Galveston Bay Personal Injury Lawyer - FDA & Prescription Drugs - Most Commented

Actos and Avandia(2)

Ashley Davis — Thu, 28 May 2009 18:13:44 GMT

The FDA has recently announced that there will now be a “Black Box” warning on the Type 2 diabetes medications Actos and Avandia due to their connection to increased risks of heart attacks and heart-related deaths. If you have taken or been prescribed Avandia or Actos, you may be at risk.

Type 2 diabetes is a very serious and potentially life threatening disease which affects about 18-20 million Ameicans. It is also the leading cause of coronary heart disease, blindness, kidney failure and limb amputation.

The increased warning advises health care professionals to be more cautious in checking for signs of heart failure in their type 2 patients who have taken Avandia or Actos. Negative side effects associated with these drugs are:

Excessive, rapid weight gain
Shortness of breath
Swelling of the extremeties or organs

If you or someone you know has taken Avandia or Actos and are experiencing any of these symptoms, then contact your physician immediately and be aware of the risks.

Originally posted at InjuryBoard by Ashley Davis

Lawsuits Filed Over Digitek Recalls

Scott Kappes — Fri, 09 May 2008 17:28:33 GMT

Two weeks after Actavis issued a recall for its heart medication Digitek, or digoxin, the first lawsuits have been filed. Very little information has been made available on this recall other than that some tablets may be twice as thick and therefore contain twice the active ingredient as intended. It is unclear how many batches may be affected or which particular batches are affected.

In announcing the recall, Actavis said the double-strength tablets pose a risk of toxicity in patients with renal failure. The right amount of digoxin can strengthen a weak heart and calm fluttering heartbeats. Too much digoxin can make you nauseous, depress your blood pressure, slow down your heart rate or kill you.

Several reports of injury and illness have been reported in association with the recall. Plaintiffs are seeking damages over alleged injuries as well as compensation for monitoring for possible future health problems.

Originally posted at InjuryBoard by Scott Kappes

Judge Dismisses Case Due to Chantix Induced Psychotic Episode

Scott Kappes — Thu, 27 Mar 2008 23:35:20 GMT

A federal judge has dismissed the case of a 25 year-old California man who charged the cockpit of a plane on Thanksgiving forcing an emergency landing in Fargo, North Dakota. Prosecutors asked for the interfering with an airplane flight crew charge to be dropped against Andrew Smith after psychiatric exam revealed that Smith was suffering from psychotic disorder caused by Pfizer's smoking cessation medication Chantix.

Reports of adverse effects associated with prompted an FDA investigation of the drug. The FDA issued an warning that drug could be linked to serious psychiatric disorders and possibly even suicidal acts. No causal relationship has officially been established but the FDA has said that a link cannot be ruled out at this time.

Originally posted at InjuryBoard by Scott Kappes

Accutane Risks

Ashley Davis — Wed, 11 Mar 2009 10:53:00 GMT

Do you take Accutane to treat severe acne? If you do, hopefully your doctor has already warned you about all of the possible risks. If you are thinking about using Accutane, then there are some serious side effects that you need to be aware of.

Some common reactions to Accutane include:

Pain and swelling of lips
Severe itching
Alopecia (hair-thinning/hair-loss/baldness)
Fragile and weaker skin
Vision problems
Decreased night vision (onset may be sudden)
Conjunctivitis (pink eye)
Contact lens intolerance
Dry mucous membranes (dry nose, lungs, bladder, anus)
Peeling skin on palms/soles
Nail changes
Nosebleeds
Photosensitivity (sensitivity to light)
Elevated triglycerides in the blood
Elevated liver enzymes (indicating liver damage)
Tinnitus (ringing or buzzing in ears)
Joint pain and muscle pain
Back pain
Depression

Some SERIOUS reaction to Accutane include:

Severe depresseion
Erectile dysfunction (difficulty in maintaining erection)
Violent behavior/ aggression
Psychosis (seeing or hearing things that are not real)
Suicidal ideation (rare)
Suicide attempts
Hearing impairment
Pseudotumor cerebri (swelling pressure in the brain)
Osteopenia/osteoperosis (loss in bone mass and strength/weak and fragile bones)
Hepatotoxicity (liver damage)
Anaphylaxis (rapid and deadly allergic reaction)
Allergic vasculitis (inflammation and damage to blood vessels)
Major birth defects
Cataracts/corneal opacities (can cause a decrease in vision and lead to eventual blindness)
Premature epiphyseal closure (short stature)
Neutropenia (low white blood cell count, which makes the body vulnerable to bacterial and fungal infections)
Agranulocytosis (a serious condition in which the white blood cells decrease in number or disappear altogether) (rare)
Rhabdomyolysis (potentially fata disease that destroys skeletal muscle)(rare)
Inflammatory bowel disease (inflammation of the intestine and resulting in abdominal cramping and persistent diarrhea)
Pancreatitis (inflammation of the pancreas, on organ important in digestion)
Vascular thromosis (heart attack)
Stroke
Seizures

So do the benefits outweigh the risks? Accutane is the first drug in history of medicine for which a woman has to sign a consent to read the warnings, and the FDA had to issue a black box warning because of the serious and life threatening side effects.

