Columbia Personal Injury Lawyer - FDA & Prescription Drugs

Controversy Ridden Accutane Pulled from Pharmacy Shelves

Pete Strom — Tue, 30 Jun 2009 14:52:36 GMT

Roche Holding AG announced last week that it is pulling its popular acne medicine Accutane from the U.S. market citing economic reasons for its decision.

Accutane was released on the market in 1982. It is estimated that about 13 million people took Accutane before the patent expired in 2002, making it Roche’s second-best selling medicine. Roche claims that after the patent expired, it faced serious challenges from its competitors reducing its market share to less than 5%.

Although the company cites economic reasons, Accutane has always been cloaked in controversy. Controversy surrounding the drug first began in the late eighties when Accutane was linked to serious birth defects.

In 2002, Roche and the Food and Drug Administration launched what became an unsuccessful tracking program designed to reduce the number of pregnant women taking the drug. Nearly 80 percent of pregnancies reported by women taking Accutane during the tracking program’s first year ended in elective abortion because of concerns over the high rates of birth defects.

Accutane has also been reported to cause psychiatric problems including depression and suicide. In 2004, lawmakers and Michigan Representative Bart Stupak sent a letter to Health and Human Services urging the agency to take the drug off the market after Stupak’s 17-year-old son committed suicide while taking Accutane four years prior. Lawyers for John Mullarkey, a 20 year old man currently facing murder charges for the death of his 16 year old girlfriend, claim that he was suffering from an Accutane fueled depression when the deaths occurred.

Roche currently faces nearly 5,000 product liability lawsuits. Recently, the company lost several lawsuits to plaintiffs who claimed Accutane caused them to develop inflammatory bowel disease. Juries have awarded over $33 million to multiple victims across the United States.

Accutane has already been pulled from the market in 11 other countries. June 25th, 2009 was the last day for distribution in the United States. Although Accutane is no longer available from Roche directly, it may still be available at pharmacies.

Strom Law Firm is a personal injury and criminal defense law firm centrally located in Columbia, South Carolina. Our firm proudly handles personal injury, criminal defense, defective products, class actions, pharmaceutical liability, toxic torts, medical malpractice, nursing home neglect, workers compensation, social security, veteran's benefits, qui tam, predatory lending, tax investigations, business litigation, and wills and estates. Our lawyers proudly edit the Columbia, South Carolina Injury Board as well as the Strom Law Blog as a pro bono effort to provide the public valuable information. Our lawyers are licensed in: South Carolina, New York, Georgia, Florida, and the District of Columbia.

Originally posted at InjuryBoard by Pete Strom

Reglan Users Beware, Temporary Reflux Relief May Lead to Incurable Twitching

Pete Strom — Fri, 26 Jun 2009 13:52:06 GMT

That is enough to give you heartburn in and of itself, right?

Statistics indicate that approximately 25 million Americans suffer from some form of heartburn and/or gastric reflux.

Statistics also indicate that as many as 74% of new moms choose to feed their babies breast milk over formula.

So what in the world do these two facts have in common? Both groups make up the estimated 2 million users who were prescribed and may be currently taking Reglan.

Reglan is the brand name for metoclopramide. Metoclopramide is a substance that helps to speed the stomach muscles, thereby shortening the time it takes for stomach contents to empty into the stomach. One of Reglan's side effects is that it increases prolactin, the milk-making hormone in the brain, which in conjunction with pumping will stimulate milk production (hence the prescription for new moms). Reglan is additionally prescribed to women who are pregnant and experiencing morning sickness, infants and children with reflux, and for nausea associated with migraines.

No, its not a snake oil, it’s a drug that has recently come under scrutiny after being tied to tardive dyskinesia, a condition that causes rapid muscle movements that are repetitive, involuntary and purposeless. The condition may affect facial muscles, resulting in grimacing, tongue protrusion, lip smacking, puckering and pursing of the lips, and rapid eye blinking. Patents with tardive dyskinesia have difficulty not moving and are often embarrassed by the symptoms of the disease, causing them to withdraw socially, leading to depression.

Although the drug has not been recalled, the FDA issued a black box warning advising you to carefully consider its potential side effects and make an informed decision before taking Reglan for any period of time. The black box warning is the strongest labeling that the FDA may place upon a drug. The FDA press release specifically advises “[t]he chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”, leaving consumers the choice of whether to continue taking the drug. Notably, the symptoms are rarely reversible even if you stop using Reglan.

