Tag Archives: FDA

FDA backs expanded use of medical abortion pill

WASHINGTON (Reuters) – The U.S. Food and Drug Administration on Wednesday agreed to allow more access to Danco Laboratories’ abortion pill Mifeprex, likely making it easier and cheaper for women to have an abortion by medication.

The FDA increased authorized use of the pill to 70 days of gestation from the current 49 days, cut the recommended dose of the drug and reduced the number of required visits to a doctor.

The changes are expected to allow greater access to medication abortions, particularly in Texas, North Dakota and Ohio, which have laws that require providers to prescribe the drug according to a more restrictive FDA label in place since 2000.

On Wednesday, the agency updated the Mifepfrex requirements to bring them in line with the most up-to-date scientific studies, which have shown that a third of the dose works as well.

“The FDA label has finally caught up to the evidence based practice in the United States,” said Vicki Saporta, president and chief executive of the National Abortion Federation, an organization of abortion providers. “It has the potential of opening medical abortion care in more rural areas because it does not have to be given by a surgical abortion provider,” she added.

The FDA decision comes amid a heated 2016 presidential race.

Earlier this month, the Supreme Court took up a major abortion case which represents a test for a strategic shift that abortion opponents have taken in recent years: to apply restrictive regulations to abortion doctors and facilities rather than try to ban the procedure outright.

Mifeprex was approved in 2000 to terminate early pregnancy when given in combination with misoprostol, an anti-inflammatory drug that was originally approved to prevent gastric ulcers.

Under the new prescription information on the label, patients will take one 200 mg tablet of Mifeprex on day one instead of three 200 mg tablets. They will take 800 mcg of misoprostol 24-48 hours after taking Mifeprex. Previously they took 400 mcg on day three.

Under the old label, patients were asked to return to their doctor 14 days after taking Mifeprex for an examination. The new label requires that they return between seven and 14 days for an “assessment.”

As far back as 2001, an estimated 83 percent of U.S. providers were no longer using the old FDA-approved regimen, according to the Guttmacher Institute, which backs abortion rights but whose research is used by both sides of the debate.

(Reporting by Toni Clarke, Jilian Mincer and Jon Herskovitz; Editing by Alistair Bell)

Trader Joe’s recalls cashews amid salmonella concerns

A possible salmonella contamination has prompted Trader Joe’s to recall some cashews.

The grocery store chain issued a statement about the recall late last week, saying that one particular kind of Trader Joe’s Raw Cashew Pieces could be contaminated with the bacteria.

The cashews are marked “BEST BEFORE 07.17.2016TF4,” the company said, and were distributed to stores in 30 states across the country, as well as the District of Columbia.

It wasn’t clear exactly how many packages were included in the recall.

Trader Joe’s said it learned of the possible contamination from a supplier, but didn’t elaborate.

A recall notice on the Food and Drug Administration website says Heritage International (USA) Inc. was voluntarily recalling the cashew lot after routine lab tests found salmonella in it.

The bacteria can cause people to fall ill.

Trader Joe’s said it hasn’t received any reports of anyone getting sick from the cashews, though it has stopped selling all Trader Joe’s Raw Cashew Pieces in its stores pending an investigation.

The grocery chain encourages anyone who bought the cashews marked “BEST BEFORE 07.17.2016TF4” to return them for a full refund or throw them out without eating them.

According to the CDC, salmonella sickens about 1.2 million Americans every year. Symptoms include diarrhea, fever and abdominal cramps, and most people fully recover in 4 to 7 days. In extreme cases, though, infections can spread beyond the intestines and become more severe.

The bacteria leads to about 450 deaths and 19,000 hospitalizations every year, the CDC says. Children, older adults and people with weak immune systems are particularly at risk.

FDA Approves First 3D Printed Drug

The U.S. Food and Drug Administration (FDA) has approved the first drug that is created using a 3D printer.

The drug, Spritam, is designed for the treatment of epilepsy according to a statement from the manufacturer Aprecia Pharmaceuticals.

The printed pills were created by what the company calls “ZipDose.”  The printer creates a pre-measured dose that dissolves in the mouth when you consume a liquid.  Tests showed the pill dissolves significantly faster than “fast melt” drugs because the pill is powdered medication bound together by the printer.

“As a result, Spritam enhances the patient experience — administration of even the largest strengths of levetiracetam with just a sip of liquid,” Aprecia said in a statement on Monday. “In addition, with Spritam there is no measuring required as each dose is individually packaged, making it easy to carry this treatment on the go.”

Scientists are hailing the decision by the FDA, saying that the use of 3D printing technology could revolutionize the way medication is given to patients.

The technology could allow doctors to put all of a patient’s medication into a single pill with precise monitoring of the dosages of each medication.  If the doctor needs to make a change, they just change the amount in the printing program for that patient.

Spirtam is the first 3D printed drug approved by the FDA.

Supreme Court Blocks Arizona Abortion Law

The Supreme Court is blocking Arizona from enforcing restrictions on medical abortions while a series of court challenges works through lower courts.

The ruling by the Court upheld a lower court ruling that blocked the rules regulating where women can take abortion-inducing drugs.  Abortion-inducing drugs would also be prohibited after the 7th week of pregnancy instead of the current restriction of the 9th week.