If you are taking acne and start to develop severe side effects, contact your doctor immediately!

Originally posted at InjuryBoard by Ashley Davis

Stricter Rules for Diabetes Medications

Scott Kappes — Mon, 07 Jul 2008 13:05:23 GMT

A panel of outside medical experts met last week to discuss the need for new diabetes medications to undergo more extensive testing to prove that they do not increase the likelihood of cardiovascular problems. The panel voted overwhelmingly, 14-2, to require the new regulations for diabetes medications. Over the past year the diabetes medications Avandia and Actos have been at the center of the controversy after studies linked the drugs to an increased risk of heart attack and stroke among other heart conditions.

The panel recommended the FDA instruct drug manufacturers to conduct long-term studies in order to rule out cardiovascular risks in the diabetes drugs. Most panel members also suggested that companies start the studies before the drug is approved and complete them after approval.

The FDA is not required to follow the advice of advisory panels but usually does.

Recent studies have shown that the diabetes epidemic is not going away anytime soon. Over the past two years we have seen a 17 percent increase in the number of people with diabetes, bringing the number up to 24 million in the US alone. With more people taking diabetes medications than ever before, the safety of these medications should be of the utmost concern to the FDA.

Originally posted at InjuryBoard by Scott Kappes

Merck Concealed Vioxx Data

Scott Kappes — Wed, 16 Apr 2008 11:54:26 GMT

A report published in today’s Journal of the American Medical Association (JAMA) makes accusations that Merck, one of the world’s most powerful and influential pharmaceutical companies, participated in various forms of scientific fraud in order to mask the effects of the now recalled pain medication Vioxx. The information comes after a long and tedious examination of thousands of documents made public through the thousands of lawsuits filed over Vioxx. Researchers claim that Merck pursued a deceptive marketing campaign, and deliberately moved slowly to warn consumers of the possibly fatal side effects associated with Vioxx.

One study alleges that Merck gave the Food and Drug Administration an incomplete accounting of deaths in a clinical trial of Vioxx in people with mild dementia. Federal regulators eventually received the data, which added to growing evidence that Vioxx increased the risk of heart attacks and strokes.

Merck has also been accused of using what JAMA authors described as “ghostwriters,” to pass off research done by Merck employee as the work of scientists, giving the research much more clout when posted in medical journals and other peer review sources.

While this new evidence of fraud likely comes to late to impact the $4.85 billion settlement from last fall, it should provide a little more insight to the public on the inner workings of big pharma. It is unrealistic to assume that other large pharmaceutical companies do not employ similar deceptive tactics to those allegedly used by Merck.

A spokesman for Merck's legal team dismissed the JAMA authors as "people in the pay of trial lawyers."

Originally posted at InjuryBoard by Scott Kappes

Dilantin Linked to Stevens-Johnson Syndrome

Scott Kappes — Mon, 15 Mar 2010 15:53:18 GMT

Stevens-Johnson Syndrome (SJS) is a rare-but-severe condition in which a person's skin and mucous membranes have a severe reaction, usually to a medication or infection. Before evidence of the disorder appears on the skin or in the mucous membranes, the affected person often has flu-like symptoms including a sore throat and cough.

According to the Mayo Clinic, symptoms of SJS can include:

Facial swelling

Tongue swelling

Hives

Skin pain

A red or purple skin rash that spreads within hours to days

Blisters on your skin and mucous membranes, especially in your mouth, nose and eyes

Shedding (sloughing) of your skin

The anti-convulsant medication Dilantin (phenytoin sodium) has been linked to SJS. Dilantin is approved by the Food and Drug Administration (FDA) for the prevention of temporal-lobe and grand mal seizures. Patients also often are prescribed Dilantin after brain or spinal surgery to help prevent post-surgical seizures. In addition to skin disorders, Dilantin side effects have been known to affect the nervous, immune, gastrointestinal, hemopoietic and connective tissue systems.

