FDA Warns on E-Cigarettes
Source: FDA (U.S. Food & Drug Administration) Consumer Updates
Have I been living under a rock? (Rhetorical). Apparently the smoking experience has been brought into the electronic age with battery operated cigarette look-a-likes. Now with real glowing tip.
The draw (if you’ll pardon the pun) is a smokeless product which somehow manages to avoid the whole restriction of tobacco sales to minors. Plus it comes in neat flavors, such as chocolate, strawberry and mint!
The product does, however, produce a vapor from a cartridge that the user inhales and which contains, nicotine, (and potentially addictive accordingly) diethylene glycol (used in antifreeze) and nitrosamines (which are known carcinogens). The FDA is now officially “concerned” about the product and it’s use as it escapes traditional FDA labeling scrutiny. Gotta love a good loophole.
posted by David Marc Schwadron, Esq.
FDA MedWatch Quickies
Source: FDA (U.S. Food & Drug Administration) Website. http://www.fda.gov/
Because there’s always time for a quickie. (Stop snickering). The FDA is investigating the diabetes drug Lantus (insulin glargine) for a potential associated risk of cancer. No less than 4 observational studies recently published in the journal Diabetologia suggest such a risk.
It should be noted that even the FDA picked up on the fact that all 4 studies had inconsistencies which preclude any actual conclusions. Hence the “investigation” and interim “warning.” As with all medications you may be taking, please continue and consult with your physician if you have any specific questions.
The FDA has also revised the Warnings and Precautions label for Etravirine (Intlence) and HIV medication. Apparently the severity of the potential skin reactions was at issue. Apparently they are quite severe, potentially life-threatening and fatal. Among them are: Stevens-Johnson syndrome; toxic epidermal necrolysis; and erythema multiforme. If you think they sound nasty, you should Google them.
To their credit, Etravirine’s manufacturer, Tibotec, contacted the FDA to discuss labeling revisions after receiving 2 postmarketing reports of severe reactions to the drug. I could quibble about the premarketing and marketing reports but I will be kind today.
posted by David Marc Schwadron, Esq.
And What's with the Stupid Facemasks?
Source: US CDC (Centers for Disease Control and Prevention); The Beeb
Okay, with all of the irresponsible reporting and mass hysteria over H5N1 (Bird Flu) and H1N1 (Swine Flu) and the likely emergence of H7N7 and H3N8 (Equine Flu), (Okay, I may be teasing about that last one, but it’s real. Look it up), one naturally wonders, what’s up with the surgical masks? Should we all be walking around like the late Michael Jackson or any stock media photo of a Tokyo Subway stop?
CDC says No. More officially, “Very little is known about the benefits of wearing facemasks and respirators to help control the spread of pandemic flu.” Oh they say other helpful things of course like, “Facemasks are loose-fitting, disposable masks that cover the nose and mouth.” But echoing a prior post here in this very blog, WASH YOUR HANDS seems to be the real mantra.
Very important sounding Professor John Oxford, a virologist at The Barts and London Hospital (because Oxford would have been too serendipitous) says, because everything sounds better in a British accent, “Really, there is very little evidence that masks actually offer much protection against flu.“ Right O.
That plus, apparently most people take masks off to sneeze which, well, sort of defeats the entire purpose. Any questions? Good. So now we can add surgical masks to the list of unnecessary medical/fashion accessories for the general public.
posted by David Marc Schwadron, Esq.
Wait, what?!
Source: BBC News
Because it’s Friday and we all need a lift. The H1N1 virus (that’s the swine flu) has infected Turkey’s in Chile. The UN (that’s the United Nations) warns that birds elsewhere may also become infected. Yes, birds (of H5N1 virus or bird flu fame) contracting the swine flu (of pig fame). There have been recent reports of H1N1 affecting poultry in Southeast Asia as well.
Elsewhere in the world of irony, the countries of Canada, Argentina and Australia have reported the spread of H1N1 TO PIGS from farm workers. No. I am NOT making this up.
According to Colin Butler of the UK’s Institute of Animal Health, “It’s not just about the H5N1 strain. Any further spread of the H1N1 virus between birds, or from birds to humans would not be good.” No Colin. No it would not.
Loosely, in the words of George Orwell (Animal Farm), “4 legs good. 2 legs bad. Wings. . .hey, we’ve got wings! Pass the bleu cheese.” Or something like that.
posted by David Marc Schwadron, Esq.
Tamoxifen Linked to Secondary Cancers
Source: BBC Health; Cancer Research Journal; Cancer Research UK
A recent US study of more than 1,000 women at Seattle’s Fred Hutchinson Cancer Research Center suggests that Tamoxifen, a common drug used to treat breast cancer, increases the risk of developing aggressive secondary tumors by 4x.
Dr. Alison Ross of Cancer Research UK, advises that the benefits for breast cancer patients of taking Tamoxifen outweigh this risk and that despite the increase, the odds of secondary tumors are still low.
