News

Hospira Injectable Drug Manufacturer Issues Two Nationwide Recalls
Wed, 05/15/2013 - 16:46

Hospira, the leader of sterile injectable drugs, has discovered problems with multiple lots of its drugs and one of its medical products.  In the last few weeks, Apotex, the company who markets Hospira’s products, has issued two nationwide recalls:  one for Piperacillin and Tazobactum for injection and the other for Hospira’s GemStar Infusion System.  Both the company and the FDA have alerted health care providers of the issues.

On April 29, the FDA announced a Class I recall of the GemStar Infusion System.  The device is used for intravenous, arterial, subcutaneous, short-term infusion and parenteral administration of general IV fluids and medications.  Patients can use the device at home or in the hospital, as the system is small and lightweight.  According to the recall, however, the lithium battery voltage may drop below 2.4 volts and interrupt the system operations.  The disruption also can delay the patient’s therapy, which can result in significant injury or death, depending on the patient’s condition.

During the following week, Apotex issued another recall on behalf of Hospira for 21 lots of Piperacillin and Tazobactam for Injection.   Although the company had originally recalled 15 lots, the FDA added another six lots on May 10.  The drugs, which are used to treat severe infections, can potentially show precipitation/crystallization in the IV bag or IV line after reconstitution.  As a result patients may suffer from phlebitis, renal impairment, end-organ embolism and ischemia.  Additionally, patients may not get the proper treatment for infection, which can potentially lead to minor or permanent impairment of the body structure or function.   

Patients who use the GemStar Infusion System may want to consider use of another product if a delay or interruption in the therapy can result in significant injury or death.  The internal AA batteries and battery compartments should be inspected for signs of leakage, corrosion, or other damage prior to each use to ensure that the power remain on.  If an individual notices damage caused by leaking batteries, they can return it to Hospira for repair.

Hospira is investigating the cause of the problems with Piperacillin and Tazobactam.  Health care providers and customers who have the recalled product should immediately stop use and distribution, quarantine the recalled lots immediately and call GENCO at 1-877-674-2078 to schedule product return.

FDA Issues Warning Over DMAA Stimulant In Popular Supplements
Wed, 05/08/2013 - 12:16

Although many people believe that dietary supplements are safe and undergo an FDA regulation process similar to drugs, many supplements contain unknown or unapproved ingredients that can be dangerous.  The FDA doesn’t have to review the supplements before they’re sold, and they must undergo a lengthy scientific and legal process to ban compounds in supplements.  Last month, the FDA issued a statement that declared they are using all available resources to ensure that supplements containing DMAA are no longer distributed or available for sale.

Dimethylamylamine (DMAA) is often found in products marketed to boost endurance, aid in weight loss and help build muscle.  However, it can lead to a number of side effects and health complications, including high blood pressure, chest tightness, shortness of breath, and heart attacks, among other problems.  Consumers may have a difficult time identifying whether their supplement contains the potentially harmful ingredient, as DMAA is known by ten different names. 

As of April 11, 2013, the FDA received 86 reports of illnesses and death associated with supplements containing DMAA.  The ingredient is especially dangerous when taken with caffeine, and it can lead to nervous system and psychiatric disorders, in addition to its cardiovascular side effects.  Although companies often market dietary supplements as natural, dietary supplements that contain unapproved ingredients accounted for just over half of all major drug recalls.  

Last year, the U.S. military removed supplements containing DMAA after two soldiers’ deaths may have been linked to the ingredient.  The agency sent warning letters to 11 companies requesting to stop further production and distribution of dietary supplements containing DMAA.  Although the FDA has questioned the legality of DMAA in the past, the new warning firmly states its stance:  “FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal.”

All but one of the companies complied with the FDA’s request.  USPLabs, which makes OxyElite Pro and Jack3d, “stands behind the safety and quality of its products,” and the company sent published studies to the FDA that challenged safety claims.  However, the FDA states that the studies are not sufficient enough to defend use of DMAA in dietary supplements, as the studies were each conducted with 50 or fewer participants.  The FDA will send a formal response to USPLabs and will continue its efforts to get the stimulant off the market.

Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance in Boston, notes how dietary supplements should follow the same rigorous regulation process as pharmaceutical drugs, as “the consumer is flying blind when it comes to purchasing supplements.”  Consumers are urged to report any DMAA-related problems to the company or the FDA, and they should contact a health care provider if they become ill. 

