Woman Disfigured by Generic Drug Loses $21 Million Award

General Health, blog, Drug Safety News

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Eight years after she was burned and blinded by a prescription drug, Karen Bartlett feels numb.

This week the Supreme Court ruled that Mutual Pharmaceutical Co., the maker of the drug Bartlett took for shoulder pain, should not be held responsible for her injuries because the company had copied the brand drug’s formula and warning label.

“I was numb,” Bartlett said of the moment her lawyer delivered the news. “I don’t even have words to describe it because I can’t believe that they would do that.”

In a five-four decision, the court ruled Monday that generic drug makers could not be sued by patients over defective drug design because they’re required by federal law to copy their brand-name counterparts. The ruling overturns the verdict from Bartlett’s 2010 New Hampshire Superior Court trial in which a jury awarded her $21 million in damages, as well as the decision by an appeals court to uphold the verdict.

“I can’t believe the Supreme Court can just say, ‘I’m sorry, you guys are wrong,'” said Bartlett, whose body is scarred from the fierce reaction to sulindac, a generic version of the nonsteroidal anti-inflammatory drug Clinoril. “It boggles my mind. I just don’t get it.”

Bartlett remembers little from the three months she spent at Massachusetts General Hospital in 2004, “wrapped up like a mummy” as the skin eroded two-thirds of her body. She was diagnosed with Stevens-Johnson syndrome, a rare and sometimes fatal reaction triggered by certain medications, including NSAIDS like Clinoril and sulindac.

The ordeal left her disfigured and legally blind. She also has lung damage and difficulty swallowing.

“I have no independence,” said Bartlett, 53, who lives off disability checks for a fraction of the salary she once earned as a secretary at an insurance company in Plaistow, N.H. “This ruined my life, basically.”‘

Motrin Lawsuit: Jury Awards Girl $10 Million for Burns and Blindness

In a lawsuit against Mutual Pharmaceutical Co., Bartlett’s lawyer argued that the company “failed to adequately warn users” about Stevens-Johnson syndrome, one of sulindac’s more serious, albeit very rare side effects. A jury in New Hampshire Superior Court agreed, awarding Bartlett the $21 million payout to cover medical and legal costs, and compensate her for “physical and mental pain and suffering” as well as “loss of enjoyment of life,” according to the complaint.

At the time of Bartlett’s reaction, sulindac’s label did not specifically warn about Stevens-Johnson Syndrome, the Supreme Court acknowledged, though it did warn that the drug could cause “severe skin reactions” and “fatalities.” But under federal law, generic drugs must be chemically identical to the FDA-approved brand-name drug and don the same warning label.

“Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac’s label or composition and its state-law duty to either strengthen the warnings on sulindac’s label or change sulindac’s design,” Supreme Court Justice Samuel Anthony Alito Jr. wrote in the majority opinion of the court.

In 2005, one year after Bartlett’s reaction, the Food and Drug Administration recommended changes to the labeling of all NSAIDs, including Clinoril and sulindac, to more explicitly warn about Stevens-Johnson syndrome.

Alito noted that Bartlett’s case “arises out of tragic circumstances” and “evokes deep sympathy.

“But sympathy for [Bartlett] does not relieve us of the responsibility of following the law,” he wrote.

Jay P. Lefkowitz, the lawyer who represented Mutual Pharmaceutical Co., said the ruling “vindicates the authority” of the FDA, the federal agency charged with assessing drug safety.

“The FDA has the scientific and medical expertise to make decisions about the safety and efficacy of drugs based on all of the data,” said Lefkowitz, whose office is based in New York City. “State court juries that are only looking at one example of a tragic side effect don’t have the ability to make an assessment about the safety and efficacy of a drug that millions of people use with good results.”

Lefkowitz said his “heart was filled with sympathy” for Bartlett.

“Every one of us takes prescription drugs. We give them to our kids, and this can happen to anyone,” he said. “But I think the court got it right, even though it’s obviously a tragic set of circumstances.”

Supreme Court Justice NSAIDS disagreed with the court’s decision, writing in her dissent that it “leaves consumers like Karen Bartlett to bear enormous losses on their own.”

Bartlett said, “I walk away with nothing except disability checks. They don’t seem to care that this has affected me for rest of life.”

