Health & Fitness (60)
BOSTON (AP) -- Kaitlyn Greeley burst into tears when a car backfired the other day. She's afraid to take her usual train to her job at a Boston hospital, walking or taking cabs instead. She can't sleep.
"I know this is how people live every day in other countries. But I'm not used to it here," said Greeley, 27, a technician at Tufts Medical Center who was on duty Monday when part of the hospital was briefly evacuated even as victims of the blast were being treated in the emergency room.
Anger, crying jags and nightmares are all normal reactions for both survivors of the Boston Marathon bombings and witnesses to the mayhem. While the injured and those closest to the blasts are most prone to psychological aftershocks, even people with no physical injuries and those like Greeley might feel the emotional impact for weeks afterward as they struggle to regain a sense of security. What's not clear is who will suffer lingering anxiety, depression or even post-traumatic stress disorder.
But specialists say that how resilient people are helps determine how quickly they bounce back. The resilient tend to be people who share their emotions before becoming overwhelmed, who know how to copewith stress, and who have the ability to look for a silver lining - such as focusing on bystanders who helped the wounded.
Focusing on the horror, "that's harder on our body and our mind," said Dr. Catherine Mogil, co-director of the family trauma service at the University of California, Los Angeles. "People who tend to be able to make positive meaning out of tough situations are going to fare better."
Among the typical reactions that psychologists say anyone who witnessed the bombings or their aftermath might experience include difficulty sleeping or eating; sweats or stomachaches; anxiety or fear - especially in crowded situations that remind people of the bombing. People may have a hard time focusing on work or other everyday activities. They may feel numb, anger easily, or cry often.
Priscilla Dass-Brailsford, a psychologist at Georgetown University Medical Center, said that if those symptoms don't fade in about a month, of if they are bad enough to impair function, people should seek help.
But for most, "time is a great healer," said Dass-Brailsford, who served on disaster mental health teams that counseled survivors of 9/11 in New York.
Specialists say only a small number of people are expected to be so severely affected that they develop PTSD, a disorder that can include flashbacks, debilitating anxiety, irritability and insomnia months after the trauma. Even among veterans of the Iraq and Afghanistan wars, the best estimate was that just under 20 percent returned with symptoms of PTSD or major depression.
More at risk for lingering psychological effects are people who've previously been exposed to trauma, whether from the battlefield, a car crash or a hurricane.
During two stints in Iraq as a Marine, Eusebio Collazo of Humble, Texas, was gravely wounded and today runs regularly to help deal with PTSD. Running with a veterans group called Team Red, White & Blue, he was at mile 25 of the marathon when the bombs detonated - and adrenaline fueled his frantic race to find his wife, Karla, at the finish line. She was unharmed.
"My wife keeps asking me, `I don't know how I should be feeling. I want to cry but I can't.' And then I want to cry, and I can't cry either. So, there's a lot of weird, different feelings going on," Collazo said Thursday. It's harder, he said, to handle explosions on the home front than in a war zone.
In Boston's hospitals, teams of counselors and social workers are telling patients and their families what to expect in the difficult days and weeks ahead.
"Most people are having a lot of flashbacks," and thoughts of the bombing interrupt their days and nights, said Lisa Allee, who directs the Community Violence Response Team at Boston Medical Center. "These are very typical, normal, expected emotions after any traumatic event or disaster."
Beyond hospitalized patients, part of coping is awareness about how to take care of the psyche - turning off scary TV coverage and reading a book, going out for a quiet dinner, anything to temporarily cut the stress, says Dass-Brailsford, the disaster specialist.
That's especially true for parents who are trying to calm their children, added UCLA's Mogil, because kids take their emotional cues from the adults around them. Younger children especially don't need to see repeated footage of the blasts, because they may think it's happening again.
For a lot of people, psychiatrists say, talking about their experience can be cathartic.
A cashier's routine "how are you?" was enough for Anndee Hochman to tear up in a Philadelphia hardware store Wednesday. Hochman and her 12-year-old daughter had traveled to Boston to watch her partner run the marathon - and all three were in different places when the bombs exploded, Hochman herself just a few blocks from the finish line.
