Fluoroquinolone Antibiotics Linked to Aortic Injuries

Recent studies* indicate that users of fluoroquinolone antibiotics, including Cipro®, Levaquin® and Avelox® are twice as likely to suffer from aortic aneurisms and tears of the aorta—the largest blood vessel in the body.

Last year, doctors wrote more than 26 million fluoroquinolone prescriptions to treat common infections. Unfortunately, these antibiotics have been linked to collagen degradation, which can weaken the aorta, causing it to bulge (aortic aneurysm) and split apart (aortic dissection). Damage to the aorta can lead to strokes, heart attacks, internal bleeding and death.

What are fluoroquinolones?

Fluoroquinolones are a group of wide-spectrum antibiotics, used to treat a variety of problems, including sinus infections, bronchitis and urinary tract infections. They include:

  • Avelox ® (moxifloxacin hydrochloride)         
  • Cipro ® (ciprofloxacin)
  • Cipro ® XR (ciprofloxacin)
  • Factive ® (gemifloxacin mesylate)
  • Floxin ® (ofloxacin)
  • Levaquin ® (levofloxacin)
  • Maxaquin ® (lomefloxacin hydrochloride)
  • Noroxin ® (norfloxacin)        
  • Proquin ® XR (ciprofloxacin hydrochloride)
  • Raxar ® (grepafloxacin hydrochloride)         
  • Zagam ® (sparfloxacin)        

How do fluoroquinolones damage the aorta?

Use of fluoroquinolone antibiotics has been associated with several collagen-related disorders, including tendon rupture, tendinopathy, and retinal detachment. In 2008, the USA Food and Drug Administration issued a black box warning for fluoroquinolones, indicating that these medications were associated with tendonitis and tendon rupture.

Collagen is also a major component of the aortic wall. Since fluoroquinolones have been known to degrade collagen, researchers began to question whether fluoroquinolones may cause or aggravate damage to the aorta, including aortic aneurysm and dissection.

A study by researcher Chien-Chang Lee, MD, of National Taiwan University Hospital and colleagues published in JAMA Internal Medicine found, “Use of fluoroquinolones was associated with an approximately 2-fold increase in risk of aortic aneurysm and dissection within 60 days of exposure.”

What is an Aortic Aneurysm?

The aorta is the largest blood vessel in the body. It carries oxygenated blood away from the heart to the rest of the body. Weakness in the aortic wall can cause it to widen and balloon outward, much like a damaged garden hose. In acute cases, the aorta can rupture and cause severe internal bleeding.

Warning Signs of Aortic Aneurysm

Unfortunately, many people with aortic aneurysms don’t know there’s a problem because they do not experience any symptoms. However, if the aneurysm becomes very large, it may cause pain, numbness, blood clots, or other symptoms. Affected areas vary, depending whether the bulge in the aorta is located in the chest (thoracic aneurysm) or abdomen (abdominal aortic aneurysm). A ruptured aneurysm causes a dramatic drop in blood pressure, sending the person into shock and damaging vital organs.

What is an Aortic Dissection?

An aortic dissection happens when the inner layer of the aorta tears, causing the inner and middle layers of the aorta to separate (dissect). This can lead to aortic rupture or decreased blood flow (ischemia) to organs. Aortic dissections most frequently occur in the upper (thoracic) part of the artery, but may also occur in the abdominal aorta. An aortic dissection may also cause aortic aneurysm. Symptoms of aortic dissection usually begin suddenly and include severe chest pain.

Sources:

Lee C, Lee M, Chen Y, et al. Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral FluoroquinoloneJAMA Intern Med. 2015;175(11):1839-1847. doi:10.1001/jamainternmed.2015.5389.

Daneman N, Lu H, Redelmeier DA. Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study. BMJ Open 2015;5:e010077. doi:10.1136/bmjopen-2015- 010077

Essure Birth Control Under Fire

iStock_000013959692XSmallUPDATE (2/15/16) Elk & Elk is now actively pursuing legal action for victims of Essure. Call 1-800-ELK-OHIO for a free consultation.

