<![CDATA[Consumerist: side effects, ]]> http://cache.gawker.com/assets/base/img/thumbs140x140/consumerist.com.png <![CDATA[Consumerist: side effects, ]]> http://consumerist.com/tag/side effects/ http://consumerist.com/tag/side effects/ <![CDATA[ Brooke Shields Has Hypotrichosis ]]> Oh no! Brooke Shields used to have stringy, stick-figure eyelashes! I figured this out after watching Consumer Reports' video dissection of a new commercial for Latisse, the glaucoma medication that has been rebranded as an expensive, temporary eyelash enhancer with side effects.

Since it's still a drug and not an actual beauty product, you have to have some sort of medical condition to take it. That's why one of the first bits of fine print in the commercial says that the drug is only for people who suffer from "inadequate or not enough lashes, also known as hypotrichosis." Like Brooke, apparently.



"Ad for eyelash drug Latisse goes too far" [Consumer Reports Health Blog]

RELATED
"Yeah, Your Eyes Are Discolored And Red, But Your Lashes Look Great!"

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Consumerist-5390996 Tue, 27 Oct 2009 16:04:38 EDT Chris Walters http://consumerist.com/index.php?op=postcommentfeed&postId=5390996&view=rss&microfeed=true
<![CDATA[ Yeah, Your Eyes Are Discolored And Red, But Your Lashes Look Great! ]]> Lash-lengthening drug Latisse can make your eyelashes longer — but it can have some pretty hardcore side effects for a cosmetic. The FDA has issued a warning letter to the manufacturer (PDF) of the glaucoma-drug-turned-cosmetic-product, saying that many claims on its website are misleading and, in fact, unlawful.

CR Health breaks it down for us:

Latisse's Website says:
In the "Is Latisse safe?" section of the drug's website: "The FDA reviewed clinical study results to verify the identity, potency, purity and stability of the ingredients, and demonstrated that the product is safe and effective for its intended use if used as prescribed."

The FDA says:
This description is misleading and it fails to mention that Latisse may have side effects, or mention any of those side effects. It also implies, according to the FDA, that Latisse is "especially safe because the FDA has verified the identity, potency, purity, and stability of the ingredients."

Latisse's Website says:
The website also answers the question, "Why do the directions say to only apply Latisse solution to the base of the upper eyelashes?" by saying: "A clinical trial of Latisse was conducted on patients who applied the product to the base of their upper lashes only. Applied nightly, the transfer of Latisse solution from the upper to lower eyelid may occur naturally because the eyelids are closed and the eyelashes touch each other."

The FDA says:
The answer fails to warn users of the real reason why Latisse should not be applied to the lower eyelid: If Latisse comes in continued contact with skin outside the treatment area, it could lead to excess, unwanted hair growth.

Latisse's Website says:
The Latisse website claimed that "increased brown iris pigmentation has occurred when similar medications were instilled directly into the eye to treat elevated intraocular pressure/glaucoma."

The FDA says:

In fact, the "similar" medication was actually the same medication. Both Latisse and Lumigan, a glaucoma drug also from Allergan, are actually bimatoprost ophthalmic solution. Though Latisse is applied differently, brown iris pigmentation has been reported from use of the drug. The FDA says, "by omitting this material information and suggesting this side effect has only occurred with ‘similar' medications, this claim minimizes the risk of increased iris pigmentation."

Latisse's website says:
The site repeatedly mentions that the eye redness and itching that can accompany the use of Latisse are "not allergic reactions."

The FDA says:
That's misleading. In fact, allergic conjunctivitis is an adverse reaction reported with the use of the active ingredient, bimatoprost ophthalmic solution. Further, these symptoms are usually resolved only after discontinuing treatment with the drug. The FDA was particularly concerned about these claims, according to the letter, "because patients are highly unlikely to be able to differentiate between eye redness associated with conjunctival hyperemia, allergic reaction, or inflammation without the advice of a healthcare provider."

Yeah, but you look awesome.

FDA warns maker of Latisse about misleading claims [Consumer Reports Health]

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Consumerist-5362862 Fri, 18 Sep 2009 16:26:45 EDT Meg Marco http://consumerist.com/index.php?op=postcommentfeed&postId=5362862&view=rss&microfeed=true
<![CDATA[ FDA May Take Vicodin And Percocet Off The Market ]]> Bad news for Dr. Greg House and other, non-fictional chronic pain patients. The FDA advisory panel that met yesterday about the effects of excessive doses of acetaminophen made another recommendation to the FDA—to take popular painkillers Vicodin and Percocet (and their generic versions) off the market because of the effect both drugs can have on the liver when taken for extended periods. The FDA will most likely follow this recommendation.

