Medical Injury Lawyer Blog : Houston Medical Injury Lawyer & Attorney : Arnold & Itkin Law Firm : Pharmaceutical Injuries, Medical Devices : Texas, Dallas, Fort Worth, San Antonio

New York-based company, Universal ABC Beauty Supply International Inc., recalled 34 weight loss products after the U.S. Food and Drug Administration (FDA) warned of risks from consuming the products.

The FDA informed the company that the diet pills and supplements contain Sibutramine, a drug that can lead to a substantial increase in blood pressure and an accelerated heart rate. This could cause health risks in people with a history of cardiac problems. None of the products have been approved by the FDA, although, Sibutramine has been approved by the agency for use as a weight loss drug. Because these weight loss products have not received FDA approval, there can be no guarantees of the safety and effectiveness of the products.

The list of weight loss products, includes:

1. ProSlim Plus
2. 3 DAYS fit
3. EIGHT FACTOR DIET
4. 24hours Diet
5. Slim 3 in1 M-18 ROYAL DIET
6. 3X SLIMMING POWER
7. Extrim Plus 24hours Re-BURN Formula
8. Slim 3in1 EXTRA SLIM FORMULA
9. Slim 3in1 SLIM WAIST FORMULA
10. SLIM EXPRESS 360 C
11. SLIM EXPRESS 4in1
12. ROYAL SLIMMING FORMULA
13. BODY CREATOR
14. Slim Waistline
15. BODY SHAPING
16. PERFECT SLIM
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula
20. Super Slimming
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER
25. SLIMMING FORMULA
26. SLIM FAST 2
27. SLIM FAST
28. Slim up
29. 7 DAYS DIET
30. Perfect Slim Up
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2

There have been no reports of illness or injury related to these products; the company said it will discontinue the recalled defective drugs. The company is offering refunds on unused pills. If you have any of these weight loss supplements in your home, discontinue use and contact the company.

Diet pill and supplement companies make up a billion dollar industry. However, some pills may have side effects, including nervousness, diarrhea, accelerated heart rate, tremors, increase in blood pressure, and cardiac arrest. Just because pills promise to give you a slim figure does not mean they are completely harmless and contain no side effects. Medical injury lawyers advise people who use these drugs to follow all dosage instructions carefully and consult their physician before they begin taking them.

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Last month, the Food and Drug Administration (FDA) sent letters to major pharmaceutical companies, warning them that their Google search ads will be removed unless they start including information about the risks of the drugs.

Most of the top pharmaceutical companies received the letter, which included two pieces of information the agency expects pharmaceutical search ads to have:

• The full name of the drug
• Risk factors associated with the drug

Until now, pharmaceutical marketing companies followed the “One Click" rule. As long as all risk information was provided on the page users were directed to after clicking the ad once, risk information was considered sufficient. Now, the agency is demanding that ads include the risks and explains that, laws for print or television marketing are the same for internet marketing. Many pharmaceutical companies have complied, but argue that the FDA should look further into internet advertising and understand that including the risks of a drug is, not only impossible considering Google's guidelines, but also more confusing for consumers. The FDA set April 9th as the deadline for companies to change their ads.

Medical injury lawyers support the FDA's decision to regulate pharmaceutical companies' internet advertising. After all, if a company has is able to describe a product in glowing terms within the Google character limit, it should have no problem including risk information within the character limit as well. However, what we would like is for Google, the FDA, and pharmaceutical companies to come up with ways in which consumers would have all pertinent information about the drug, including risks, when a search ad catches their attention. Currently, the FDA’s new system has online pharmacies showing up as the top listings in text ad results; this is not very helpful for consumers.

This is one more example of good intentions, but flawed methods. The FDA needs to put a little more effort into defining the rules clearly, and pharmaceutical companies must work with the agency to ensure that customers have all risk information at a glance. This is all new territory for the agency. Clear guidelines will give companies no excuse for disobeying the rules and will provide consumers with all the information they need.

Pharmaceutical Attorney

Pharmaceutical companies are required to disclose the risks of their products. Failure to do so can result in seriously injured consumers and even death. Luckily, the FDA is doing what they think is best to protect American consumers, lets just hope they are not confusing the situation even more.

If you or a loved one has been injured by a defective pharmaceutical drug an experienced medical injury lawyer can help you find the answers and resources you need to recover. For a free evaluation of your case, contact a medical injury attorney at Arnold & Itkin LLP.