Asthma Drug Singulair Linked To Neuropsychiatric Reactions and Suicidal Thoughts
Wed, 05/01/2013 - 13:35

In 2009, the U.S. Food and Drug Administration investigated the clinical trial reports of the popular asthma drug Singulair.  Although they determined psychiatric problems were not frequently reported, the FDA noted that the trials were not designed to look for that issue.  Now, four years later, Australia’s medicine watchdog has revealed that Singulair has been linked to suicidal thoughts in children and teenagers, and medical experts are cautioning doctors to prescribe it with caution, according to the Herald Sun.

Also known as montelukast, Singulair is often used to help treat adults and children with chronic asthma and seasonal allergic rhinitis.  Approximately 20,000 Australians use Singulair, and according to medical expert Professor Adam Jaffe, it is more commonly used to treat children than adults.  Although he notes that the drug is “highly effective” in the majority of cases, the Therapeutic Goods Administration has warned health professionals of montelukast’s potential risk of neuropsychiatric adverse events.

According to the Australian Prescriber’s Medicines Safety Update, the TGA received reports of neuropsychiatric adverse events in 58 children and adolescents treated with montelukast over a thirteen-year period that began on January 1, 2000.  Of the reports, five cited suicidal ideation, five cited depression, and eight cited agitation.  Nightmares, altered mood, and insomnia were also among the reports, and the TGA noted that patients often experienced multiple neuropsychiatric reactions.

While the number of reports seems small considering the length of collection time, the TGA notes that this could be an underestimate of the problem as it is often difficult to establish psychiatric diagnoses in children.  Additionally, Pharmacy News notes that the potential risk of these adverse events is generally higher when initiating therapy or increasing the dosage.

The TGA advises health professionals to be aware of the potential adverse effects of singulair and encourage patients and parents to seek medical advice should they occur.  Professor Jaffe notes that parents shouldn’t automatically rule out use of montelukast for their children:  “With any medication you have got to balance the risks versus the benefits and singulair is no different.”

Use Of Seizure Drug Valproate During Pregnancy Tied To Autism
Wed, 04/24/2013 - 13:48

Although valproate in pregnancy has been previously linked with congenital malformations, a ten-year Danish study revealed yet another reason why women might avoid use of the popular epilepsy drug.  According to Medscape, researchers found that women who take valproate during pregnancy are three times more likely to have a child with an autism spectrum disorder and five times more likely to have a child with profound childhood autism when compared with unexposed children. 

Also known by its commercial name, Depakote, valproate is used for the treatment of epilepsy and other neuropsychological disorders.  The drug has been previously associated with low intelligence in children who were exposed during pregnancy, and it also increases the risk of malformations.  Although valproate may be the only treatment option for women of childbearing potential, researchers speculated that prenatal exposure to the drug may increase the risk of autism.

Denmark researchers conducted a study of 655,615 children born in Denmark from 1996 through 2006.  With the use of national registries, they were able to determine that 5,437 children were identified with autism spectrum disorder, including 2,067 with childhood autism.  During their pregnancy, 508 women took valproate.  Even after adjusting for parental age at conception and psychiatric history, gestational age, sex, and other potentially confounding factors, the risk of autism for valproate-exposed children remained elevated.

While past use of the drug did not raise a child’s risk of being diagnosed with autism spectrum disorder, its use by a woman during pregnancy resulted in an absolute risk of 4.42 percent that the child would receive such a diagnosis at some point in his or her early years.  When the child’s mother took valproate during pregnancy, the absolute risk of childhood autism diagnosis, which is generally a more disabling condition, was 2.4 percent. 

Although the increased risk seems small, these numbers are significant.  According to the study that was published in The Journal of the American Medical Association, “because autism spectrum disorders are serious conditions with lifelong implications for affected children and their families, even a moderate increase in risk may have major health importance.” 

For women of childbearing age with epilepsy, the elevated risk of autism development in their child should be weighed against the important of managing their condition.  Dr. Jakob Christensen, who led the study, notes that women who may become pregnant certainly should discuss possible alternative treatments with their doctors, as knowledge is key to making these decisions:  “There must be a continuous effort to include this information along with all the other risks in discussions with women of childbearing age who are candidates for valproate.”

GranuFlo Linked To Cardiac Arrest And Manufacturer Fails To Inform Patients And Doctors
Mon, 11/26/2012 - 15:18

One of the most widely prescribed dry acid products used in the dialysis industry today, GranuFlo, was found to increase patient risk of sudden death from cardiac arrest, according to the New York Times. The manufacturer of GranuFlo, Fresenius Medical Care, treats more than a third of Americans who receive dialysis through their own clinics, or through other clinics where their products are used. Although the company sent a memo to their own clinics explaining the cardiac arrest risk that had been linked to the acid, they failed to immediately warn other centers that use GranuFlo, sparking an FDA investigation.

