March 1st, 2012 laurie
There is an ongoing safety review of the multiple sclerosis (MS) drug Gilenya occurring in Canada in the wake of reports of serious adverse events, including 11 deaths worldwide. None of the deaths occurred in Canada.
Gilenya is a drug prescribed to reduce the frequency of MS attacks and delay physical disability in patients who have relapsing-remitting MS. It is generally prescribed when other MS treatments have been unsuccessful or canâ€™t be tolerated by the patient. Continue Reading »
March 1st, 2012 joshua
The Food and Drug Administration has threatened pharmaceutical giant Merck & Co. for not submitting the results of post-market safety reviews of its diabetes drugs Januvia and Janumet by an agreed-upon deadline.
According to a Reuters report, Merck had until June 15 last year to submit the results of post-markets studies investigating the allegations that Januvia and/or Janumet increased the likelihood a person would experience an inflamed pancreas. Just under two weeks ago, the FDA posted its letter to Merck on its Web site which indicated the agency was ready to fine the company for failing to adhere to a deadline on that study.
The FDA can order a drug maker to conduct a post-market safety review of a new or old drug if it’s believed that drug may be causing severe side effects. Merck agreed to the FDA’s order last year, saying it would test for the cause-and-effect relationship between its diabetes drugs and acute pancreatitis in lab mice. The sides agreed the review should be completed last June and since then, Merck continues to miss one new deadline after another in producing this report. Continue Reading »
March 1st, 2012 joshua
People taking prescription sleep drugs like Ambien, Lunesta, Restoril, and Sonata face a greater risk of developing cancer or dying early than those who avoid the medications altogether.
According to an L.A. Times report on a study appearing in British Medical Journal’s BMJ Open publication, researchers reviewing the safety of these drugs noted that between six and ten percent of people taking them were more likely to develop a cancer or die before their normal life expectancy. It could not be determined if the sleeping drugs were the cause of these side effects or if people who sought prescription sleep drugs were more likely to experience them.
The increased risk was noted even among the most casual users of sleep aids. Taking up to just 18 pills per year, people were three times as likely to die early when compared to a person who hadn’t taken one of these drugs ever. Taking the equivalent of a pill every three days or more often increased that risk to five times more than a person not taking these drugs.
Researchers from Scripps Clinic in La Jolla, Calif., and Jackson Hole Center for Preventive Medicine conducted research for the study.
In addition to the risk of early death, the study also noted that people taking the most prescription sleep drugs during their study period were 35 percent more likely to be diagnosed with cancer in that time than those taking no sleep drugs. More than 10,000 people participated in the study and they were followed for anywhere between three months to four years. Nearly half the participants took Ambien, reflective of the drug’s dominance in a billion-dollar business of marking prescription sleep aids.
Millions of people in the U.S. seem to “rely” on the benefits of drugs like Ambien and Lunesta and marketing campaigns for the drugs are heavy on those benefits, but seem to gloss over these and other side effects.
February 29th, 2012 joshua
Glenmark Generics Inc. has issued a recall on select oral contraceptives Norgestimate and Ethinyl Estradiol Tablets due to a packaging error which could lead to dosage confusion and result in an unexpected pregnancy.
According to a statement issued by the company, the recall includes Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. Seven Lots are included in the recall (04110101, 04110106, 04110107, 04110114, 04110124, 04110129, and 04110134. The products included in the recall were distributed nationwide to retail pharmacies from Sept. 21 through Dec. 30, 2011.
The drug is dispensed in blister packs and designed to be taken in a specific order through the pack. There are several colors of tablets in the blister pack, each containing a different amount of the Active Ingredient. Continue Reading »
February 27th, 2012 joshua
American Regent has issued a recall on an prescription injection drug because vials in a specific Lot of the drug may contain particulate matter.
Injection drug vials which contain foreign substances, anything from dust to microscopic pieces of chipped glass, could lead to life-threatening complications for patients being treated with the drug.
