Posts Tagged ‘Overdose’

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New Warnings on Propoxyphene Overdoses (Sept. 2009)

Friday, September 4th, 2009

Video originally created by FDA -- posted by Lawsuit.com on September 3, 2009

FDA is taking action to reduce the risk of fatal overdoses in patients taking the pain medication propoxyphene, an ingredient in drugs such as Darvon and Darvocet. Some European studies have indicated that propoxyphene may be more lethal than other pain medications when taken in higher-than-recommended doses. Because of these concerns, FDA is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, to emphasize the danger of overdosing. Manufacturers will also be required to develop a Medication Guide to be given to patients with each prescription, that stresses the importance of using the drugs only as directed.

Based on the available evidence, FDA believes that the benefits of using propoxyphene for pain relief outweigh the risks when it is taken at recommended doses. But FDA also recognizes that more safety information is needed about propoxyphene’s effects at higher doses, especially on the heart. And so the manufacturer will be required to conduct a safety study to provide more information on this potential risk. FDA will also work with other Federal agencies to explore additional sources of data for comparing propoxyphene’s safety with other pain medications.

In the meantime, physicians and patients need to be aware of the possible danger involved if propoxyphene is taken at doses higher than those in the labeling.

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Dont Overdo It with Acetaminophen (June 2009)

Tuesday, August 11th, 2009

Video originally created by FDA -- posted by Lawsuit.com on June 9th, 2009

If you woke up with a headache this morning, you may have reached for an over-the-counter pain reliever. Millions of people do that everyday, and there’s usually no problem. Over-the-counter pain relievers are effective for treating minor aches and pains. But they’re only safe if you follow the directions.

That’s particularly important with acetaminophen, an active ingredient in many over-the-counter and prescription medicines that are used to relieve pain or reduce a fever. Acetaminophen is generally safe at recommended doses, but if you take more than that, even just a little more, it can cause serious, even fatal liver damage. In fact, acetaminophen poisoning is a leading cause of liver failure in this country.

You don’t have to look very far to find acetaminophen. It’s sold under a number of brand names, such as Tylenol, and it’s often included with other ingredients in over-the-counter cough and cold medicines, as well as sleep aids. Acetaminophen is also found in prescription medicines, such as Vicodin and Percocet, but that may not be clear from the label.

If you take several medicines that all contain acetaminophen, you might take more than the recommended dose without realizing it.

To avoid taking too much acetaminophen, it’s important to know if your medicine contains it. If you’re taking an over-the-counter medicine, look for the name acetaminophen on the Drug Facts label under the section called “Active Ingredients.” If you’re taking a prescription medicine and you don’t know the active ingredients, ask your doctor, nurse or pharmacist.

Then follow all the directions on the Drug Facts label or prescription label. For safety’s sake, don’t take more than one medicine at a time that contains acetaminophen. And don’t take more than the maximum amount, even if your pain or fever isn’t getting better. Be sure you know how many hours you need to wait before taking another dose.

If you have 3 or more alcoholic drinks per day or have liver disease, this could increase your risk of liver damage, so talk to your doctor before taking medicines that contain acetaminophen.

Finally, when giving acetaminophen to children, make sure to use the right formulation for your child’s age and weight. Use that formulation in the right amount and at the right time. To avoid error, use the measuring tool that comes with the medicine and keep a record of the times and doses you give your child. Share that record with your child’s caregivers, so they’ll know how much medicine your child has had.

If you take acetaminophen, please be careful. Read the label and follow the directions.

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Campaign on Using Methadone Safely (June 2009)

Monday, August 10th, 2009

Video originally created by FDA -- posted by Lawsuit.com on June 9th, 2009

FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) have launched a campaign to increase awareness about the risks associated with using methadone and how to minimize them. Methadone has long been used to treat drug addiction, but it is now also being used to treat moderate to severe pain in patients who don’t respond to non-narcotic pain medications. Healthcare professionals and patients need to understand the power and potential dangers of methadone in order to reduce the risk and get the maximum benefit from the drug.

Healthcare providers should make sure patients understand that methadone remains in the body even after the pain relief wears off, so taking an additional dose to relieve pain while the earlier dose is still in the body could lead to an unintentional overdose. Also, methadone interacts with many other drugs and supplements. These interactions could decrease a patient’s pain relief, or cause a toxic buildup of methadone in the body. That could lead to dangerous changes in breathing or heart beat that could be fatal.

Here are some of the things patients should do if they take methadone:

• Share your complete medical history with your healthcare provider, especially if you are using methadone for the first time.

• Take methadone exactly as prescribed and be sure to follow all your doctor’s directions.