Hochman spent 10 minutes telling the store clerk her family's story of reuniting - and said it helps every time she's told friends, family, even a near-stranger about the experience.
Unknowingly, Hochman echoed the advice to look for a silver lining as she counseled daughter Sasha, who was nervous about returning to school.
"I reminded her, " `Sweetie' - and reminded myself, too - `there may have been a few people who planned those bombs and wanted to hurt people," Hochman said, "but there are so many more people there and in the world who want to help.'"
---
AP Medical Writer Lauran Neergaard reported from Washington. AP writer Kevin Freking contributed to this report.
© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
"I know this is how people live every day in other countries. But I'm not used to it here," said Greeley, 27, a technician at Tufts Medical Center who was on duty Monday when part of the hospital was briefly evacuated even as victims of the blast were being treated in the emergency room.
Anger, crying jags and nightmares are all normal reactions for both survivors of the Boston Marathon bombings and witnesses to the mayhem. While the injured and those closest to the blasts are most prone to psychological aftershocks, even people with no physical injuries and those like Greeley might feel the emotional impact for weeks afterward as they struggle to regain a sense of security. What's not clear is who will suffer lingering anxiety, depression or even post-traumatic stress disorder.
But specialists say that how resilient people are helps determine how quickly they bounce back. The resilient tend to be people who share their emotions before becoming overwhelmed, who know how to copewith stress, and who have the ability to look for a silver lining - such as focusing on bystanders who helped the wounded.
Focusing on the horror, "that's harder on our body and our mind," said Dr. Catherine Mogil, co-director of the family trauma service at the University of California, Los Angeles. "People who tend to be able to make positive meaning out of tough situations are going to fare better."
Among the typical reactions that psychologists say anyone who witnessed the bombings or their aftermath might experience include difficulty sleeping or eating; sweats or stomachaches; anxiety or fear - especially in crowded situations that remind people of the bombing. People may have a hard time focusing on work or other everyday activities. They may feel numb, anger easily, or cry often.
Priscilla Dass-Brailsford, a psychologist at Georgetown University Medical Center, said that if those symptoms don't fade in about a month, of if they are bad enough to impair function, people should seek help.
But for most, "time is a great healer," said Dass-Brailsford, who served on disaster mental health teams that counseled survivors of 9/11 in New York.
Specialists say only a small number of people are expected to be so severely affected that they develop PTSD, a disorder that can include flashbacks, debilitating anxiety, irritability and insomnia months after the trauma. Even among veterans of the Iraq and Afghanistan wars, the best estimate was that just under 20 percent returned with symptoms of PTSD or major depression.
More at risk for lingering psychological effects are people who've previously been exposed to trauma, whether from the battlefield, a car crash or a hurricane.
During two stints in Iraq as a Marine, Eusebio Collazo of Humble, Texas, was gravely wounded and today runs regularly to help deal with PTSD. Running with a veterans group called Team Red, White & Blue, he was at mile 25 of the marathon when the bombs detonated - and adrenaline fueled his frantic race to find his wife, Karla, at the finish line. She was unharmed.
"My wife keeps asking me, `I don't know how I should be feeling. I want to cry but I can't.' And then I want to cry, and I can't cry either. So, there's a lot of weird, different feelings going on," Collazo said Thursday. It's harder, he said, to handle explosions on the home front than in a war zone.
In Boston's hospitals, teams of counselors and social workers are telling patients and their families what to expect in the difficult days and weeks ahead.
"Most people are having a lot of flashbacks," and thoughts of the bombing interrupt their days and nights, said Lisa Allee, who directs the Community Violence Response Team at Boston Medical Center. "These are very typical, normal, expected emotions after any traumatic event or disaster."
Beyond hospitalized patients, part of coping is awareness about how to take care of the psyche - turning off scary TV coverage and reading a book, going out for a quiet dinner, anything to temporarily cut the stress, says Dass-Brailsford, the disaster specialist.