Reglan is recommended for up to 3 months. However, may reports claim that as many as 20% use it for longer periods due to the chronic nature of their condition.

If you or someone you know uses Reglan and suffers from tardive dyskinesia we urge you to contact one of our Reglan lawyers as soon as possible to protect your legal rights.

Strom Law Firm is a personal injury and criminal defense law firm centrally located in Columbia, South Carolina. Our firm proudly handles personal injury, criminal defense, defective products, class actions, pharmaceutical liability, toxic torts, medical malpractice, nursing home neglect, workers compensation, social security, veteran's benefits, qui tam, predatory lending, tax investigations, business litigation, and wills and estates. Our lawyers proudly edit the Columbia, South Carolina Injury Board as well as the Strom Law Blog as a pro bono effort to provide the public valuable information. Our lawyers are licensed in: South Carolina, New York, Georgia, Florida, and the District of Columbia.

Originally posted at InjuryBoard by Pete Strom

ETHEX Recalls Continue

Amanda Wick — Thu, 12 Feb 2009 10:24:49 GMT

ETHEX CORPORATION and KV Pharmaceuticals Continuously Expand List of Recalled Drugs

If you've been watching the news or FDA recalls list lately, a name that pops up over and over again is ETHEX Corporation. Over the past several months, Ther-Rx Corporation and ETHEX Corporation, subsidiaries of KV Pharmaceutical Company, have issued urgent, nationwide recalls of several products due to their potential harm to consumers.

In November 2008, ETHEX Corporation issued a voluntarily recall of specific lots of at least four generic pharmaceutical products that it markets. These included:

Morphine Sulfate Extended Release Tablets (15 and 30 mg)
Dextroamphetamine Sulfate Tablets (10 mg)
Propafenone HCl Tablets (150, 225, and 300 mg)
Isosorbide Mononitrate Extended Release Tablets (30 and 60 mg)

According to the Food and Drug Administration, these lots were recalled due to the possibility that they may contain oversized tablets. These oversized tablets potentially contain more than the intended levels of the active drug ingredient, which can result in patients receiving nearly twice the prescribed dosage of the drugs. Overdoses of these drugs can have serious or life-threatening consequences which can include: irregular heartbeat, dangerous changes in blood pressure, fainting, difficulty or lack of breathing, and rapid heart rate.

A list of recalled drugs can be found by visiting the FDA website. Although the recall was originally issued at the wholesale level, it was expanded to the retail level in February 2009. This resulted in consumers receiving letters from their pharmacies that their drug had been recalled. However, by the time the pharmacy sent out the letter, patients had often already consumed the prescribed drugs and had thrown away the medication bottles. Please note that if you are taking a drug that is recalled, keeping your empty prescription bottles can be vital to the process of establishing causation between any injury you suffer and the recalled drug. Sadly, often the letters come out after a recall is issued and in some cases, after patients have taken the oversized drugs and have suffered illnesses or died.

The ETHEX recall debacle continued when, in January 2009, the ETHEX Corporation recalled an additional set of drugs because the products may have been manufactured under conditions that did not sufficiently comply with current FDA guidelines on Good Manufacturing Practices (GMPSs). The FDA guidelines on GMPs regulate various aspects of production including the design, manufacturing, packaging, labeling, storage, and installation of a product. These guidelines can be found on the FDA’s webpage. While some violations can be as small as improper packaging, other violations can cause the pills to be defective including coating that might be too thin, an active ingredient might be double in strength, and a number of other problems that could cause injury to consumers.

The ETHEX Corporation expanded its recall in February 2009 to include several prenatal and iron supplements. Recalls and letters issued to retailers and consumers, which contain instructions on how to return recalled products for a refund, can be viewed at the KV Pharmaceutical website.

If you or a loved one is currently taking or has an order in progress for any of the products listed above, contact your prescriber or health care professional immediately. While patients should continue to take medications in accordance with their prescriptions, as suddenly stopping needed medication may also place patients at risk, the best thing to do is to call your doctor immediately.