Facing a wave of public criticism, Bayer has agreed to add warnings to the patient information booklet for Essure – a permanent birth control device consisting of coils inserted into a woman’s Fallopian tubes. The new language includes warnings of pelvic pain and device migration.

On the market since 2002, the device has been implanted in nearly 1 million women worldwide. Promoted by manufacturers as cheaper and less invasive than traditional tubal ligation, the Essure system has become a source of irritation for both Bayer and patients, with over 3,000 women speaking out about adverse reactions to the implants on social media sites.

According to news reports, a majority of the women are experiencing side effects from an allergy to nickel, which is a component of the coils. Originally, doctors were advised to test women for nickel allergies before implanting the Essure coils, but the manufacturer asked the FDA to remove that requirement a few years ago.

Other women complain of extreme bloating, skin rashes and headaches. Photos posted include broken coils that had been removed and X-rays of coils that perforated the fallopian tubes.

Reporting is crucial

Despite the growing anecdotal evidence regarding alleged risks associated with Essure, the FDA can only respond to official reports of serious adverse events. Even if you have spoken to your physician, it does not guarantee a report has been filed. If you wish to file a report, you can complete the paperwork yourself or ask for assistance from a friend, family member, or healthcare professional.

Adverse Events

According to the FDA, an adverse event is “any undesirable experience associated with the use of a medical product in a patient.” If an event is serious, it should be reported to the FDA. Examples of serious adverse events include, but are not limited to, death, life-threatening effects, hospitalization, disability or permanent damage, birth defects, and other important medical events.

For more information about reporting adverse events or to file a report online, visit the FDA’s MedWatch website.

You can also download instructions with the Consumer-Friendly Voluntary Reporting Form (PDF – 1.2MB).

 

NOTE: This blog was originally posted in November of 2013 and has been updated to include new information.

 

Source:

“Bayer changes Essure patient booklet to include health warnings on its birth control” by Lauren Gilger and Maria Tomasch, ABC, November 12, 2013.

Dangers of Off-Label Drug Use

We recently reported on the possible dangers of the anti-nausea drug Zofran® and equivalent generics when they are used off-label. But what does “off label” really mean?

What is Off-Label Use of Medications?

As we explained in an earlier post, “When a drug is used in a way that is different from that described in the FDA-approved drug label, it’s said to be an ‘off-label’ use.” The FDA issues instructions and warnings based on clinical studies that drug makers submit to the FDA. If researchers have not tested a drug for a particular use, instructions, dosages and warnings do not appear on the insert or label.

Many drugs are prescribed for off-label use, but is it safe?FDA Does Not Regulate What Doctors Can Prescribe

The bottom line is this:  The FDA regulates drug approvals and thus the ability of the drug manufacturer to make a medication available for sale. It does not control how doctors actually prescribe drugs.  As a consequence, doctors can essentially do whatever they want with drugs, and one medical ethicist has said that off-label use is so common that almost every drug available today has been used off label for something.

Off-Label Use has Benefits, But…

This isn’t necessarily bad, say the experts. And in some cases, drugs that were first used off-label to treat a particular condition eventually receive FDA approval. Beta-blockers are one example of this.  First approved for treatment of high blood pressure, doctors now use some approved beta-blockers to treat patients with heart failure after having been used off-label for this purpose for many years. And using even unapproved beta-blockers now represents the standard of care for treatment of heart failure.

Despite success stories such as this one – and there are others – using drugs in unapproved ways is controversial. Medical ethicists remind physicians that off-label prescribing can expose patients to unnecessary risk.  It can also leave medical providers vulnerable to legal action when an unapproved drug causes injury, illness or death.

Research has showed that even doctors are often not aware that they are prescribing a drug unapproved for a particular use. Sadly, this puts the burden on patients to determine whether the medications they were prescribed received FDA approval for a particular use or not.