 

ABC News Story: health

By 

FDA Changes for Sunscreen Labels

General Health, blog, Drug Safety News

 

sun fda

 

The United States Food and Drug Administration has announced significant changes to sunscreen product labels that will help consumers decide how to buy and use sunscreen, and allow them to protect themselves and their families from sun-induced damage more effectively.

How sunscreen works. Most sun protection products work by absorbing, reflecting, or scattering sunlight. They contain chemicals that interact with the skin to protect it from UV rays. All products do not have the same ingredients; if your skin reacts badly to one product, try another one or call a doctor.

 

SPF. Sunscreens are assigned a sun protection factor (SPF) number that rates their effectiveness in blocking UV rays. Higher numbers indicate more protection. You should use a sunscreen with at least SPF 15.

 

Reapplication. Sunscreen wears off. Put it on again if you stay out in the sun for more than two hours, and after you swim or do things that make you sweat.

 

Expiration date. Check the sunscreen’s expiration date. Sunscreen without an expiration date has a shelf life of no more than three years, but its shelf life is shorter if it has been exposed to high temperatures.

 

Cosmetics. Some make-up and lip balms contain some of the same chemicals used in sunscreens. If they do not have at least SPF 15, don’t use them by themselves.

 

Avoid Indoor Tanning

Using a tanning bed, booth, or sunlamp to get tan is called “indoor tanning.” Indoor tanning has been linked with skin cancers including melanoma (the deadliest type of skin cancer), squamous cell carcinoma, and cancers of the eye (ocular melanoma).

 

new-sunscreen-labels-graphic

Source: CDC & FDA

FOUND GUILTY!

General Health, blog

 

ap_dr_kermit_gosnell_jef_130318_wgPhiladelphia abortion doctor Kermit Gosnell was found guilty today of first degree murder in three of four infant deaths.

Gosnell was also convicted of involuntary manslaughter in the death of a female patient who was given a lethal dose of sedatives and pain killers in 2009, according to the Associated Press.

Gosnell, 72, could face the death penalty and jurors will begin hearing testimony on Tuesday to determine if they will condemn him to death row.

The verdict came hours after the jurors alerted the judge that they were deadlocked on two counts. The judge told the jurors to try again for a unanimous verdict. The decision came on the jury’s 10th day of deliberations.

It was not clear which of the more than 200 counts in the case, which include racketeering, had deadlocked the jury.

Gosnell was accused of performing late-term abortions on four babies who were born alive, but were then allegedly killed by Gosnell.

 

For two months, the jury heard often grisly testimony, including from members of Gosnell’s staff. Eight staffers have pleaded guilty to several crimes. Prosecutors said none of the staff were licensed nurses or doctors.

Gosnell ran the Women’s Medical Society in West Philadelphia for decades until February 2010, when FBI agents raided his clinic looking for evidence of prescription drug dealing.

Instead they found, as reported in a nearly 300-page grand jury report released in 2011, a filthy, decrepit “house of horrors.”

Blood was on the floor, the clinic reeked of urine and bags of fetal remains were stacked in freezers. The clinic was shut down and Gosnell’s medical license was suspended after the raid.

Despite repeated complaints to state officials over the years — as well as 46 lawsuits filed against Gosnell — investigators said in the report that state regulators had conducted five inspections since the clinic had opened in 1979.

Gosnell’s lawyer Jack McMahon maintains his client served his community and never killed a live, born baby.

The grand jury report, however, said there had been hundreds of “snippings,” in which live babies were born and then killed.

“Gosnell had a simple solution for the unwanted babies he delivered. … The way he ensured fetal demise was by sticking scissors into the back of the baby’s neck and cutting the spinal cord. He called that ‘snipping,'” the report alleged.

The report also said that many of the women patients were infected with sexually transmitted diseases from contaminated instruments, had suffered from botched procedures or had been given overdoses of dangerous drugs.

 

 Source: ABC News
http://abcnews.go.com/US/abortion-doctor-kermit-gosnell-guilty-degree-murder/story?id=19168967#.UZFDjJX3A6U

Breast-Feeding Could Lower Breast Cancer Rates

, , , , , , , , Well Woman, blog, General Health

Breast-feeding isn’t only good for the developing infant: It helps mom out too.

A study published in Obstetrics & Gynecology on June 5 revealed that if people stuck with the recommended length of breast-feeding their newborn for at least one year, there would be 5,000 fewer cases of breast cancer, 54,000 fewer cases of hypertension and almost 14,000 less heart attacks in women each year. The researchers say low breast-feeding rates are racking up billions of dollars in health care costs each year.