Dialysis, which takes on the kidney’s role and clears toxic waste from the blood, requires bicarbonate to neutralize the acid that builds up in the blood. Compared to competitor drugs, GranuFlo contains more of the ingredient that the body converts to bicarbonate.

On November 4, 2011 the company’s medical office sent a memo to their dialysis centers that warned against the misuse of the company’s products. The internal memo detailed a study that showed an increased death risk associated with acidosis and high pre-dialysis bicarbonate. According to the memo, 941 patients had suffered cardiac arrest inside the company’s clinics in 2010. High levels of bicarbonate in the patients’ blood increased their risk of cardiac arrest about six times that of patients with low levels of bicarbonate.

Although Fresenius’s centers received the info, the non-company clinics that buy the product to help treat an estimated 125,000 patients did not receive the memo. Doctors at these centers continued to prescribe the drug without knowing about the increased risk of cardiac problems associated with extra bicarbonate.

In late March, the company finally notified its customers, after the F.D.A. received a copy of the internal memo. The F.D.A. issued an alert in late May cautioning against inappropriate prescription and dosing errors. Steven Silverman, director of compliance for the F.D.A.’s medical devices division, notes that the troubled findings should have been addressed urgently in order to keep the patients safe: “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.” 

Mirena Patient Sues After Doctor Leaves Device in Abdomen
Fri, 09/28/2012 - 09:55

Angela Collins of Virginia filed a medical malpractice lawsuit against an OB/GYN clinic and her doctor for allegedly leaving her Mirena IUD birth control floating in her system.  After years of pain, doctors eventually found that the device had migrated to her abdomen.  Collins filed a lawsuit against Blue Ridge Gynecology and Obstetrics, and their employee, Dr. Karen Wade, as North Virginia Daily reported.

The FDA approved the Mirena IUD as a birth control device in 2000, although some users have reported a number of cases due to experiencing painful problems with the device.  In December 2009, the FDA issued a warning letter to Bayer Inc. in response to a promotional program it used to tout Mirena.  Bayer partnered with a social networking site, known as Mom Central, and created a direct marketing campaign.  The FDA warning letter faulted the marketing script for misbranding the drug and omitting certain information regarding the risks of using Mirena.

In September 2006, Collins had the Mirena IUD implanted as a method of birth control.  Upon developing a left ectopic pregnancy, Wade performed various procedures, including laparoscopy, to treat the pregnancy.  Collins states that in February 2007, Wade could not find the IUD and she allegedly did not use an imaging device to find the IUD, despite her realizing that the device was missing.

As Collins continued to experience abdomen pain, she went to the defendants who treated her on April 1, April 20, May 11 and May 24, 2007.  According to Collins, no test, image or action of any kind was taken that would have revealed the migrated device.  According to the complaint, the defendants advised Collins that she was ovulating, and suggested she take ibuprofen for the pain.

On June 3, 2007, Collins suffered abdominal pain and went to the Winchester Medical Center emergency room.  The complaint asserts that about two weeks later, when Collins sought treatment from the defendants, Wade advised that her pain was caused by scar tissue and “told her to deal with [it].”  Wade also gave Collins a prescription for pain medicine and warned her to make it last “because she would not give her anymore.”  The Plaintiff believed Wade’s diagnosis that scar tissue was causing pain and nothing could be done to relieve it.  Collins therefore did not return for any further treatment.

More than three years later, Collins still suffered from abdominal pain and returned to the emergency room on November 20, 2010.  They conducted a CT scan and found the Mirena floating in Collin’s abdomen.  In January 2011, she had the device removed at the University of Virginia Medical Center.

Collins is suing the defendants for $2 million, claiming medical negligence for the following:  failing to properly assess and diagnose the plaintiff or to “image” Collins to search for the missing device during the February 2007 surgery; leaving a foreign object in her body that had no therapeutic or diagnostic effect on her body; ignoring the patient’s request to search the missing IUD; and misdirecting Collins by stating the source of pain was scar tissue.

According to the lawsuit, Collins is seeking a jury trial and compensation for physical, mental and emotional pain, temporary and permanent disability and disfigurement, health care costs, lost wages, and loss of enjoyment for life.

FDA Warns of Counterfeit, Potentially Dangerous Adderall Sold Online
Wed, 05/30/2012 - 10:44

 

The U.S. Food and Drug Administration (FDA) has warned health care professionals and consumers that a counterfeit version of Teva’s Adderall is being sold online.  Adderall is an extremely popular stimulant which has been in short supply since at least last year “due to active pharmaceutical ingredient supply issues,” the FDA explains.     