It should be re-stated that this is not an indictment of Tamoxifen. According to the study, Tamoxifen decreased recurrences of estrogen positive breast cancer by 60%, attesting to its therapeutic validity. However, following 5+ years of Tamoxifen therapy there was a 440% increase in the risk for aggressive and non hormone receptive tumors in the contra-lateral (opposite) breast.
Clearly women on long-term Tamoxifen therapy following diagnosis and treatment of primary breast cancer should be monitored closely to ensure that they do not develop a secondary cancer. Common sense approach here. Not a medical opinion.
posted by David Marc Schwadron, Esq.
Ovarian Cancer is Not Being Diagnosed
Source: British Medical Journal; Cancer Research UK
Companion studies to that previously mentioned here in this blog http://www.medicalmalpracticelawyerblogphiladelphia.com/?p=21 support the notion that Ovarian Cancer is problematic for clinicians and patients alike.
The British Medical Journal Study (Bristol) reviewed charts of over 200 women diagnosed with cancer finding that symptoms associated with Ovarian Cancer were reported by patients to their doctors 3-6 months before actually being diagnosed.
Ovarian Cancer has historically been described as a “silent killer” because there are few associated symptoms and it is often diagnosed in advanced stages.
So what symptoms may be important? Abnormal vaginal bleeding, palpable masses, and abdominal distension or permanent bloating. The fact that symptoms were reported in this study has lead researchers to conclude that Ovarian Cancer is not silent after all but “Its sound is going unheard.”
posted by David Marc Schwadron, Esq.
From the Ministry of No Fun
Source: BBC Health; Cancer Research UK
Might want to re-think that candlelit aromatherapy bath to de-stress. That is if you don’t want to increase your risk of lung cancer. Huh? No, really. South Carolina State University Researchers performed serial analysis of paraffin wax candle fumes in laboratory testing.
Their conclusion? Paraffin wax candles cause exposure to harmful fumes associated with lung cancer and asthma. Most at risk were those who frequently used candles to relax in the bath in unventilated bathrooms and to provide dining room ambience.
Not so, says Dr. Joanna Owens of Cancer Research UK who would prefer people to focus upon, “Things we have hard evidence for.” Even the South Carolina Researchers admitted that the, “Occasional paraffin candle and its emissions will not likely affect you.”
Confused? In the meantime perhaps you should stick to the bath salts and scented oils. That is, until further research can be conducted of course.
posted by David Marc Schwadron, Esq.
Liver Cancer on the Rise
Source: BBC Health; Cancer Research UK
Cancer, in general, has increased in prevalence due primarily to people living longer and advances in medical detection of cancer. Liver Cancer, however, is apparently among the most frequent primary cancer sites.
Why? Good question. As a population, we are fat (putting greater demand on the liver) and we drink too much (leading to cirrhosis). Oh and there’s that pesky Hepatitis C, a virus which is spread from blood to blood. The pesky thing being that the majority of carriers don’t know they have Hepatitis C.
Hepatitis B is also associated with liver cancer although no one actually knows the difference between Hep C and B. (I’m kidding about that last part of course. Type B is slightly more mild, may be transmitted from mother to infant and there’s a vaccine for that one).
At any rate the best advice seems to be stop eating and drinking so much and having unprotected sexual intercourse. Or at least try to avoid doing all three simultaneously. And as always, if you are concerned, see your doctor and get tested. A public service announcement, of a sort.
posted by David Marc Schwadron, Esq.
From across the pond: On Women and Sleep
Source: BBC Health and Sleep journal
Lack of sleep is worse for women according to a University College London and University of Warwick Study.
Sleeping less than 8 hours is associated with increased inflammatory markers for heart disease and an increased risk of dying from heart disease at less than 5 hours per night.
The study of more than 4,600 London civil servants between 35-55 consisted of 73% men. However, even with that pronounced slant, researchers determined that women demonstrated higher levels of inflammatory markers for the same lack of sleep. As usual, hormones are likely to blame. They do, after all, cause all of your problems, right? At least according to medical researchers anyway.
At any rate, not starting a flame war here. Just reminding women that sleep is more important for you than you may have realized.
posted by David Marc Schwadron, Esq.
Accutane no more.
The acne “cure” so many teens are familiar with is being pulled from the market.
Roche Holding, AG, has taken Accutane off of the US Market following 6 adverse (that means bad for Roche) jury awards of over $33 million for allegations that it caused bowel disease in users. Specifically ulcerative colitis and Chron’s Disease. The most recent check in the loss column was a $12.9 million New Jersey Verdict last fall. Accutane has previously been alleged to cause both birth defects and depression.
Every jury to hear an Accutane case has reached the same determination that Roche failed to properly warn of the risks to patients who were prescribed Accutane. Apparently Roche was aware of a potential bowel disease incidence as early as 1994.
And for you American Judicial System haters, note that Roche claims safety is not the reason for pulling Accutane from the US market, oh and from, 11 other countries, including: France, Denmark, Austria, Germany, Portugal, Norway and Spain. Yeah. Riiiigggghhhhhttt.
~posted by David Marc Schwadron, Esquire