“We know that 60 percent of women don’t even meet their personal breast-feeding goals, whether it’s three or four or six months,” author Dr. Melissa Bartick, assistant professor of medicine, said to TIME. “We need to do more to support women so they can breast-feed longer. There are thousands of needless cases of disease and death that could be prevented.”

The American Academy of Pediatrics recommends that babies are breast-fed exclusively for the first six months of life, and then have breast-milk supplementally given to them until they at least a year. Breast-feeding can continue as long as the mother, baby and physician feel it is appropriate. Solid food should only be introduced starting at six months of age, but the Centers for Disease Control and Prevention recently discovered that 40 percent of parents are giving their children solid food by the time they reach 4 months.

The World Health Organization recommends even longer breast-feeding, with complementary foods through a child is 2-years-old and beyond.

Though rates have increased in the U.S., only 45 percent of mothers are still breast-feeding at some level by six months, and only 23 percent continue on for one year.

It is recommended that women breast-feed because it provides protection for the babies, from the early “liquid gold” colostrums full of nutrients and antibodies produced at the end of pregnancy to the mature milk that has the right amount of fat, sugar, water and protein to nourish a healthy child. Breast milk is easier to digest, and the hormones and antibodies inside may help ward off diseases for the child.

Children who are breast-fed have lower rates of necrotizing enterocolitis, a gastrointestinal tract disease, respiratory infections, asthma, type 2 diabetes, and obesity, although the last factor was debated in a March 2013 study in JAMA. Some other studies have shown that breast-feeding can lower rates of type 1 diabetes and sudden infant death syndrome (SIDS) as well.

Mothers can also benefit from breast-feeding. In addition to helping mothers bond with their children and helping them save time from boiling milk, breast-feeding saves money. Formula and supplies cost about $1,500 a year, and breast-fed children get sick less often — which means less sick days for the parents.

In addition, breast-feeding has shown to lower rates of type 2 diabetes, breast cancer, ovarian cancer and postpartum depression in women.

The new study is a response to a 2010 study in Pediatrics, which Bartick was a lead author on, that looked at how low breast-feeding rates impacted children and subsequent costs to society. It revealed that about 900 babies would be saved if 90 percent of mothers breast-fed their children exclusively for the first six months of their lives. In addition, low breast-feeding rates leading to infant deaths leads to a societal cost of $13 billion, that study found. The figure was calculated from many factors including the potential wages lost by the children who did not grow up to be adults.

“We got a million inquiries saying, ‘That doesn’t include the women!’ We wanted a complete picture,” Bartick remarked.

Researchers from Harvard University used a model to simulate the lives of about 2 million U.S. women from the age of 15 to 70. They looked at outcomes for five diseases that are linked to lower rates if a mom breast-feeds: Breast cancer, premenopausal ovarian cancer, hypertension, heart attack and type 2 diabetes. They also looked at health care costs over their theoretical lifestimes.

The researchers factored in the current breast-feeding rate — about 25 percent of moms breast feed the entire recommended 12 months — and the ideal breast-feeding rate, which would be about 90 percent of mothers.

In addition to the lower adverse health events, they found out that if 90 percent of mothers breast-fed for a year it would cost $860 million less in health care fees. The study showed that the low rates of breast-feeding cost society $17.4 billion from maternal deaths before 70.

Experts are trying various methods to boost breast-feeding rates. A May 2013 study in Pediatrics showed that giving babies that lost a lot of weight minimal amounts of formula actually increased long-term breast-feeding rates. Ninety-five percent of mothers whose infants were given early limited formula (ELF) were still breast-feeding at three months at some level, compared to 68 percent of mothers who did not receive ELF.

 

– CBS News By MICHELLE CASTILLO

Girls Age Gets Bumped Up to Qualify for Lung Transplant

General Health, blog, Family and Internal Medicine

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Sarah Murnaghan now has two records in the official organ transplant database: one with her real birthday and one with a birthday to make the system treat her as a 12-year-old.

The 10-year-old Pennsylvania girl is dying of cystic fibrosis and won a federal court order Wednesday to sidestep a controversial transplant rule that had been preventing her from getting new lungs.