No Clear Research Results for One Drug Used Off-Label, the Anti-Nausea Drug Zofran®

In the case of Zofran (ondansetron), doctors learned about the off-label uses in pregnancy from other doctors, at conferences, and, in some instances, from sales reps who allegedly provided kickbacks. The drug, which was approved in 1991 for controlling nausea and vomiting in chemotherapy patients, has not been the subject of many studies for off-label use in pregnancy. The studies that do exist are somewhat contradictory, with some saying that there is no link between Zofran and birth defects in infants while others say that taking the drug during pregnancy can cause birth defects that include heart and kidney problems, cleft palate and other mouth defects, and musculoskeletal problems.

In 2012, GlaxoSmithKline pleaded guilty[1] to “unlawful promotion” and paying kickbacks to physicians to prescribe Zofran and other drugs. As part of a global resolution, GSK consented to pay $3 billion to settle a number of charges. However, in recently filed lawsuits, plaintiffs allege the pharmaceutical giant continued marketed and urged physicians to prescribe Zofran to pregnant women. Since the FDA cannot prevent doctors from prescribing the drug, many physicians still use it for nausea and vomiting in pregnancy.

Recently, there has been enough publicity about Zofran (ondansetron) that some parents whose babies were born with birth defects after taking Zofran have filed lawsuits against GlaxoSmithKline. More are expected.

 

Zofran® is a registered trademark of GlaxoSmithKline, PLC.

Do not stop taking medications except on your doctor’s advice.


 

[1] GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. U.S. Department of Justice, Office of Public Affairs. Washington: Press Release, July 2, 2012. (Civil Division, Consumer Protection, 12-842).

Zofran Lawsuits

Zofran® and its generic equivalents have been linked to birth defects and other problems when the medication is taken during pregnancy.  The manufacturer, GlaxoSmithKline, promoted the off-label use of the drug as a remedy for morning sickness in addition to its approved use as a drug for controlling nausea and vomiting after chemotherapy and surgery.

Zofran has been linked to birth defects and other problems when taken during pregnancy.

Two Recent Lawsuits Filed Alleging Birth Defects Caused by Zofran

At least two lawsuits were recently filed against GlaxoSmithKline because women who took the drug during pregnancy gave birth to children with heart problems.  One mother from Minnesota[1] charged that she had used Zofran during two pregnancies, and that both babies had been born with heart defects.

Another lawsuit, filed in Massachusetts[2], claimed that the baby was born with several heart abnormalities.  The baby in question has undergone more than a dozen surgeries, has developmental delays and has experienced other problems. The suit also charges that GlaxoSmithKline failed to warn the mother and doctor about the potential side effects and dangers of the drug.

Legal Issues in Zofran Lawsuits

The legal allegations and issues in these lawsuits include:

  • The manufacturer had a duty to ensure the safety of the drug and did not adequately determine its safety
  • The manufacturer did not warn the public about potential side effects and dangers
  • The manufacturer advertised and promoted Zofran as a treatment for the nausea and vomiting of morning sickness during pregnancy without the drug being approved for that use
  • The manufacturer incorrectly relied on animal studies even though the research actually showed the opposite
  • The manufacturer was selective in its evaluation of study results about the safety of Zofran
  • The drug was defective
  • The manufacturer falsely claimed that the drug was not dangerous to pregnant women

In addition to facing lawsuits about its negligence in developing, testing and marketing the drug, GlaxoSmithKline has been accused of bribing physicians to prescribe the drug for patients suffering from severe morning sickness.  This is not unusual for this drug company; according to an article published in the British Medical Journal[3], GlaxoSmithKline has paid out almost eight billion dollars in fines and penalties since 1991 for similar practices with other drugs.

In 2012, the pharmaceutical giant consented to pay $3 billion[4] to settle a number of charges, including that it wrongfully promoted the Zofran for unapproved uses. However, the plaintiffs allege it continued to be marketed and prescribed, despite the company’s agreement to settle.  It is very likely that many more Zofran lawsuits charging the company with negligently marketing the drug for off-label uses will emerge in the coming months and years.

 

Zofran® is a registered trademark of GlaxoSmithKline, LLC.

Do not stop taking medications except on your doctor’s advice.


