The Food and Drug Administration this week restricted the use of excessive doses of the cholesterol-lowering drug, Simvastatin.  The drug is available under the brand names Vytorin and Zocor, and is also available in generic form.  According to the Food and Drug Administration, a high dose of this drug can cause muscle problems, and especially a form of muscular degeneration called myopathy.  California pharmaceutical liability attorneys are especially concerned about this warning because of the widespread use of these drugs the country.

Statins are used to lower cholesterol levels by lowering the production of cholesterol in the liver.  These medications are often prescribed for persons with high cholesterol levels to reduce the risk of suffering a heart attack.  However, statins have been linked to serious health risks.  The Food and Drug Administration is now warning that people who use more than 80 mg of Simvastatin may be at risk of muscle injury. 

The FDA is advising people who have taken Simvastatin for more than a year without any symptoms of muscle injury, to continue to do so.  However, the agency is warning doctors not to increase the dosage from 40 mg 80 mg to get cholesterol levels under control.

Muscle injury risks from the use of Simvastatin had come to light earlier.  In 2009, a similar drug called Cerivastatin was recalled because of a similar muscle injury risk.

For now, medical experts don't believe that there is any reason to be worried about the other kinds of statins.  Statins come with different types of chemical compositions, and the same kind of side effects may not be seen in all such medications.  However, if you're on Simvastatin, you should discuss this warning with your doctor.  The risk of muscle injury from the use of the drug seems to be the highest in the first year of use of the drug.

It’s official-the federal government has announced that anti-diabetes drug Avandia will be pulled off from pharmacy shelves by the end of the year.  The decision is related to the high concerns about the health effects from Avandia use.

Avandia will not be available on pharmacy shelves after November 18 this year.  The agency's decision aims to reduce the risk of persons suffering from heart attacks after prolonged use of the medication.  For a while now, Avandia has been linked to an increased risk of heart attacks. 

Last year, the Food and Drug Administration took some of its strongest steps to limit the health effects of Avandia by placing severe restrictions on prescriptions for Avandia.  The Food and Drug Administration’s action limited Avandia to those people who were already on the medication, and those who could not be benefited from the use of other anti-diabetes drugs. However, the agency’s measures were in contrast to those in Europe, where safety regulators immediately banned Avandia. 

However, after November 18, Avandia may not be available to purchase of pharmacy shelves.  Avandia users will have to order the drug through mail-order.  Under the new rules announced by the federal agency, both patients and doctors will have to enroll under the Avandia-Rosiglitazone Medicines Access Program.  Only specific, certified pharmacies will be able to supply prescriptions by mailing the drug to patients.

The Food And Drug Administration's action severely limits access to Avandia. California pharmaceutical liability attorneys believe that the use of the drug will begin to taper off dramatically, and eventually even end.  According to statistics, from January through October 2007, approximately half a million patients in the country filed prescriptions for Avandia. 

In 2007, a study indicated that Avandia increased the risk of heart attack by about 40% in people who already suffered from type II diabetes.  A number of studies after that confirmed that the use of Avandia significantly increased heart attack risks. 

The Food and Drug Administration has been concerned enough about the numbers of people with hip implants who have suffered metal poisoning, to ask manufacturers of these implants to study the effects of metal levels in the body.

Earlier this month, the Food and Drug Administration sent a letter to at least 20 implant manufacturers, including Johnson & Johnson, Zimmer Holdings Inc., Biomet Inc. and Stryker Corporation, asking them to test the levels of metals, including cobalt and chromium, in patients for at least eight years after implantation of these devices.

Manufacturers of metal hip implant devices have been under increased scrutiny over the past couple of years.  Johnson & Johnson, in particular, faces a number of hip implant lawsuits related to the high risk of revision surgeries from its two best selling hip implants manufactured by Johnson & Johnson’s subsidiary, DePuy Orthopedics.  Approximately 9 months ago, DePuy announced the recall of the hip implant devices after these had been implanted in more than 90,000 patients across the globe.  During the recall, DePuy admitted that a study conducted in the United Kingdom had revealed a high risk of revision surgeries in patients that have been implanted with these devices.  In some cases, the risk of the implants failing, leading to revision surgeries was as high as 12%.  Other than Johnson & Johnson, Stryker and Zimmer are two of the biggest implant manufacturers in the industry.

California pharmaceutical liability attorneys have seen some signs that the Food and Drug Administration is beginning to take the health risks from these implant devices more seriously.  Earlier this year, the agency dedicated a section on its website to explain the health risks of these devices.  Among the health concerns that the agency mentions on its website is that some of the patients who have been implanted with these devices have been diagnosed with high levels of metal ions in the bloodstream, possibly leading to complications of the heart, nervous system and thyroid gland.

The Food and Drug Administration and California pharmaceutical liability lawyers are once again drawing attention to a recall of alcohol prep pads that was announced last month. The recall involves alcohol prep pads, or swabs, that were included in convenience kits manufactured by Triad Group. The recall was linked to possible contamination of these prep pads with the potentially deadly Bacillus cereus organism. This infection can lead to serious, and even life-threatening, infections.

According to Triad Group, the company has received at least one report of an infection that was contracted from using these alcohol prep pads. However, the infection, in this case a skin infection, was not life-threatening.  Watson Pharmaceuticals, the company that announced the recall, has rushed to assure consumers that none of the other products in the convenience kits are contaminated. The convenience kit also contains drugs and injection kits, and these are not contaminated.

This week, the Food and Drug Administration once again reminded consumers about the possible contamination of the non-sterile prep pads. The products have already been removed from the market, but it's important for people to know that not all pads are safe for use before procedures. For instance, non-sterile pads are not meant to be used before performing procedures that require strict and high degrees of sterility. For example, non-sterile pads are not meant for use before a catheter is inserted. They are also not meant to be used on patients who suffer from a weak immune system. Patients who have just had surgery or have just recovered from a long illness, may have a weakened immune system. These patients may be much more likely to contract infections from contaminated alcohol prep pads.

The products that have been included in this recall are marked with a label that mentions Triad Group. The Food and Drug Administration is insisting that these pads not be used to disinfect and sterilize the skin even before an injection. The FDA also wants consumers to know that the pads should not be used on IV ports and other medical devices and equipment.

For California pharmaceutical products liability attorneys, 2011 is turning out to be a repeat of 2010 as far as Johnson & Johnson recalls is concerned. The pharmaceutical giant has announced another recall of some of its most popular products, including Tylenol and Benadryl because of yet more quality control issues.

In January, the company announced a massive recall of close to 50 million bottles and packages of some of its most popular drugs, including Benadryl, Tylenol and Sudafed. According to the company, some 43 million units of the products have been recalled because of inadequate equipment cleaning procedures at the company’s Fort Washington, Pennsylvania plant. It's the same plant involved in several earlier recalls by Johnson & Johnson in 2010. The Pennsylvania plant has since been shut down. Apart from these 43 million units, approximately 4 million Rolaids have been recalled because of labeling irregularities. Johnson & Johnson has assured consumers that the recalled medications do not have any quality-control problems, and will not harm anybody.

Johnson & Johnson's recall last year involved a number of its most popular blockbuster medications, including a number of widely-used children's medications like Tylenol, Motrin, Zyrtec and Benadryl for children. Some of these recalls were linked to the presence of particulate matter in some of the bottles, while other recalls were linked to a higher concentration of the active ingredient in the medications than required. Other recalls were linked to the presence of a moldy odor in the packaging, due to chemicals that leached from the packaging. Besides, the company is under scrutiny over a phantom recall, in which the company pulled off several bottles of medications from store shelves, without giving any reason.