Galveston Bay Personal Injury Lawyer - FDA & Prescription Drugs

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

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

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

Harmed by Trasylol?

Ashley Davis — Mon, 20 Apr 2009 16:02:41 GMT

Trasylol was commonly given to patients during heart surgery to control blood loss, but has now been shown to cause adverse, and even fatal side effects. A study released in January of 2006 in the New England Journal of Medicine highlighted the adverse Trasylol side effects that were previously unknown.

The side effects that were found include a significantly increased risk of heart attacks, strokes, kidney failure, and heart failure. The manufacturer of Trasylol, Bayer, has suspended worldwide marketing of Trasylol due to these overwhelming concerns. Some experts are saying that the use af Trasylol could be responsible for as many as 1,000 deaths per month.

Originally posted at InjuryBoard by Ashley Davis

List of Tainted Weight Loss Drugs Expanded by the FDA

Scott Kappes — Tue, 24 Mar 2009 18:16:35 GMT

Late last year the FDA alerted consumers to not purchase or consume a list of over 25 products marketed a dietary supplements or weight-loss aids after the products were found to contain undeclared and potentially dangerous ingredients. The FDA has now expanded this alert to include a total of 72 different products.

These undeclared pharmaceutical ingredients found in some of the supplements include controlled substances, drugs not approved for sale in the U.S., experimental chemicals, and suspected carcinogens.

The FDA strongly advises consumers who have taken these medications to immediately discontinue use and contact their healthcare provider immediately. Health risks associated with these products can be very serious, including high blood pressure, seizure, tachycardia, heart palpations, stroke and even heart attack.

To view the list of dangerous weight-loss drugs click here

If you or a loved have been injured as a result of taking a tainted weight loss supplement contact one of our experienced dangerous drug attorneys today for a free consultation.

Originally posted at InjuryBoard by Scott Kappes

Medicated Patches Risks

Ashley Davis — Wed, 18 Mar 2009 17:57:01 GMT

On March 5, the FDA put out a warning on adhesive patches that deliver medication through the skin. If these patches are worn while undergoing magnetic resonance scans (MRI) then burning of the skin may occur.

The warnings go for the brand name and the generic products and patches purchased over the counter without a prescription. The public heath advisory on transdermal drug patches that was issued by the FDA says “while not attracted to the magnetic field of the MRI, the metal can conduct electricity, generating heat which can cause burns. Users of the patches reported receiving skin burns at their patch site when wearing the patch during the MRI scan.

If you use these medicated patches the make sure to tell your MRI facility in order to prevent skin irritation and burning. It is recommended that people using the patches talk to their doctor about whether or not the patch is right for them.

Originally posted at InjuryBoard by Ashley Davis

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

FDA Posts List of Drugs They Are Watching

Scott Kappes — Wed, 10 Sep 2008 17:37:15 GMT

The FDA has the responsibility of protecting citizens of the United States from potentially harmful and dangerous drugs. Late last week the agency released a list of drugs that are currently on the FDA’s watch list of potentially harmful medications. The list names 20 different medications, citing particular issues associated with each of them. There is no indication of how many reports the FDA has received concerning the injuries associated with each medication nor is there any indication for patients to stop taking medications included in the list.

Food and Drug Administration officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation.

The list includes drugs several drugs that have already had highly publicized problems, like Heparin; as well as several other medications that have not been in the public eye. A number of drugs on the list were cited as having confusing instructions or similar names that has lead to overdoses or improper use.

This list is the first of its kind, but in coming months and years the FDA will continue to post a list of drugs under investigation each quarter.

Consumer advocates are pleased with the recent actions and are calling it “a step in the right direction;” however, many industry groups are concerned that the list will created unwarranted panic among patients taking these medications.

The full list of can be viewed here.

Originally posted at InjuryBoard by Scott Kappes

FDA Reinforces Pancreatitis Warnings Associated with Byetta

Scott Kappes — Thu, 21 Aug 2008 16:02:33 GMT

In October of 2007 the FDA first warned healthcare professionals about a possible link between the type 2 diabetes medication Byetta and acute pancreatitis. This warning urged physicians to be on the lookout for warning signs and symptoms of acute pancreatitis in patients taking Byetta. In January of 2008 the label of Byetta was amended to include acute pancreatitis in the precautions section of the drug’s label. Since last October the FDA has seen six cases of hemorrhagic or necrotizing pancreatitus in patients taking Byetta. Of these six cases all have needed hospitalization have two have died. The other four were still in the process of recovery when the FDA published the update.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

Patients taking Byetta should seek immediate medical attention if they experience persistent, unexplained abdominal pain. While this is no cause for patients who are effectively controlling diabetes with Byetta to abandon the medication it should encourage them to be very cognoscente of the warning signs associated with pancreatitis and allow them to act more quickly if a problem were to occur.

Originally posted at InjuryBoard by Scott Kappes

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