Phenytoin levels can be raised or lowered when Dilantin is taken with other drugs, and Dilantin has also been shown to affect the efficacy of other drugs, including contraceptives.

If a patient is experiencing adverse effects of Dilantin or finds that the medication is not controlling seizures, it may be important to talk to a healthcare provider about possible Dilantin alternatives. Medication should never be stopped without first consulting a doctor.

http://www.youtube.com/watch?v=NHgScJ13AUE

Originally posted at InjuryBoard by Scott Kappes

Depakote Linked to Spina Bifida

Scott Kappes — Mon, 01 Mar 2010 16:03:36 GMT

The FDA has recently come out with a warning for women using depakote and depakene, which are generic names for valproic acid and valproate. These drugs, which were first approved in 1978 to treat epilepsy, are now being used to treat migraines and bipolar disorder in both men and women. But according to the FDA, women who have taken these drugs while pregnant have a higher risk of giving birth to a baby with birth defects than women who take alternative forms of medication.

According to the article,

Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant.

Using valproate during pregnancy increases the chance of having a baby with a birth defect. Neural tube defects, such as spina bifida, are the birth defects most often seen with valproate use in early pregnancy.These defects of the brain and spinal cord occur when the developing spinal canal does not close normally.

For this reason, a woman of childbearing potential should generally not take valproate unless it is considered essential for her treatment. Women of childbearing potential are women who have passed puberty and have not passed through menopause and have not had their uterus or ovaries removed.

The risk of a child getting spina bifida from a mother who took these medications while pregnant is 1-2%. That's one out of every one hundred children. In the population at large the odds of a child being born with spina bifida are about 1 in 1000.

Women who take Depakote or Depakene to control bi-polar disorder or another ailment should be very conciencious of the harm that can be caused to the fetus if they were to be come pregnant. Women taking these medications should consult thier physician if they plan to be come pregnant.

The defects that can be caused by the use of these medications are serious, and should not be taken lightly. While birth defects can happen even when you do everything right, the use of dangerous medications like Depakote greatly increases the risk of a child being born with a birth defect.

If you or loved one took depakote or depakene while pregnant and as a result have given birth to a child with spina bifida or another birth defect the birth defect attorneys at Reich & Binstock can help.

Originally posted at InjuryBoard by Scott Kappes

Eyelash Thickener Gets Warning From FDA Over Misleading Website

Scott Kappes — Thu, 17 Sep 2009 17:47:55 GMT

The Food and Drug Administration has issued a warning to Allergan Inc., the makers of the eye lash thickener Latisse, claiming that the Latisse website downplays the risks associated with the product.

In a letter dated September 10 the FDA said that the Latisse site did not display adequate warnings about potential side effects associated with Latisse. According to the letter the website either failed to mention or displayed potential side effects in small text that does not attract the same attention as the text highlighting the product’s efficacy.

Potential side effects of Latisse include bacterial eye infection, allergic reactions, excess hair growth outside intended treatment area, and permanent changes in eyelid and iris pigmentation.

Latisse was approved last December by the FDA to make eyelashes fuller, thicker, and darker.

The FDA ordered Allergan to immediately discontinue distribution of “misleading” marketing materials and send an written response to the FDA by the September 24.

Originally posted at InjuryBoard by Scott Kappes

Hydroxycut Recall

Ashley Davis — Tue, 12 May 2009 20:40:47 GMT

Hydroxycut, a popular weight loss supplement, has now been recalled by the FDA due to its link with several liver injuries. Hydroxycut’s manufacturer has now recalled a total of 14 products, which are all marketed as fat-burners, diet aids, and energy boosters.

The FDA has received a total of 23 reports of people who have experienced adverse side effects including:

Liver damage requiring a liver transplant
Seizures
Cardiovascular disorders
Elevated lever enzymes (an indicator of potential liver injury)
Jaundice

In 2007, a young 19-year-old died of liver failure after using Hydroxycut. Now, consumers are urged to stop the use of Hydroxycut and to consult with their physician if they have experienced any of the side effects that could have been related to their use of Hydroxycut.

Liver injury symptoms that could be related to the use of Hydroxycut include:

Jaundice
Brown urine
Nausea
Vomiting
Light-colored stools
Excessive fatigue
Weakness
Stomach or abdominal pain
Itching
Loss of apetite

Hydroxycut contains many ingredients such as hydroxycitric acid, but the FDA has yet to figure out which ingredient causes the liver damage.

Originally posted at InjuryBoard by Ashley Davis