The Murnaghan family of Newtown Square, Pa., had been fighting a little-known organ transplant policy that had been effectively pushing its daughter Sarah to the bottom of the adult transplant waiting list because it mandated that adult lungs be offered to all adult patients before they could be offered to someone younger than 12 years old.

The family filed an emergency motion on Wednesday to prevent Secretary of Health and Human Services Kathleen Sebelius from enforcing the policy. Sebelius said Tuesday that she would not make an exception for Sarah.

But on Wednesday afternoon, Federal Judge Michael Baylson ordered Sebelius to stop enforcing the under-12 rule for Sarah “so that she can be considered for receipt of donated lungs from adults based on the medical severity of her condition as compared to the medical severity of persons over 12 in the Organ Procurement and Transplantation Network system.” The order is effective immediately and will remain in effect unless the court rules otherwise at a preliminary injunction hearing on June 14.

The case prompted a second family at Sarah’s hospital – the Children’s Hospital of Philadelphia – to sue to be considered equally on the adult lung waiting list, according to a complaint filed Thursday. Javier Acosta, an 11-year-old from in the Bronx who is dying of cystic fibrosis, has now been granted the same exception as Sarah, according to a statement from his lawyer at Pepper Hamilton LLP. Javier ‘s brother, Jovan, died at the age of 11 while waiting for a lung transplant, according to the complaint.

Eleven “priority 1” children under 12 years old are currently waiting for lung transplants, according to OPTN data compiled on May 24 for ABCNews.com. Nine under-12-year-olds awaiting lung transplants are categorized as “priority 2.”

This morning, Sebelius wrote a letter to the president of the Organ Procurement and Transplantation Network’s president to send him the signed court order.

In the letter, Sebelius wrote that she was aware that a duplicate organ candidate record was created for Sarah at 10:34 p.m. It explains that Sarah is still a priority on the pediatric list, but she will now also be considered as a 12-year-old.

“I appreciate your immediate attention to the court’s order,” she wrote.

But the clock is still ticking for Sarah. A judge could rule to reinstate the under-12 rule on June 14 at the preliminary injunction hearing.

If she doesn’t receive lungs by then, it’s not clear whether the duplicate organ candidate record will be deleted. A spokesman for HHS said he could not speculate on what might happen.

Bioethicist Art Caplan wrote on Wednesday that politicians and bureaucrats shouldn’t decide whether Sarah gets lungs because of the medical complexities of her case.

Speaking to ABCNews.com before the judge ruled in Sarah’s favor, he said he didn’t expect the Murnaghans to win because it would involve challenging the legitimacy of the entire organ transplant system. That is, unless lawyers could make a pure discrimination case. Otherwise, he said the effort was “doomed to fail.”

“I don’t think they have any other options to get her on the list,” Caplan told ABCNews.com Wednesday after the emergency motion was filed but before the judge ruled in Sarah’s favor. “Do I begrudge them the right or the effort to try to do what they can? No.

June 6, 2013
read full story here: http://abcnews.go.com/Health/judge-blocks-enforcement-age-rule-girl-awaiting-lung/story?id=19334516#.UbVyEODT022

‘Low-T’ Ads Cause Major Jump in Prescriptions

General Health, blog, Drug Safety News

 

Researchers sounded  an alarm today on ads touting the wonders of testosterone treatments.

Testosterone is billed by some as a virtual fountain of youth — a miracle drug for middle-aged men looking for a boost from the boardroom to the bedroom.

CEO Chris Running, 57, told ABC News “low-T” was a wonder drug that had helped him lose weight, gain muscle and generally feel young again.

“When I get out of the shower, and look in the mirror, I’m impressed,” Running said. “I really mean that. I mean like looking at myself in the mirror, I look freaking awesome!”

 

gty low t drug nt 130603 wblog Low T Testosterone Ads Leading to Increase in Prescriptions, Experts Warn

Researchers in Texas, however, said that all those ads may be driving a potentially worrisome amount of overtreatment.

Between 2001 and 2011, they said testosterone prescriptions tripled among men older than 40.

But they said  a full quarter of those men had been put on testosterone without even having had their levels checked first to see whether they needed it.

“It’s become a near-epidemic proportions, what we’re seeing in our clinics,” said Dr. Edmund Sabanegh, the chairman of urology at the Cleveland Clinic.

The New England Journal of Medicine warned that only about 2 percent of men older than 40 should be getting a boost at all.

