FDA Codeine risk for some nursing moms
Sat, 18 Aug 2007 03:59:34 GMT
WASHINGTON - Nursing mothers who take codeine should watch their infants for increased sleepiness or other signs of overdose, federal health officials warned Friday.
The Food and Drug Administration warning of the rare but serious side effect was prompted by a 2006 report of the death of a nursing infant whose mother was given codeine for episiotomy pain.
Genetic testing later showed the woman's body converted the codeine to morphine more rapidly and completely than in other people. That led to higher-than-expected morphine levels in her breast milk.
While the rapid conversion of codeine to morphine is a very rare side effect in some mothers, it can result in high and unsafe levels of the latter drug in the blood and breast milk, the FDA said in an alert.
Codeine is among the most common drugs taken by new mothers, FDA officials said.
It is included in several prescription pain drugs and in some over-the-counter cough syrups, Dr. Sandra Kweder, the FDA's deputy director, Office of New Drugs, Center for Drug Evaluation and Research, said in a telephone briefing.
The risk of having the genetic mutation ranges from about 1 percent in Hispanics, Chinese and Japanese, to 3 percent in African-Americans, 1 percent to 10 percent in Caucasians, and as high as 16 percent to 28 percent in North Africans, Ethiopians and Saudis, Kweder said.
Given the risk, doctors should prescribe nursing mothers the smallest dose of codeine for the shortest period of time, the FDA recommended. Doctors also should closely monitor both mother and child.
In children, signs of morphine overdose, beyond increased sleepiness, include difficulty breast-feeding or breathing and limpness. Nursing mothers may also experience overdose symptoms, such as extreme sleepiness, confusion, shallow breathing or severe constipation, the FDA said.
The FDA has asked drug companies that make those products to include information about the potential risks to nursing mothers who are ultra-rapid metabolizers of codeine.
There is a test available to determine if an individual is a rapid metabolizer of codeine, but Kewder said the agency is not currently recommending routine testing.
"Our point is to pay attention," she said.
New mothers taking codeine who find themselves extremely sleepy should consult their doctor, and if their baby seems unusually sleepy or has trouble nursing they should contact their physician or take the baby to an emergency room, she said.
Tiny N.J. baby ready to return home
Sat, 18 Aug 2007 02:49:13 GMT
By DANIELA FLORES, Associated Press Writer
TRENTON, N.J. - After almost four months of waiting, Tamera Dixon, who weighed less than a soda can when she was born on April 25, is ready to head home. Believed to be one of the smallest babies ever born in New Jersey, the Trenton preemie has spent most of her life in an incubator.
Tamera weighed slightly more than 11 ounces and measured 10 inches when she was born after only 6 months in the womb. Now that she's 4 pounds, 8 ounces, doctors have given her the OK to go home with her parents.
She was scheduled to leave the hospital Friday, but after the excitement of a news conference, hospital officials said she'll most likely head home Saturday.
"It is a miracle, she is a miracle," her mother, Andrea Haws, said with a bright smile Friday as she held the baby girl she'd prayed for.
"From when she was born, I think everyone knew she was a fighter," she said. "She's going to be a feisty little girl."
Tamera was delivered by Caesarean section at 25 weeks — 15 weeks short of a normal gestation period. Haws had already experienced complications during her pregnancy, but when her kidneys started failing and Tamera stopped growing, doctors decided they couldn't wait any longer to deliver her.
Haws, 40, recovered, but still spent most of her time at Capital Health System's Neonatal Intensive Care Unit visiting a child who she said at one point "didn't look like a human being."
That's all changed for Tamera, who would have been about a week old on Friday had she arrived near her due date. While being fed on Thursday, the pink onesie-wearing bundle of energy wriggled in a nurse's arm and looked around the room attentively — her size the only sign of her past troubles.
Dr. Stephen Moffitt, Tamera's doctor, said he's cautiously optimistic that she'll develop normally.
"She's breathing perfectly well on her own," said Moffitt, adding that doctors gave Tamera a 10 to 15 percent chance of survival before she was born.
Seeing Tamera transform into the bright-eyed center of attention at the NICU has been very exciting, Haws said. She credits the hospital and her faith in God for helping her through the hard times.
