Taking the Pill for Acne Was Fatal, Dad Says
A father says his 15-year-old daughter, who was not sexually active, died of pulmonary embolisms from taking Yasmin and Ocella, contraceptives that a doctor prescribed for acne. The father claims Bayer “aggressively” promoted the contraceptives for off-label uses, and “ignored” the “serious risks associated with the drug.”
Scott Prewitt claims his daughter’s pediatrician dismissed her embolisms, which began in one leg, as a skin infection.
Prewitt sued drug manufacturers and distributors Bayer, Barr Laboratories, Teva Pharmaceuticals and Intendis for wrongful death and product liability, and the Asheville Children’s Medical Center, Dr. William Bryan III and Kelly Klaaren for negligence, in Buncombe County Court.
Dozens of lawsuits have been filed in recent years claiming Yasmin’s side effects increased the risk of heart attack, stroke, pulmonary embolism and other serious injuries. Ocella is the generic form of the drug.
Prewitt says his daughter, Brittany Nicole, started taking Yasmin when she was 13. He says a dermatologist prescribed the drug for acne in 2007. Brittany was 13 at the time.
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The dermatologist, Dr. Hilary Krueger, of Hendersonville, N.C., is not named as a defendant. Brittany’s “regular physician” had been “Dr. Bryan at ACMC” since September 2006, according to the complaint.
Brittany took Yasmin until August 2008, when Dr. Krueger changed the prescription to Ocella, “a generic form of Yasmin,” according to the complaint. Brittany “continued taking the medication as prescribed by Dr. Krueger until her death on June 13, 2009,” according to the complaint.
The USDA has approved Yasmin for contraception. Doctors may legally prescribe drugs for off-label uses, but drug companies are not allowed to promote them for that.
But Prewitt says Bayer “aggressively marketed” Yaz – a variation of Yasmin, with a smaller dose of estrogen – to dermatologists: “The Bayer defendants aggressively marketed Yaz to the dermatology community, and relied in part upon data assessing the effectiveness of Yasmin upon acne, thus persuading the dermatology community that both Yasmin and Yaz were safe and effective in the treatment of acne,” the complaint states. It continues: “Yasmin never received approval for treatment of acne.
“Yaz only received approval for ‘the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Yaz should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.’”
Prewitt claims that he and his wife and their daughter “read magazines, newspapers, and other media, and watched television, all of which communicated Yasmin and the sister medication Yaz advertisements which minimized the risks of Yasmin and Yaz, and overstated the benefits and shaped their favorable perception of Yasmin, Yaz and Ocella.”
He adds: “Use of the drug Yasmin and its generic counterpart Ocella are associated with increased risks of several serious health conditions, including thromboembolism. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors, including obesity.” Brittany weighed 199 lbs.
Prewitt says Brittany’s pediatricians were aware of these increased risks to his daughter. He adds that Klaaren, Bryan and ACMC “knew that Brittany Prewitt was taking Yasmin, and subsequently Ocella, on a regular basis as prescribed for her acne condition and made regular notes of same in Brittany Prewitt’s medical records maintained at ACMC.” And he says they misdiagnosed the signs of the embolism that killed her.
Prewitt says Brittany saw Dr. Bryan on May 20, 2009 for pain in her left leg behind the knee, which was red and swollen. The doctor noticed a red, warm area on her inner thigh, but diagnosed it as “superficial cellulitis” and prescribed an antibiotic, the complaint states. It adds: “Her current medication was noted as ‘Yaz’ and her weight was recorded as 199.6 pounds.”
On June 4, 2009, Kelly Klaaren, a physician assistant supervised by Bryan, examined Brittany’s rash, which had extended to her lower abdomen, between her breasts, on her wrists and under her neck, and diagnosed the condition as “dermatitis,” according to the complaint.
Brittany collapsed on June 13, had seizures and was taken to (nonparty) Memorial Mission Hospital, where she was pronounced dead. An autopsy determined that Brittany died as a result of blood clots in both lungs, or pulmonary emboli.