That’s because while added testosterone can lead to increased muscle mass and sex drive, some doctors said too much raises the risk of prostate cancer and liver damage.

In an interview with ABC News, Greg Miley of AbbVie, the makers of AndroGel, a popular low-T treatment, said: “The prescribing of topical testosterone replacement therapies can only be prescribed by a physician after taking the patient’s complete medical condition into consideration.”

Eli Lilly, the makers of another low-T treatment called Axiron, told ABC News:  ”We encourage patients to talk to their physicians to weigh the benefits and risks before taking any prescription. … Axiron is a prescription medication, approved by the FDA, for men with certain conditions associated with a deficiency or absence of testosterone. Lilly does not condone the use of our medicines for off-label purposes. ”

The red flags raised by researchers, however, don’t seem to be having any effect on the business of low-T.

Walk-in clinics have sprung up across the country. And according to Bloomberg, sales are expected to triple from $1.6 billion in 2011 to $5 billion by 2017.

Jun 3, 2013
Read story here: http://abcnews.go.com/blogs/health/2013/06/03/low-t-testosterone-ads-leading-to-increase-in-prescriptions-experts-warn/

A More Fit Family

, , , , , , General Health, blog, Family and Internal Medicine
Guide To a More Fit Family
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Are you wondering what you and your family are going to this summer? The most important thing is to keep yourselves active! Try these simple suggestions to getting in better shape:

  • Take the family to an activity that requires walking. Instead of going to a movie why not try a trip to the park, zoo, botanical gardens, museum exhibits or something similar. Make sure to pack healthy snacks for the day!
  • Plan family exercise excursions: jogging and walking around the neighborhood is a great idea, especially if you have family pets that you would like to take out.
  • Sign up for activities or classes at your local YMCA, gym or summer school sports programs. Many of these places offer family oriented activities.
  • Go grocery shopping together so you can get out of the house and teach your kids the importance of foods that fuel them after exercise.

 

Click link to read chart of 60 Minutes a Day: Where Kids Live, Learn & Play!

http://www.health.gov/paguidelines/midcourse/infographic.pdf

family-fitness-plan

For more information visit the President’s Council on Physical Fitness and Sports

Source: www.fitness.gov

Common Labor Hormone Harmful?

, , , , , , , , , , , , General Health, blog, Hormone Therapy

pitocin

After delivering over 1000 babies as Board-certified ob-gyn, many of these babies with the use of Pitocin, I have heard concerns about this drug from hundreds of pregnant moms-to-be.

Most women want to know if the medication is necessary.

This is really the most important question, and it speaks to the issue of appropriate obstetric indication for this, or any other, intervention.

Pitocin is the synthetic brand name of the labor hormone, Oxytocin.

This is the hormone that causes the uterus to contract during labor, and to contract after delivery, preventing postpartum hemorrhage.

When Pitocin is used prior to delivery, it is used either to induce labor, or to augment (or strengthen) labor that has slowed down or stalled completely.

The medication is given through an IV, and is run through a pump that regulates the dose and the frequency with which the dose is increased. Nurses and obstetricians and other trained obstetric personnel monitor the well-being of the pregnant woman and the fetus closely whenever Pitocin is used.

This recent study is the first time that the effects of Pitocin on the fetus were studied. Though this was a relatively small, retrospective study, the results did reveal that women who were given Pitocin to induce or augment their labors did have an increased risk of having a baby with lower Apgar scores or who required admission to the NICU.

These findings suggest an association of Pitocin use with these outcomes but did NOT reveal a cause and effect between use of this drug and these fetal outcomes.

Folklore regarding Pitocin use extends equally amongst obstetricians and moms alike. Many women feel Pitocin causes worse pain during labor than labor without Pitocin. Many obstetricians feel a contraction caused by Pitocin is no different than a ‘natural’ contraction.

As an obstetrician AND a mom who has two babies (one with and one without Pitocin), I did not experience any difference in my two labor experiences. However, every woman is different, and every woman is entitled to her own subjective experience and opinions thereof.

What complicates the opinions of this mainstay drug in modern obstetrics is that there are many other factors that enter into a pregnant woman’s labor and delivery experience, and one of the greatest is the reason or indication for Pitocin’s use in the first place.

It is important to remember that when labor has stalled, intervention MUST occur or both the mother and the fetus could die of sepsis or severe infection that will occur if delivery does not occur. In this situation, use is indicated and appropriate.

