Archive for February, 2012

Prevnar Vaccine Recalled by Pfizer

Wednesday, February 29th, 2012

The world’s largest drugmaker, Pfizer, is recalling a batch of Prevnar pneumonia vaccine.  Those needles were filled with expired material.  The recall only affected one wholesaler.

Prevnar is a vaccine that fights pneumonia, meningitis, and other diseases related to pneumococcus bacteria.  It is predicted that this vaccine will become one of Pfizer’s biggest brands.

According to Pfizer, they “continuously monitor the safety of all medications and do not believe the recalled doses pose any health risks.”

Pfizer recently had to recall 1 million packages of birth control pills due to packaging errors.

 

Certain Drugs Raise Death Risk In Dementia Patients

Monday, February 27th, 2012

A new study has found that elderly nursing home residents who take antipsychotic drugs for dementia have an increased risk of death.

The study, published in the journal BMJ, followed more than 75,000 nursing home residents with dementia, all of whom were 65 or older, and found that those taking Haldol and Risperdal had double the risk of death.  According to the result, the risk was the highest during the first 40 days of treatment.

According to epidemiologist Krista Huybrechts, the study “underscores the need to try alternative means of dealing with behavioral problems in older patients with dementia”.

Previous studies imply that up to 1/3 of nursing home patients are treated with antipsychotic medications, even though the drugs have a limited effectiveness in treating behavioral and psychological symptoms of dementia.

Huybrechts stated:  “The types of behaviors that physicians are trying to target with these drugs are aggression, agitation, and delusions, which can make patients uncomfortable and lead to behaviors that are harmful to themselves and others.”

 

394,000 Bottles of DynaCirc Recalled by GlaxoSmithKline

Monday, February 27th, 2012

394,200 bottles of the hypertension drug DynaCirc has been recalled by GlaxoSmithKline due to the potential for tablet mixups at a Novartis plant that supplies the drug.

The voluntary recall was issued to wholesalers, pharmacies, and hospitals.  Due to the recall, the drug will not be available to patients.

Recently, the Novartis plant that manufactured DynaCirc suspended operations in order to address problems identified by the FDA.  One problem cited by the inspectors were reports of certain medications being placed in bottles labeled for other products.

This is not the first time Novartis has faced other manufacturing quality issues.  Last year, they were cited by the FDA for manufacturing deficiencies in it’s Sandoz generic drug unit.

 

Teva Will Pay $250 Million In Propofol Cases

Wednesday, February 22nd, 2012

Teva Pharmaceuticals will be paying $250 million in an effort to settle over 80 lawsuits filed in 2008 that allege that the drug maker sold the anesthetic Propofol in such a way that colonoscopy patients developed hepatitis C.

These Las Vegas claims state that the company intentionally sold Propofol in vials that were large enough to be reused by doctors.  Nevada health officials and regulators from the federal Centers for Disease Control and Prevention blamed the 2008 hepatitis C outbreak on the reuse of Propofol vials.

 

Merck Closes Down Its Propecia Website

Wednesday, February 15th, 2012

The Propecia webpage owned by Merck Pharmaceuticals provided links to current prescribing information, patient product information, and a link encouraging visitors to report any adverse effects associated with use of Propecia to the FDA’s MedWatch program.

Merck has abruptly shut down this website, which has prompted speculation that new or additional warnings may be on their way to consumers regarding the sexual side effects that have been reported with the use of Propecia.

Several lawsuits have been filed against Merck Pharmaceuticals, manufacturer of Propecia,

Propecia is used to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland) and baldness.  The lawsuits accuse Merck of downplaying the risks associated with Propecia and failing to warn patients about the severity of sexual side effects.

The side effects that have plagued men are:  decreased libido, decreased semen output, and depression.  Because so many men feel embarrassment about the side effects of Propecia, scores have chosen to remain anonymous or to not report their conditions.  In June 2011, the FDA issued a warning that Propecia could be linked to an increased risk of high-grade prostate cancer.