Prewitt says that “the primary difference between Yasmin and Ocella and other oral contraceptives on the market is that [one of their ingredients, the hormone] drospirenone has never been marketed in the United States and is unlike other progestins available in the United States.
“In April 2002, the British Medical Journal reported that “the Dutch College of General Practitioners recommended that older second generation birth control pills be prescribed in lieu of Yasmin as a result of 40 cases of venous thrombosis among women taking Yasmin, two of which were fatal.”
The British Medical Journal carried another report in February 2003 citing “additional reports of thromboembolism where Yasmin was suspected as the cause,” the complaint states.
But Prewitt claims that “the Bayer defendants, Barr, and Teva ignored the correlation between the use of Yasmin, Ocella, and Yaz and the increased risk of developing thromboses, despite the wealth of scientific and medical evidence available.”
He claims that the “Bayer defendants have been warned multiple times by the FDA for misleading the public through use of television advertisements which overstate the efficiency of Yasmin and Yaz and minimize serious risks associated with the drug.”
Prewitt seeks compensatory and punitive damages for wrongful death, negligence, failure to warn, product liability, breach of warranty and unfair trade practices.
Cosmetic Executive Women Beauty Award for Best Acne Treatment
Up against major competitors, including household skincare names Clean & Clear and Neutrogena, ZENO HEAT TREAT won Best Acne Treatment in the 2011 Cosmetic Executive Women (CEW) Awards. Unique from the common acne treatment, HEAT TREAT was acclaimed for its two-in-one solution designed to simultaneously treat and prevent common types of acne using a salicylic acid serum and device combination.
With award criteria weighing heavily on the product’s innovation, delivery system and packaging, HEAT TREAT prevailed through a very competitive process. CEW Members consisting of over 4,000 beauty editors and other industry professionals tested the product live during the March 2011 Product Demonstration. Members voted on what they believed to be the best product in each beauty category and winners were announced at the May 20th Beauty Awards Luncheon held at the Waldorf-Astoria Hotel in New York City. Andrea DiNunzio, Chief Marketing Officer for Zeno, accepted the award, thanking the CEW and the Beauty Press for their support of the brand and creative partners Alison Brod PR, Cake Creative and Viacom for their dedication and focus on breakthrough communication.
HEAT TREAT’s unique two-part system includes a 99% body-natural Blemish Prevention Treatment with salicylic acid, soothing plant extracts and other moisturizing agents and a hand-held vibrating device that emits soothing gentle heat. Users apply a thin layer of the treatment over the face and follow with the device to help penetrate deep into the upper layers of the skin to unclog pores, fight acne bacteria, and prevent and minimize future breakouts.
Priced at $39.99, each ZENO HEAT TREAT Kit contains a device that is powered by two AA batteries (included) plus a .5oz tube of the Blemish Prevention Treatment. The device has unlimited life and Treatment refills (1oz) can be purchased separately for $11.99.
ZENO Corporation is the maker of the world’s most effective, safe and easy-to-use, over-the-counter thermal-based blemish devices. Doctor-recommended, ZENO devices use natural, soothing heat to treat and prevent blemishes by killing the bacteria that causes them to surface. ZENO’s breakthrough device – the HOT SPOT – is FDA-approved and uses the company’s revolutionary, patented and proprietary ClearPoint™ technology to eliminate or fade pimples within 24 hours for 90% of users. Their second launch, the HEAT TREAT, is a blemish prevention product, which prevents future breakouts by destroying 99.9% of acne causing bacteria in 1 hour. The brand has most recently brought their exclusive technology to the anti-aging category. The new LINE REWIND combines heat, vibration and red-light technology to reduce fine lines and wrinkles. All ZENO devices are painless, chemical-free and non-drying, and are available without a prescription at major mass and drug stores and online.
Fight acne by creating a diversion
Acne breeds a special kind of hysteria. From mild to psychotic, our reactions to pimples too often lead to desperate, reckless attempts to vanquish the offending skin disturbance.
Sure, the experts tell us to leave it alone. We know they are right, but when we feel that prickly, itchy sensation, it taunts our fingertips into action.
The professionals are not entirely unsympathetic.