In its recall, American Regent said Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vials included with Lot 0693 must be recalled because they contain particulate matter. The company does not indicate in its press release announcing the recall if any injuries or incidents have resulted from a foreign substance found in one of these vials. Continue Reading »
February 24th, 2012 Julie
Parker Waichman LLP has filed three lawsuits against Bristol-Myers Squibb Company and Sanofi Aventis. The suits were filed on behalf of individuals who allegedly suffered life-threatening bleeding side effects from taking the blood-thinning drug Plavix. The cases were filed in New York State Supreme Court on Feb. 21.
The lawsuits allege that people who use Plavix have a higher risk of serious and potential side effects that include heart attack, stroke, internal bleeding, blood disorder and/or death. Two plaintiffs say they suffered gastrointestinal hemorrhage as a result of taking the drug. The third lawsuit was filed on behalf of the estate of a Washington State man who suffered cerebral hemorrhage and died after using Plavix for less than a year. Continue Reading »
February 24th, 2012 Julie
Bedford Laboratories has announced a voluntary recall of three lots of Cytarabine for Injection, USP:
Cytarabine for injection, USP 1 gram per viral - NDC #55390-133-01
â€˘ Lot 2066986 - Exp. Date March 31, 2014
â€˘ Lot 2111675 - Exp. Date April, 30, 2014
â€˘ Lot 2131148 - Exp. Date May, 31, 2014
Continue Reading »
February 24th, 2012 joshua
The Food and Drug Administration has issued an import alert for 22 Chinese companies which it believes are distributing adulterated products used to make the blood thinning drug heparin.
The import ban stops any shipments from these 22 companies based in China which manufacture heparin, a widely used drug most often after surgeries to prevent blood clots. In 2008, two Chinese companies were found to be selling a counterfeit version of the Active Ingredient in heparin to Baxter International, distributors of heparin worldwide.
Heparin containing this adulterated product was blamed on 81 deaths in the U.S. The discovery of the contaminated heparin prompted the recall of 13 drug products which contain it. Subsequent investigations revealed the makers of the contaminated Active Ingredient had never been inspected by the FDA because the spellings of the Chinese company were very similar to those previously inspected by the agency. Foreign drug suppliers are typically only visited by FDA inspectors once every 5 or 10 years while the agency relies on third-party inspection reports for much of its data. This lax regulation allowed another manufacturer of an adulterated heparin ingredient to get its product into the drug’s worldwide supply.
The FDA’s ban on imports from 22 Chinese companies of any heparin-related products is a follow-up to a previous action. According to a brief from InPharmaTechnologist.com, the action includes some companies already blocked from importing products to the U.S. The FDA determined these 22 companies are selling adulterated heparin products.
To remove itself from this import ban list, the company must submit third-party inspection reports to the FDA showing it is following safe manufacturing practices. These reports will then be used by the FDA to determine which facilities it will inspect before lifting the ban.
February 23rd, 2012 Julie
Trouble for Abbott Laboratories just keep coming and coming. New legal battles are looming for the company regarding its sales and marketing of the anti-seizure drug, Depakote. Attorney generals in eight states have formed a committee to investigate the marketing of the drug and whether or not it violated those statesâ€™ consumer protection and other laws.
Abbott is also facing eight lawsuits filed against some current and former directors and senior executives of the company in Illinois federal and state courts. The lawsuits accuse top brass of breaching fiduciary duty in connection to some fishy business practices regarding the sales and marketing of the medication. Continue Reading »
February 22nd, 2012 Julie
A new study out of Denmark contains disturbing information for parents: babies who got a single shot that included vaccines against tetanus and whooping cough were at a higher risk of having a fever-related seizure on the same day.
The seizures were still considered unlikely after the shots, and researchers say the children who got them did not stand a greater chance of developing epilepsy than those who werenâ€™t vaccinated, as was suggested by some. The information might startle parents, initially, but one expert says the information should actually be reassuring. Continue Reading »