Michigan Personal Injury Blog - food and drug administration

FDA Issues Warning to Evenflo After Reports of Electrical Shock from Breast Pump Use

David Mittleman — Thu, 17 Sep 2009 10:00:00 GMT

Several women who used the Evenflo breast pump were shocked while expressing their breast milk—literally. Recently, the Food and Drug Administration issued a warning to the Evenflo Company for failing to properly investigate the complaints of several women who reported receiving electrical shocks while using the company’s breast pump.

In an August 25^th letter that was released on Tuesday, the FDA said it found manufacturing violations at two Ohio Evenflo plants. Inspections at the two facilities revealed that Evenflo wasn’t in compliance with the federal manufacturing rules that make it mandatory for companies to review and evaluate all complaints. In fact, Evenflo received a total of 55 various complaints and only reviewed 37 of those. The 18 other complaints were left uninvestigated, with at least three of those complaints specifically relating to reports of electrical shock from using the breast pumps.

Moreover, according to federal regulations, companies are required to report issues with medical devices to the FDA. However, Evenflo did not follow through on these requirements, and the FDA reports that the company has still failed to address these concerns. Lindsay Harris, Evenflo’s vice president of quality and product integrity, maintains that the company is “working cooperatively with the FDA” to address the agency’s concerns.

Originally posted at InjuryBoard by David Mittleman

Alli Weight Loss Medication Under Investigation, Potentially Linked to Cases of Liver Damage

David Mittleman — Thu, 03 Sep 2009 10:00:00 GMT

The weight loss pill, Alli, seemed like a welcome relief for many people struggling to lose weight. Tired of yo-yo dieting, overweight individuals were eager to try the first Food and Drug Administration approved weight loss pill, hopeful to lose the weight without the horrible and long-lasting side effects of other diet pills. Unfortunately, a diet pill receiving FDA approval is not proving to be a cure all for dieters. In fact, the FDA recently announced that they are investigating reports of 32 cases of serious liver injury after consumers took Alli.

Alli is the brand name of a drug called Orlistat, which works by blocking the absorption of fat into the body. The pill is aimed specifically at overweight adults who have a Body Mass Index (BMI) of 28 or more. The drug was named Alli, as its appeal is that it can “help people lose 50% more weight than dieting alone”. However, side effects include diarrhea and gas if a person continues to eat too much fat while taking the drug. Furthermore, there are more serious side effects such as yellowing of the skin and whites of the eyes, as well as weakness and stomach pain.

According to the FDA, there were 32 reports of serious liver damage and 6 reports of liver failure between 1999 and 2008. 30 of the reports of liver damage occurred outside of the U.S. In total, 27 cases required hospitalization. FDA experts are stressing that individuals go to the hospital immediately if they experience possible symptoms of liver injury such as fatigue, fever, jaundice, or brown urine.

GlaxoSmithKline, the maker of Alli, continues to defend the medication’s safety. They maintain that the drug was tested in clinical trials with 30,000 patients. Please remember that the simplest and safest way to lose weight is the old-fashioned way: eat moderate amounts of wholesome foods and get regular exercise.

Originally posted at InjuryBoard by David Mittleman

Transdermal Patches Could Cause Burns During MRI

David Mittleman — Tue, 18 Aug 2009 11:38:03 GMT

Magnetic resonance imaging, or MRI, is an incredibly useful diagnostic tool. These scans offer unparalleled imaging of soft tissue, making MRIs particularly helpful in identifying and treating everything from traumatic brain injuries to torn ligaments. In general, MRIs are exceedingly safe procedures, with most adverse effects being related to contrast dyes (especially those containing gadolinium). However, it appears that a new risk has emerged: burns from transdermal drug patches.

A transdermal drug patch is essentially a medicated patch that slowly releases a given drug into the blood stream. They are affixed to the skin by way of an adhesive pad. Some transdermal patches contain metal (aluminum, for example) in the part of the patch known as the backing. According to the Food and Drug Administration (FDA), some patches with metal backings have been known to overheat during an MRI scan and cause burns on the skin of the patient. If you are using a transdermal patch and anticipate undergoing an MRI, ask your doctor for advice about removing the patch during the procedure. In addition, be sure to tell the MRI facility that you are using a transdermal patch.

