Posts Tagged ‘ drug shortage ’

FDA to Import Drugs for Critically Ill Premature Babies

Monday, June 3rd, 2013

Faced with a shortage of injection drugs used to provide nutrition to critically ill premature babies and cancer patients who can’t eat any other way, the US Food and Drug Administration said it will begin importing the medication from Norway.  NBC News has more:

The agency said Wednesday it immediately will begin importing trace elements, potassium phosphate and sodium phosphate — drugs used in total parenteral nutrition or TPN — from a Norwegian plant affiliated with Fresenius Kabi USA LLC, based in Lake Zurich, Ill.

“Hospitals can start ordering the drugs today,” said Valerie Jensen, associate director for the FDA’s drug shortage program.

That should start reversing a two-year shortage that has forced hospitals to ration the drugs that provide essential nutrients for patients who can’t eat or drink by mouth, said Jay Mirtallo, past president of the American Society for Parenteral or Enteral Nutrition, or ASPEN.

“I think it’s huge. It’s a great win for us,” said Mirtallo. “For too long, we’ve been limping along trying to feed our patients.”

Without adequate TPN drugs, tiny babies and other patients can develop severe side effects, including horrifying skin lesions and deficiencies that can demineralize their bones, leading to fractures, experts say. Some may have lasting developmental delays caused by missing nutrients.

The FDA is exercising regulatory discretion in allowing the drugs to be imported. When the agency turns to a foreign source, as it has for 14 other drugs in the past two years, officials evaluate the foreign drugs to make sure quality is adequate and does not pose undue risk to U.S. patients, officials said.

The move comes after 14 U.S. senators demanded earlier this month that the FDA act to end the shortage of infant drugs.

Image: Premature baby in a NICU, via Shutterstock

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UPDATED: Zinc Shortage Could Endanger Premature Babies

Wednesday, March 27th, 2013

A drug that is crucial to helping doctors feed the smallest premature infants is in dwindling supply because of a shortage of the injectable form of the mineral zinc.  More from NBC News:

At least 120,000 more fragile babies may be at risk each year from an ongoing shortage of injectable zinc, a trace element added to intravenous nutrition solutions, government and medical officials say.

“It’s very frustrating,” said Dr. Lamia Soghier, medical director of the neonatology unit at Children’s National Medical Center in Washington, D.C. “What can we do? We’re just short. We don’t have it. We can’t borrow it.”

The crisis is the latest in the nation’s ongoing struggle with drug shortages. After federal intervention in 2012, the number of new shortages has fallen markedly, down to just 26 this year from a record high of 267 in 2011. But the number of active shortages of essential medications — including injectable trace elements, vitamins and electrolytes — is now 323, higher than it’s ever been, according to the University of Utah Drug Information Service, which tracks the problem.

UPDATE 3/28/13:  Emily Hartman from Children’s National Medical Center contacted PNN to clarify the following:  “While Dr. Soghier is quoted as saying “What can we do? We’re just short. We don’t have it. We can’t borrow it,” she is referring to when the original MMWR article on zinc shortages was written in December 2012. Children’s was able to get an emergency supply soon after that original article was released and we’re actually okay in terms of supply. We don’t want our patients and families to worry that this is still a problem at Children’s.”

Image: Premature baby, via Shutterstock

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FDA: Counterfeit ADHD Medication in Circulation

Thursday, May 31st, 2012

The U.S. Food & Drug Administration has announced that counterfeit versions of the 30 milligram dose of the drug Adderall, which is commonly used to treat attention deficit hyperactivity disorder (ADHD) in children, are in circulation.  The counterfeit medications might be tempting to some because of a months-old shortage of Adderall and other drugs.  But the counterfeit drugs, which are being sold on the Internet, are incorrectly made and could be dangerous to children.  The Boston Globe reports:

According to the FDA, the counterfeit version being sold on the Internet contains the wrong active ingredients — containing tramadol, a narcotic-like painkiller, and acetaminophen (Tylenol). Tramadol isn’t a controlled substance and may be easier to obtain for fraudulent purposes than the active ingredients in Adderall, which are all forms of amphetamine stimulants.

“Consumers should be extra cautious when buying their medicines from online sources,” said the FDA in a media statement. “Rogue websites and distributors may especially target medicines in short supply for counterfeiting.”

Counterfeit Adderall tablets, which are white, look strikingly different from the real version, which is orange/peach in color and manufactured by Teva Pharmaceuticals. Real Adderall, in a 30-milligram dose, is imprinted with a “dp” on one side and “30” on the other side of the tablet.

Photos of the counterfeit version and the real drug can be found posted by the FDA on flickr. The agency added that the Adderall 30-mg. product may be counterfeit if:

– The product comes in a blister package.

– There are misspellings on the package such as “NDS” instead of “NDC”; “Aspartrte” instead of “Aspartate”; Singel” instead of “Single”

– The tablets are white in color, round in shape, and are smooth.

– The tablets have no markings on them.

Consumers who suspect they’ve purchased the fraudulent Adderall should file a report online at the FDA’s MedWatch site or call 1-800-332-1088 to request a reporting form.

Image: Prescription bottle, via Shutterstock.

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FDA Attempts to Stop Children’s Cancer, Other Drug Shortages

Wednesday, February 22nd, 2012

Methotrexate, a drug used to treat children with leukemia, is among the drugs that are in short supply in America, prompting President Barack Obama to issue an executive order to prevent future shortages, and the FDA to announce a series of steps to increase the supply of methotrexate and other badly-needed drugs. reports:

“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,” said FDA Commissioner, Dr. Margaret A. Hamburg….

As for methotrexate, the FDA has approved a new manufacturer of a preservative-free form of methotrexate that is expected to boost the supply. The manufacturer, APP Pharmaceuticals, expects its methotrexate product to become available next month and continue indefinitely.

The New York Times reports that shipments from abroad will also arrive this week.  Some doctors, however, are worried that the current steps will not be a permanent solution to the very serious problem of drug shortages.  “Children are at such risk from drugs in short supply that it doesn’t give me a whole lot of comfort that we’ve moved past one or two of these shortages,” Dr. Peter C. Adamson, chairman of the Children’s Oncology Group, which is financed by the National Cancer Institute, told the Times. “What about the next one? And the one after that?”

Image: Empty prescription bottle, via Shutterstock.

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Hospitals Face Dire Shortage of Childhood Cancer Drug

Monday, February 13th, 2012

The Food and Drug Administration says supplies of a drug used to treat childhood leukemia are dwindling. Supplies of methotrexate, a chemotherapy drug given to children with acute lymphoblastic leukemia (A.L.L.), are likely to run out in the next two weeks, the New York Times reports.

Without methotrexate, hundreds of children may die from a disease that is usually curable, officials say. A.L.L. is most common in children 2 to 5 years old.

One of the nation’s largest suppliers of methotrexate voluntarily stopped making it this fall because of what the company called “significant manufacturing and quality concerns,” the Times says. The four other American companies that make the drug are trying to increase production. The FDA is also looking for foreign suppliers.

The Times report included the story of Jackson Schwartz, 6, a Pennsylvania child with A.L.L. who needs treatment with methotrexate over the next two months. “It would be devastating if we can’t get this drug,” his father said.

Image: Cancer chemotherapy via Shutterstock.

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