Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, August 19, 2015

Harmed by Invokana



Two years ago, Invokana, an oral diabetes medicine that helps control blood sugar levels, was FDA approved to treat Type 2 diabetes. Since then, the FDA has received numerous adverse event reports involving side effects from the medication, including kidney failure or impairment, myocardial infarction (heart attacks), and ketoacidosis, a serious condition that occurs when insulin levels are too low. Without enough insulin, the body breaks down fat as an alternative source of energy, resulting in a buildup of toxic acids in the bloodstream . If untreated, ketoacidosis can result in a patient suffering a diabetic coma, extended hospitalization and even death.

While Invokana has not been recalled to date, in May 2015, the FDA issued a warning to doctors and patients to be aware of the ketoacidosis symptoms including dehydration, difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Patients experiencing these side effects should seek immediate medical attention.

It often takes many years before all the facts come out that will lead to a voluntary or involuntary recall. In the meantime, lawsuits have begun against Janssen Pharmaceuticals, alleging that the drug maker failed to adequately warn consumers and the medical community about the potential risks of kidney failure, heart attacks and ketoacidosis. Victims may recover damages including:
  • Past and future medical expenses
  • Disability and impairments
  • Lost income
  • Pain and suffering 
If a person dies from complications caused by Invokana, family members may be able to recover damages, including:
  • Funeral expenses
  • Medical expenses prior to death
  • Loss of financial support
  • Loss of companionship
  • Pain and suffering
If you have suffered serious side effects from taking Invokana and do not have legal representation, Lawsuit Financial can assist you with obtaining an attorney from our nationwide database, free of charge. Unfortunately, these cases can take years for a settlement to be reached because pharmaceutical companies have “deep pockets” and a large legal team to fight claims. For victims not in the financial position to wait for their case to settle, lawsuit funding can help.

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Tuesday, June 21, 2011

Dangerous Product Burning Consumers For Years. Will the FDA’s New Sunscreen Rules Give Us Enough Protection?

The FDA has traditionally only required sunscreens to protect against sunburn. Until now, products could claim broad-spectrum protection without any basis for it. Maybe you wouldn’t leave the beach looking like a tomato, but your sunscreen may not have been shielding you from subtle damages caused by Ultraviolet A (UVA) rays.
For the first time in 33 years, new rules will require sunscreens to protect against ultraviolet B rays—which cause sunscreen, and not ultraviolet A rays—which cause skin cancer and wrinkles—to carry a warning label. The new regulations, effective next year, will force companies to improve the accuracy of their sunscreen protection claims.
Here are highlights of the new rules:
The claim “broad spectrum” will appear only on sunscreens tested for a minimum standard of UVA protection.
All sunscreens will carry their SPF rating. Those without the broad-spectrum claim, SPF will rate only UVB protection. Higher SPF numbers mean more protection against UVB as well as more protection against UVA. Warning labels will read: "Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging."
Sunscreens will have a “fact box” listing warnings and other important information in an easy-to-find location.
Manufacturers cannot make claims that sunscreens are "waterproof" or "sweatproof," or identify their products as a "sun block." Water resistance claims on the product's front label must tell how much time a user can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing. Sunscreens that claim to be water resistant must show how long they last after a person has been swimming or sweating: 40 minutes or 80 minutes.  It must be noted in the “fact box” if they are not water resistant.
SPF values higher than 50 will be labeled as "SPF 50+." FDA does not have adequate data demonstrating that products with SPF values higher than 50 provide additional protection compared to products with SPF values of 50.
The new requirements will be effective by summer 2012, although some sunscreen makers will launch their new labels sooner. What does this mean for your summer in the sun this year? Experts say that although the inconsistency is the UVA protection, the SPF tests should be accurate. Since some protection is better than none, they do not suggest throwing out your sunscreen or staying indoors all summer long. Here are three simple ways to protect your skin from damaging sun exposure:
  • Use sunscreen regularly and re-apply every two hours.
  • Avoid the midday sun, when rays are the strongest.
  • Wear a hat to shade your face and neck.
You may also check out Screen Test,” to learn what to look for in your sunscreen and how to apply it for best results.
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