This is not the first time transdermal patches have come under fire. Last month the FDA issued another advisory warning about the dangers of patches containing Fentanyl, a potent narcotic drug.

Originally posted at InjuryBoard by David Mittleman

FDA Warns Consumers to Stop Using Clarcon Hand Sanitizer and Hand Protectant

David Mittleman — Sun, 02 Aug 2009 14:18:00 GMT

Officers from the U.S. Marshals Service seized all skin sanitizers and skin protectants, including ingredients and components, from the Clarcon Biological Chemistry Laboratory in Roy, Utah, according to a statement released by the Food and Drug Administration.

Clarcon products may contain harmful bacteria: analyses of several antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, some of which can cause infections of the skin and underlying tissues. According to the FDA, these infections can be very serious, resulting in permanent damage if left untreated without proper medical, or even surgical, attention. Therefore, the FDA has issued a warning to all consumers to discontinue use of any Clarcon hand disinfectant or protectant products, which are marketed under several different brand names.

The FDA first discovered the problem in June, and Clarcon agreed to a voluntary recall. However, the U.S. Marshals Service confiscated the products, ingredients and components, after Clarcon failed to destroy the recalled items. Moreover, the inspection in June also revealed serious violations of the FDA’s regulations, including poor practices that led to the contamination. No cases of infection have been reported to the FDA; however, the FDA said it is protecting the public by preventing the products from entering the marketplace.

Originally posted at InjuryBoard by David Mittleman

Tysabri: Multiple Sclerosis Medication Linked to 13th Brain Infection Case

David Mittleman — Tue, 30 Jun 2009 13:02:55 GMT

Biogen Idec Inc., a biotechnology company, announced Friday that another patient who was taking its Tysabri multiple-sclerosis medicine is infected with progressive multifocal leukoencephalopathy, or PML. Their announcement marks the 13^th case of the infection in patients taking Tysabri. Three other patients have already died from taking the medication and contracting PML. PML is a serious brain infection that attacks the central nervous system and damages and inflames the white matter areas of of the brain. Immune suppressing drugs such as Tysabri put patients at serious risk for contracting PML and potentially dying as a result.

Tysabri was pulled from the market back in 2005 after three initial cases of PML were discovered. After holding hearings on the drug’s risks and benefits, the Food and Drug Administration allowed Tysabri back onto the market in 2006 under new monitoring rules that the drug could not be combined with other MS drugs. The FDA had hoped that the new regulations would reduce the incidence of PML cases, but there have been ten new cases since.

Several other immune suppressing drugs have also contributed to the incidence of PML. In fact, Roche Holding AG pulled its psoriasis drug, Raptiva, over reports of PML. Similarly, Roche and Biogen has also come under increased scrutiny from the FDA over reports that its cancer treatment, Rituxan, increases the likelihood of contracting PML.

Originally posted at InjuryBoard by David Mittleman

FDA Dropped the Ball on Protecting Consumers from Contaminated Syringes

David Mittleman — Sun, 14 Jun 2009 14:03:04 GMT

We already knew that under the Bush Administration, the Food and Drug Administration was underfunded and understaffed to the point of tragedy. But now we are slowly learning just how ill equipped the agency was to foster consumer safety, and what are the real costs of those decisions. The FDA failed to stop contaminated syringes from reaching consumers during several 2007 inspections of a North Carolina syringe production facility. The syringes were prefilled with Heparin, a blood thinner, and the distribution of the contaminated syringes resulted in four deaths and 162 illnesses nationwide.