“Acne is not life-threatening,” explained dermatologist Sandra Lee, who practices in Upland, Calif. But she said that she’s worked with plenty of patients who perceive blemishes in terms of life and death.
She said that women are more likely to be “pickers” than men.
“We just want to do something … have to do something and have to do it now,” Lee said.
Acne is more often associated with youth, but women in their 30s and 40s, who never had acne problems before, can experience mild but persistent flare-ups for years, if not decades.
The worst part of acne is not the three to seven days of waiting for it to run its course; it’s the potential for long-term scarring or hyperpigmention. Those with darker skin tones are at greater risk.
SCARS RUN DEEP
“Most of us think, ‘How can I be a grown woman and be a slave to my hair or my weight or a zit,’ but that kind of thing really can leave you heartbroken for the whole day, no matter who you are,” said St. Louis dermatologist Madhavi Kandula.
Should it? Obviously not. A bad hair day, an extra pound on the scale or acne should not drive us crazy. We know that consistency and good habits matter more than an arbitrary day of misfortune.
But the reality is that it matters, because it does!
“Sometimes people just need something to relieve the stress; it’s hard not to do something,” said Caroline Mann, a dermatologist with the Washington University School of Medicine.
We want to do the right thing, but when the right thing (do nothing) is unsatisfying, we’ll settle for doing the wrong thing (pick, pick, pop).
Kandula, Lee and Mann chalked it up to human nature.
I will admit to many a day of irrational bargaining with the gods of complexion to just take this or that skin affliction away. If someone told me that altars needed to be erected and chickens sacrificed, I’d have considered it.
The Latin name is “acne vulgaris,” and I can’t think of anything more apt.
So the day the Tända Zap ($49) arrived, I secretly dreamed that perhaps it would be an acne miracle cure. The device’s LED lights simulate the blue in the UV spectrum that penetrates the skin and targets the bacteria that cause acne. It was discovered and refined because sunlight does wonders for acne, but the accompanying sun damage is not so admirable.
After consulting a handful of experts about whether this thing actually works, here’s what I learned: At its best the device will destroy the most common acne-causing bacteria under the skin before the bacteria can achieve critical mass (i.e., no zits). At its worst, the device will have no effect on your pimple.
But everyone recommended it anyway, sight unseen and untested.
Madhavi said that even at its worst, the product has one crucial benefit: It gives you something to do.
But she warns it may simply offer a placebo effect. I was a little embarrassed to confess that I’d been carrying this device around in my purse for three days and subconsciously using it much like a pacifier. The pamphlet recommends two to three treatments a day to an area (each treatment is a steady stream of blue light, vibration and mild heat meted out in timed, two-minute intervals), and I used it diligently morning, noon and night.
The quarter-sized treatment area required moving the device five to eight times (that takes 10 to 20 minutes) along my acne-prone jawline. It felt therapeutic, but people in control groups have said the same. I continued to use it, and by day four, I had to replace the three AAA batteries that work the gizmo. And 10 days later, I’d been through three sets of batteries.
Mann uses a full-face blue light treatment in her office. She couples it with a topical cream and said that it can be highly effective for some patients who reject other treatments. She was curious to try the handheld device because she suspected that having it could just make people feel better. As a bonus, it’s a treatment that won’t dry or bruise the skin.
Madhavi and Lee agreed that the science behind the device is valid, but people have to use it with the right expectations. It’s not going to eliminate outbreaks. Much like the Zeno Heat Treat ($40), one of the first popular, high-tech handheld acne treatment gadgets, the Tända is likely to be popular because it provides peace of mind, the dermatologists all said.
But Mann said that what’s most appealing about the device is the fact that it’s hard to abuse (although she said that complusive use could be negative). It’s typical for patients to overuse every treatment, she said. If a thin layer of a topical serum is prescribed once or twice a day, patients think using it five or six times a day will be better. Not true.
It’s almost always best to do less, not more, when acne flares up, Mann said, but she understands why many patients find this level of inaction to be nearly impossible to achieve. So having a device on hand to administer emergency, proactive spot treatment is not such a bad idea.
“And the best thing, is that it might work,” Madhavi said.
