Before You Take That Pill » Side Effects

Dear Doctor, Cipro and Levaquin Might Make Your Tendons Snap Off

Doug Bremner — Sun, 05 Feb 2012 22:35:14 +0000

That’s a translation into person speak from a letter I got a couple of years ago from Bayer Healthcare Pharmaceuticals that started out with “Dear Healthcare Professional” and went on to their new “black box warning” for their antibiotic drugs Avelox (moxifloxacin hydrochloride) and Cipro (ciprofloxacin). Here is their warning:

Fluoroquinolones, including Avelox/Cipro, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Well it’s about time. I wrote about this nasty habit of cipro to snap tendons and mess up joints in my book Before You Take that Pill: Why the Drug Industry May Be Bad For Your Health because at the time Cipro was the most poorly rated drug on askthepatient.com. I hate to say I told you so, but, I did tell you so. It’s just too bad that it took the manufacturers a couple of years to get the word out. I wish people in the healthcare industry would read these websites, which patients go to only out of desperation.

Unfortunately, 81% of the time this toxic drug, Cipro is prescribed inappropriately, and 32% of women get this drug inappropriately for new onset urinary tract infections, when the preferred first drug is Septra.

Another drup in the same class as Cipro is Levaquin, which is the third most discussed drug on medications.com, just behind my other two faves, Yasmin (the birth control pill that might make you nuts) and Singulair (asthma drug with similar problems). Levaquin and like drugs also seems to drive people nuts, which reinforces my conclusion that when it comes to drug companies, if they don’t kill you they might drive you crazy.

So let’s all sing “I need a drug that won’t drive me crazy” to the tune of I need a lover that won’t drive me crazy,” by John Cougar Mellencamp.

[update from the previous post of Feb 15, 2009]

Big Pharma v. The Truth

Doug Bremner — Sun, 18 Dec 2011 23:40:55 +0000

A review of Goose That Laid the Golden Egg by freelance writer Bob Etier, follow her on twitter @katelier, and read the full review here.

Did you know that Vitamin A, taken in excess, is believed to cause depression? Accutane, that remarkably popular drug once prescribed to teens and still available in generic form, is a “molecular cousin” of Vitamin A.

Accutane was prescribed for people suffering from “extreme scarring acne,” but in 2001, Dr. Doug Bremner began research that indicated a very different, extreme effect of Accutane. He found a causal relationship between Accutane and depression—a relationship believed to have resulted in hundreds of teen suicides and homicides.

Manufacturer Hoffman-LaRoche did not welcome Bremner’s findings. In fact, according to Bremner, the drug giant launched a campaign to discredit him that was “designed to suppress his findings and destroy his career and livelihood.” Written in a tremendously informal, nearly stream-of-consciousness style [...]

Health News You Won’t Read About in the New York Times

Doug Bremner — Wed, 19 Oct 2011 15:49:38 +0000

Here’s a forgotten chapter from pharmaceutical history. The acne drug, Accutane, manufactured by Roche Pharmaceuticals, has been associated with hundreds of birth defects. Since 2005 the iPLEDGE program has required that patients, doctors, and pharmacists register and that patients prove they are on birth control before they can be prescribed this potentially dangerous drug. But it wasn’t always that way.

When Accutane came out on the American market, after being rushed through the FDA approval process, it was listed as a category C drug for risk of birth defects, meaning that it was only of moderate risk. The PDR said that women “should not” get pregnant while on Accutane. Moderate risk means that there are some studies in animals showing birth defects, but it isn’t clear that it is really relevant to humans. There was no requirement that doctors test for pregnancy, or that women take birth control.

Accutane hit the media and was hailed as a wonder drug. Sales soared far being the wildest expectations of Roche executives. Soon every girl with pimples was demanding that pill that her school-mate got that had made her blemishes vanish away.

But not everyone was so sanguine. The Europeans weren’t impressed by Accutane. It was banned in Sweden and Italy and sharply curtailed in other countries, probably related to the results of those trials, which might have included birth defects associated with the use of Accutane.

