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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Critics of the U.S. Food and Drug Administration (FDA) have long believed that the agency should be split into two parts to ensure adequate safety processes for drug approvals and, in turn, fewer medical injuries. If President Obama’s recent actions are any indication of whats to come, these critics will soon have their wish.

Last month, President Obama appointed two health experts to top positions at the FDA. Former New York City health commissioner, Margaret Hamper, is the President's choice for the agency's commissioner; while pediatrician and child safety expert, Joshua Sharfstein, is the President's choice for deputy commissioner. Experts believe that the President's choice of two experts is an indication that he is in favor of splitting the FDA into two separate units.

FDA critics have long argued that the agency is overworked and simply unable to monitor the safety of the vast amounts of pharmaceutical drugs, medical products, and medical devices that come through its doors. The agency suffers from under staffing and a shortage of resources necessary to ensure drug safety. FDA officials, themselves, admit that the agency is unable to meet the changing demands of a globalized world, where pharmaceutical drugs are frequently sourced from foreign plants. In 2005, the FDA approved close to 3,200 applications for marketing of new medical devices. Yet, the agency has only a fraction of the scientist and researchers necessary to process so many applications. Because of this the FDA often has no other option, but to rely on the device makers themselves to disclose the risks of their products.

FDA Division Supporters

The drug industry has been quietly supporting a possible division of the agency, because it could result in faster approvals of pharmaceutical drugs. The FDA experiences frequent delays in its approval and review processes for pharmaceutical drugs due to its shortage of staff. However, medical injury lawyers would welcome an FDA split due to the possibility of more stringent monitoring of review processes and, therefore, enhanced safety of drugs and devices approved for promotion.  

In recent years the FDA has battled several food safety crises. Every time there is a contaminated batch of peanut butter or pistachios, the agency is forced to turn its attention to food safety. It has become increasingly clear that we cannot continue to expect the agency, responsible for making sure tomatoes and peppers are free of pathogens, to also be responsible for monitoring the safety of bone graft products, implantable cardioverter defibrillators and drug eluting stents.

If you've been injured through use of a defective drug, medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation.

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Watson Pharmaceuticals Inc. announced that it is recalling one lot of Propafenone HCL 225 mg tablets because they may contain a more intense dose of the active ingredient than is needed. The recall affects a single lot of the tablets that was shipped between October 15th and November 26th of 2008.

Propafenone is used in the treatment of cardiac arrhythmias, including conditions associated with accelerated heartbeat, like ventricular and atrial arrhythmias. However, it can be dangerous if not used as prescribed. The drug is believed to increase the risk of dangerous arrhythmias if taken by patients who have an underlying heart disease. Patients who suffer from liver problems, asthma, or bradycardia are also advised to avoid Propafenone. The long term effects of the drug have not been extensively researched. Even minor over-dosage of Propafenone has been found to have serious effects. Patients who take even small quantities of the drug above the prescribed limit could experience a drop in blood pressure and arrhythmias.

Watson Pharmaceuticals Inc. says they are voluntarily recalling the lot of tablets to prevent any risk to patients due to over dosage. The Food and Drug Administration (FDA) has been informed of the recall and the company has asked patients who are in possession of the 225 mg tablets to check the container and see if the tablets belong to the lot being recalled. Consumers should return the recalled tablets by calling the company. Any adverse reactions should be reported to the FDA’s MedWatch program. Patients currently using 225 mg Propafenone HCL tablets have been asked to contact their physician if they have any questions.

Last year, Ethex Corporation announced a recall of over sized morphine Sulphate, Propafenone HCI, and other tablets because they contained twice the necessary amount of the drug. Those over sized tablets caused morphine over dosage injuries and resulted in several medical injury lawsuits filed by medical injury lawyers against Ethex. Also, medical injury lawsuits continue to be filed against Mylan Pharmaceuticals over double strength Digitek tablets that contain extra dosages of the active ingredient Digoxin. 

Injuries Caused by Defective Drugs

Over dosage due to a defective pharmaceutical drug containing a greater amount of the active ingredient than is necessary is entirety preventable by the company if it follows stringent manufacturing and quality control processes. There is no excuse for releasing batches of drugs that expose users to dangerous effects of over dosage because of careless errors made at the manufacturing plant.  

If you've been inured by the use of recalled Propafenone HCL tablets manufactured by Watson Pharmaceuticals Inc., contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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Bodee LLC is conducting a voluntary nationwide recall of the male enhancement drug Zencore Plus. Due to a combination of ingredients, the drug can cause a sudden, life-threatening drop in blood pressure.

After being alerted by the U.S. Food and Drug Administration (FDA) of its danger, Bodee LLC recalled Zencore Plus on March 11, 2009. The drug contains benzamidenafil, which, when mixed with organic nitrates, can cause serious health risks. According the the FDA, "The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure". One user reported that the drug caused nausea, excessive sweating, and caused their vision to go "white". The probability of these health risks is unknown; anyone with this drug in their possession should stop use immediately.

Zencore Plus is sold in health food stores and over the internet. It comes in 2-capsule packs, five packs at a time or in a single 10-capsule pack. The drug is supplied by Hi-Tech Pharmaceuticals, Inc. in Norcross, GA.

Dangerous Pharmaceuticals

If you have been negatively affected by this drug or experienced any of the above mentioned side effects, an experienced medical injury lawyer can help you get the compensation you deserve.

If you have this drug do not take it. If you have taken it and it caused any adverse effects please contact the FDA at 1-800-FDA-1088 or a medical injury attorney at Arnold & Itkin LLP for a free consultation.

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