If you or someone you know was injured as a result of taking these medications, try to retain all documents, receipts and empty medication bottles related to the drug. This includes keeping any letters you may have received from your pharmacy regarding a recall. But especially, try to retain the prescription bottle in which you received the medication. And seek help from an attorney who will preserve your rights.

Originally posted at InjuryBoard by Amanda Wick

Bayer HealthCare Illegally Markets Unapproved Drugs

Amanda Wick — Tue, 28 Oct 2008 15:42:41 GMT

Today the U.S. Food and Drug Administration sent Warning Letters to Bayer HealthCare regarding two aspirin products. According to the FDA, Bayer has illegally marketed two over the counter products: Bayer Women’s Low Dose Aspirin and Bayer Aspirin with Heart Advantage.

Both products contain aspirin plus either phytosterols or calcium and are unapproved new drugs. ”New drugs” must be approved by the FDA through a new drug application in order to be legally marketed.

These tablets are also a combination of a drug and a dietary supplement. When these two functions are combined into a single tablet, the product is considered a drug and is regulated by the FDA. Because the FDA considers these products new drugs, they must undergo the FDA’s drug approval process before they can be marketed and sold over the counter.

Before these products receive FDA approval, they must meet a number of different requirements. First, the drugs must be approved for all uses. This includes any secondary uses such as reducing the risk of heart disease and fighting osteoporosis, as these drugs claim to do. Second, they must also contain clear directions that can be followed by consumers without guidance by a health care professional.

Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, said that “[because over the counter] drugs are widely used by consumers, without the supervision by a doctor or other health care professional, the overuse or misuse of these aspirin containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations.”

Although the FDA is not aware of significant adverse events associated with these products, people who took these drugs while they were on the market may suffer adverse side effects. If you haven taken these drugs and suffered adverse side effects, you should seek medical care and discuss the situation with your doctor.

Originally posted at InjuryBoard by Amanda Wick

Rituxan Cause of Brain Disorder Death, FDA says

Amanda Schlager — Fri, 19 Sep 2008 01:00:00 GMT

The Food and Drug Administration recently reported that the pharmaceutical drug Rituxan was the cause of a brain disorder death. The female victim passed away just 18 months after consuming her last dose of the drug. The diagnosis was a result of a safety clinical extension study conducted by MedWatch, an adverse events reporting system of the FDA.

The drug Rituxan, marketed by leading U.S. biotechnology companies Genentech and Biogen Idec, is a unique treatment for arthritis. Rituxan has also been used to treat certain cases of non-Hodgkin’s Lymphoma.

On December 18, 2006 the FDA released a safety alert for Rituxan following the death of two patients using the drug to treat systemic lupus erythematosus (SLE). The cause of death in both patients was a viral infection, progressive multifocal leukoencephalopathy (PML), in the brain. For the complete FDA safety alert click here.

Cases of this viral infection in the past have been reported in instances in which patients used Rixan for unapproved uses such as treatment for lupus and blood cancer.

It is estimated that over 10,000 patients have been treated with Rituxan. However, this is the first fatality case in which a patient has taken Rituxan for rheumatoid arthritis.

If you or a loved one has been injured as a result of taking Rituxan, consider contacting an attorney to preserve your rights. Pharmaceutical liability cases require experience and familiarity with the medical and legal issues involved.

Originally posted at InjuryBoard by Amanda Schlager

A New Use for Botox?

Amanda Schlager — Thu, 18 Sep 2008 01:00:00 GMT

“Botox” is a popular quick fix for many men and women who wish to eliminate wrinkles. However, new studies show this bacteria-derived serum may also be used to treat and prevent migraines.

Richard Glogau, Professor of Dermatology at the University of California San Fransisco, conducted a study which tested the uses of Botox as a migraine treatment. This study of 24 patients found that 75 percent of participants experienced migraine relief for up to six months. In these cases, Botox was injected into muscles of the patients’ brows, eyes, forehead, side of the head, and the back of the neck.

Two similar studies were also conducted by Michigan State University and the University of California, Los Angeles.

Allergan Inc., the California company who produces Botox, is in Phase 3 of its own studies regarding its product’s effectiveness in migraine treatment. The goals of this study are to reduce the number of headache episodes in patients compared with those who are treated by a placebo. However, the Food and Drug Administration measures effectiveness according to the reduction in the number of headache days, a secondary goal that was reached in this study.

