Personal Injury Lawyer Blog
Anti-Psychotics Overprescribed to Kids - Friday, November 21, 2008
Over 389,000 children and teenagers were prescribed an atypical antipsychotic called Risperdal last year. More than 240,000 of these were under 12-years-old. The problem, according to a panel of federal drug experts that met Tuesday, is that many of the patients were given the drug to treat attention deficit disorders. Risperdal is not approved to treat ADD. The risks of Risperdal, which can be permanent, include weight gain, muscular tics, and metabolic disorders. Panel members say these risks are "too profound to justify its use" in treating ADD.
The panel was to meet to review the pediatric safety of Risperdal and Zyprexa, two atypical antipsychotics made by Johnson & Johnson and Eli Lilly & Company respectively. Officials from the FDA were hoping the committee would endorse the agency's routine monitoring of the safety of the medications, as well as support previous efforts to highlight the risks. However, the panel unanimously rejected proposals put forth by the FDA. The panel says more needs to be done to discourage the growing use of these medications in children, especially to treat conditions the drugs are not meant for. Agency officials and spokespeople from the manufacturers said strongly worded warnings were already placed on the labels. Other drugs the panel is concerned about include Seroquel, Abilify and Geodon.
According to a report in the New York Times, prescription rates for these drugs has dramatically increased in the last 15 years, and they are now used by doctors to control aggression and outbursts in children by diagnosing them with a variety of issues. Children are particularly susceptible to the side effects of these antipsychotics.
One of the most popular diagnoses is pediatric bipolar disorder. A leading proponent of this diagnosis is Harvard University child psychiatrist Dr. Joseph Biederman. Biederman's work recently came under scrutiny after a Congressional investigation showed he had not reported nearly $1.4 million to the university he received as outside income from the makers of antipsychotics.
Psychiatrists have written a majority of the prescriptions for Risperdal, and these prescriptions given to children 17 years and under have increased ten percent in the last year. Over 1,200 children have suffered serious problems related to Risperdal since 1993, and 31 have died. This includes a nine-year-old who suffered a stroke almost two weeks after Risperdal treatment started for ADD. Eleven of those deaths were children whose treatment by Risperdal was not approved by the FDA.
Doctors from the FDA claim the agency can't do much to fix the problem of off-label usage, and say medical specialy societies should be doing a better job at educating doctors about the side effects.
Window Blind Recall - Thursday, November 20, 2008
The U.S. Consumer Product Safety Commission announced that Insulated Black-out Roller Shades and Insulated Roman Shades made by Green Mountain Vista are being recalled due to the strangulation hazard they pose to children. This voluntary recall concerns over 7,000 units that have already been sold.
The shades have a looped bead chain that hangs loose when it is not attached to the wall or floor. The recall comes after the news that a two-year-old girl from Connecticut nearly died in June when she placed the looped cord around her neck, and then slipped off a radiator. She was saved by her older brother, but suffered a deep neck bruise and vomiting.
The recall includes all insulated black-out roller shades and Roman shades with sizes 48, 60, and 72. The shades have RN number 107875. This number can be located on the care label. There were sold nationwide from June 2005 to September 2008 at Country Curtains, Plow & Hearth, The Linen Source, Sturbridge Yankee Workshop, Ann & Hope, The Sportsman's Guide, Target.com, The Curtain Shop of Maine, and Solutions Catalog.
Consumers who may have purchased these blinds are advised to check their windows to make sure the tension device is attached. If it is not attached, they should contact Green Mountain Vista Inc. to receive a repair kit free of charge. Those unable to install the tensioning device should contact Green Mountain Vista for further instructions.
If you or a loved one has been injured by a defective product, please contact Personal Injury.com to find an experienced injury lawyer in your area.
FDA Scientists Call Out Agency Officials for Misconduct - Wednesday, November 19, 2008
In a letter to Congress dated October 14th, eight scientists with the Food and Drug Administration say federal health officials ignored their and other scientists concerns by approving unsafe or ineffective medical devices for sale. They say this move is cause for "serious misconduct."
The House Committee on Energy and Commerce, headed by Representative John D. Dingell, is investigating the accusations and promises they will uncover whether activity at the top of the FDA's management "has compromised the health and safety of American consumers."
Agency managers are more likely to want to approve drugs or devices, while scientists want to be more certain of the trials and tend to call for further testing before the drugs and devices are put on the market. And usually these internal conflicts are done in private. However, the scientists state in their letter that agency managers ordered experts to change their opinions and conclusions. This "corrupted the scientific review of medical devices."
Some of the devices in question include cardiac stents, imaging equipment, breast implants, and nerve stimulators that relieve depression.
FDA assistant commissioner for integrity and accountability, William McConagha, believes the evidence is compelling and is pushing for the removal of some of the agency's managers. Of course, agency managers who have done an investigation of their own have refused to take any action. The letter to Congress states that scientists who raised questions were instead targeted for reprisals by their managers.
Pain Pump Tied to Degenerative Shoulder Condition - Monday, November 17, 2008
Intra-articular pain pumps, implanted during shoulder surgery to release pain medication directly into the joint, have been used by doctors on thousands of shoulder surgery patients. However, a recent study released by the American Journal of Sports Medicine says these pain pumps are likely tied to a condition known as Postarthroscopic Glenohumeral Chrondrolysis (PAGCL). This condition is associated with consistent shoulder pain, constant need for medication, and inevitable shoulder joint replacement surgery.
The medical study looked at 152 anthroscopic shoulder surgery patients, and found that 12 of them developed PAGCL. All twelve of these patients had received pain pumps during their surgery. It was noted that this was the only thing the 12 had in common, and that, while this analysis is not conclusive, it raises the need for more studies in this particular surgery and corresponding side-effect.
Symptoms of PAGCL include:
- Shoulder pain even when shoulder is in resting position
- Increased stiffness
- Grinding and popping when shoulder is in motion
- Loss of strength at the joint
- Decreased range of motion
PAGCL can be diagnosed with an x-ray, which will show the joint space of the shoulder narrowing. This is due to the cartilage thinning and the bones grinding together. Pain can be extreme and be accompanied by chronic and severe arthritis.
Shoulder surgery may not always help to completely reduce pain. Patients may in fact end up with more pain than they had before the shoulder surgery.
Litigation concerning this defective medical device has already begun.
Speak to your physician prior to your shoulder surgery to find out more information about pain pumps and if one will be used in your surgery. Notify your doctor if you are experiencing any of the symptoms associated with PAGCL.
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