Vicodin is a combination of hydrocodone and acetaminophen; Percocet is oxycodone and acetaminophen. While oxycodone is available without the acetaminophen (as OxyContin) hydrocodone is not available alone in the United States. A ban would be problematic for patients and doctors alike.

"It ties the doctor's hands when you put the two drugs together," said Dr. Scott M. Fishman, a professor of anesthesiology at the University of California, Davis, and a former president of the American Academy of Pain Medicine. "There's no reason you can't get the same effect by using them separately."

Dr. Fisher said the combinations were prescribed so often for the sake of convenience, but added, "When you're using controlled substances, you want to err on the side of safety rather than convenience."

Still, some doctors predicted that the recommendation would put extra burdens on physicians and patients.

"More people will be suffering from pain," said Dr. Sean Mackey, chief of pain management at Stanford University Medical School. "More people will be seeing their doctors more frequently and running up health care costs."

Most discussion after this panel has been about the restrictions on over-the-counter medications contaning acetaminophen, but removing commonly prescribed drugs from the market entirely is something else entirely.

Panel Recommends Ban on 2 Popular Painkillers [New York Times] (Thanks, Kelly!)

(Photo: veeliam)

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Consumerist-5305155 Wed, 01 Jul 2009 08:00:15 EDT Laura Northrup http://consumerist.com/index.php?op=postcommentfeed&postId=5305155&view=rss&microfeed=true
<![CDATA[ Have You Taken Alli Or Xenical? We Want To Hear From You ]]> Have you or someone you know taken the weight loss drug Orlistat, marketed as Alli (OTC) and Xenical (prescription)? Our colleagues at Consumer Reports would like to know what kind of side effects you've experienced for a future article, no matter how disgusting.

See, orlistat is under investigation by the FDA again. Alli made an appearance in our disturbing side effects collection back in April. "... gas with oily discharge, an increased number of bowel movements, an urgent need to have them, and an inability to control them," we quoted. 7.7% of patients in one Xenical study experienced "fecal Incontinence." Other, less common, side effects are scarier and deadlier.

Send your orlistat side effect horror stories to tips@consumerist.com with "Orlistat" in the subject line, and we'll send them along.

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Consumerist-5301809 Tue, 23 Jun 2009 20:48:08 EDT Laura Northrup http://consumerist.com/index.php?op=postcommentfeed&postId=5301809&view=rss&microfeed=true
<![CDATA[ Watch Out, Ambien Makes You Slutty ]]> We knew Ambien could cause sleep driving and sleep eating, but this man blames it for causing him to hook up with a woman he barely knows. Now he says the woman has called his home and refers to him as her f*** buddy, and yet he can't even remember the act. Oh also, he's married.

"Dream Lover" [Slate]
(Photo: Martin Kingsley)

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Consumerist-5229902 Tue, 28 Apr 2009 10:14:10 EDT Chris Walters http://consumerist.com/index.php?op=postcommentfeed&postId=5229902&view=rss&microfeed=true
<![CDATA[ 9 Legal Drugs With Extremely Disturbing Side Effects ]]> We asked for it and you sent them in, a smorgasbord of drugs with extremely disturbing side effects. Here's nine of the most disturbing we found. Jeez! Sometimes the cure really can be worse than the disease...









MIRAPEX - for "Restless Leg Syndrome"
"...hallucinations may occur..."
"...increased gambling, sexual, or other overpowering urges..."




ABILIFY - bipolar disorder, schizophrenia
"coma or death...And trouble swallowing."




FLOMAX - decreases symptoms from having an enlarged prostate (mainly frequent urination)
* runny nose
* dizziness
* decrease in semen



ALLI - weight loss aid
"These changes may include gas with oily discharge, an increased number of bowel movements, an urgent need to have them, and an inability to control them."



VERAMYSYT - "treats allergy symptoms with a gentle fine mist that is scent-free."
"nasal sores, glaucoma, cataracts and nasal fungal infection"
More disturbingly, ads for Veramyst used to say, "The way VERAMYST works is not entirely understood."

ORTHO-NOVUM - birth control pill
"...benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer."



ADVAIR - asthma treatment
"asthma related death"





CHANTIX - anti-smoking aid
"Nausea, sleep disturbance, constipation, flatulence, and vomiting."