• Never take more methadone than the amount prescribed, at the times prescribed. If you miss a dose or feel it is not working, do not take more. Instead, call your doctor.

• Do not consume alcohol and be careful driving or operating machinery.

• Never give methadone to anyone else, and take steps to keep children from accidently taking it.

• Stop taking methadone and call your doctor or 911 if you have trouble breathing; feel dizzy, lightheaded or faint; have chest pain or a fast or pounding heartbeat; are confused or have hallucinations; or develop hives or a rash, or have swelling in the face, lips, tongue or throat.

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Warning on Accidental Ingestion of Benadryl Topical Gel (July 2009)

Thursday, July 30th, 2009

Video originally created by FDA -- posted by Lawsuit.com on July 8th, 2009

FDA and the Institute for Safe Medication Practices (ISMP) recently reported on several cases where people swallowed Benadryl Itch Stopping Gel, an OTC product that’s supposed to be used topically. This has led to serious adverse reactions requiring hospitalization or emergency treatment.

Benadryl Gel contains the antihistamine diphenhydramine as well as camphor, which is toxic and potentially fatal if ingested. Camphor can cause a variety of symptoms, such as burning of the mouth and throat, nausea and vomiting, irritability, confusion, seizures, coma, and respiratory difficulties. It is not clear whether the adverse reactions experienced by the people who ingested Benadryl Gel were due to the camphor or to an overdose of Benadryl, since the symptoms can be similar.

FDA and ISMP suggest that the way the product is packaged may contribute to these errors. Instead of being packaged in a tube, like many topical products, the Benadryl Gel is available in a 4 ounce bottle. That means it can be mistaken as an oral liquid, particularly since the bottle has the same shape and size as other oral liquid products. And although the Benadryl brand now includes many combination products, most are intended for oral or parenteral use. ISMP also points out that although the words “external use” appear on the back of the bottle, the front of the bottle says “Topical Analgesic” in small letters that consumers could miss or not understand.

Here are some ways that pharmacists can help consumers avoid confusion:

• Keep topical products separated from the ones intended for ingestion.

• Advise consumers to keep topical and oral products separated when they store OTC products and prescription medicines at home.

• Remind consumers to read the drug facts label before using OTC products.

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Help Patients Use Acetaminophen Safely (June 2009)

Wednesday, June 10th, 2009

Video originally created by FDA -- posted by Lawsuit.com on June 9th, 2009

Acetaminophen toxicity is a leading cause of acute liver failure, resulting in an estimated 400 deaths in the U.S. annually.  Many of these events are happening because patients are unknowingly taking too much of the drug.

Taking too much acetaminophen can easily occur because acetaminophen is widely found in a variety of both OTC and prescription drug products, including: up to 600 analgesics, antipyretics, cough/cold remedies and sleep aids.

Unintentional acetaminophen overdose may occur for several reasons, including:

  • people may not be aware that they are in danger of liver damage if they exceed the maximum recommended dose
  • alcohol exacerbates the risk of liver damage in acetaminophen users.
  • people may not realize how much acetaminophen they are consuming if they take more than one product containing acetaminophen.
  • peoplemay not look at over the counter drug labels to notice acetaminophenin the drug.

Pharmacists Findings Cause for Alarm

One study, published in the Journal of the American Pharmacists Association in 2007, surveyed 104 adult patients presenting to an internal medicine clinic. The findings were remarkable, including:

  • 79% reported using a product that contained acetaminophen within the previous six months, but only 43% could identify problems that could arise from high doses of acetaminophen. 71% of patients recognized that Tylenol contains acetaminophen.
  • less than 15% knew that Vicodin (hydrocodone/ acetaminophen), Darvocet (propoxyphene napsylate/) and Percocet (oxycodone/acetaminophen) contain acetaminophen.

Children are also at risk of acetaminophen overdose if they are given the adult formulation or the wrong pediatric formulation, if the dose is not calculated correctly for the child’s weight, or if the wrong dosing device is used.

FDA is encouraging health care providers to educate patients and caregivers about how to use pain medicines safely in the following ways.

  • Instruct about the correct dosing frequency for products that contain acetaminophen,
  • Be certain it is understood that having three or more alcoholic drinks per day can raise the risk of acetaminophen toxicity.
  • Warn  about taking multiple products containing the same active ingredient.
  • Instruct parents on the correct weight-based dose for their child and remind them to use the proper measuring device for liquid formulations.

Acetaminophen is a safe and effective analgesic and antipyretic when it is used properly. But careless or uninformed use can lead to serious liver damage and death. Healthcare providers can play an important role in protecting their patients from acetaminophen toxicity.

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