That's especially true for parents who are trying to calm their children, added UCLA's Mogil, because kids take their emotional cues from the adults around them. Younger children especially don't need to see repeated footage of the blasts, because they may think it's happening again.
For a lot of people, psychiatrists say, talking about their experience can be cathartic.
A cashier's routine "how are you?" was enough for Anndee Hochman to tear up in a Philadelphia hardware store Wednesday. Hochman and her 12-year-old daughter had traveled to Boston to watch her partner run the marathon - and all three were in different places when the bombs exploded, Hochman herself just a few blocks from the finish line.
Hochman spent 10 minutes telling the store clerk her family's story of reuniting - and said it helps every time she's told friends, family, even a near-stranger about the experience.
Unknowingly, Hochman echoed the advice to look for a silver lining as she counseled daughter Sasha, who was nervous about returning to school.
"I reminded her, " `Sweetie' - and reminded myself, too - `there may have been a few people who planned those bombs and wanted to hurt people," Hochman said, "but there are so many more people there and in the world who want to help.'"
---
AP Medical Writer Lauran Neergaard reported from Washington. AP writer Kevin Freking contributed to this report.
© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
LOS ANGELES (AP) — Dick Van Dyke is seeing doctors for an undiagnosed health problem, and he's seeking advice online as well.
"My head bangs every time I lay down," the 87-year-old actor posted on his Twitter account. "I've had every test come back that I'm perfectly healthy. Anybody got any ideas?"
Bob Palmer, a spokesman for Van Dyke, said Thursday that he's undergoing tests for "cranial throbbing" that's causing him to lose sleep. The sensation occurs when Van Dyke lies down, and scans and other tests have yet to yield a diagnosis, Palmer said.
Van Dyke drew a number of responses to his tweet for help Wednesday, including questions about what's been done so far for the problem he described as stubborn.
"It has been going on for 7 years. I've had every test you can think of," he replied, including an MRI and spinal tap.
Van Dyke has a strong constitution and is otherwise OK, but the "fatigue factor has become acute," Palmer said. Until he receives a diagnosis and treatment plan he's been advised not to fly, and is resting at his Malibu home.
He was to accept an award next week from New York's 92nd Street Y but canceled the trip.
Van Dyke's credits include "The Dick Van Dyke Show" and "Diagnosis Murder."
SPRINGFILED, IL (AP) - State health officials are urging parents to make sure their children have received all their recommended vaccinations.
The Illinois Department of Public Health says the state is reporting its highest number of pertussis cases since 1950.
In 2012 there were 2,026 cases of the illness, also known as whooping cough.
Dr. LaMar Hasbrouck is director of the state public health department. He says the record number of cases is "the perfect example of the importance of continued immunization."
Saturday marks the start of National Infant Immunization Week.
Hasbrouck says parents may visit the department's website to find a list of recommended vaccines and the age at which children should receive them. Illinois residents who cannot afford to pay for the immunizations may be eligible for assistance.
BRUSSELS (AP) -- The European Union says more than 7,000 tests across the 27-nation bloc on products labeled as beef show that nearly 5 percent of them contained horse meat.
The tests also showed the veterinary anti-inflammatory drug phenylbutazone, or bute, was present about .50 percent of the horse meat. Bute is banned for human use because in rare cases it causes severe side effects, but veterinary experts say there is little risk from consuming small amounts of the drug in horse meat.
European Health Commissioner Tonio Borg said Tuesday that "today's findings have confirmed that this is a matter of food fraud and not of food safety."
Borg said in the upcoming months the European Commission, the EU's executive arm, would propose measures "to strengthen the controls along the food chain."
© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
The tests also showed the veterinary anti-inflammatory drug phenylbutazone, or bute, was present about .50 percent of the horse meat. Bute is banned for human use because in rare cases it causes severe side effects, but veterinary experts say there is little risk from consuming small amounts of the drug in horse meat.
European Health Commissioner Tonio Borg said Tuesday that "today's findings have confirmed that this is a matter of food fraud and not of food safety."
Borg said in the upcoming months the European Commission, the EU's executive arm, would propose measures "to strengthen the controls along the food chain."
© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
WASHINGTON (AP) -- DNA may be the building block of life, but can something taken from it also be the building block of a multimillion-dollar medical monopoly?
The Supreme Court grapples Monday with the question of whether human genes can be patented. Its ultimate answer could reshape U.S. medical research, the fight against diseases like breast and ovarian cancer and the multi-billion dollar medical and biotechnology business.
"The intellectual framework that comes out of the decision could have a significant impact on other patents - for antibiotics, vaccines, hormones, stem cells and diagnostics on infectious microbes that are found in nature," Robert Cook-Deegan, director for genome ethics, law & policy at Duke University, said in a statement.
"This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications," he said.
The nine justices' decision will also have a profound effect on American business, with billions of dollars of investment and years of research on the line. The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years.
And Myriad Genetics alone has $500 million invested in the patents being argued over in this case. Without the ability to recoup that investment, breakthrough scientific discoveries needed to combat all kind of medical maladies wouldn't happen, the company says.
"Countless companies and investors have risked billions of dollars to research and develop scientific advances under the promise of strong patent protection," said Peter D. Meldrum, the president and CEO of Myriad Genetics, in a statement.
But their opponents argue that allowing companies like Myriad to patent human genes or parts of human genes will slow down or cripple lifesaving medical research like in the battle against breast cancer.
"What that means is that no other researcher or doctor can develop an additional test, therapy or conduct research on these genes," said Karuna Jagger, executive director of Breast Cancer Action.
The Supreme Court has already said that abstract ideas, natural phenomena and laws of nature cannot be given a patent, which gives an inventor the right to prevent others from making, using or selling a novel device, process or application.
Myriad's case involves patents on two genes linked to increased risk of breast and ovarian cancer. Myriad's BRACAnalysis test looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer.
Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer. Men can also carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer. The mutations are most common in people of eastern European Jewish descent.
Myriad sells the only BRCA gene test.
The American Civil Liberties Union challenged Myriad's patents, arguing that genes couldn't be patented, and in March 2010 a New York district court agreed. But the U.S. Court of Appeals for the Federal Circuit has now twice ruled that genes can be patented. In Myriad's case, it's because the isolated DNA has a "markedly different chemical structure" from DNA within the body.
Mark C. Capone, president of Myriad Genetics Laboratories, Inc., a subsidiary of Myriad, said some of the concerns over what they have patented are overblown and some simply incorrect.
"Myriad cannot, should not and has not patented genes as they exist in the human body on DNA," Capone said in an interview. "This case is truly about isolated DNA molecules which are synthetic chemicals created by the human ingenuity of man that have very important clinical utilities, which is why this was eligible for a patent."
But the ACLU is arguing that isolating the DNA molecules doesn't stop them from being DNA molecules, which they say aren't patentable.
"Under this theory, Hans Dehmelt, who won the Nobel Prize for being the first to isolate a single electron from an atom, could have patented the electron itself," said Christopher A. Hansen, the ACLU's lawyer in court papers. "A kidney removed from the body (or gold extracted from a stream) would be patentable subject matter."
The Obama administration seems to agree. Artificially created DNA can be patented, but "isolated but otherwise unmodified genomic DNA is not patent-eligible," Solicitor General Donald Verrilli said in court papers.
That was the ruling of the original judge who looked at Myriad's patents after they were challenged by the ACLU in 2009. U.S. District Judge Robert Sweet said he invalidated the patents because DNA's existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body or the information it encodes. But the federal appeals court reversed him in 2011, saying Myriad's genes can be patented because the isolated DNA has a "markedly different chemical structure" from DNA within the body.
The Supreme Court threw out that decision and sent the case back to the lower courts for rehearing. This came after the high court unanimously threw out patents on a Prometheus Laboratories, Inc., test that could help doctors set drug doses for autoimmune diseases like Crohn's disease, saying the laws of nature are unpatentable.
But the federal circuit upheld Myriad's patents again in August, leading to the current review. The court will rule before the end of the summer.