 Sources:

[1] Flynn v. GlaxoSmithKline, LLC (2:15-cv-00709), United States District Court for the Eastern District of Pennsylvania, Filed: 02/12/2015

[2] LeClair v. GlaxoSmithKline LLC (1:15-cv-10429), United States District Court for the District of Massachusetts, Filed: 02/16/2015.

[3] Escalating criminal and civil violations: pharma has corporate integrity? Not really. BMJ 2013;347:f7507 doi: http://dx.doi.org/10.1136/bmj.f7507 (Published 18 December 2013)

[4] GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. U.S. Department of Justice, Office of Public Affairs. Washington: Press Release, July 2, 2012. (Civil Division, Consumer Protection, 12-842).

Zofran Linked to Birth Defects

The anti-nausea drug Zofran® has often been prescribed off-label to pregnant women suffering from serious morning sickness.  However, the evidence is growing that taking this drug may cause women to give birth to babies with a variety of birth defects.

Zofran was approved in 1991 by the Food and Drug Administration (FDA) for treating nausea and vomiting in cancer patients receiving chemotherapy and surgical patients with reactions to anesthesia. However physicians also prescribed it for severe nausea and vomiting during the first trimester of pregnancy.

Studies About the Safety of Zofran During Pregnancy

A recent article in the American Journal of Obstetrics and Gynecology[1] reported in drugwatch.com found that the babies of women who took Zofran faced a “two-fold increase” in the risk of heart problems in general and a 30 percent chance of suffering serious congenital heart malformations. The study, conducted in August 2013 among 900,000 Danish women, found that around one million pregnant women each year were exposed to Zofran (or the generic version ondansetron) worldwide.

The study also compared Zofran with other anti-nausea drugs and found that there were safer alternatives to the medication, such as doxylamine and pyridoxine. The conclusion: There is no reason to expose women to an unproven drug that carries such risks when there are safer alternatives.

Although early research was inconclusive, more recent studies indicate that there are significant risks to taking Zofran during pregnancy.  For example, a study published in 2013 in the New England Journal of Medicine[2] found that the drug posed no significant risks.  However, the majority of women in the study took the drug after 10 weeks, which is when the vulnerability of fetuses to drugs and other external substances lessens. The more recent Danish study[3], which studied women during the first trimester, when severe nausea and vomiting usually occur, found that 58 women out of the 1,248 who were prescribed the drug in the first trimester had babies with birth defects, a thirty percent increase over the control group.

Birth Defects Linked To Zofran

Babies whose mothers took the drug in the first three months of pregnancy have been born with a variety of birth defects, including:

  • Cleft Palate
  • Cleft Lip
  • Heart Defects (Cardiac Murmurs and Arrhythmia)
  • Limb Defects (Musculoskeletal abnormalities)
  • Kidney Defects
  • Lawsuit Against Zofran’s Manufacturer

The U.S. Department of Justice brought a lawsuit against the manufacturer of Zofran, GlaxoSmithKline for “unlawful promotion” and failure to include research data in safety reports on the drugs it manufactured and sold. The company pleaded guilty in 2012 to illegally advertising the drug as a morning sickness pill and agreed to pay $3 billion to settle the suit.

At least two individual lawsuits have been filed against GlaxoSmithKline, one in Minnesota and another in Massachusetts. Moreover, the manufacturer has been accused of illegal doctors to prescribe Zofran off-label, something that the company is known for doing.

 

Zofran® is a registered trademark of GlaxoSmithKline, PLC.

Do not stop taking medications except on your doctor’s advice.


 

[1] Koren, Gideon, “Treating morning sickness in the United States—changes in prescribing are needed,”  American Journal of Obstetrics and Gynecology, vol. 21, issue 6, December 2014, pp. 602-606.

[2] Pasternak, Bjorn, et. al., “Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes,” New England Journal of Medicine, vol. 368, February 28, 2013, pp. 814-823.

[3] Andersen JT, Jimenez-Solem E, Andersen NL, Poulsen HE. Ondansetron use in early pregnancy and the risk of congenital malformations—a registry based nationwide cohort study. Abstract presented at: 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25–28, 2013; Montreal, Canada. Abstract 25, Pregnancy Session 1. Pharmacoepidemiol Drug Saf. 2013;22(suppl 1):13–14.