If there were any birth defects in the European trials, were they reported to the FDA?

Nobody seems to remember. Hmm…

In a series of articles over a decade ago in a newspaper called the Columbus (Ohio) Dispatch, Mark Somerson reported on this story in a series of investigative journalism articles. Remarkably this story about a drug that was equally dangerous as thalidomide never made it beyond the shores of the Wabash River.

Thanks New York Times!

Here’s a scoop for you guys, Mike and Juliet, to add to your ongoing Accutane “investigations”!

It wasn’t only the Europeans that were wary of Accutane, some American dermatologists were as well. In fact, Frank W Yoder, MD, who with Gary L. Peck MD was the first to report on the use of isotretinoin for the treatment of acne in 1977, long before Roche picked it up, warned against the dangers of the drug in the January 1983 edition of the Journal of the American Medical Association, saying that “the potential toxicity of this drug has been seriously underemphasized”. Both American doctors and scientists working for Roche later testified that is was known before it came out on the market that Accutane potentially had a very dangerous risk of birth defects, based on the fact that it was derived from Vitamin A related compounds, well known for many years to cause birth defects in women. Yoder and another doctor involved in the US trials remembered discussing birth defects that occurred during the European trials, although exact names of individuals involved were never produced.

In fact, Roche had known about Accutane for years before the American dermatologists had written about it, but did nothing with the drug. Somerson reported that Dr Werner Bollage, a scientist with the company, wrote in 1971 that it was “inconceivable to develop an agent” that caused birth defects for such a “common complaint as acne.”

For their US clinical trial in the early 1980s, Roche required that all women get tested for pregnancy, and one woman who got pregnant was advised to get an abortion. However, once the drug went on the market, this was no longer required, according to reporting by Somerson.

Henry H. Roenigk MD, another dermatologist who had been involved in the US Accutane trial, was quoted as saying that he published a letter in the May 1982 edition of the journal Dermatology warning of the risk of birth defects, and stating that there had already been birth defects with Accutane (presumably in Europe). Following this Roche wrote a letter to all doctors who had been involved in the US trial and told them not to “divulge trade secrets.”

Nine months after Accutane went on the market in May 1982, babies with birth defects started to appear.

In Sept 8 1983, after the first US birth defect cases were reported, Health Research Group wrote to the FDA urging them to require pregnancy tests and not to bury the warnings about birth defects in the “fine print” at the end of the product labeling.

By 1988 the FDA estimated there could be as many as 1,300 babies born with birth defects because of Accutane. Some of the babies were so deformed that they died in pain after only a few years of life in an institution. Probably many times more babies had mild cognitive defects. And what is worse, despite all efforts, rates of birth defects never went down until iPLEDGE.

Noone deserves that, for any reason.

Originally posted September 28, 2008

My book The Goose That Laid the Golden Egg: Accutane, the truth that had to be told, has been released with 39/42 five star reviews on Amazon and available in paperback or $0.99 on Kindle here. See here for all outlets where it can be obtained.

Are Birth Control Pills Safe?

Doug Bremner — Sun, 04 Sep 2011 21:19:46 +0000

After their introduction in the 1960s, it was noticed that women on OCPs were developing blood clots in their legs and having heart attacks and strokes at higher rates. Newer generations of OCPs came with reduced doses of hormones, which lessened the risks.

So at this point in OCP history, how safe and effective are these pills? For non-smoking women age 15-30, there is no increase in death rate for a comparable form of contraception, the IUD. Because of the health risks of pregnancy, the death rate amongst women from age 15-34 who are on the pill is actually lower than for women who do not use any form of birth control.

OCPs can be unsafe in older women smokers. They should not be used in women with a history of blood clots, untreated high blood pressure, breast or uterine cancer, migraine headaches with focal neurological symptoms, known pregnancy, liver or cardiac disease. The same side effects women experienced with early pills are still a problem for some women taking modern versions: headaches, nausea, bloating, breast tenderness, and weight gain. Your OCP should have low estradiol (less than 50 µg) to decrease the risk of blood clotting.