The news release explains that “[r]ogue websites and distributors may especially target medicines in short supply for counterfeiting.”  However, counterfeit online medication sales have been an increasingly serious issue for many popular drugs in the last few years as consumers go online to find cheaper ways to fill their prescriptions.  Web users are often redirected to deceptive websites made to look legitimate without ever knowing they have accessed a non-reputable medication provider.   

Adderall, a prescription medication classified as a controlled substance, is approved for the treatment of attention deficit hyperactivity disorders (ADHD) and narcolepsy.  Reuters reports that the drug has soared in popularity recently, with a 13.4 percent increase in prescriptions written for it from 2009 to 2010.    

The reason the FDA tightly regulates the drug’s active ingredients to manufacturers is to prevent misuse.  Adderall is popular with students who use it to improve focus during exams.

In preliminary tests, the FDA found this counterfeit version of Adderall lacks the correct active ingredients of the real medication, making it both ineffective and potentially dangerous.  The true medication contains four active ingredients-dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfatehese.  

However, the counterfeit pills some consumers received contain the acute pain medicines tramadol and acetaminophen instead.  Furthermore, the counterfeit pills are white instead of orange or peach in color and lack the “dp” embossing and “30” on the sides.  The fake pills are free of any markings or writing.   

The authentic pills are round and come in 100-count bottles with the National Drug Code (NDC) 0555-0768-02 listed, while the counterfeit pills come in foil packages with some misspellings on their packaging. The FDA notes that the following misspellings have been found on the counterfeit packaging:

  • “NDS” instead of “NDC”
  • “Aspartrte” instead of “Aspartate”
  • “Singel” instead of “Single”

Teva, Adderall’s manufacturer, said they notified the FDA of this counterfeit concern after a consumer came forward who noticed these misspellings after purchasing the drug online.  At this point, the FDA is uncertain how many consumers may have purchased these counterfeit versions, or which websites may be involved in their sale. 

Study Finds Hospitals May Give Patients Too Much Acetaminophen
Thu, 05/24/2012 - 10:50

 

A new study carried out by researchers from Philadelphia’s Thomas Jefferson University Hospital found that hospitals may be giving patients higher-than-recommended doses of Tylenol (acetaminophen).  According to the HealthDay report, about 2.5 percent of patients may “receive more than the safe daily cumulative dose of the pain-reliever” at least one day during their hospital stay. 

The U.S. Food and Drug Administration (FDA) explains that acetaminophen is an active ingredient in hundreds of prescription and over-the-counter (OTC) medications.  It may also be found in other medications used to treat allergies, cough, cold, sleeplessness, and the flu.  In prescription medications, it may be present with other chemicals that treat moderate or severe pain.

Acetaminophen-containing products may be found in a number of forms, including drops, syrups, capsules, and pills.  In prescription medications, acetaminophen may also be abbreviated as “APAP.”  In other countries, it may also have a completely different name, as it does in the United Kingdom where it’s called paracetamol. 

However, this medication can cause serious liver damage if used in higher-than-recommended doses or if alcohol is consumed along with it.  Signs of liver damage may at first be mistaken for other conditions, such as the flu.  Patients may also fail to notice the early signs of liver damage because it can take time for these symptoms to become apparent.  

However, over the course of several days, liver damage can eventually lead to liver failure or even death.  Serious Tylenol side effects, some of which may also indicate liver damage, include the following:

  • Vomiting
  • Diarrhea
  • Nausea
  • Sweating
  • Loss of appetite
  • Irritability
  • Abdominal pain
  • Heart problems
  • Seizures
  • Coma

An FDA safety announcement from December noted that correct dosing of acetaminophen is of particularly great importance for infants and young children.  In response to their risk of acetaminophen overdose, manufacturers have released infant-safe versions of the liquid acetaminophen medications that have a different drug concentration to keep them safe.

The Thomas Jefferson University Hospital study reported that a major culprit for patient intake of more than the recommended 4 grams per day of acetaminophen was the administration of multiple drugs containing this pain reliever.  Two extra-strength Tylenol tablets contain 1 gram of acetaminophen and this is a common dose given to patients to relieve pain and reduce fever. 

During this two-year study, the researchers looked at 46,000 hospital admissions and the medications given to those patients.  On at least one day of hospitalization, they found that about 1,100 patients were given more than the recommended 4 grams of acetaminophen through Tylenol, Percocet, and other similar medications.  

Furthermore, only a small minority of these patients received a blood test to evaluate their liver function.  Researchers noted that patients typically only receive a liver function test when doctors have specific concerns regarding possible problems.  