 

Side Effects of Anti-Nausea Drug Zofran

The drug Zofran® , also known as Ondansetron, is approved by the Food and Drug Administration to treat nausea and vomiting resulting from chemotherapy treatment for cancer and after being administered anesthetic during surgery. The medication works by blocking serotonin, a natural substance in the human body, which can cause vomiting, It is manufactured by pharmaceutical giant GlaxoSmithKline and is also available as a generic. The medication comes both in pill form, as a liquid and as an injection.

When the FDA approved the drug for generic manufacture in 2006, Zofran was the 20th most frequently sold prescription medication in the United States, according to the Food and Drug Administration (FDA) website. In 2005, sales of the medication totalled $839,256,543.

Common Side Effects of Zofran

Zofran has side effects, including the following:

  • Diarrhea
  • Headache
  • Fever
  • Dizziness
  • Sleepiness
  • Constipation
  • Rash
  • Blurred vision
  • Muscle spasms
  • Accelerated heartbeat
  • Rash
  • Weakness

Severe Side Effects of Zofran

The common side effects above are not usually life- threatening.  However, Zofran has also been shown to have more serious consequences that include:

  • Abnormal heart electrical signals
  • Abnormal liver function tests
  • Abnormally low blood pressure
  • Acute liver failure
  • Bronchospasm
  • Decreased oxygen in the tissues or blood
  • Extrapyramidal reaction
  • Fast heartbeat
  • Giant hives
  • Life-threatening allergic reaction
  • Prolonged q-t interval on ekg
  • Shock
  • Slow heartbeat
  • Stevens-Johnson syndrome
  • Temporary blindness
  • Toxic epidermal necrolysis
  • Trouble breathing
  • Very rapid heartbeat – Torsades de pointes
  • Vocal cord swelling

Drug Interactions With Zofran

In addition to causing sometimes-severe side effects, Zofran is known to have negative interactions with other prescription drugs and common supplements.  These include medications for

  • Breathing problems
  • Cancer
  • Chest pain
  • Depression or other mental or mood problems
  • Fluid retention
  • High blood pressure
  • Immune system suppression
  • Infections
  • Irregular heartbeat
  • Nausea or vomiting
  • Pain
  • Sleep problems
  • Stomach or bowel problems
  • Swelling
  • Tourette syndrome

In addition to being used for nausea and vomiting after chemotherapy, radiation treatments or surgery, Zofran is also used off-label to treat severe morning sickness in pregnant women.  This use of the drug has been controversial, and we will discuss issues related to off-label use in future blog posts.

 

Zofran® is a registered trademark of GlaxoSmithKline, PLC.

Do not stop taking medications except on your doctor’s advice.

 

Acne Treatments Can Cause Dangerous Side Effects

The U.S. Food and Drug Administration (FDA) issued a warning that some products used to treat acne may cause potentially life-threatening side effects. According to an agency press release, over-the-counter acne products containing the active ingredients benzoyl peroxide or salicylic acid can cause severe irritation or even fatal allergic reactions.

FDA warns acne products may cause severe allergic reactions.
Acne treatments such as Proactive may cause severe irritation or fatal allergic reactions.
(Photo credit: Yuki Matsukura – Flickr)

The FDA warning names popular topical acne medications such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear. Available without a prescription, these treatments are available as gels, lotions, facial washes, solutions, cleansing pads, toners and face scrubs.

Serious allergic reactions differ from the less harmful irritations included in acne treatment warnings, which include burning, dryness, itching, peeling, redness, and slight swelling where the product is applied.

“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says FDA medical officer Dr. Mona Khurana. “It’s important that consumers know about them, and that they know what to do if they occur.”