"The key issue now for the court will therefore be whether the scientist working in the lab to isolate a particular gene innovated in a way that allows for that isolated gene to be patented," said Bruce Wexler, a lawyer with the law firm Paul Hastings, who advises pharmaceutical and biotech companies on patent issues.
The case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.
© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
The Supreme Court grapples Monday with the question of whether human genes can be patented. Its ultimate answer could reshape U.S. medical research, the fight against diseases like breast and ovarian cancer and the multi-billion dollar medical and biotechnology business.
"The intellectual framework that comes out of the decision could have a significant impact on other patents - for antibiotics, vaccines, hormones, stem cells and diagnostics on infectious microbes that are found in nature," Robert Cook-Deegan, director for genome ethics, law & policy at Duke University, said in a statement.
"This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications," he said.
The nine justices' decision will also have a profound effect on American business, with billions of dollars of investment and years of research on the line. The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years.
And Myriad Genetics alone has $500 million invested in the patents being argued over in this case. Without the ability to recoup that investment, breakthrough scientific discoveries needed to combat all kind of medical maladies wouldn't happen, the company says.
"Countless companies and investors have risked billions of dollars to research and develop scientific advances under the promise of strong patent protection," said Peter D. Meldrum, the president and CEO of Myriad Genetics, in a statement.
But their opponents argue that allowing companies like Myriad to patent human genes or parts of human genes will slow down or cripple lifesaving medical research like in the battle against breast cancer.
"What that means is that no other researcher or doctor can develop an additional test, therapy or conduct research on these genes," said Karuna Jagger, executive director of Breast Cancer Action.
The Supreme Court has already said that abstract ideas, natural phenomena and laws of nature cannot be given a patent, which gives an inventor the right to prevent others from making, using or selling a novel device, process or application.
Myriad's case involves patents on two genes linked to increased risk of breast and ovarian cancer. Myriad's BRACAnalysis test looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer.
Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer. Men can also carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer. The mutations are most common in people of eastern European Jewish descent.
Myriad sells the only BRCA gene test.
The American Civil Liberties Union challenged Myriad's patents, arguing that genes couldn't be patented, and in March 2010 a New York district court agreed. But the U.S. Court of Appeals for the Federal Circuit has now twice ruled that genes can be patented. In Myriad's case, it's because the isolated DNA has a "markedly different chemical structure" from DNA within the body.
Mark C. Capone, president of Myriad Genetics Laboratories, Inc., a subsidiary of Myriad, said some of the concerns over what they have patented are overblown and some simply incorrect.
"Myriad cannot, should not and has not patented genes as they exist in the human body on DNA," Capone said in an interview. "This case is truly about isolated DNA molecules which are synthetic chemicals created by the human ingenuity of man that have very important clinical utilities, which is why this was eligible for a patent."
But the ACLU is arguing that isolating the DNA molecules doesn't stop them from being DNA molecules, which they say aren't patentable.
"Under this theory, Hans Dehmelt, who won the Nobel Prize for being the first to isolate a single electron from an atom, could have patented the electron itself," said Christopher A. Hansen, the ACLU's lawyer in court papers. "A kidney removed from the body (or gold extracted from a stream) would be patentable subject matter."
The Obama administration seems to agree. Artificially created DNA can be patented, but "isolated but otherwise unmodified genomic DNA is not patent-eligible," Solicitor General Donald Verrilli said in court papers.
That was the ruling of the original judge who looked at Myriad's patents after they were challenged by the ACLU in 2009. U.S. District Judge Robert Sweet said he invalidated the patents because DNA's existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body or the information it encodes. But the federal appeals court reversed him in 2011, saying Myriad's genes can be patented because the isolated DNA has a "markedly different chemical structure" from DNA within the body.
The Supreme Court threw out that decision and sent the case back to the lower courts for rehearing. This came after the high court unanimously threw out patents on a Prometheus Laboratories, Inc., test that could help doctors set drug doses for autoimmune diseases like Crohn's disease, saying the laws of nature are unpatentable.
But the federal circuit upheld Myriad's patents again in August, leading to the current review. The court will rule before the end of the summer.
