The anticonvulsant Sabril (vigabatrin) was approved by the FDA last Friday for the treatment of epilepsy and infantile spasms. The drug was already available in Canada, the U.K., Denmark and Mexico.
The Los Angeles Times reports that Sabril is the first drug approved in the United States for infantile spasms, a terrible disease that can cause babies to have hundreds of spasms in a day.
The onset of infantile spasms usually occurs between the ages of four and eight months. The seizures are characterized by a sudden bending forward of the body and a stiffening of the arms and legs. U.S. doctors have used prednisone to treat the condition to date, with limited success.
Here’s video of a baby named Kailani having infantile spasms:
Although infantile spasms generally clear up by age 5, patients are prone to other forms of epilepsy later in life.
In addition to infantile spasms, Sabril is approved to treat epilepsy sufferers with so-called “complex partial seizures,” which affect about 1 million Americans.
As the Times points out, there are reasons the FDA took its time to OK Sabril:
The drug … is not perfect. As many as 30% of those who use it suffer from a loss of peripheral vision, although it does not affect central vision and such tasks as reading. Patients who use the drug will have to be monitored very closely for loss of vision…
The Times adds that many U.S. parents have been buying Sabril from Canadian pharmacies for years to treat infantile spasms.
Millions of Americans take oral ibuprofen (in products like Advil) for pain relief. What’s great about ibuprofen is that it is chemically similar to aspirin but easier on the stomach. So if you have body aches and pains that acetaminophen (Tylenol) can’t treat, ibuprofen is a great solution for ailments like arthritis, sunburns, sprains, etc.
Since people associate ibuprofen with the relief of body aches, it was probably inevitable that drugmakers would market it in topical ointments. And indeed, numerous ibuprofen creams and gels are now available.
Late last week, however, the FDA announced that it has issued warnings to eight makers of these over-the-counter products, telling them to take their products off the market.
The FDA said in its announcement:
Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products … Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.
The specific products whose manufacturers received warning letters are called Emuprofen, BioEntopic 15% Ibuprofen Crème, Ibunex Topical Ibuprofen, LoPain AF 15% Ibuprofen Crème, IB-RELIEF, Profen HP, IbuPRO-10 Plus, and IBU-RELIEF 12.
Interestingly, other topical ibuprofen products, such as those by Mentholatum, were not mentioned in the announcement.
The FDA did not comment on whether topical ibuprofen actually works. It only said that these products need to earn FDA approval before being sold.
So, does topical ibuprofen work?
Some people swear by it. For example, when a questioner on Yahoo! Answers asked, “How good is topical ibuprofen?”, one respondent answered:
I use ibuprofen gel on my neck when I get a tension headache – its about the only thing that works!
But another person responded:
Topical ibuprofen is of limited use as it only penetrates about 0.5cms, this means it can’t really reach the knee joint if you rub it in.
We did find some medical studies that argued the effectiveness of topical ibuprofen. The maker of the ibuprofen cream Ibunex states its case this way:
Topical supplementation is the best way for addressing soft tissue and joint pain because it is applied directly to the target area that is causing the pain or discomfort. Over 80% of oral medicines and supplements are filtered out by the digestive system, thus minimizing their effect in the easing of pain … Ibunex is a unique, topically applied formula. One pump (.2 grams) contains Ibuprofen (10 mg) plus Glucosamine (4 mg), Chondroitin (4 mg), MSM (5 mg) and Bromelain (5 mg). Recent clinical research has found that 5% topical Ibuprofen resulted in comparable effectiveness relative to 400 mg oral Ibuprofen.
In the wake of the FDA warning letters, the continued availability of these products at your local drugstore is obviously in question. In the meantime, if you currently use topical ibuprofen, ask your doctor to recommend alternatives.
Last week, the FDA approved the drug Saphris to treat schizophrenia and bipolar disorder in adults. Saphris will compete with other drugs in the class known as “atypical antipsychotics,” which also includes Risperdal, Abilify and Seroquel.
So, how do you know which (if any) of these drugs is the best choice for you?
Unfortunately, the FDA does not require comparative effectiveness testing before approving new drugs. As a result, we only know that Saphris is more effective than a placebo. A June memo by the director of the FDA’s division of psychiatry products said efficacy results for schizophrenia were “not overwhelming” for Saphris. It also said the drug’s effectiveness in treating bipolar disorder was merely “sufficient.”
In other words, all we really know is this: It’s better than nothing. We’ll have to see over time how it compares to the other drugs on the market.