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You can add yet another medical injury to the long list of risks associated with Avandia – this time it is the increased likelihood of developing an eye disorder called Diabetic Macular Edema (DME). According to studies, people who take a group of anti-diabetes drugs called glitazones, including Avandia, are at a greater risk of contracting the disorder.

Avandia and DME

The research was conducted at the Southern California Permanente Medical Group, and was published in the April issue of the American Journal of Ophthalmology. The study is not the first one suggesting a link between glitazone use and DME, but has confirmed a "modest" association between the two. DME is linked to the accumulation of fluid in the eye and swelling, and may eventually lead to loss of vision.

The study, which was conducted on a total of 996 DME patients, revealed that people who took glitazone-containing drugs, like Avandia, were up to 2.6 times more likely to develop the disorder than those who were not taking the drugs. In fact, the risk of developing DME for glitazone users was up to 68% higher than for non-glitazone users. Avandia contains rosiglitazone, which belongs to the glitazone family.

According to the authors of the study, the safety of a drug is as important is its efficacy in treating a disease. However, current safety evaluations for drugs do not take into account long-term safety because approvals are based on short term clinical drugs. This lack of intensive study could result in the release of a potentially defective pharmaceutical drug into the market. The authors have found enough of a link between DME and glitazone use to advise ophthalmologists treating DME patients to consider glitazone use during diagnosis.

Dangers of Avandia

Recently, a study by the Canadian Medical Association Journal found a link between Avandia and a higher incidence of bone fractures in women. Previous clinical studies have also linked the anti-diabetes drug to chest pain, heart failure, and other heart problems. Medical attorneys have been pursuing lawsuits against GlaxoSmithKline, the company that markets Avandia, for these injuries.

The list of risks associated with Avandia use continues to grow. Eye problems are one of the effects of uncontrolled diabetes which, ironically enough, Avandia is supposed to keep under control. If you are currently taking Avandia, you should consult your doctor about the risks of DME. Your doctor may be able to prescribe a less risky substitute.

If you or a loved one has been injured by the use of Avandia or any other pharmaceutical drug, contact a medical injury attorney at Arnold & Itkin LLP for a free consultation.

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The Food and Drug Administration (FDA) has issued a health advisory warning, about a reported link between the use of the psoriasis drug Raptiva and the occurrence of a rare brain infection injury.

FDA regulators received 3 reports of progressive multifocal leukoencephalopathy (PML) in patients using Raptiva, a psoriasis drug manufactured by Genentech. The agency was also informed of at least one "possible" case of infection. Two of the confirmed PML patients as well as the sole possible patient died. All 4 patients had been taking the psoriasis drug for more than 3 years. The agency is reviewing the incidence of PML in patients using Raptiva and has announced that it will take steps to ensure that patients taking the medication are not placed at excessive risk.

Progressive multifocal luekoencephalopathy (PML), which usually occurs in people with weakened immune systems, can result in a decline in nerve function and is usually fatal. The infection is marked by an inflammation of the white matter of the brain. It is seen very often in patients suffering from AIDS or other immune deficiency disorders. Symptoms may include:

• muscle weakness
• loss of coordination
• speaking difficulties
• vision problems
• personality changes

Individuals often become progressively clumsy and are, ultimately, left with serious disability. People who suffer from PML have a grim prognosis. Approximately 80% of PML patients can die within 6 months of contracting the infection. Those who do survive may find themselves with severe neurological difficulties. People with AIDS who suffer from PML may find that the anti-HIV drugs they take can help alleviate the symptoms of PML. People taking medications that suppress immunity are especially at risk for PML. Of the 4 Raptiva users who contracted PML, no one was taking any other immune-suppressive medications.  The FDA has confirmed that it will take steps to make sure that patients taking Raptiva are informed of PML symptoms and that these patients are monitored by healthcare professionals for any sign of the infection.

Almost all pharmaceutical drugs come with a set of side effects or adverse reactions. Therefore, testing pharmaceuticals is very important – the benefits of the drug should be weighed against its risks and it should be prescribed accordingly. If a drug is proved to cause a risk of a potentially fatal and debilitating disease, its generally safe to say that the benefits of the drug are not worth the risk of serious illness. Unfortunately, very often, inadequate testing and rushed approval processes cause adverse reactions to come to light only after illnesses and injuries have resulted from the use of the drug.  

Medical Injury Lawyers

People injured by the use of a defective pharmaceutical drug often need the help of a medical injury lawyer to recover damages for their injuries.

If you have been injured by a dangerous drug, contact a medical injury attorney at Arnold & Itkin LLP for a free evaluation of your case.