That doesn't sound so bad, except "sleep disturbance" is more like psychotic nightmares that persist even after you stop taking the pill. To wit:

By night four, my dreams began to take on characteristics of a David Cronenberg movie. Every time I'd drift off, I'd dream that an invisible, malevolent entity was emanating from my air conditioner, which seemed to be rattling even more than usual. I'd nap for twenty minutes or so before bolting awake with an involuntary gasp. I had the uneasy sense that I wasn't alone.

Did we mention the killing of yourslef? Another side effect is, "suicide ideation"

Like a spoiled teenager, I'd suddenly uproot drawers from the bureau, push all the belongings off shelves with a sudden swat of the arm, smash a glass against the wall, and then the crying would take over yet again. Meanwhile, the room seemed to be pulsing and reverberating around me, and my eye would keep zeroing in on objects-the television, the AC, a pair of shoes-and feel as though they were somehow buzzing with life and gleefully watching me endure the biggest meltdown I'd ever had. I had somehow ruined myself, and suicide seemed like a good way to avoid the embarrassment of this fact's being exposed.

This Is My Brain on Chantix [NY Mag]

ACCUTANE - acne
* depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
* sudden numbness or weakness, especially on one side of the body;
* blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
* hearing problems, hearing loss, or ringing in your ears;
* seizure (convulsions);
* severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
* loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
* severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
* fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding; or
* joint stiffness, bone pain or fracture.

But hey, at least you don't have pimples!

Undoubtedly we've missed some deservingly disturbing drugs. Rectify our omissions in the comments.

(Photo: Maddest Hatter)

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Consumerist-5213814 Wed, 15 Apr 2009 20:22:13 EDT Ben Popken http://consumerist.com/index.php?op=postcommentfeed&postId=5213814&view=rss&microfeed=true
<![CDATA[ Glaucoma Drug Might Grow Lashes, Or Turn Your Blue Eyes Brown ]]> Latisse, a new drug that promises longer, fuller lashes, started out as Lumigan, a glaucoma drug. Now's been approved by the FDA to treat "inadequate" eyelashes, but there are some pretty crazy possible side effects. Like permanent changes to your eye color.

Our sister-publication Consumer Reports Health has this to say about Latisse:

If you go to the Latisse Web site you'll see an eye as blue as a tropical sea, surrounded by lush, palm-tree-like eyelashes. But that Caribbean-blue iris could change to dark brown in patients using the drug. Some people could see a permanent change in the color of their eyes, with lighter greens and blues turning to darker browns.

And then there's the possibility of a permanently darkened eyelid. We are concerned that the Latisse trial included too few African-Americans, who may be especially prone to this side effect. And it can cause itchy, red eyes in a significant number of users.

We're also worried that the people using Latisse for cosmetic reasons could be less likely than users of Lumigan to use the medication as directed. Might some people apply more than necessary in an effort to get even longer eyelashes? If so, it might exacerbate some of the cosmetic side effects that appeared in the drug's trials.

And then of course, there's the possibility that using Latisse for cosmetic reasons might mask the symptoms of glaucoma — causing the disease to go undiagnosed.

Drug promises fuller lashes, but at what cost? [CR Health]

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Consumerist-5165476 Fri, 06 Mar 2009 11:15:40 EST Meg Marco http://consumerist.com/index.php?op=postcommentfeed&postId=5165476&view=rss&microfeed=true
<![CDATA[ Why Is The New Centrum Advanced Formula Causing Stomach Pains? ]]> con_newcentrum158.jpgKevin writes, "I have been experiencing stomach pains after buying the new formula of Centrum Multivitamins. A co-worker had the same pain." It turns out, Kevin and his co-worker aren't alone—the Amazon product page for the reformulated ("now with lycopene!") vitamins are overwhelmingly negative, with nearly everyone reporting stomach pains. However, there are only eleven reviews for the product, so we're wondering how many people have actually tried the new Centrum and suffered for it. Anyone here?

Kevin's also unimpressed with how Centrum handled his complaint. Instead of offering a refund or, heck, even a coupon, they simply recorded his information and threw up a "proprietary" defense against any questions:

I'm not sure what to do. I called them and they took my name and symptoms for their research purposes. I didn't get any feedback and when I asked how many people have reported this issue they said it was proprietary information.
 
This really makes me feel like I'm part of a research study instead of a consumer.

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Consumerist-385408 Tue, 29 Apr 2008 17:13:08 EDT Chris Walters http://consumerist.com/index.php?op=postcommentfeed&postId=385408&view=rss&microfeed=true
<![CDATA[ Tamiflu And Relenza Treat Flu, But Might Make You Crazy ]]> con_thetamiflueffect.jpg This week, an FDA advisory panel will review a recommendation to put a warning on flu drugs Tamiflu and Relenza that says there have been "psychiatric events observed in some patients." The companies who make the drugs have both responded that they've found no causal link between their drugs and "psychiatric events."