For young, non-smoking women without hypertension or diabetes the health benefits balance the health risks of OCPs. For these women there is no increased risk of heart attack or stroke. There is a 28% increased risk of blood clot in the leg, but since this is rare the risk than any one particular woman will get one from an OCP is still very rare. For smokers there is an increased risk with OCPs that gets worse with age. For instance, the risk of death is 1 in 200,000 per year in non-smoking women under the age of 35. However risk increases with age and smoking to 1 in 700 per year for smokers over age 35.

The risk of cervical cancer doubles after 10 years of oral contraceptive therapy in women with a history of human papilloma virus infection (HPV). It is not clear if the risk is from the OCP or the increased risk of being infected with HPV for women on OCPs who may not use barrier protection. However since the risk of getting cervical cancer is .008% in any given year a doubling of risk means increasing your risk by another .008% per year. OCPs increase the risk of liver cancer. Liver cancer, however, is rare. OCPs increase the risk of breast cancer by 10-20%.

In women of childbearing age breast cancer is rare, and any increased risk and goes away after OCPs are stopped. In addition the types of breast cancers that develop in women on OCPs are more easily treatable; therefore the overall risk from breast cancer is not increased. OCPs reduce the risks of ovarian and uterine (endometrial) cancers. OCPs reduce the risk of anemia, through reduction of iron loss in menses, pelvic inflammatory disease, and osteoporosis (since estrogen promotes the laying down of calcium in the bones).

Women who take the pill have identical fertility rates after going off the pill compared to women who never took the pill. OCPs are safe for teenage girls to use, with the exception of Depo-Provera.

Use an OCP with low doses of estradiol.

Side Effects of Quinolone Antibiotics

Doug Bremner — Sat, 03 Sep 2011 21:13:02 +0000

The fluoroquinolone antibiotics, which include drugs like Cipro, were first introduced in the 1980s. They inhibit DNA gyrase, an enzyme needed for bacterial DNA replication and therefore bacterial cell replication. Fluoroquinolones are used for lower respiratory tract infections, especially in the treatment of infections caused by methicillin-sensitive or resistant staphylococci, Pseudomonas and intracellular organisms.

Fluoroquinolones are widely overprescribed for problems like urinary tract infection, in spite of the fact that they cost over 10 times as much as drugs like Septra, and are not more effective. A recent study showed that 81% of patients prescribed fluoroquinolones were not prescribed these drugs appropriately.

The fluoroquinolones are the most commonly used antibiotics today and are potentially very toxic. For example, amongst women with a new onset bladder infection, only 37% were given the preferred treatment, which is Septra, while 32% were given Cipro. In addition, most women were treated for a week or more, while the preferred treatment is only three days. Cipro is the most complained about medication on the web site http://www.askthepatient.com, where patients log on their reactions to different medications. Cipro and all of the fluoroquinolones can cause damage to cartilage, leading to pain in the joints that could last for years, and even rupture of the tendons.

The most common side effects of fluoroquinolones are nausea, vomiting, and diarrhea, which occur in 3-6% of patients. Other side effects include headache, confusion, and dizziness, phototoxicity and cardiotoxicity. Most of them have interactions with warfarin (Coumadin), a medication used to decrease blood clotting. They also require dosage adjustment in patients with kidney disease. Animal studies show that quinolones can have effects on cartilage in young animals; these drugs are therefore not recommended for children. Related to this, quinolones have been associated with the development of joint pain and even tendon rupture.

Bottom line is these drugs are to be avoided unless absolutely indicated.

Article Source: http://EzineArticles.com/1103307

Review: The Evidence, However, Is Clear: The Seroxat Scandal

Doug Bremner — Sun, 07 Aug 2011 22:54:20 +0000

The Evidence, However, Is Clear: The Seroxat Scandal, by Bob Fiddaman.