"The key issue now for the court will therefore be whether the scientist working in the lab to isolate a particular gene innovated in a way that allows for that isolated gene to be patented," said Bruce Wexler, a lawyer with the law firm Paul Hastings, who advises pharmaceutical and biotech companies on patent issues.
The case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.
© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
WASHINGTON (AP) - A congressional investigation finds that specialty pharmacies like the one that triggered a deadly meningitis outbreak last year have little state oversight.
The report being released Monday by House Democrats shows that most states do not track or routinely inspect compounding pharmacies and that pharmacy boards in nearly all 50 states lack the information and expertise they need.
Missouri and Mississippi were the only two states that require permits or licenses and also the only ones with complete data on how many facilities they had.
None of the states indicated that they track whether pharmacies sell compounded drugs across state lines or in large quantities. Twenty-two states said they do not keep histories of problems.
Compounding pharmacies mix customized medications based on doctors' prescriptions. There have been calls for more federal oversight.
WASHINGTON (AP) -- Talk about a comeback: A treatment pulled off the market 30 years ago has won Food and Drug Administration approval again as the only drug specifically designated to treat morning sickness.
That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm.
Monday's FDA decision means a new version of the pill once called Bendectin is set to return to U.S. pharmacies under a different name - Diclegis - as a safe and effective treatment for this pregnancy rite of passage.
In the intervening decades, the treatment is widely believed to have undergone more scrutiny for safety than any other drug used during pregnancy.
"There's been a lot of buzz about this. Nothing better has come along" to treat morning sickness in those 30 years, said Dr. Edward McCabe, medical director for the March of Dimes, who welcomed the step.
"We know safety-wise, there's zero question," said Dr. Gary Hankins of the University of Texas Medical Branch in Galveston, who headed one of the company-financed studies of Diclegis that led to its approval.
U.S. sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer Duchesnay Inc. The company has long sold a generic version of the pill in Canada under yet another name, Diclectin.
For all the names, the main ingredients are the same: Vitamin B6 plus the over-the-counter antihistamine doxylamine, found in the sleep aid Unisom. U.S. obstetricians have long told nauseated pregnant women how to mix up the right dose themselves.
In fact, in 2004 the American College of Obstetricians and Gynecologists issued guidelines calling the combination a first-line therapy.
The difference that prescription-only Diclegis would offer: Combining both ingredients with a delayed-release coating designed to help women take a daily dose before their nausea sets in.
The return of an FDA-cleared treatment is needed, said ACOG spokesman Dr. Jeffrey Ecker, an obstetrician at Massachusetts General Hospital who wasn't involved in the study of Diclegis.
"It's not magic," Ecker cautioned, saying few women see their symptoms completely disappear with the medication. "But for some it allows them to be much more functional."
In Hankins' study, about 260 U.S. women with morning sickness were given either Diclegis or a dummy pill for two weeks. The Diclegis users missed on average 1 1/2 fewer days of work than their counterparts.
Duchesnay wouldn't reveal a U.S. price.
About three-quarters of women experience at least some nausea and vomiting with the hormonal surges of early pregnancy. Although it often occurs upon waking, some women have trouble all day. It usually ends by the second trimester.
About 1 percent of women undergo dangerously severe vomiting called hyperemesis gravidarum, the condition that made headlines last December when in Britain, Prince William's wife Kate was briefly hospitalized.
An initial version of Bendectin began selling in 1956, and 33 million women around the world were estimated to have taken it before the lawsuits began. At the time, the FDA continued to call the drug safe; appeals courts ruled in favor of Bendectin maker Merrell Dow Pharmaceuticals; and eventually a U.S. Supreme Court decision would render continuing suits unlikely. But Merrell Dow declared the litigation cost too high, and quit making Bendectin in 1983.
What happened? The government estimates 1 in 33 babies are born with birth defects regardless of medication use during pregnancy, and studies eventually concluded that Bendectin didn't increase that baseline risk. McCabe of the March of Dimes says it's important to recognize that when a drug is widely used in pregnancy, some babies will be born with birth defects that are a coincidence.