Use Acne Products Safely

While severe reactions are rare, there are important steps you can take to protect yourself. For example, if you have never used a topical acne treatment before, the FDA recommends applying a small amount of the product to a small affected area for three days. If no discomfort occurs, then follow label directions for normal use. Other safety measures include the following:

  • Avoid using the product if you’ve had previous allergic or hypersensitivity reactions
  • Stop using the product if you develop hives or itching of the face or body
  • Discontinue use and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue; feel faint; or have difficulty breathing

Although no deaths have been reported, nearly half of the 131 known cases of allergic and hypersensitivity required hospitalization, with the majority since 2012. Approximately 86 percent of the patients were female, and the average patient age was 32 years. Based on the information reported, the FDA cannot determine if these reactions were triggered by the products’ active ingredients, the inactive ingredients, or a combination of both.

“FDA will continue to monitor closely and evaluate this safety issue,” Khurana says. The FDA encourages consumers to report any negative reactions or side effects from use of these products to the FDA’s MedWatch program.

 

Source:FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products.” U.S. Food and Drug Administration, Safety Announcement, June 25, 2014.

Fibroid Treatment May Spread Hidden Cancer

The FDA has issued a warning that certain surgical procedures used to treat uterine fibroids can cause the spread of undetected cancer.

What are Fibroids?

A uterine fibroid is a tumor that grows in the wall of the uterus. While many women who develop fibroids experience no symptoms, those who do may require surgery to remove them. Fibroids can grow as a single tumor or in clusters and are usually not cancerous. However, according to the FDA, as many as 1 in 350 women who undergo myomectomy (removal of uterine fibroids) or hysterectomy (removal of the uterus) for symptomatic fibroids has an undiagnosed type of cancer called uterine sarcoma.

Uterine Power Morcellation in Hysterectomy and Myomectomy

If fibroid removal is necessary, many women opt for a minimally invasive or robotic procedure such as a laparoscopic hysterectomy or myomectomy, in which the surgeon accesses and removes the fibroids or the uterus through several small abdominal incisions. To remove the tissue, the surgeon may use a power tool, to chop up, or morcellate, the fibroids and/or uterus.

Cancer Seeding

If power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue to other parts of the abdomen and pelvis. This “cancer seeding,” or spread of cancer cells, puts women at risk for cancer in other organs.

Since there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids. The agency is considering requiring a “black box warning” – the strongest warning it can mandate – for laparoscopic power morcellators.

The New York Times reports:

Sarcomas are a particular concern, because they are aggressive and almost never detectable with imaging or other tests before surgery. The diagnosis is usually made only after surgery, when the tissue is biopsied. By then, if a morcellator was used, it is too late to prevent the spread of the cancer, and the woman’s chances of long-term survival are significantly worsened, the agency said.

Morcellator Cancer Lawsuits

A growing number of lawsuits have been filed against the manufacturers of power morcellators, including Ethicon Inc., Blue Endo, Lina Medical, and others. Plaintiffs in these lawsuits claim that they were never warned that morcellation has the potential to “seed” undiagnosed uterine sarcoma (leiomyosarcoma), leading to the spread of the cancer.

FDA Recommendations

For women with fibroids and other gynecological health problems that may require surgery, it’s important to talk to your doctor. The FDA has released the following recommendations:

  • Ask your health care provider to discuss all the options available to treat your condition and discuss the risks and benefits of each.
  • If laparoscopic hysterectomy or myomectomy is recommended, ask your health care provider if power morcellation will be performed during your procedure, and to explain why he or she believes it is the best treatment option for you.
  • If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care provider.

UPDATE:

7/24/14 – According to The Washington Post, “A study by doctors at Columbia University, published Tuesday in the Journal of the American Medical Association, found that nearly 1 in 370 women who undergoes a hysterectomy using a surgical device called a power morcellator is found to have previously undetected uterine cancers.”

Sources:

“Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy” FDA Safety Communication, Issued April 17, 2014.

F.D.A. Discourages Procedure in Uterine Surgery” by Denise Grady, The New York Times, April 17, 2014.

Research supports FDA warning about a medical device that could spread cancer” by Caelainn Hogan, The Washington Post, July 22, 2014.

Dangerous Diet Pills

The FDA has issued a warning that some over-the-counter weight loss pills, being sold as dietary supplements, are actually dangerous, unapproved and misbranded drugs. 