Schizophrenia affects about two million Americans. It is an incurable mental illness characterized by episodes of hallucinations, delusions, loss of contact with reality and difficulty functioning socially or at work. Bipolar disorder affects about 10 million Americans. It is characterized by alternation between episodes of depression that can last for several months and shorter periods of mania.
Currently, so-called “atypical antipsychotics” are the first choice in treating these conditions, even though the FDA says all have “significant risks,” including movement disorders, sedation, weight gain, and concerns about diabetes and other conditions related to weight gain. All must carry the FDA’s “black box” warning.
Additionally, in the case of Saphris, one FDA reviewer said there were indications that the drug “causes pulmonary arterial hypertension and cardiac effects” and that the drug’s maker, Schering-Plough, “knew about this toxicity and specifically tried” to prevent the FDA from finding out about it.
Schizophrenia and bipolar disorder are serious conditions, and all of these drugs can have serious side effects. One reason physicians (as well as the FDA) like to have a number of medications to choose from in treating patients is that individuals can react very differently to different drugs. One patient may do better on Risperdal; another may do better on Seroquel. And some may respond better to Saphris.
And it’s possible that none of these drugs is the best choice for you. The Los Angeles Times reports that “mounting research has made clear that the atypical antipsychotics are not only less safe than originally thought; they are not, on balance, any safer or more effective than older drugs for schizophrenia.”
The older drugs (as you might have guessed) are classified as “typical antipsychotics.” These drugs are significantly less expensive than atypical antipsychotics as well.
Whatever drug you end up taking, consulting with your doctor or psychiatrist is critical — because all these drugs are powerful stuff.
And let me add one more point. Think twice about using any of these drugs for simple depression. Currently, the makers of Abilify are spending millions of dollars in advertising to promote the drug as a depression treatment. The makers of other atypical antipsychotics are following suit.
But there is little evidence that these powerful drugs work very well in treating depression. And there is evidence that these drugs are being overprescribed to patients. The Clinical Psychology and Psychiatry blog reports:
According to a freshly published study, one in five depressed patients receiving services through the VA healthcare system in the United States is taking an antipsychotic. Of those taking antipsychotics, 43% were taking them at high doses … I’m aware that many of these patients are suffering much more than a simple case of the blues. That doesn’t mean we should throw heavy duty antipsychotics at them, particularly at high doses.
Frankly, if you’re suffering from depression and your doctor or psychiatrist recommends any of the atypical antipsychotics as a treatment, I would seek a second opinion.
Heartburn drugs called proton pump inhibitors (PPIs) — such as Nexium, Prevacid, Protonix and Aciphex — were prescribed 80 million times in 2008. And millions more Americans used over-the-counter Prilosec to treat their acid reflux.
Why are these acid suppressants so popular?
Obviously, the biggest reason is that Americans eat a lot of junk. But another suspected reason, which you’re probably not aware of, is that these drugs are actually addictive.
No, they don’t cause you to get “high” — but they do leave you with serious withdrawal symptoms when you don’t take them.
[Danish] researchers randomly assigned 120 healthy volunteers to receive either a PPI (Nexium) or a look-alike placebo. After eight weeks on the acid-suppressing drug, a placebo was substituted without the subjects’ knowledge. Heartburn symptoms were evaluated in both groups.
The people who had taken Nexium for two months suffered significant heartburn, indigestion and acid regurgitation after they were switched to placebo. The investigators concluded: “PPI therapy for 8 weeks induces acid-related symptoms in healthy volunteers after withdrawal.”
This doesn’t come as a complete surprise to readers of The People’s Pharmacy. Many have shared stories like this: “I started taking Prilosec in the ’90s. I now take Prevacid every day. Without it, I had heartburn so bad I thought I was having a heart attack.”
Another reader reported: “I’ve had exactly the same problem with Protonix and Nexium. I’ve tried to go off Protonix three times, but I suffer terrible burning in my stomach. My doctor just says, ‘Maybe you need it.’ But I know there are side effects, and I’d like to find another way to take care of my stomach problems.”
An editorial comment on the Danish study suggests that the indiscriminate use of PPI medications could aggravate the very symptoms that these drugs are supposed to treat and lead to an increased requirement for long-term therapy.
This is a great argument for attempting to treat the root cause of your heartburn, rather than immediately resorting to a PPI. Eating less is a good start. Avoiding fatty, acidic and spicy foods is also good, as is quitting smoking. And elevating your head when sleeping is an effective preventative.
