News

FDA Issues Safety Warning for Acetaminophen Due to Skin Reactions

Fri, 08/16/2013 - 14:37

The United States Food & Drug Administration recently issued a safety warning stating that acetaminophen can, in some rare cases, cause severe skin reactions. Acetaminophen is a popular and commonly-used pain-killing and fever-reducing ingredient found in Tylenol and other well-known medications. Currently, the FDA is in the process of adding warnings about possible effects on the skin on the labels of over-the-counter medications with acetaminophen on the ingredients list. Prescription medications containing acetaminophen will also be required to include the warning on their labels, according to the Huffington Post.

The skin conditions that could occur from taking products with acetaminophen include Steven-Johnson Syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis, according to the FDA. TIME reports that:

“Many of the reactions start with flu-like symptoms of fever and muscle aches, which are followed by rash, blistering and sloughing off of the outside of the skin, which can expose patients to potentially fatal infections. It’s possible for victims to experience scarring, skin pigment changes, blindness and organ damage. The recovery can take weeks or months.”

The risk of skin conditions was discovered after the FDA reviewed adverse effects of medications in its database from 1969 to 2012. During those years, there were 107 reported cases of skin reactions in which 12 people died and 67 people were hospitalized, according to TIME. In a statement, a spokeswoman for the FDA stated that while the information isn’t intended to scare or worry consumers or convince them to stop the use of medications containing acetaminophen, “it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious side effects, which are potentially fatal."

The FDA urges consumers to immediately stop the use of a medication containing acetaminophen if any adverse reactions are present. Unfortunately, the FDA has no way of determining who is at risk for the skin conditions.
 

FDA Issues Recall for Dietary and Sexual Supplements Due to Adverse Reactions

Fri, 07/26/2013 - 11:03

Recently, the U.S. Food & Drug Administration called for HardMenStore.com, an erotic retailer geared towards men, to recall 430 lots of its Silver Sword and Clalis brand dietary and sexual supplements. According to the recall notice, the supplements contain amounts of the PDE-5 Inhibitor Sildenafil that can cause reactions usually associated with the active ingredient in the enhancement pill Viagra.

The pills could be harmful for consumers because they can potentially lead to lower blood pressure, light-headedness and dizziness. The tan and red Silver Sword tin contains eight doses with two pills per dose, while Clalis is packaged in a blue box with a bottle of six pills. The affected lots were produced on or before April 2, 2013, and the date of production can be found on the back of the packaging of both products.

An article by Medscape warns consumers about the potential misleading information coming from manufacturers and marketers of sexual enhancement or supplementary drugs. According to the article, “many consumers are placing their trust in products promoted by manufacturers who do not invest the funds to carry out research to prove the safety and efficacy of these products.” HardMenStore.com states its products were sealed, packaged and delivered to the online retailer as “having contained only legitimate and lawful ingredients.”

The company is currently notifying distributors and consumers with an email and an online press release. The company will arrange for the return of all the affected lots. For now, it is recommended that all consumers and retailers who possess the product should immediately stop using it, and should contact a physician if there have been any side effects from the use of the product.

HardMenStore.com can be contacted through email at info@hardmenstore.com.
 

First Non-Hormonal Menopause Medication Approved by FDA

Thu, 07/18/2013 - 10:49

The United States Food and Drug Administration recently approved a non-hormonal medication, Brisdelle, to treat the symptoms of hot flashes and night sweats for women going through menopause, according to a press release by the FDA. The drug, which was developed by the drug manufacturer Noven Pharmaceuticals and is currently the only FDA-approved non-hormonal medication for menopause, will be available at U.S. pharmacies this November.

Brisdelle contains a low dose of paroxetine, a drug traditionally used to treat depression, obsessive-compulsive disorder, panic disorder and other conditions. According to Noven, the drug was clinically tested on 1,276 women experiencing hot flashes and night sweats stemming from menopause. Menopause occurs when a woman’s period stops, usually after she has reached the age of 45, according to MedLinePlus. Menopause is characterized by a change in period flow, hot flashes or night sweats, difficulty sleeping and other changes. The changes from menopause can occur many years before the period fully stops.

Extreme symptoms of menopause were traditionally treated through hormonal therapy that replaced hormones the female body stops making, such as estrogen and progesterone. Hormonal therapy decreased in popularity after 2002 “when a large clinical trial showed the therapy increased the risk of heart disease and breast cancer,” according to the Reuters.