Although no serious liver injuries were noted in patients who did have liver function tests, researchers said that more information was needed to determine if any “abnormal test results were the result of excessive exposure to acetaminophen.”  Furthermore, the study concluded that more research is needed to decide whether new safe daily dosing recommendations are needed for acetaminophen.  

However, the study authors did feel that better patient education is needed to ensure safe acetaminophen use, particularly after they leave the hospital.  The article notes that “patients may try to duplicate the medications and doses they were given during their admission,” which can be problematic if they were given unsafe amounts of acetaminophen-containing products.

Study Warns of the Cardiovascular Death Risk of Zithromax
Fri, 05/18/2012 - 12:28

 

Yesterday the U.S. Food and Drug Administration (FDA) issued a statement acknowledging a recent medical journal report which found an increased risk of cardiovascular death in patients taking azithromycin (Zithromax).  This antibiotic comes in a pill form and is used in the treatment of several types of infection.    

According to the study of patients on Zithromax, this cardiovascular death risk, as well as death from any cause, was higher than those treated with amoxicillin, ciprofloxacin, or no drug at all.  The cardiovascular death risks for patients taking levofloxacin were similar to those associated with the use of Zithromax.      

The New England Journal of Medicine article explains that researchers looked at 347,795 patients taking Zithromax over a five-day period.  Bloomberg News reports that this research found that “85 of every 1 million treatment courses of the drug were associated with cardiac death,” which is over twice the death rate as the alternative antibiotic amoxicillin.   

The FDA explains that Zithromax “belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval.”  The QT Interval is the measure of the time between the beginning of the Q wave and the end of the T wave in the heart’s electrical cycle.  The prolongation of the QT interval can lead to potentially fatal abnormal heart rhythm issues, such as torsades de pointes.

In March 2012, the drug label for Zithromax was revised to include this QT interval prolongation risk.  The FDA explains it is currently in the process of updating the drug labels for other macrolide antibiotics. 

The FDA approves the use of Zithromax for the following conditions:

  • Acute bacterial exacerbations of chronic pulmonary disease
  • Acute bacterial sinusitis
  • Community-acquired pneumonia
  • Pharyngitis/tonsillitis
  • Uncomplicated skin and skin structure infections
  • Urethritis and cervicitis
  • Genital ulcer disease 

Zithromax is a Pfizer product which earned the company $453 million last year.  Bloomberg reports that a spokeswoman for Pfizer, Joan Campion, said in an email that “We are thoroughly reviewing this observational study within the overall context of the data we’ve collected for more than two decades on Zithromax’s benefits and risks.”

The FDA warns patients not to stop taking Zithromax without first speaking to a healthcare professional.  The public health agency also said they are looking at the results of this study and will release any new information that comes out of their review. 

Hospira Recalled Due to Incorrect Drug Volume, Potential Overdoses
Thu, 05/17/2012 - 16:04

The U.S. Food and Drug Administration (FDA) recently announced the nationwide voluntary recall of a lot of Hospira, a hydromorphone hydrochloride injection.  According to the announcement, this recall has been initiated due to two reports of single drug delivery cartridges containing more than the 1 mL volume of the labeled medication. 

These Hospira cartridges are part of the Carpuject Syringe System, which consists of prefilled glass cartridges that are loaded into a syringe holder to deliver the drug.  This system is intended to provide an easy, safe, convenient, and time-saving method of delivering this medication. 

However, the FDA explains that opioid pain medications such as hydromorphone have life-threatening overdose consequences which include the following:

  • Respiratory depression-slowed or suspended breathing
  • Low blood pressure
  • Reduced heart rate and circulatory collapse

The faulty lot was distributed from September to October of 2011 and has the lot number 07547LL.  The expiration date for this lot is July 1, 2013.  The medication was first distributed to wholesalers and some hospitals in the following locations: Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.

Although the drug’s manufacturer, Hospira, Inc., says they have not yet received any adverse event reports related to this lot defect, they have begun an investigation to coincide with this recall.  Through this investigation, the manufacturer hopes to determine the root cause of this defect, as well as determine any preventative actions that need to take place. 

The recall announcement explains that anyone who experiences problems that may be related to this medication is encouraged to contact their physician or healthcare provider to report these issues.  Furthermore, anyone possessing this medication is instructed to stop using or distributing it and to quarantine what they have. 

Individuals are then instructed to call Stericycle at 1-888-912-7093 to arrange the return of the product.  The FDA explains that replacements from safe lots of this medication are available to customers and can be received by sending their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083.