That’s not to say that some people don’t need to take medications for their heartburn. There are all kinds of reasons why individuals, including otherwise fit and healthy ones, can come down with acid reflux.
If you are prescribed a PPI, be sure to talk with your doctor about timeframes and a game plan for discontinuing the drug. Research indicates that long-term use of PPIs can lead to pneumonia, weakened bones and other ailments.
I went to my doctor with an infection recently, and he prescribed the antibiotic Levaquin. He didn’t say the drug was different from other antibiotics or spell out any specific risks associated with the drug.
Then I saw an ad on TV from a law firm warning that taking Levaquin could be harmful — even deadly.
As much as we might tend to group antibiotics as a single category of medication, they are anything but. Some antibiotics are more powerful than others. For example, fluoroquinolone antibiotics — such as Levaquin, Cipro, Avelox and Floxin — are among the most potent on the market.
With this potency comes risks and side effects. Specifically, fluoroquinolone antibiotics carry a black-box warning from the FDA stating that they increase the patient’s chance of developing tendonitis or having a sudden tendon rupture, among other dangers.
One legal site tells the story of Melissa, who was prescribed Levaquin in 2007. She says that a few months after taking a course of Levaquin,
I started having trouble with my feet. I couldn’t walk and I didn’t know what was going on. I went to a foot doctor and I was diagnosed with contracted tendons. I was in terrible pain …
The problems with my feet were sudden. One morning I got up and I said, ‘I don’t think I can stand up.’ I would try to stand but it was like everything in my feet was ripping. The left foot went first, followed by the right in a few weeks … I use a cane half the time and I’m only 46. In the house, the pain can be really bad, so I’ll use a walker.
In March of this year I had surgery on my left foot. I was scheduled for surgery on my right foot, but I did not like results from the left foot. On a pain scale of one to 10, I was at a 10 before the surgery. I’m at a nine now, and I’m out $10,000 and I have a scar on my foot and leg.
I also found a consumer site that called Levaquin an antibiotic to “avoid like the plague.” It says:
Most likely a great deal of the toxicity of these drugs is that they contain the highly toxic poison, fluoride.
Drugs with an attached fluoride can penetrate into very sensitive tissues that used to be impenetrable. The fluoroquinolones have the unique ability to penetrate your central nervous system, including your brain.
According to Bob Patton, a private citizen in England fighting to get the truth out about these antibiotics, about half of the fluoroquinolone antibiotics that were once on the market have been removed from clinical practice due to their horrific side effects.
Omniflox, Raxar, Trovan, Zagam, and Tequin have all been banned.
However, Cipro, Levaquin, Avelox, and Floxin continue to be prescribed for a variety of infections, both major and minor. Cipro and Levaquin are by far the favorites.
Although they are admittedly powerful anti-infectives, they are too often prescribed as a first-line defense for minor problems such as sinus, bladder, and prostate infections. These super-antibiotics should be used as a last line of defense, not handed out like candy for every patient with a sore throat, which has unfortunately become the norm.
And with devastating results.
I did a little more research on Levaquin and saw that, indeed, the drug is limited in its licensed uses to “serious and life-threatening” infections. However, doctors have the discretion to prescribe the drug more liberally — for even minor infections — and many of them do.
So don’t assume that all antibiotics are alike. Do your research, and if you don’t like what you find, ask your doctor for a milder substitute.
The osteoporosis drug Fosamax went on trial today in New York, facing the first of 900 lawsuits that claim the medication causes the death of jawbone tissue.
The plaintiff, Shirley Boles, 71, claims that the drug’s maker, Merck, failed to warn doctors and patients that it might hamper blood flow to the jaw, ultimately leading to osteonecrosis. Merck says there is no proof that the drug causes osteonecrosis.
Fosamax (alendronate sodium), along with generic versions of the drug, remain big sellers. Fosamax has been one of the most frequently dispensed drugs in the United States in recent years.
So, is Fosamax safe for you?
Fosamax is in a category of drugs called bisphosphonates. The category also includes Actonel and Boniva. The latter drugs, which came on the market after Fosamax, have also been linked to osteonecrosis of the jaw.
According to the FDA, Fosamax can lead to severe bone, joint or muscle pain, and the agency has advised doctors to take their patients off the drug should it occur. The FDA also asked Merck to add a warning about osteonecrosis of the jaw to its labeling. Merck’s warning currently reads:
Fosamax may cause jawbone problems in some people. Jawbone problems may include infection, and delayed healing after teeth are pulled.