The liberal-leaning 9th Circuit Court of Appeals blocked the state of putting the restrictions in place while the legal challenges are taking place.  North Dakota, Ohio and Texas have similar laws to Arizona.

Abortionist Planned Parenthood says that drug conducted abortions for more than 40 percent of abortions in their abortion centers.

The Arizona restrictions were put into place following the deaths of 8 women who had taken the drugs.  The FDA claims there is no connection between the drugs and the deaths.

North Dakota Court Upholds Abortion Drugs Ban

The North Dakota Supreme Court upheld a state law that limits abortion drugs.

The court reversed the ruling of a lower court judge last year that said the law violated the state constitution.

“Beginning tomorrow morning, there will not be any medication abortions in North Dakota,” said David Brown, an attorney for the Center for Reproductive Rights.

The North Dakota law says that no drugs can be used to induce abortions that are not approved for that use by the FDA.  The North Dakota clinic involved in the lawsuit uses misoprostol as part of their process, which is not approved by the FDA for abortions.  The drug is a treatment for stomach ulcers.

A spokeswoman for the Fargo abortionists say about 20 percent of their abortions each year are done with drugs.

North Dakota Attorney General Wayne Stenehjem praised the court’s decision and said the state will wait to see what the abortionists do before deciding how to proceed with the case

Government Admits More Infectious Diseases In Unsafe Storage

The Food and Drug Administration said that a federal employee who found six vials of the deadly smallpox virus in a cardboard box in a storage room at a Maryland lab also found hundreds of vials of other diseases.

The samples included influenza, rickettsia (which can cause the lethal Rocky Mountain Spotted Fever) and dengue.

FDA official said Wednesday the collection of 327 vials of the various diseases was found at the same time as the smallpox virus vials announced last week.

Testing at the CDC discovered the smallpox viruses in the vial were alive and infectious.

“The fact that these materials were not discovered until now is unacceptable,” said Karen Midthun, of FDA’s director for biologics. “However, upon finding these materials our staff did the right thing – they immediately notified the appropriate authorities who secured the materials and determined there was no exposure.”

The FDA said 32 vials of tissue samples and non-contagious virus were destroyed at the laboratory and the remaining 279 samples were sent to the Department of Homeland Security for storage.

Judge Refuses To Block Arizona Abortion Law

A U.S. District Court judge has refused to block a new set of abortion regulations in Arizona.

The regulations now in effect will require abortionists to follow FDA guidelines for prescribing and dispensing abortion producing drugs such as RU486.  The FDA guidelines prohibit the use of those drugs after the seventh week of pregnancy.

Attorneys for Planned Parenthood has sued to stop the law claiming that requiring abortionists to follow the federal government’s guidelines on the drug would harm women.

Judge David C. Bury ruled that it was still to be seen if the law is an obstacle to abortion but that based on what was presented to the court the measure did not create irreparable harm.

The pro-life Center for Arizona Policy released a statement praising the court’s action saying that the decision upheld a common sense health and safety standard and that it was a victory for anyone who truly cared about the well-being of women.

Scientists Working To Create “Disease Free Babies”

Scientists are working on a technology that would eliminate genetic disease in newborns by combining the DNA of three people instead of two in a single embryo.

However, the announcement of the study raised the alarm that the scientists would open the door for people to create “designer babies” with special features such as eye color, hair color or skin.

Food and Drug Administration officials are meeting over the next two days with the scientists in the project to see if they will allow testing on humans.  The process is currently only approved to be used on monkeys.

“Once you make this change, if a female arises from the process and goes on to have children, that change is passed on, so it’s forever,” Phil Yeske, chief science officer of the United Mitochondrial Disease Foundation, told Bloomberg. “That’s uncharted territory; we just don’t know what it means. Permanent change of the human germline has never been done before, and we don’t know what will happen in future generations.”

Four monkeys have been created using the process and have been healthy through their first three years.

Drug Shortages Continue To Run Rampant

A new report from the Government Accountability Office says that drug shortages are continuing to hamper doctors nationwide.

The GAO report is mandated by a 2012 law that gives the Food and Drug Administration the power to manage drug shortages.  The GAO was to determine if the FDA has improved responses to the problems.

The report concludes the FDA is preventing more shortages than in the past but that the total number of shortages is increasing.  In 2012, the FDA managed 154 potential shortages compared to 35 in 2010.  However, the number of drugs in shortage in 2012 was 456 compared to 154 in 2007.

Some of the drugs in the “shortage” category include nitroglycerine for heart issues and cisatracurium, the drug used to paralyze muscles for surgery.

Hospitals Hit With Shortage Of Intravenous Saline

The U.S. Food and Drug Administration released a statement on Tuesday saying they are working with three companies that produce intravenous saline to combat a shortage at American hospitals.

Valerie Jensen, FDA’s Associate Director for Drug Shortages, says that the product manufacturers, Baxter International, Hospira and B. Braun Medical, have committed to stepping up production.

“We have not heard of anyone running out of the IV solutions at this point,” Jensen said, “but we know the hospitals are not comfortable with the low supplies.”

Manufacturers had notified the FDA at the end of 2013 they anticipated delays in filling orders but a significant increase in flu cases have magnified the shortages.

Healthcare providers are reportedly saving saline only for the most seriously ill patients and in many cases using smaller bags to extend the supply.