Even the FDA has mixed feelings about it, which it may resolve this week.

The FDA staff said the evidence is "conflicting" as to whether the events are medication-related, a manifestation of disease or a combination of the two.

Tamiflu has been more widely used in Japan than in the United States, and there is some evidence that the Japanese are more vigilant about reporting side effects, the FDA has said.

FDA staff based its recommendations on a review of nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.

Tamiflu already has a warning label that says patients should be closely monitored "for abnormal behavior such as delirium or self-injury," which the FDA placed on it after a report two years ago that 12 Japanese children who were taking Tamiflu died. Relenza is currently free from any psychiatric warning.

The new Tamiflu warning would state: ""In some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients."

For Relenza, the proposed warning would caution that "reports of hallucinations, delirium and abnormal behavior" have been observed in some patients.

"FDA staff urge psych warnings for two flu drugs" [Reuters]
(Photo: Getty)

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Consumerist-326676 Mon, 26 Nov 2007 19:16:24 EST Chris Walters http://consumerist.com/index.php?op=postcommentfeed&postId=326676&view=rss&microfeed=true
<![CDATA[ Antifungal Medication Makes You See Chewbacca ]]> con_patientwithmonsterhead.jpg A new antifungal drug, voriconazole, causes patients to "develop a range of neurological side effects, including auditory and visual hallucinations," within 24 hours to 2 weeks of beginning treatment. The drug is marketed as Vfend, and is administered intraveneously to treat serious fungal infections. The National Institute of Health has been testing the toxicity of the drug and reported the neurological side effects at a recent conference.

The visual hallucinations frequently consisted of seeing people or scenes. One patient reported seeing flying objects, another saw scenes of Montana and New York City, and a third patient saw a giant "Wookie" from the movie Star Wars bending over his bed. The auditory hallucinations often consisted of hearing voices and music, and one patient reported hearing TV commercials.
Among the non-fun side effects: 5% of patients studied developed signs of liver damage.

But back to the hallucinations: we wonder if taking large doses of vitamin C along with the treatment would make them any more intense?

"Hallucinations not unusual with antifungal therapy" [Reuters]
(Photo: Getty)

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Consumerist-302607 Fri, 21 Sep 2007 19:41:44 EDT Chris Walters http://consumerist.com/index.php?op=postcommentfeed&postId=302607&view=rss&microfeed=true
<![CDATA[ Zicam Nasal Gel Vanquishes Colds, Sense Of Taste, Smell ]]> Goodbye%20Smell.jpgA chewing gum company turned cold remedy manufacturer is under fire for selling a nasal spray that destroys people's sense of taste and smell. Over 400 lawsuits have been filed against Matrixx Initiatives for the side effects associated with Zicam nasal gel, a zinc-based homeopathic cold remedy. Matrixx has already spent $12 million to settle 340 lawsuits, but some customers won't be satisfied until the FDA is involved.

Two years ago, Richardson first tried Zicam after his mother, a registered nurse, brought him a package. At the time, Richardson was suffering from a cold and wanted quick relief because he was about to start a new job.

"I squirted it up my nose and felt a burning sensation," Richardson said.

A few days later, he noticed that scents seemed distorted. Even strong odors, such as gasoline, had a metallic scent. He also claimed he lost his sense of taste as the two senses are linked.

Richardson wants the FDA to require an independent study of Zicam's safety.

"If I took this product and I was just out $6, that's one thing," Richardson said. "This has changed my whole life... Heaven forbid some mother gives it to her 6-year-old kid."

Rather than settle the remaining lawsuits, Matrixx has started to successfully challenge the expert-status of doctors who claim a link between sensory loss and Zicam. They even hired their own crack team of experts to prove that Zicam is 100% safe, and won't burn your nasal tissues and cause you to lose all sense of taste.

Zicam raises the larger issue of the FDA's limited oversight of homeopathic treatments. Unlike conventional medicines, natural remedies are not subject to a rigorous approval process, nor are they put through clinical trials. Both, according to the agency, would cost too much time and money.

Lawsuits claim loss of smell [The Arizona Republic]

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Consumerist-281275 Mon, 23 Jul 2007 11:20:53 EDT Carey Alexander http://consumerist.com/index.php?op=postcommentfeed&postId=281275&view=rss&microfeed=true