An FDA inspector visited the plant three months prior to their shipping in October 2007 to investigate reports that the syringes contained red, brown, and black particles—signs of rust. Managers at the plant had previously been ordered by FDA officials to deal with the rust, except their method of sterilization was still unreliable when the inspector visited in October. A week later, the FDA learned the distributor was recalling 1.3 million syringes. This is specifically when the FDA should have launched a full-scale investigation, except it didn’t, claiming that the agency was so understaffed that it followed a policy whereby the agency did not inspect a product after a recall, unless the product posed a serious probability of injuries or deaths.

Federal prosecutors attempted to go after the president of the syringe company, but he fled the country to evade charges of fraud and conspiracy as well as other charges that he and his firm lied about performing sterility tests. If charged, he could have received up to 95 years in prison. However, two employees of the plant, including a plant manager, were sentenced to 4 ½ years each for fraud and for allowing tainted drugs onto the marketplace.

Many of the affected families have filed lawsuits against the syringe company, but this incident represents yet another case where the FDA failed to do their job during the Bush administration. It is becoming increasingly more difficult for critics not to point a finger at the FDA for “being in bed” with the very companies who produced products that could potentially harm consumers. Since the FDA decided to turn a blind eye, there was no one left to do the job of protecting the American public from hazardous medical devices or medicines, because as is becoming more clear by the day – Americans cannot count on corporations to regulate and police themselves any longer.

Originally posted at InjuryBoard by David Mittleman

FDA Warns Of Risk To Children When An Adult Uses Testosterone Gel

David Mittleman — Tue, 12 May 2009 08:00:00 GMT

The Food and Drug Administration has required the manufacturers of two testosterone gel products to place its strongest warning label to reduce the chances that children will have secondary exposure to the products.

The gels AndroGel 1% and Testim 1% are designed to help men who do not produce enough testosterone. It is a gel that is applied to the body of the man on either the abdomen, shoulders, and arms. However, the FDA has discovered that there is a risk of secondary exposure to children if men apply the gel and then hold or carry children without wearing a shirt. People are also urged to wash their hands after using the product.

The consequences of secondary exposure to the testosterone gels have included either enlarged genitalia that in some cases, has not receded to an age appropriate size, as well as instances of more aggressive behavior in children.

Originally posted at InjuryBoard by David Mittleman

FDA Holds Meeting on Medical Device Approval

David Mittleman — Wed, 22 Apr 2009 12:19:14 GMT

In a rare move, the U.S. Food and Drug Administration (FDA) is conducting an "all-hands" meeting to discuss concerns regarding its medical device division. The meeting, set to happen today, is the first such gathering in years.

The division of the FDA responsible for approving medical devices has come under heavy fire in recent months. In January, nine agency scientists authored a letter to then-President-elect Obama in which they accused the FDA of mismanagement, lack of accountability, and even possible corruption. Also in January, the Government Accountability Office released a report criticizing the FDA for lacksidasical regulation of high-risk Class III medical devices. In addition to its questionable approval process, the agency has evidently permitted healthcare facilities to wash and reuse equipment intended to be used only once.

According to the scientists who wrote the letter, the FDA is "fundamentally broken" and honest employees at the agency face intimidation from dishonest employees. As a result of the FDA’s shortcomings, the scientists claim that the agency is "placing the American people at risk."

Originally posted at InjuryBoard by David Mittleman

FDA Demands Info on Older Medical Devices

David Mittleman — Fri, 10 Apr 2009 08:33:00 GMT

Earlier this week, the Food and Drug Administration (FDA) requested information on decades-old medical devices marketed by companies such as Medtronic. These devices, which range from wheelchairs to pacemakers, hit the market prior to 1976 – the year the FDA was first authorized to review and approve medical devices. According to an article by the Wall Street Journal, these medical products were allowed to remain on the market after only a cursory review of their safety.

One major concern is that high-risk devices such as pacemakers – known as Class III devices – might not be as safe and effective as previously believed. Due to what is essentially a loophole in the approval process, the FDA has approved Class III products without the stringent testing now required of new devices.

Medical device companies have 120 days to comply with the request for information. Medtronic claims that its devices are safe and that they have some thirty years’ worth of evidence to back up their assertion.

Originally posted at InjuryBoard by David Mittleman