Osteonecrosis of the jaw is very rare, and only a small percentage of Fosamax users have been affected by the condition. Researchers say Fosamax users are more likely to develop osteonecrosis if they have cancer or have been treated with chemotherapy, radiation or steroids. Blood clotting disorders, anemia and pre-existing dental problems have also been linked to osteonecrosis of the jaw.
Talk with your doctor about Fosamax and whether the benefits outweigh the risks for you.
When Protopic and Elidel ointments came on the market to treat eczema — particularly atopic dermatitis — they were viewed as an attractive alternative to steroid ointments.
Atopic dermatitis is a disease that can result in scales on the skin surface, red blotches, lesions, and oozing sores. It can vary greatly in severity, and as many 25 of the world’s population suffers from it to some degree, often starting in infancy or childhood.
For nearly 50 years, atopic dermatitis has been treated with topical corticosteroids. Unfortunately, not all patients respond to topical steroids, and others have unpleasant side effects. Additionally, long-term steroid use can cause thinning of the skin and other consequences.
That’s where Protopic (tacrolimus) and Elidel (pimecrolimus) entered the picture in 2000. Known as topical calcineurin inhibitors (TCIs), these drugs suppress inflammation in a similar way to steroids, but are steroid-free. As such, they can be prescribed for longer periods and be applied to thinner skin, such as on the face and eyelids. They also do not cause side effects such as pigment changes, blood vessel formation and striae formation, which can occur with steroids. They are gentler on the skin of small children.
But there are now questions about the safety of these drugs. The ointments were prescribed heavily by pediatricians and others until 2005, when the FDA slapped both drugs with a “black box” warning, as a result of reports of children and adults who developed cancer — such as skin cancers and lymphomas — while using these medications. Many researchers, allergists and dermatologists do not believe there is any proof of a causal link between these medications and cancer. However, the warnings are still in place.
Today, because of the possible cancer risk, among other considerations, Elidel and Protopic are considered a second line of treatment — after topical steroids — for atopic dermatitis in adults and children two years and older. In general, these medications should only be used for short-term bouts of eczema; over the long term, the best and safest approach is the liberal use of moisturizers to maintain good skin hydration.
Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults, has been approved by the FDA to compete with the other DPP-4 inhibitor on the U.S. market, Januvia (sitagliptin).
So, is Onglyza or Januvia the better choice for you?
Let’s look at the two drugs along a number of criteria –
Price. Both drugs are priced at approximately $5.72 per pill for common dosages (U.S. wholesale).
Effectiveness. Both drugs improve the body’s ability to lower elevated blood sugar levels and are part of a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. This is a relatively new class of drugs that can be taken along with older diabetes drugs, such as metformin. The potential advantages for Onglyza are (1) that it’s a smaller pill than Januvia and thus easier to swallow; and (2) that it can be taken as a once-daily combo with metformin, whereas the Janumet combo is taken twice daily.
Side effects. The most common side effects of Onglyza are the headache and runny nose that are also found with Januvia; these result from the inhibition of the immune system these drugs cause.
Safety. There is some concern that Onglyza may increase the risk of “cardiovascular events” for those who already have heart problems. The FDA is requiring Onglyza’s makers to conduct testing to address this issue. General concerns have been expressed about the potential cardiovascular risks of DPP-4 inhibitors, which is one reason similar drugs by Novartis and Takeda are still not available on the U.S. market.
In general, the prescribing information on Onglyza seems to offer no advantages over Januvia. And since the drugmaker has decided to match the price of Januvia, rather than getting in a price war, there’s no financial advantage to picking one over the other, either.
Of course, most physicians like to have more than one drug choice in the same class, because individual patients respond to medications differently. So ask your doctor.
Either way, we’re sure to get saturation TV advertising on Onglyza now that it is FDA-approved. So if you love watching pharmaceutical ads, stay tuned.
The anticonvulsant Sabril (vigabatrin) was approved by the FDA last Friday for the treatment of epilepsy and infantile spasms. The drug was already available in Canada, the U.K., Denmark and Mexico.
Millions of Americans take oral 
Last week, the FDA approved the drug Saphris to treat schizophrenia and bipolar disorder in adults. Saphris will compete with other drugs in the class known as “atypical antipsychotics,” which also includes 
Heartburn drugs called proton pump inhibitors (PPIs) — such as 
I went to my doctor with an infection recently, and he prescribed the antibiotic 
The osteoporosis drug 
When 
Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults, has been approved by the FDA to compete with the other DPP-4 inhibitor on the U.S. market, 