"To see an 11 ounce-baby, you wouldn't believe what it looked like," said Haws, who moved to Trenton from Jamaica a few years ago. "It was just skin and bones. She had all those wires all over and it was very scary."
Haws, who already has two boys, ages 11 and 7, with her husband, Terry Dixon, is enrolled in a family support program at the hospital.
Christy Keppel, a family support specialist with the March of Dimes who works at Capital Health System, said it's rare for babies who are born Tamera's size to survive and go home without complications. She's been working with Haws to let her know what to expect when she brings Tamera home. As part of that program, Haws spent Thursday night at the hospital alone with her baby.
"It gives them a chance to make sure that they're fully prepared to take the baby home," Keppel said.
Haws said she's nervous because Tamera is so small, but after praying for a girl and then waiting more than a month to even hold her, she's more excited to be able to take care of her baby.
"She has overcome all her obstacles," Haws said. "I'm very excited to bring her home."
FDA takes caution on approving new drugs
Fri, 17 Aug 2007 22:24:14 GMT
By LINDA A. JOHNSON, AP Business Writer
TRENTON, N.J. - Under growing scrutiny since the blockbuster painkiller Vioxx was pulled from the market, the Food and Drug Administration in recent months has rejected a slew of experimental drugs or delayed their approval and required more data.
Besides keeping drugs some patients might desperately need off the market, the rejections have battered drug company stock prices and are expected to increase the cost and time it takes to develop a new drug, not to mention the price of developing future ones.
Denials and delays have hit everyone from pharmaceutical giants such as GlaxoSmithKline PLC, Merck & Co., Novartis AG, Sanofi-Aventis and Wyeth down to struggling startups trying to get their first drug on the market. The FDA also has recently stiffened warnings on several drugs, most prominently diabetes drugs Avandia and Actos, and five months ago made Novartis withdraw its constipation drug, Zelnorm.
"There have been no systematic changes in how we are approaching the approval standards for new applications," FDA spokesman Christopher Kelly said in an e-mail. "Whether the current public debate and criticism of FDA on drug safety has played any role in our actions is very hard to quantify."
But Chris Milne, associate director of the Tufts Center for the Study of Drug Development, said Friday the FDA has systematically implemented more controls for scrutinizing drugs, particularly for heart and liver side effects. While he thinks the trend on approvals is not yet clear, he said the FDA now is requiring experimental drugs similar to ones already on sale to be more effective and safer than their predecessors.
Some experts say they already see a trend toward increased rejections, although drugs for life-threatening diseases or conditions with no good current treatment are generally being approved.
"The FDA is being more cautious," analyst Steve Brozak of WBB Securities said, explaining that FDA staff now realize new drugs will be used by many patients beyond those intended — known as off-label use because the drug is taken for another condition than the one it was approved to treat. That often boosts the chances that some patients will be harmed by side effects.
He sees the FDA mentality now as: "It's got to be so safe that we're not going to be criticized ever" for approving a drug.
The agency has approved 61 percent of drug applications through mid-August, down from 73 percent in the same period last year, according to BioMedTracker, a biotech and pharmaceutical research service.
James Kumpel at Friedman, Billings, Ramsey & Co. just published a report showing FDA approvals of "new molecular entities" — drugs made from new chemical compounds rather than just twists on existing drugs — so far this year are at their lowest level in at least a decade. Only seven were approved through the end of July, versus an average of 12 over the first seven months of each year since 1998.
"The FDA certainly has made it more difficult for pharmaceutical companies by pushing for more data and for more participants and for longer studies," said Kumpel, barriers he said will start limiting the number of new blockbusters.
Already, the average cost of shepherding a potential drug from discovery through approval is $980 million, up from $802 million in 2000, and the process takes 14.2 years on average, according to Tufts.
"It appears that FDA has been on defense since 2004," Kumpel said.
That's when Merck withdrew its blockbuster painkiller Vioxx from the market because of increased risk of heart attacks and strokes, making Vioxx an instant poster child for drug safety issues.
Last April, the FDA rejected Merck's Arcoxia, a long-planned successor to Vioxx on sale in many other countries.