Doctors advise trying some other steps before turning to medication for morning sickness: Eat protein snacks before bed. Nibble crackers or sip ginger ale before getting out of bed. Eat frequent small meals. Avoid nausea-triggering odors.
When that doesn't work, Ecker says vitamin B6 alone helps some women. His next step is the B6-and-antihistamine combination that will form Diclegis. A next-step option includes the drug Zofran, normally used to treat nausea from cancer therapy.
© 2013 THE ASSOCIATED PRESS. ALL RIGHTS RESERVED. THIS MATERIAL MAY NOT BE PUBLISHED, BROADCAST, REWRITTEN OR REDISTRIBUTED. Learn more about our PRIVACY POLICY and TERMS OF USE.
That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm.
Monday's FDA decision means a new version of the pill once called Bendectin is set to return to U.S. pharmacies under a different name - Diclegis - as a safe and effective treatment for this pregnancy rite of passage.
In the intervening decades, the treatment is widely believed to have undergone more scrutiny for safety than any other drug used during pregnancy.
"There's been a lot of buzz about this. Nothing better has come along" to treat morning sickness in those 30 years, said Dr. Edward McCabe, medical director for the March of Dimes, who welcomed the step.
"We know safety-wise, there's zero question," said Dr. Gary Hankins of the University of Texas Medical Branch in Galveston, who headed one of the company-financed studies of Diclegis that led to its approval.
U.S. sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer Duchesnay Inc. The company has long sold a generic version of the pill in Canada under yet another name, Diclectin.
For all the names, the main ingredients are the same: Vitamin B6 plus the over-the-counter antihistamine doxylamine, found in the sleep aid Unisom. U.S. obstetricians have long told nauseated pregnant women how to mix up the right dose themselves.
In fact, in 2004 the American College of Obstetricians and Gynecologists issued guidelines calling the combination a first-line therapy.
The difference that prescription-only Diclegis would offer: Combining both ingredients with a delayed-release coating designed to help women take a daily dose before their nausea sets in.
The return of an FDA-cleared treatment is needed, said ACOG spokesman Dr. Jeffrey Ecker, an obstetrician at Massachusetts General Hospital who wasn't involved in the study of Diclegis.
"It's not magic," Ecker cautioned, saying few women see their symptoms completely disappear with the medication. "But for some it allows them to be much more functional."
In Hankins' study, about 260 U.S. women with morning sickness were given either Diclegis or a dummy pill for two weeks. The Diclegis users missed on average 1 1/2 fewer days of work than their counterparts.
Duchesnay wouldn't reveal a U.S. price.
About three-quarters of women experience at least some nausea and vomiting with the hormonal surges of early pregnancy. Although it often occurs upon waking, some women have trouble all day. It usually ends by the second trimester.
About 1 percent of women undergo dangerously severe vomiting called hyperemesis gravidarum, the condition that made headlines last December when in Britain, Prince William's wife Kate was briefly hospitalized.
An initial version of Bendectin began selling in 1956, and 33 million women around the world were estimated to have taken it before the lawsuits began. At the time, the FDA continued to call the drug safe; appeals courts ruled in favor of Bendectin maker Merrell Dow Pharmaceuticals; and eventually a U.S. Supreme Court decision would render continuing suits unlikely. But Merrell Dow declared the litigation cost too high, and quit making Bendectin in 1983.
What happened? The government estimates 1 in 33 babies are born with birth defects regardless of medication use during pregnancy, and studies eventually concluded that Bendectin didn't increase that baseline risk. McCabe of the March of Dimes says it's important to recognize that when a drug is widely used in pregnancy, some babies will be born with birth defects that are a coincidence.
Doctors advise trying some other steps before turning to medication for morning sickness: Eat protein snacks before bed. Nibble crackers or sip ginger ale before getting out of bed. Eat frequent small meals. Avoid nausea-triggering odors.
When that doesn't work, Ecker says vitamin B6 alone helps some women. His next step is the B6-and-antihistamine combination that will form Diclegis. A next-step option includes the drug Zofran, normally used to treat nausea from cancer therapy.
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