Reuters reports that an advisory committee for the FDA originally voted against Brisdelle’s approval, explaining that the drug did not show “enough benefits to offset the risks.” Along these lines, the FDA notes that the drug will come with “a Boxed Warning about suicidality.” The FDA further notes that the Boxed Warning was included because the drug contains the same active ingredient as some depression medications, and all approved depression medications include a Boxed Warning concerning suicide. Other side effects reported for Brisdelle include headache, fatigue, nausea and/or vomiting.

Noven has been developing the drug since 2007. It originally took over the manufacturing of the drug from another pharmaceutical company when the drug was in the infancy of its development. Noven Pharmeceuticals is based in Miami.
 

FDA, International Regulators Crack Down on Dangerous Medication Sold by Illegal Online Pharmacies

Thu, 07/11/2013 - 15:24

It’s common knowledge that the Internet is rife with false information and potential consumer hazards. In order to protect consumers, the United States Food and Drug Administration, in conjunction with international regulatory and law enforcement agencies, recently took action against more than 9,600 websites that illegally sell unapproved prescription medication. The agencies and law enforcement issued warnings, and seized websites and more than $41 million worth of illegal medications worldwide.

The crackdown was a part of the 6th annual International Internet Week of Action (IIWA), a global cooperative effort against internet sales and distribution of counterfeit and illegal medical products. The website crackdown, referred to as Operation Pangea VI, occurred from June 18 to June 25, according to the Associated Press. The goal of the operation was to identify the manufacturers and distributors of illegal, unapproved medications and medical devices and remove them from the market.

A total of 1,677 illegal pharmacy websites were seized and shut down by the FDA’s Office of Criminal Investigations and the United States Attorney’s Office for the District of Colorado. As part of the investigation, websites that sold unapproved and potentially dangerous prescription medications were targeted by the FDA. The websites, in addition to being harmful to consumer health, are harmful to consumers because of potential credit card fraud, identity theft or computer viruses.

Among the websites were many that appeared to be a part of a criminal network that falsely claimed its websites were Canadian pharmacies with displays of fake licenses and certifications. Many of the websites also advertised the medications sold as “brand name” and “FDA approved,” and used certain major pharmacy retailer names to trick U.S. consumers. Now, when consumers visit these websites, they’ll see a FDA Office of Criminal Investigations Unit banner that states that the website has been seized.

The FDA recommends that consumers report suspected criminal activity at www.fda.gov/oci.
 

FDA Investigating Two Deaths Following Use of Antipsychotic Zyprexa Relprevv

Wed, 07/03/2013 - 09:29

The United States Food and Drug Administration is currently investigating the death of two individuals who died a few days following the injection of the intramuscular antipsychotic drug Zyprexa Relprevv (olanzapine pamoate).

The FDA reports that the individuals died three to four days after receiving “an appropriate dose of the drug.” The individuals died “well after the 3-hour post-injection monitoring period,” which “is required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS).” The REMS requires the injection to occur at a certified healthcare facility with continuous monitoring for at least three hours following the injection. It also requires the patient to be accompanied home from the facility.

Both individuals allegedly had very high olanzapine blood levels after their deaths. Elevated levels of olanzapine can lead to a condition defined and included on the Zyprexa label as post-injection delirium sedation syndrome (PDSS). PDSS is “a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium.”

According to MedScape, the Zyprexa Relprevv label also contains black box warnings stating it is not approved for dementia-related psychosis. The label further states that short-term clinical trials show that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. The deaths occurring during the short-term trials appeared to be related to either cardiovascular problems or infections. It is unclear if the recent deaths happened because of these black box warnings.

Zyprexa is typically used for treating aggression, depression, manic episodes, schizophrenia and bipolar disorders, according to Bloomberg. Zyprexa’s sales peaked at $5.03 billion in 2010. The intramuscular form of Zyprexa Relprevv is meant to offer schizophrenia patients, who often fail to regularly take medication, weeks of symptom control.

A spokesperson for Eli Lilly & Co., the manufacturer of Zyprexa Relprevv, told Reuters that while there have been 82 previous deaths of patients who took the drug since it first hit the market, the company couldn’t determine a pattern or trend between the deaths of the patients and the use of the drug.

The FDA is still conducting its investigation into the deaths of the two individuals.
 

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.”