Just Friday, Endo Pharmaceuticals Holdings Inc. said the FDA for the second time asked for more time to review its approved migraine drug Frova for a new use, preventing menstrual migraines.
In between, the FDA has cited safety or effectiveness questions in rejecting or delaying approval for experimental drugs including Novartis' diabetes drug Galvus, Sanofi-Aventis' weight-loss drug Zimulti, and even a higher dose of GlaxoSmithKline's Advair Diskus for bronchitis and emphysema symptoms. Also shot down: Wyeth's experimental schizophrenia drug bifeprunox and Wyeth's Pristiq, which would have been the first nonhormonal drug for menopause symptoms.
Likewise, small pharmaceutical companies have been hurt. One, Pozen Inc., this month got its second FDA request for more information about a migraine treatment called Trexima it is jointly developing with GlaxoSmithKline. That news sent Pozen shares down 46 percent.
Scott Gottlieb, an American Enterprise Institute fellow who was FDA deputy commissioner until January, said drug companies have long complained that FDA was too conservative. Now, there's even more uncertainty both at the agency and in the industry.
For drugs where benefits don't strongly outweigh risks, Gottlieb said, "The agency errs on the side of caution."
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On the Net:
Food and Drug Administration: http://www.fda.gov
Toys R Us pulls bibs as a precaution
Fri, 17 Aug 2007 22:25:56 GMT
By JEFFREY GOLD, AP Business Writer
NEWARK, N.J. - Toys "R" Us Inc. on Friday said it was removing all vinyl baby bibs from its Toys "R" Us and Babies "R" Us stores as a precaution after two bibs made in China for one supplier showed lead levels that exceeded Toys "R" Us standards.
Toys "R" Us, which operates over 1,500 stores, said the result came in testing this month of bibs supplied by Hamco Inc. and marketed under the Koala Baby, Especially for Baby and Disney Baby labels.
Tests of Hamco bibs in May were within standards, Toys "R" Us said.
Vinyl bibs made by other companies have been temporarily removed to avoid any confusion among customers and allow further testing, Wayne-based Toys "R" Us said.
A message seeking comment from Hamco, based in Gonzales, La., was not immediately returned.
Childhood exposure to lead can cause learning problems, reduced intelligence, hyperactivity and attention deficit disorder, studies have shown.
Toys "R" Us, the nation's second-largest toy seller after Wal-Mart Stores Inc., said customers can return any vinyl bib purchased from a Toys "R" Us or Babies "R" Us store for a full refund.
Information is available at 1-800-869-7787.
The bib removal is the latest in a series of recent problems involving imports from China. Products including tires, toys, toothpaste, seafood and pet food have been recalled.
The Toys "R" Us move involves about 160,000 vinyl bibs, including some in its warehouses. Nearly 90 percent of the bibs are from Hamco, and all of them were made in China, Toys "R" Us spokeswoman Kathleen Waugh said.
The action by Toys "R" Us came two days after a California environmental group said that some vinyl bibs made in China and sold at Toys "R" Us stores contained lead levels well above federal safety limits for lead in paint.
Toys "R" Us has said its May tests were prompted by Wal-Mart's decision that month to recall lead-tainted vinyl bibs from its stores nationwide. Wal-Mart's recall came after a lawsuit brought by the Center for Environmental Health, the California group.
Both the bibs sold by Wal-Mart and Toys "R" Us were manufactured in China for Hamco.
A statement issued by Hamco at the time of the Wal-Mart recall did not address whether their bibs contained lead but ed an industry trade group statement suggesting that the risk of babies ingesting lead even if the bibs were tainted was slight.
The U.S. Consumer Product Safety Commission issued a statement in May saying that the lead-contaminated bibs were safe if in good condition. But if a bib "deteriorates to the point that a baby could pull or bite off and swallow a piece of vinyl containing lead, then the amounts of lead consumed could approach levels of concern," the agency said.
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On the Net:
Toys "R" Us: http://www.toysrus.com
Hamco Inc.: http://www.crowncrafts.com
Center for Environmental Health: http://www.cehca.org/babybibs.htm