If labor is being induced (for a medically valid reason), Pitocin use is indicated and appropriate. If a doctor is anxious to leave the hospital and starts Pitocin to accelerate the timeline of labor, that is inappropriate. These are extreme examples but there are plenty of times in L&D that Pitocin is used for “gray zone” indications.

Risks of Pitocin include contractions that are too close together and that don’t give the uterus a chance to relax and recover, which can result in fetal distress.

Maternal risks of the medication are water intoxication, pulmonary edema and abnormal sodium levels. The bottom line is that if Pitocin is recommended, a pregnant woman has every right to ask why, what the indications are, and if there are any reasonable options.

Every single drug has risks and benefits. Aspirin can save a life if you are having a heart attack, but it can also cause severe internal bleeding. Pitocin is no different: it can and is a safe medication, but it can also cause problems if not administered properly.

There is an art to the practice of Obstetrics and the team involves the health care professional, the mom-to-be AND the fetus. The process of labor and delivery can be a straight-forward natural one, or it can be very complex and require extremely sophisticated intervention to achieve the ultimate goal: a healthy baby and a health mother.

 

Source:  Jennifer Ashton M.D.

May/2013

How to survive a worse-than-usual allergy season!

General Health, blog, Allergy Treatment

Allergy sufferers dread hearing the following words: “It’s going to be the worst allergy season ever!”

So, how is spring 2013 shaking out? Unfortunately, it’s true. This likely will be one the worst allergy seasons to date due to an explosion of powerful pollens brought on by climate change and increased greenhouse gases.

This means allergy sufferers will endure a double-blow this spring as the pollen season is already here, and will last four weeks longer, into mid-fall. Additionally, since many were exposed to early tree pollens this winter (because it was so mild), we all have to be “re-introduced” to those pollens this spring as the weather warms up.

This can mean more significant itchiness, sneezing and stuffiness associated with seasonal allergies.

What does all this mean for you? How can you be pro-active in this pre-allergy season?

To fight allergies, the best defense is a good offense.  Follow these seasonal allergy survival tips to get you ready for the onslaught of pesky pollens about to visit your eyes and nasal passages.

• Start early. Many allergy medications work best when started before the symptoms begin.

• Know the pollen count. During peak pollen periods, stay inside if you can. Use air conditioning as a weapon – it can help filter out allergy busting pollens.

• Be a ‘movie star.’ Wear oversized sunglasses to block airborne seasonal pollens and molds from entering your eyes and lids that cause uncomfortable redness, itchiness, watery eyes, and puffiness, too.

• Wear a hat. Preferably a wide-brimmed one.  This will block out pollen, and for extra safety, skip the hair gel and spray. These act like a “pollen magnet,” especially when planning extended periods of time outdoors on high-pollen days.

• Stay clean. By showering nightly, you’ll rinse pollen from your hair and skin to get a good night’s sleep.  Also, change your clothing before entering the bedroom to reduce pollen transfer into your personal “breathable” space.

 

By: Dr. Clifford Bassett
FoxNews.com

http://www.unitedallergyservices.com/how-to-survive-a-worse-than-usual-allergy-season/

Woman Pregnant After Uterus Transplant

General Health, Well Woman, blog

The first woman to receive a uterus from a dead donor is now pregnant, her doctors announced in Turkey.

Doctors waited 18 months after Derya Sert’s uterus transplant in August 2011 before they implanted an embryo on April 1 using Sert’s own egg.  Sert, a 22-year-old homemakers, is now about two weeks pregnant, her doctors at Akdeniz University Hospital in Antalya  announced Friday.

“She is doing just fine at the moment,” Dr. Mustafa Unal said in a written statement to Agence France-Presse. The baby will be born  through  cesarean section, according to the news agency.

Sert was born without a uterus, but her ovaries were intact, according to a hospital press release. The condition affects one in 5,000 women, according to the hospital.

Dr. Jennifer Ashton, a senior medical contributor at ABC News, said doctors could detect the pregnancy early because they closely monitor the pregnancy hormone,  human chorionic gonadotropin, or hCG, in in-vitro fertilization patients. When  hCG  rises to  a certain level, it indicates pregnancy, she explained.

Although Sert’s ovaries provide hormones, she may need additional “hormonal support,” Ashton said, but it’s not exactly clear what Sert can expect in the coming months.