Pure Edge Nutrition recently announced that it is recalling several of its products, after it was discovered the supplements contained undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein. Sibutramine, a previously approved controlled substance, was removed from the US market in October 2010 for safety reasons. Phenolphthalein is used medicinally as a laxative and not approved for marketing in the United States.

Products containing sibutramine and phenolphthalein pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke.

These products may also interact in life threatening ways with other medications a consumer may be taking.

Click here to read the complete recall.

Different Regulations for Dietary Supplements

dietary supplements

Although dietary supplement manufacturers must register their facilities with FDA, the dietary supplements themselves are not subject to premarket testing or FDA approval. Additionally, manufacturers are not required to provide the FDA with any evidence that a supplement is safe or even effective.

According to agency’s website, this is because the FDA regulates dietary supplements under a different set of regulations than conventional drug products:

  • Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of federal regulations.
  • The FDA is only responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market. 

Misbranded – A dietary supplement is misbranded if its labeling is false or contains misleading information regarding nutrition and health claims, ingredients and quantities.

Adulterated – According to the Dietary Supplement Health Education Act (DSHEA) of 1994, adulteration of a dietary supplement occurs when it does any of the following:

  • Presents a significant or unreasonable risk of illness or injury when used in accordance with the suggested labeling or, if unlabeled, under ordinary conditions of use
  • Is a new entity and lacks adequate evidence or information to ensure its safety of use
  • Has been declared an imminent hazard by the Secretary of the Department of Health and Human Services
  • Contains a dietary ingredient that is present in sufficient quantity to render the product poisonous or deleterious to human health 

Before taking any dietary supplements, including diet pills, herbs, vitamins or minerals, you should speak to a qualified health care provider. He or she can help best determine the benefits and risks.

 

Source:Bella Vi, Super Fat Burner contain dangerous drugs: Tainted dietary supplements” by Brie Zeitner, The Plain Dealer, March 27, 2014.

Bed Rails in Nursing Homes: What you need to know

A 94-year-old woman died last weekend when her head became stuck between her mattress and a bed rail at a Pennsylvania nursing home. The county coroner ruled the cause of death as “accidental asphyxiation due to compression.” Sadly, this tragic event could have been prevented.

Experts have known about bed rail dangers for nearly two decades

Dr. Steve Miles, a bioethicist and medical professor at the University of Minnesota, first made federal regulators aware of bed rail-related deaths in 1995. Since that time, over 500 patients have died due to bed rails, with 155 deaths occurring from 2003-2012.

Despite repeated efforts by consumer groups to increase regulations, such as requiring warning labels, the FDA decided against it due to resistance from manufacturers. In 2006, the FDA issued voluntary guidelines for hospitals and nursing homes that included recommended size limits for openings and identified common entrapment risks.

While regulatory challenges remain, the FDA has a new website on bed rail safety that offers information for consumers, caregivers, health care providers and manufacturers.

Identify Risks

High-risk people include those with pre-existing conditions such as confusion, restlessness, lack of muscle control, or a combination of these factors. Additionally, people who are cognitively impaired from the use of

medication or from a medical condition, such as Alzheimer’s or dementia, are at a higher risk of entrapment and injuries, including:

  • Strangling, suffocating, bodily injury or death when patients or part of their body are caught between rails or between the bed rails and mattress
  • More serious injuries from falls when patients climb over rails
  • Skin bruising, cuts, and scrapes
  • Inducing agitated behavior when bed rails are used as a restraint
  • Feeling isolated or unnecessarily restricted.
  • Preventing patients, who are able to get out of bed, from performing routine activities such as going to the bathroom or retrieving something from a closet

If your loved one is in a nursing home or other long-term health care facility, talk to their health care planning team to find out which options are best for them, remembering to reassess their needs on a regular basis.

 

Sources:

Greene nursing home resident dies in bed mishap.” By Tom Fantaine, Pittsburgh Tribune-Review, February 25, 2014.

After Dozens of Deaths, Inquiry Into Bed Rails.” By Ron Nixon, The New York Times, November 25, 2012.