 

Lawsuit Floodgates Potentially Opened by Pfizer Misstep

Wednesday, February 8th, 2012

Last week Pfizer recalled fourteen lots of Lo/Ovral and fourteen lots of generic Norgestrel & Ethinyl Estradiol tablets.  This number equaled 1 million packets of birth control pills.

The basis of the recall was that the hormones were manufactured with inadequate levels of hormones, which increases the risk of pregnancy.  Some packages had too many active tablets, while others had too few.

But could this manufacturing mishap open the gates for millions of lawsuits?  Some ethics professionals say “Yes!”  Thirty-two states recognize “wrongful pregnancy” cases (a case in which a healthy baby is born from an unwanted pregnancy).  Women could potentially be allowed to sue Pfizer for damages related to the pregnancy itself, the cost of emotional distressed from an unwanted pregnancy, the cost of taking time off from work, and economic expenses related to raising a child until he or she is 18 years old.

Although there are some factors that Pfizer could bring to light that would complicate the case, this will be an interesting string of events to follow.

 

 

20,000 Lawsuits to be settled by GlaxoSmithKline

Wednesday, February 8th, 2012

Three billion dollars will be paid by GlaxoSmithKline in order to resolve government claims that it illegally marketed drugs such as Avandia (a diabetes medication).  GlaxoSmithKline also agreed last month to resolve more than 20,000 cases that allege that Avandia causes heart attacks.  This agreement was reached in court ordered mediation.

If you or a loved one are an Avandia user and have been injured due to this drug, contact one of our medical malpractice attorneys immediately.  They will be able to answer your questions and ascertain if you have a case.

 

Dietetic Supplements Recalled by Healthy People Company

Tuesday, February 7th, 2012

Several supplements manufactured and distributed by Healthy People Company have been recalled due to their contents.  These supplements contain appetite suppressants and a drug for male erectile dysfunction.

Five of the supplements (Mince Belle, Everlax, Ever Slim, Ever Slim Shake Mix, and Ever Slim Shake Mix Dietary Supplement) contain sibutramine, which is an appetite suppressant.  Sibutramine is known to increase blood pressure or heart rate and has been withdrawn from the U.S. market.

Two of the company’s other supplements, Perfect Man Dietary Supplement and Mangosteen Dietary Supplement, contain tadalafil, which is used to treat male erectile dysfunction.  Tadalafil may interact with nitrates in prescription drugs such as nitroglycerin and may dangerously lower blood pressure.

 

It is unclear as to whether injuries or deaths have occurred from use of the supplements, but they are dangerous enough to have been pulled from the market.

 

28 Lots of Birth Control Pills Recalled by Pfizer

Tuesday, February 7th, 2012

Pfizer is recalling fourteen lots of Lo/Ovral and fourteen lots of generic Norgestrel & Ethinyl Estradiol tablets.  This number equals 1 million packets of birth control pills.

The basis of the recall is that the hormones were manufactured with inadequate levels of hormones, which increases the risk of pregnancy.  Some packages had too many active tablets, while others had too few.

According to a Pfizer spokeswoman, the problem was caused by mechanical and visual inspection failures as well as failures on the packaging line.

 

 

 

Johnson & Johnson To Pay Texas $158 Million for Fraud

Tuesday, February 7th, 2012

Trial began on January 9 in Texas for for Johnson & Johnson Inc. and its subsidiary Janssen Pharmaceutical LLC, along with five other related companies which are accused of having defrauded the state in a “sophisticated marketing scheme” that caused the Texas Medicaid program to pay too much for the schizophrenia drug Risperdal.  The State is also alleging that the company misled state health officials about the drug’s effectiveness.

On January 19, it was ruled that Johnson & Johnson would pay $158 million to the State of Texas to resolve the state’s Medicaid claims.

Texas Attorney General Greg Abbott stated:  “Today’s agreement sends a strong message that the State will pursue those who defraud Texas taxpayers.  Johnson & Johnson’s scheme to profit from the Medicaid program by overstating the safety and effectiveness of an expensive drug and improperly influencing officials ended up costing taxpayers millions of dollars.”