Botox injections are not currently covered by health insurance and are estimated to cost around 350 dollars per injection. Botox is also not currently approved by the FDA for the treatment of headaches –Botox injections for headaches are considered an “off-label use.” Off-label prescribing is a legal practice for physicians but manufacturers are not allowed to promote off-label uses.

Patients who are taking Botox, or who are considering using it as a treatment, should be informed of the risks. Botox is derived from Botulinum Toxin Type A, a form of one of the deadliest poisons known today. In raw toxin form, it kills by interrupting the communication between nerves and muscles, causing muscle relaxation or paralysis and leaving the victim susceptible to suffocation. Thus, a side effect that can occur is the loss of the ability to swallow, which causes a slow death from starvation or asphyxiation. If you or a loved one has suffered an adverse reaction to Botox, whether from an on- or off-label use, you should seek legal assistance to protect your rights.

Originally posted at InjuryBoard by Amanda Schlager

Brayer to Suspend Trasyol Marketing

Pete Strom — Fri, 09 Nov 2007 15:56:24 GMT

The United States Food and Drug Administration announced that Bayer Pharmaceuticals Corporation has agreed to suspend marketing of the drug Trasyol until preliminary results from a Canadian study suggesting an increased risk for death can be reviewed.

Trasyol is used to control bleeding during heart surgery in patients with an increased risk for blood loss. In 2006, the FDA strengthened the safety warnings required for labeling of Trasyol to reflect the risk for increased blood loss.

The FDA requested the marketing suspension based on the expected data of a Canadian study at Ottawa Health Research Institute. The FDA is still awaiting the full study results. Because of a lack of treatment options for patients at risk for excessive bleeding during heart surgery, the FDA is working with Bayer to phase out Trasyol's use so as to avoid alternative drug shortages.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Pete Strom

Avandia and Actos to Contain "Black Box" Warning Labels(2)

Pete Strom — Fri, 17 Aug 2007 13:32:20 GMT

Health officials announced this week that the diabetes drugs Avandia and Actos will contain "black box" warnings. "Black box" warnings are the most severe warnings that a prescription drug can receive.

The new warnings will alert consumers that the drugs may cause or worsen heart problems and that patients should be carefully monitored.

The new warnings come just weeks after the Food and Drug Administration meet with experts to discuss the health risks of Avandia. One expert told the FDA that the heart attack risks associated with Avandia fail to justify the continued use of the drug. The FDA, however, has not seen enough evidence to pull the drug from shelves. Instead, Avandia and Actos labels will now include updated information about possible heart risks.

Originally posted at InjuryBoard by Pete Strom

Diabetes Drug Avandia Linked to Increased Risk of Heart Attacks

Pete Strom — Fri, 27 Jul 2007 16:18:35 GMT

Avandia, a drug prescribed for diabetes patients to control blood sugar levels, has been linked to an increased risk of heart attacks and heart-related deaths, studies show. The Federal Drug Administration released a safety alert in May, warning of the increased heart associated risks linked to Avandia.

According to the FDA's release, patients on Avandia who also take insulin, particularly those with previous heart conditions or disease, have an especially high risk for heart attacks or heart-related deaths.

On Monday, the FDA will meet with outside experts to discuss what actions should be taken in light of the associated risks. The FDA could decide to stop selling the drug or require more warning labels. Avandia is the world's best selling diabetes drug, with over 3 million users in America alone.

As an attorney with experience in defective drug lawsuits, my heart goes out to anyone who has already experienced side effects from using Avandia.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Pete Strom

Arkansas Woman Sues Wyeth Over Prempro

Shannon Weidemann — Mon, 22 Jan 2007 22:24:05 GMT

Helen Rush of Little Rock, AR is suing drug manufacturer Wyeth on the allegation that the drug Prempro caused her to develop breast cancer.

She sued the company in 2005 and the jury is now being selected. Prempro is a combination of estrogen and progestin, used for hormone replacement therapy in menopausal women. Rush took the drug for nine years and was diagnosed with breast cancer in 1999. There are approximately 5000 cases against Wyeth related to Prempro. A Women's Health Initiative study in July 2002 linked hormone replacement therapy with heart related illness and breast cancer.

Originally posted at InjuryBoard by Shannon Weidemann