Bobby Fiddaman has written an interesting and well written book about his personal experiences taking the antidepressant Seroxat (Paxil, or paroxetine in the US), his struggles with withdrawal, and his work as an advocate raising attention related to the potential side effects of this drug. Fiddaman has a popular blog (Seroxat Sufferers: Stand Up and Be Counted) where he has worked tirelessley to get members of the Medicines and Healthcare Regulatory Agency (MHRA, the equivalent of the FDA in the US) to highlight potential side effects of the drug, most notably the range of cognitive and neurological and psychiatric problems that some people experience coming off the drug, such as himself. Fiddaman highlights the marketing campaign by the maker of Seroxat, GSK and others, to “sell” depression as deficiency of the neurotransmitter serotonin in the brain (it’s not) and their drug as the cure that will boost serotonin and cure depression (researchers have known for years that this explanation was bogus, but were too cowed by the drug companies to pipe up about it, I guess). He also highlights the revolving door where doctors go from high positions in drug companies, to drug regulatory agencies, and sometimes to academic jobs and then back through the wheel again. Fiddaman’s story is a testament to what health care consumers can achieve when they take charge of their treatments instead of passively following doctors advice without informing themselves about their own healthcare. He highlights the fact that pharmaceutical companies do not always have your best interests at heart (they are there to profit from their medications, after all) and you have to watch out.

By way of disclosure the author has told me on twitter (@dougbremner) that he is reading my latest book The Goose That Laid the Golden Egg in which I describe my experiences as a doctor giving paid speeches for GSK about Paxil as well as working as an expert on drug safety related issues in the courts. He also wrote a blog about the Goose book last year.

I recommend this book for anyone who has personal experiences with antidepressants or depression for themselves or family members, or for more insight into drug regulation and consumer advocacy. The writing is excellent and refreshingly honest.

You can follow the author on twitter @Fiddaman and read more about his book here.

Dr. B’s Chamber of Horrors: Lousy Treatments for Head Lice Might Make Your Children’s Head Catch on Fire

Doug Bremner — Wed, 27 May 2009 09:20:32 +0000

Head lice are a big problem, affecting 6 to 12 million people in the US every year. Head lice are becoming endemic amongst our children. Unfortunately the pharmacological treatments for head lice are not that great. Malathion (Ovide) is an organophosphate that kills lice by inhibiting the cholinesterase enzyme.

Malathion works well for lice, unfortunately it has the side effect of being highly flammable, so little children should stay away from fires, to keep their heads from catching on fire.

The most commonly used prescribed medication for these problems is lindane (Kwell). Doctors apparently have not figured out yet that it doesn’t work and has been associated with some potential safety concerns. Efficacy of lindane has been decreasing over the past few decades to lindane due to the emergence of treatment resistant lice. Lindane has limited efficacy, killing only 17% of lice after a 3 hour period, and none after 10 minutes, the recommended time of exposure.

In other words, take Lindane as directed, and it will do NOTHING!

Time to Die! (Oops I Mean Time to Quit (Smoking)!)

Doug Bremner — Fri, 20 Mar 2009 16:22:40 +0000

The news about the stop smoking drug Chantix (varenicline) just keeps getting worse. When my sister emailed a while back and said she was thinking of taking the drug to get off the weed, I said make sure you have your suicide hotline number handy. A recent report in JAMA shows an alarming number of suicides and suicide attempts on Chantix, much larger than you would normally expect.

Last year I was sitting in my car dealership waiting to get service on my car and working on my laptop while the television was droning on in front of me. I mean this was one of the rare times when I watch TV without the benefit of Tivo to pause the commercials or otherwise avoid them. And it was like one prescription medication ad after another! They were only punctuated by an ad for a device for diabetics to check their blood sugar at home. All I can say is they better get Ronald McDonald (“Don’t forget to feed the waste baskets…”) back on TV so that they can keep those diabetics rolling in to buy their blood glucose testers (not to mention their Avandia and Actos).

Anyhoo one of the ads that caught my eye was of a woman who droned on about how she needed a cigarette to wake up, one in the car, one at 10 am… Boy I know that drill. I kicked the habit by writing a book that advocated diet, exercise and lifestyle changes over prescription medications for health (works every time! No relapses!).