“Since there is scant medical literature on this, the risks for pregnancies is unknown,” she said.

Source: ABC News

http://abcnews.go.com/blogs/health/2013/04/15/woman-pregnant-after-uterus-transplant/

How Much Sleep Do We Need?

, , , , General Health, blog

How Much Sleep Do You Need?

The amount of sleep one needs can vary for each person. There is a natural sleep-wake cycle that is recommended, by age, in order to ensure that you’re getting enough sleep. The table below can help guide you on the amount of sleep that is recommended by age group:

Age Sleep Requirements
Newborns (0-2 months) 16-18 hours
Infants (3-11 months) 14-15 hours
Toddlers (1-3 years) 12-14 hours
Preschool-aged children (3-5 years) 11-12 hours
School-aged children (5-10 years) 10-11 hours
Teenagers (11-17) 9-10 hours
Adults 7-9 hours

As we progress through these life stages, we need less sleep at night to feel rested, but senior citizens generally need as much sleep as young adults. One conflicting study by the Brigham and Women’s Hospital and Harvard Medical School suggests that senior citizens may need, on average, 1.5 hours less sleep than younger adults.

This is due, in part, to changing sleep patterns as we age. Older adults are more likely to take longer to fall asleep and are also more likely to wake up during the night, even if they have no history of sleep problems.

Those adults who continue to require 7-9 hours of sleep per night may still note changes in their sleep habits, such as growing tired earlier in the day or more rapid sleep cycles that require more time spent in bed to feel rested.

These changes should be no cause for alarm in older adults, as they do not indicate a sleep disorder and are a part of the aging process. However, doctors recommend napping during the day if you feel tired or your daily activities are affected. The best time of day to nap is after lunch in the early afternoon, around 2 or 3 p.m. Naps should be short – around 10 to 30 minutes – and you should give yourself plenty of time to become alert again before resuming normal activities.

 

Sources: Mayo Clinic, National Institutes of Health, National Sleep Foundation,Balanceittakesyou.com

Compounding Pharmacists Await Changes After Fungal Meningitis Scandal

, , , General Health, blog, Drug Safety News

The International Academy of Compounding Pharmacists, or the IACP, includes more than 2,700 pharmacists, most of them in the United States, and Miller said many shouldn’t need to adhere to the same standards as drug manufactures because they are so small. The compounding pharmacists have answered primarily to state pharmacy boards — rather than the U.S. Food and Drug Administration — for decades. As such, FDA inspections have been met with unease and confusion.

“One thing we know is that FDA’s inspectors are not often familiar with pharmacy law,” Miller said. “The pharmacy could be legally compliant, following all the laws of the state. They’re not NECC in any way, and they could actually be found out of compliance by the FDA because agencies inspect using manufacturing standards.”

FDA spokeswoman Sarah Clark-Lynn said the FDA has been coordinating with state officials to conduct 30 risk-based inspections at compounding pharmacies known to mix large quantities of sterile drugs. It is also conducting inspections following complaints about “serious adverse events,” or when states have requested assistance.

So far, 14 inspections have yielded deficiency findings, which the FDA has published online. Although inspectors haven’t found “greenish black foreign matter,” as they found at NECC, the New England Compounding Pharmacy, in October, they posted findings, including how pharmacies had been deficient in practices to maintain sterility, which included keeping skin covered and maintaining proper air flow.

RELATED: NECC Blames Cleaners

“The FDA’s authority over compounding companies is limited but not nonexistent,” Clark-Lynn said. “While the current FDA oversight over compounding pharmacies is limited, the agency continues to use its existing authorities to protect consumers.”

But how limited is it?

Bernardi, who has not been visited by the FDA, said he wondered whether compounding pharmacists could refuse an FDA inspection if a state inspector wasn’t present.

The International Academy of Compounding Pharmacists, or the IACP, includes more than 2,700 pharmacists, most of them in the United States, and Miller said many shouldn’t need to adhere to the same standards as drug manufactures because they are so small. The compounding pharmacists have answered primarily to state pharmacy boards — rather than the U.S. Food and Drug Administration — for decades. As such, FDA inspections have been met with unease and confusion.

“One thing we know is that FDA’s inspectors are not often familiar with pharmacy law,” Miller said. “The pharmacy could be legally compliant, following all the laws of the state. They’re not NECC in any way, and they could actually be found out of compliance by the FDA because agencies inspect using manufacturing standards.”

