Main

FDA Video Series Covers Recalls and Safety Alerts for Prescription Drugs and Medical Devices

Apr 14, 2008 12:01:00 AM

The FDA's Patient Safety News (PSN) is a series of monthly video news shows addressing significant approvals, recalls, and safety alerts for prescription drugs and medical devices. Some of the videos contain footage and demonstrations relevant to protecting patients from serious side effects and other unwanted consequences from taking or using these products.

For example, consumers may want to watch the video concerning the recent FDA warning against giving cough and cold medicines to young children.

Click here for access to the full list of currently available videos (note: the videos are primarily targeted at doctors and other healthcare professionals and thus may be somewhat technical in nature).

Nursing Home Negligence & Elder Abuse

Jan 24, 2008 11:27:15 AM

When you are faced with having to place a loved one in the care of a nursing home, you expect that their needs will be met and that they will be in a safe environment. Unfortunately, nursing home negligence and outright abuse in this area are more common than we would like to think.

Despite many Federal and State regulations, which have been established to protect our loved ones in these settings, a gross number of violations continue to occur every single day, tragically compromising the health, dignity and safety of our elders and the disabled.  As a society, we must not forget that individuals entering nursing homes are the most vulnerable members of our society.

Nursing home negligence and elder abuse can manifest itself in a variety of ways.  While physical and sexual abuse is the one of the most common, some other examples are:

• Use of restraints without proper medical orders
• Deprivation of food or water
• Medication Errors: Over or under-dosing of medication
• Unexplained injuries or failing to report and injury
• Forcing a patient to stay in a room or placing in a secluded area
• Failure to assist with Activities of Daily Living (e.g. dressing, personal hygiene, and eating)
• Unsanitary and unclean conditions
• Stealing a patient's money and/or possessions
• Fraud, forgery, and extortion
• Wrongful use of Power of Attorney, Trusteeship, or Guardianship

Department of Human Services fields thousands of nursing home negligence and elder abuse complaints every year.  However,   investigations into these complaints can be difficult because dementia or other conditions can make residents poor witnesses.

If you must place a loved one into a nursing home, do your homework.  Research the facility.  Take a tour of the home, meet the staff, find out about their licensing and staff certification. 
You should also ask about staff training programs, particularly any on elder abuse, patient safety, and dealing effectively with difficult residents.   Request copies of the latest inspection report, which is required of a facility certified to take Medicare and Medicaid.

Once you place someone into a nursing home, watch for warning signs of abuse.  Common signs that they are suffering from nursing home negligence or elder abuse might be: sudden agitation or emotional withdrawl, unexplained bruises or other injuries and/or rapid weight loss.

The Nursing Home Negligence lawyers at D'Amore & Associates in Oregon and Washington are experienced in all types of nursing home negligence and elder abuse claims.

FDA Advises That Cold Medicines Too Risky For Children Under 2

Jan 21, 2008 9:41:00 AM

Last Thursday, the FDA issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. The side effects reported include death, convulsions, rapid heart rates, and decreased levels of consciousness.

OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds. The FDA's study of side effects of these medicines in children ages 2-11 is continuing.

Read the full FDA release here.

Drug Manufacturers Pull Infant Cold Medicines Off Market Including Pediacare, Dimetapp, and Tylenol Infant Drops

Oct 11, 2007 1:14:25 PM

We previously wrote about the FDA's warning to parents concerning giving cough or cold medicines to children under the age of 2.

Today, drug manufacturers announced that they were voluntarily pulling infant cold medicines off the market following a tentative recommendation late last month by the FDA that the words "do not use in children under two years" should be added to the products' labeling. Reviewing reports of side effects from these medicines, the FDA had found 54 child fatalities from over-the-counter decongestant medicines, and 69 reports of children's deaths connected with antihistamines (frequently used to treat runny noses).

Cold medicines being withdrawn include: Johnson & Johnson's Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic Infant & Toddler Thin Strips and Prestige Brands Holdings' Little Colds Decongestant Plus Cough. The medicines come in tiny, droplet-size doses, but parents occassionally do not consult or follow directions from physicians, which can lead to accidental overdose.

Read more about the announcement here.

FDA Warns Parents: Do Not Give Cough or Cold Medicines to Children Under the Age of 2 Unless Directed by a Physician

Aug 24, 2007 2:43:13 AM

On August 15, 2007, the FDA issued a public health advisory providing the following guidance to parents concerning the use of cough and cold medicines by children (especially those under the age of 2):

  • Do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider.
  • Do not give children medicine that is packaged and made for adults.  Use only products marked for use in babies, infants or children (sometimes called “pediatric” use).
  • Cough and cold medicines come in many different strengths.  If you are unsure about the right product for your child, ask a healthcare provider.
  • If other medicines (over-the-counter or prescription) are being given to a child, the child’s healthcare provider should review and approve their combined use.
  • Read all of the information in the “Drug Facts” box on the package label so that you know the active ingredients and the warnings.
  • Follow the directions in the “Drug Facts” box.  Do not give a child medicine more often or in greater amounts than is stated on the package.
  • Too much medicine may lead to serious and life-threatening side effects, particularly in children aged 2 years and younger.
  • For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with each different medicine formulation and that is marked to deliver the recommended dose.  A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children.
  • If a measuring device is not included with the product, parents should purchase one at the pharmacy.  Make sure that the dropper, dosing cup or dosing spoon has markings on it that match the dosing that is in the directions in the “Drug Facts” box on the package label, or is recommended by the child’s health care provider.
  • If you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing device (dropper, dosing cup or dosing spoon), DO NOT USE the medicine.  Consult your healthcare provider if you have questions or are confused.
  • Cough and cold medicines only treat the symptoms of the common cold such as runny nose, congestion, fever, aches, and irritability.  They do not cure the common cold.  Children get better with time.
  • If a child’s condition worsens or does not improve, stop using the product and immediately take the child to a health care provider for evaluation.   

If you believe your child was injured as a result of using a cough or cold medicine, contact the medication error lawyers at D'Amore & Associates in Oregon and Washington to determine your rights.

Wal-Mart Settles Drug Death Claim

Jul 16, 2007 10:42:00 AM

It was reported last week that Wal-Mart Stores Inc. settled a wrongful death lawsuit claiming a pharmacist at one of its stores sold a too-strong insulin drug to a diabetic man who died after taking it.

Terms of the settlement reached during a mediation session Wednesday in Baltimore are confidential, attorney Christopher R. Dunn said. He said the case was settled amicably, with no admission of liability or fault by anyone. John Simley, a spokesman for Bentonville, Ark.-based Wal-Mart, said: "This was the best way to resolve the matter."

If you or a loved one was injured due to a medication or prescription error, contact the prescription medication error lawyers at D’Amore & Associates for a FREE CONSULTATION.