But enough of my narcissism, back to the “My Time to Quit” campaign by the makers of the anti-smoking drug Chantix, which was gleefully playing across the screen at my auto dealership and interfering with my ability to concentrate on more important things like write a book chapter that noone would ever read.

This drug affects the frontal lobe of the brain, which regulates emotion, and has been associated with depression, psychosis, and suicidality. It made headlines when a famous country music singer from Texas who was on the drug accosted a neighbor in an apparently psychotic state of mind and was shot dead.

Thanks Texas home invasion gun laws!

What’s really annoying is that the clinical trials of Chantix excluded people with mental disorders, but smoking is increased in this population, and these people are obviously at increased risk of suicidality. In spite of this the spokespersons for Chantix say it is fine for people with depression and other mental disorders to go ahead and take Chantix.

When I think of Chantix, in spite of the PR campaign to the contrairy, rather than thinking,

Time To Quit!

The image that comes to mind is of (Governor) Arnold Schwartenagger about to finally eliminate a robot in one of the terminator movies when he says…

Time to die!

I have the best method to quit smoking. DIE!

Oh well, maybe I’ll start humming along with the “life saving drugs” theme song one of these days.

Hat tip to Philip Dawdy.

We Won!!! Supreme Court Over-rules Preemption!

Doug Bremner — Wed, 04 Mar 2009 17:21:38 +0000

“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness” – Justice John Paul Stevens

Wyeth, Drugmakers Lose as Top U.S. Court Allows Suits (Update1)
By Greg Stohr

March 4 (Bloomberg) — The U.S. Supreme Court bolstered patient lawsuits against drugmakers, upholding a $7 million award to a woman who lost her arm after being injected with Wyeth’s Phenergan nausea treatment.

The justices, voting 6-3, said patients can use state product-liability laws to accuse companies of failing to provide adequate safety warnings. Drugmakers had argued that they were shielded from suit by the Food and Drug Administration’s approval of a treatment and its packaging information.

Thanks to those of you who joined the Stop Preemption cause on FB which grew to 166 members.

via People over Profits FB group.

More Bad News on Bisphosphonates and Fractures

Doug Bremner — Thu, 19 Feb 2009 14:50:40 +0000

More bad news about bisphosphonate drugs for osteoporosis, which were bad enough to have readers write in about cases of erosive esophagitis and an incredible case of physician writing a case report (Jennifer Schneider MD, also a reader of this blog) about her own femoral fracture caused by getting out of her seat on a train while on alendronate. Well it looks like the medical community is starting to catch on as evidenced by a commentary in JAMA this week by Bridget Kuehn called “Long Term Risks of Bisphosphonates Probed” in which she highlights recent reports of increased risk of femoral fracture, atrial fibrillation, and esophageal cancer in women treated with bisphosphonate drugs like Fosamax and Boniva for osteoporosis, and points to the increasing awareness that treatment for longer than five years with these drugs probably worsens health outcomes. A recent study by Lane et al in 2009 showed that amongst a series of patients 37% of patients with subtrochanteric and femoral shaft fractures were on Fosamax (alendronate) compared to 11% of patients with hip or femoral neck fractures, indicating that long term treatment with this drug was associated with a specific type of fracture. As I have previously written about, these drugs turn off bone turnover and after five years make bones more brittle, not less. She also cited a letter to the New England Journal of Medicine by Diane Wysowski PhD of the FDA (old aquaintance from the Accutane wars) documenting 23 cases of esophageal cancer, with 8 deaths, in patients on bisphosphonates.
A terrible outcome of bisphosphonates of course is osteonecrosis of the jaw, which used to be called “Phossy jaw” cuz it was seen in match factory workers (the phosphorus in the matches got into the bone and turned off bone turnover), a condition so terrible it drove match factory workers to suicide. Nowadays we call it “Fossy jaw” in honor of our old friend, Fosamax (“Ladies Don’t Get Sucked Into the Bone Mineral Density Testing Rat Maze”).