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US to import short-supply cancer drug from India

WASHINGTON - US health authorities said Tuesday they will import a drug to treat ovarian, bone marrow and AIDS-related skin cancer from India in order to ward off a worrying shortage.

"Lipodox will be imported as an alternative to Doxil," the US Food and Drug Administration said in a statement, noting that a temporary deal has been made with Sun Pharma Global FZE in India to supply US patients with the drug.

"Temporary importation of unapproved foreign drugs is considered in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs."

Another drug that has been in short supply, methotrexate -- needed for treating a variety of cancers including children with leukemia -- was approved in preservative-free generic form for maker APP Pharmaceuticals in Illinois and should be available by March, the FDA said.

In the meantime, a shipment of 31,000 vials, or one month's supply, is being sent right away to hundreds of US hospitals and treatment centers by Hospira, the agency added.

Prescription drug shortages in the United States nearly tripled from 2005 to 2010, according to the Department of Health and Human Services.

Many drugs are falling out of production because drugmakers cannot profit when medications go generic and carry extremely low price tags. Profit-incentive for doctors to prescribe more expensive cancer meds has also contributed to the problem.

In October 2011, US President Barack Obama signed an executive order directing action to head off shortages in life-saving prescription drugs.

Obama's order strengthened the FDA's power to predict and tackle potential shortages of prescription drugs and to halt illegal price gouging of life-saving medicines during supply shortfalls.

Since then, the FDA has been able to ward off 114 drug shortages, compared to a total of 195 drug shortages prevented in 2011, the agency said.

The change is mostly due to a six-fold increase in companies complying with a request to give early warning to the FDA if they foresee a shortage, so that health authorities can seek other suppliers.

The FDA on Tuesday also "issued draft guidance to industry on detailed requirements for both mandatory and voluntary notifications to the agency of issues that could result in a drug shortage or supply disruption," it said.

"A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration," said FDA Commissioner Margaret Hamburg.

"Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need." AFP

New approach urged for late-talking bilingual babies

by Kerry Sheridan

 

VANCOUVER, February 19, 2012 (AFP) - Babies who are raised in homes where two or more languages are spoken may appear to talk later than those learning just one language, leaving parents puzzled and concerned as to the reasons why.

Conventional wisdom often suggests that such children are confused and so they take longer to talk. Or, parents may hear that any apparent delay is just an illusion because kids are little geniuses who can learn many languages quickly and easily.

"Both of these views are wrong," US psychologist Erika Hoff told the American Association for the Advancement of Science meeting in Vancouver this weekend.

"It is not the case that hearing two languages confuses the child and impairs their ability to acquire anything. But it is also not the case that children can magically acquire two languages as quickly as one."

Instead, psychologists should take a different approach to testing young children, one that measures their proficiency in both languages instead of just one.

When that is done, researchers typically find that the two tests add up to about the same level of proficiency as would be seen in a baby who is learning a single language.

"Children who are exposed to two languages... must hear less of each language than a child who hears only one and so it takes them longer to get the same amount of experience with each language," added Hoff, whose research has focused on highly educated bilingual Spanish-English families in south Florida.

Two kinds of tests have existed for decades -- the Language Development Survey and the MacArthur Bates Communicative Development Inventory -- in which parents answer questions about which words their child knows and how many word combinations the child has at around age two.

Since their inception decades ago, both paper-and-pencil surveys have been adapted into different languages, with as many as 20 variations of the LDS and more than 60 of the MacArthur Bates now out there, researchers said.

Even this low-tech approach has proven superior to modern methods, said Philip Dale, professor of speech and hearing sciences at the University of New Mexico, Albuquerque.

"Despite an understandable skepticism you might have about the ability of parents with limited training and a natural pride in their child, parent-report can be quite an accurate measure," said Dale.

Leslie Rescorla, professor of psychology at Bryn Mawr college in Pennsylvania, who devised the LDS in the 1980s, agreed that surveys can be very effective in identifying late-talkers by 24-30 months of age.

In the LDS, parents are given a 310 word checklist, and are asked to mark which words their child says. Average children have about 150 words at that age, and late talkers have 25-50.

Rescorla presented research on new versions of the LDS distributed in Greece, South Korea and the Netherlands, which showed similar results as have been seen in the United States.

For instance, eight percent of Greek children surveyed were found to be late-talkers, compared to nine percent of US children.

Knowing whether a child is a late-talker is important because it may point to disorders that could be helped with early intervention, such as autism, hearing loss, or mental impairment, said Nan Bernstein Ratner, professor of hearing and speech sciences at the University of Maryland.

"Late-talkers are at high risk for other developmental problems," said Ratner.

"If you have children who have problems with language and with reading, we have children who will not succeed in society."

Previous research has shown that as many as 20 percent of all children are late-talkers, but many of them are simply "late-bloomers" who catch up by age five, added Ratner.

"About four-fifths of children will recover. The problem is we don't know which ones, so if you don't have a crystal ball it is much better to catch them at age two and to start tracking them, rather than to wait and see what happens."

When it comes to bilingual babies, Hoff urged parents to take advantage of the second-language tests out there, rather than worry about the child's poor scores in a single survey which is missing the full extent of the child's knowledge.

"Because these inventories are available in multiple languages, you can often assess what they know in both languages," she said.

"When you do that, the bilingually developing children look exactly like the monolingually developing child. They are acquiring total language knowledge at the same rate."

Grape-flavored Infants' Tylenol recalled

WASHINGTON, February 17, 2012 (AFP) - Johnson & Johnson's subsidiary McNeil issued a recall Friday of 574,000 bottles of an infants version of its popular Tylenol pain and fever relief drug over problems with the dosing system.

The recall applies specifically to one-ounce bottles of grape-flavored Infants' Tylenol Oral Suspension distributed nationwide in the United States.

Tylenol maker McNeil Consumer Healthcare said it had received "a small number of complaints" from consumers who reported trouble with the dosing system which comes with the bottles.

Some reported that a built-in flow restrictor meant to control doses could be pushed into the bottle making it difficult to measure the correct dose for infants.

It said that if the flow restrictor remains in place there is no risk from using the medicine.

But it issued the recall as a precautionary measure.

"No adverse events associated with this action have been reported to date and the risk of a serious adverse medical event is remote," McNeil said

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