FDA spokeswoman Sarah Clark-Lynn said the FDA has been coordinating with state officials to conduct 30 risk-based inspections at compounding pharmacies known to mix large quantities of sterile drugs. It is also conducting inspections following complaints about “serious adverse events,” or when states have requested assistance.

So far, 14 inspections have yielded deficiency findings, which the FDA has published online. Although inspectors haven’t found “greenish black foreign matter,” as they found at NECC, the New England Compounding Pharmacy, in October, they posted findings, including how pharmacies had been deficient in practices to maintain sterility, which included keeping skin covered and maintaining proper air flow.

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“The FDA’s authority over compounding companies is limited but not nonexistent,” Clark-Lynn said. “While the current FDA oversight over compounding pharmacies is limited, the agency continues to use its existing authorities to protect consumers.”

But how limited is it?

Bernardi, who has not been visited by the FDA, said he wondered whether compounding pharmacists could refuse an FDA inspection if a state inspector wasn’t present.

Although FDA officials normally work with state pharmacy boards, FDApolicy states that it should “seriously consider” independent “enforcement action” against compounding pharmacists in certain scenarios, such as when they are compounding large amounts of drugs without a prescription, compounding drugs for third parties for resale or compounding drugs that are copies of existing FDA-approved drugs typically made by drug manufacturers.

However, a 2011 federal court ruling in Texas “prohibited” the FDA from inspecting compounding pharmacies beyond the U.S. Food, Drug, and Cosmetic Act, which specifies that FDA inspectors cannot demand research, financial or sales data from pharmacists who are in compliance with state law unless those pharmacists are manufacturing a new drug.

The 2011 ruling trumped a 2008 ruling that determined the FDA actually did have additional authority over compounding pharmacists because all compounded drugs are new drugs. As such, the 2011 ruling was considered a win for compounding companies and a loss for the FDA.

And those are just the two most recent battles regarding how much authority the FDA has over compounding pharmacists. There are several others.

Chuck Leiter, the third generation president of Leiter’s Compounding Pharmacy in San Jose, Calif., said more FDA regulation would be a good thing, and he’d like to see one clear law across the board.

“I think you need one law across the country,” Leiter said. “While people are arguing jurisdictions, people are dying.”

Clark-Lynn said Congress would have to pass new legislation to expand the FDA’s power and allow it to oversee compounding pharmacists more efficiently.

“There should be appropriate federal standards for these products that are consistently enforced across all 50 states,” Clark-Lynn said. “Until such legislation is enacted, the agency will continue to apply its existing legal authority to protect public health.”

Since the revelations of NECC’s business practices surfaced and continue to be exposed, notably in the March 10 episode of “60 Minutes,” Leiter said compounding pharmacies and clients who were acting wrongly began to right themselves, but the industry still wasn’t guilt-free.

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Leiter said that despite continued pressure from clinics or doctors’ offices, he still refused to fill prescriptions for patients with fake names. He said, in his experience, fake names had become an industry practice as large-scale compounding pharmacies, such NECC, began acting more like drug manufacturers.

“It’s changing, but some people are still trying to mess with the system,” Leiter said.

Though Bernardi said he had not received requests for prescriptions for patients with fake names, he said he began receiving calls for bulk compounded drug orders once NECC and its sister company, Ameridose, closed. In Massachusetts, compounding drugs for “office use,” meaning they aren’t made specifically for one patient with a prescription, is not allowed.

“The answer is, ‘We need a prescription for a patient,'” Bernardi said.”That’s usually where the conversation ends.”

Both Leiter’s and Bernardi’s pharmacies are accredited by the Pharmacy Compounding Accreditation Board, or PCAB, which is considered the gold standard of compounding pharmacy safety and efficiency.

“I like to sleep at night,” Leiter said. He intends for his daughter to follow in his footsteps and take over the family business, but she has to pass freshman chemistry first.

Since last fall, PCAB has received an increase of “300 or 400 times” its usual number of applicants, said Joe Cabaleiro, the board’s executive director, and he takes that as an encouraging sign.

“I see a lot of our colleagues have also taken a second really hard look at their operations,” Cabaleiro said, “and asked ‘how can we improve as far as what we learned here.'”

Source: ABC News by Sydney Lumpkin
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