Mouthwash" and the patient would hand over the prescription with this look of "magic."  This special blend of WHATEVER would be the cureall for their sore mouth and throat caused by thrush or radiation or any other mouth/throat pain condition.  The physician rarely would include what he/she "thought" to be their special recipe.  So, we would have to call and clarify. "What would Dr. Doe like in his magic mouthwash?"  I would ask simply.

"Magic Mouthwash?"  asks the nurse, "I don't know.  What do you normally put in it?"

Sigh.  "Well we could start with diphenhydramine, lidocaine, and nystatin all at a 1:1:1 ratio or we could do tetracycline and throw in some mylanta with the formerly mentioned ingredients at all different ratios.  There are probably a 100 different magic mouthwashes out there.  What is the doctor treating?"

And it would end up that I could pick whatever I wanted.  That made me think... hmmm  placebo effect.

So what exactly should you put in Magic Mouthwash?

The usual concoction contains equal amounts of viscous lidocaine and diphenhydramine for analgesia...and Maalox or a similar antacid to enhance coating of the ingredients in the mouth.  Some also include nystatin to prevent or treat fungal growth...a corticosteroid to reduce inflammation...or tetracycline to prevent secondary bacterial infections.

 

Who knows if this stuff even works and is worth the money since we pharmacists usually tack on a compounding fee.  I say get a prescription for lidocaine viscous and buy your own benadryl solution and mylanta and make your own... for less.

Alli - a new name = magic for the nonmedical community, apparently

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Alli was born over-the-counter recently. It's the old Xenical drug (Orlistat) made by GlaxoSmithKline. Have you ever tried this medication personally? I have to share. Though, I will warn you, this is definitely TMI (too much information for those of you not into text messaging, short cuts, or the current way to speak... LOL). I took Xenical when it came out. Um (blushing) embarrassed to say I bought 5 capsules from the independent pharmacy I was working for... I know I know... unethical right? ANYWAY! There's issues with loss of Vitamins A, D, E, and K absorptions and also the potential for ANAL LEAKAGE. Yep. Anal Leakage.

What is anal leakage? Well it's where you can't control the oil slick coming out of your ass. I remember being horrified thinking, "Oh oh." Ran in a heated sprint to the bathroom (luckily at home!) and immediately there was a layer of OIL that spread out in the toilet water. OIL. What in God's name???

The new nonprescription diet drug Alli is flying off store shelves, but most people who use it will lose very little weight and may experience embarrassing side effects.

• Forum: About 20% of people who use Alli will lose 10% or more of their body weight. But most don't lose much weight at all, and some suffer embarrassing gastrointestinal side effects. Will you try the pill? Join a discussion.

Pharmacies are reporting brisk sales of Alli (pronounced like the noun "ally"), which is sold by drug maker GlaxoSmithKline and is the first over-the-counter diet drug to win FDA approval. Unlike other prescription weight-loss drugs such as Meridia and the generic phentermine, Alli doesn't make you feel full, reduce cravings or curb your appetite. Instead, it prevents the body from breaking down and absorbing fat.

The active ingredient in Alli is orlistat, which is found in a higher dose in the prescription diet drug Xenical. Alli blocks about 25% of the fat you eat; Xenical blocks one-third of the fat you ingest. For instance, a half-cup serving of Haagen-Dazs ice cream has about 320 calories and 19 grams of fat. Alli, which is taken with meals, would prevent the body from absorbing about 4.75 fat grams or about 43 calories. If you consume about 2,000 calories a day and eat about 30% fat, the fat-blocking benefits of Alli would translate to about 150 calories a day. A pound of weight loss equals 3,500 calories.

Here's what users of orlistat, the ingredient in Alli, can expect from the weight-loss drug:

• One in five will lose 10% or more of body weight

• Half will lose less than 5% of their body weight

• Side effects include gas, oily discharge and loose stools

The downside of Alli is the fat it blocks can come out of your body in embarrassing ways. The Glaxo Web site, myalli.com, warns the drug can cause gas with oily discharge as well as frequent or loose stools. The site suggests it's probably a "smart idea" to wear dark pants and bring a change of clothes to work if you use Alli.

To avoid the side effects, Glaxo suggests limiting fat intake to 15 grams a meal. Many Americans consume 80 to 100 grams of fat a day. Glaxo officials concede that many people would lose weight on their own with a diet that's moderate in fat, but that the pill helps them lose more weight.

"If you'd lose 10 pounds on a diet, you'll lose 15 pounds by adding Alli to your diet,'' says Vidhu Bansal, director of medical affairs for Glaxo's consumer-health division.

If someone is consuming a diet already low in fat and high in carbohydrates, they likely won't get much benefit from Alli. However, doctors say most people are eating far more fat than they realize.

Orlistat has been used by an estimated 28 million people world-wide, and studied in 30,000 subjects in about 100 trials. In a 1999 Journal of the American Medical Association report, 1,187 dieters, who weighed an average of 220 pounds, took either a placebo or 120 mg of orlistat (twice the dose of Alli). After one year, individuals in the orlistat group lost an average of 19.27 pounds, about 50% more than the 12.8-pound average weight loss in the placebo group.

Yeah, um, I don't know about this one... I can see it now. Misinformed customers buying the drug and LOTS and LOTS of accidents in the underwear!

Avandia

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The Food and Drug Administration (FDA) issued an alert on May 21, 2007 informing healthcare providers of a potential cardiovascular safety issue raised by a recent meta-analysis (Nissen, 2007). Nissen and Wolski reviewed 42 randomized, controlled studies (each >6 months duration) in patients with type 2 diabetes or impaired glucose tolerance. Each study included compared rosiglitazone (as monotherapy or in combination regimens that include a sulfonylurea, metformin, and/or insulin) to a control group (another diabetic agent or placebo). The meta-analysis tabulated the number of myocardial infarctions and cardiovascular deaths from each trial. Of the 42 studies, 38 reported at least 1 MI and 22 reported at least 1 CV related death. The meta-analysis evaluated 15,560 patients who received regimens that included rosiglitazone and 12,283 patients in the group without rosiglitazone. In comparing the rosiglitazone group to the control group, the odds ratio for myocardial infarction was 1.43 (95% CI 1.03 to 1.98; p=0.03). The odds ratio for death from cardiovascular disease was 1.64 (95% CI, 0.98 to 2.74; p=0.06). Rosiglitazone was associated with a significant risk of myocardial infarction in this pooled analysis. The clinical significance of these initial results is unclear and the data has not been reviewed by the FDA. The agency is currently assessing the information. Healthcare providers should be aware of these developments and await further information as more becomes available.