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Four medical injury lawsuits have been filed in Orange County, Texas against Mylan Pharmaceuticals over the cardiac drug, Digitek. The lawsuits relate to injuries caused by Digitek tablets that contained a double strength dose of the active ingredient, Digoxin.

The double strength Digitek tablets were the subject of a massive recall in April 2008. The Food and Drug Administration (FDA) announced a Class I nationwide recall of all lots of Digitek, manufactured by Mylan Bertek Pharmaceutical Inc. and UDL Laboratories that year. Earlier, the FDA issued warnings to Mylan and UDL for failure to file regular safety reports at their New Jersey manufacturing facility. In February 2007, the FDA issued a second warning claiming that there were faulty manufacturing practices at the company. The medical injury lawsuit claims damages for “physical pain” the plaintiffs suffered after taking the double dose tablets.

Digitek Lawsuits

Digoxin, which is the main active ingredient in Digitek tablets, improves the heart's ability to pump blood, in case of heart failure. It is used to treat a range of cardiac problems, including accelerated or irregular heartbeat, heart failure, dizziness or palpitations. While it is very effective in the treatment of atrial flutter and other heart conditions, an overdose of Digoxin can have serious consequences on a person's health. Digoxin overdose can quickly lead to digitalis toxicity, whose symptoms include dizziness, blurred vision and other medical issues. In extreme cases, the victim can suffer from a decreased heart rate, pulse irregularities and palpitations. Digitalis toxicity can also impact the functioning of the kidneys. It is therefore an especially dangerous condition in patients who already suffer from kidney and renal disorders. Patients who took the double dose Digitek tablets were at risk of an overdose. The companies involved in producing the double dose tablets including Mylan Bertek Pharmaceuticals Inc, UDL Laboratories Inc., and Actavis Totowa have yet to provide solid explanations for why so many lots of these tablets contained twice the recommended dosage.

Medical Injury Lawyers

Pharmaceutical negligence can leave patients at risk for adverse reactions, side effects, and as in the Digitek case, over-dosage. Pursuing claims against these big name companies requires access to financial and medico-legal resources. Often, only specialized medical injury attorneys have access to these resources.

If you have been by the use of a defective pharmaceutical drug, contact a Texas medical injury attorney at Arnold & Itkin LLP for a free consultation. 

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As the Bush administration prepared to vacate office, the Food and Drug Administration (FDA) issued new guidelines that ease restrictions on promotion of off-label drug use by pharmaceutical companies. The rule has been severely criticized because it may lead to more dangers when pharmaceutical drugs are used in ways not approved by the FDA.

It is illegal for pharmaceutical companies to promote off-label use of their drugs, although physicians are allowed to prescribe drugs for purposes not approved by the FDA. Doctors are allowed and often do rely on published medical research to prescribe drugs for unapproved uses to their patients. In its new rule, the FDA allows pharmaceutical companies to cite medical journal research supporting off-label uses of a drug. The biggest problem with relying on medical journal articles is that such research does not go through a strict screening process. It is hardly meant to be used as a substitute for the rigorous approval procedures conducted by the FDA.  Plus, there is also the risk that pharmaceutical companies may pay medical researchers and scientists for articles that recommend promotion of the drug for off-label use, which clearly would not be genuine, in-depth research articles.

The new guideline has been criticized from both within and outside the Bush administration. The Department of Veterans Affairs, patient advocacy groups, state prosecutors and medical injury lawyers around the country stand adamant that the new guidelines will weaken an already unstable FDA and expose patients to the omnipresent dangers of off-label drug use.

Off-label drug use continues to be a major danger to patients at risk of side effects from such drugs. Recently, Eli Lilly and Company agreed to a mammoth settlement over civil and criminal lawsuits arising from off-label drug use promotion. Also, Medtronic currently faces a lawsuit arising from the same unethical practices related to its Infuse Bone Graft. The threat of massive civil and criminal liability is the only thing preventing mass off-label promotion by drug manufacturers.  In the absence of rules completely prohibiting such promotion, drug manufacturers will have the freedom to place patients at risk in order to multiply their profits.

Promotion of off-label drug use by pharmaceutical companies can expose patients to unknown side effects simply because off-label uses are not researched as extensively as approved uses and, therefore, have little research to provide help in the case of adverse effects. In such cases, patients who have been injured can file a medical injury lawsuit against the company with the help of a medical injury lawyer.

If you have been injured by the use of a defective pharmaceutical drug, contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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