Wisconsin legislature mulls bill to restrict lawsuits against some drug, med-device makers

(Oct. 17, 2011) Wisconsin Public Radio reports that a measure introduced in the Wisconsin legislature proposes to make it harder for people who get injured by certain drugs to sue manufacturers.

Wisconsin state Sen. Rich Zipperer is the author of the bill, which has drawn the ire of consumer advocacy groups, including the Coalition for Wisconsin Aging Groups.

Opponents of the proposed new law assert that it will hurt people injured by flawed drugs and medical devices.

“The plan would shield drug makers and medical device manufacturers from lawsuits if their products were [U.S. Food & Drug Administration]-approved,” WPR reported. “The trouble, critics say, is that there’s a long list of drugs that got the FDA’s OK even though it turns out they were actually harmful or even deadly.”

According to WPR, the Zipperer bill would leave vulnerable to lawsuits drug and device makers that lie to the FDA to win approval to begin marketing their products. “If you’ve complied with everything the FDA requires and all of the extensive testing that goes with it, you shouldn’t be sued for diligently following that process,” said Zipperer in one WPR audio clip.

Zipperer told WPR he hopes his bill will pass during this session of the Wisconsin state legislature.

Use of banned superdrol as ingredient means Uprizing 2.0 now gone from market

(Oct. 12, 2011) – A nutritional supplement in capsule form used by bodybuilders as an aid to increasing muscle mass has been pulled from shelves after the U.S. Food & Drug Administration found the product contained a banned synthetic anabolic steroid, superdrol.

Uprizing 2.0 maker Superior Metabolic Technologies in August received a letter of notification from the FDA informing the Marietta, Ga., company of the formulation problem.

Superior Metabolic Technologies responded by voluntarily removing superdrol-containing Uprizing 2.0 from the market. Uprizing 2.0 was sold through retail health-food stores in Alabama, Arizona, California, Georgia, Mississippi, New Jersey, South Carolina, and Texas, but also worldwide through online distributors.

According to the FDA, acute liver injury is a known possible harmful effect of using products containing synthetic anabolic steroids, such as superdrol.

“…[S]ynthetic anabolic steroids may cause…shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to mis-use other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death,” the FDA said.

The FDA advises consumers who purchased Uprizing 2.0 to return it to the place of purchase. Side-effects or adverse health events suspected as being related to the taking of the ingredient superdrol should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, the agency said.

Drospirenone birth control (Yaz, others) to be topic of FDA special meeting Dec. 8 examining deep-vein thrombosis risks

(Oct. 11, 2011) – The U.S. Food & Drug Administration plans to convene a joint meeting of two advisory committees Dec. 8 to explore whether Yaz, Yasmine and all other birth-control pills containing drospirenone pose enough risk of causing blood clots and deep-vein thrombosis to warrant some sort of federal action.

The FDA cites conflicting findings from six published studies evaluating this risk – plus preliminary data from its own investigation, which suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone birth-control pills (compared to users of other hormonal contraceptives) – as reasons for calling the meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and the Risk Management Advisory Committee.

No conclusion about what these various studies reveal has yet been drawn by the FDA, although the regulatory agency earlier took the step of recommending physicians exercise caution when prescribing this type of birth-control pill and that they discuss with users the signs and symptoms of deep-vein thrombosis and pulmonary embolism.

Australia, Euro Union advise physicians

Australia, too, has issued a recommendation to physicians through its national Therapeutic Goods Administration (that nation’s equivalent of the FDA). Per the TGA, “health professionals should weigh the clinical needs of patients against the possible risk, and educate patients to recognise the signs and symptoms of venous thromboembolism.”

The TGA also encouraged physicians to report adverse events associated with all oral contraceptives, and reminded them that such drugs are contraindicated in women 35 and older who smoke or who sit for very long periods – both considered serious risk factors for venous or arterial thrombosis.

Meanwhile, the European Medicines Agency (EMA), another FDA counterpart, announced in May that product information for birth-control pills with drospirenone and ethinyl estradiol will be updated once health officials there finish reviewing much the same data currently under FDA examination.

Up to three-fold greater risk

Concerns about deep-vein thrombosis and pulmonary embolism reached the current heightened state following the publication of the two most recent studies, published in the online April edition of British Medical Journal [BME].

These studies showed as much as a three-fold greater risk for pulmonary embolism and deep-vein thrombosis in women taking drospirenone birth-control pills.

A third study of importance is the one funded by the FDA. In that investigation, more than 800,000 women participated.

Drospirenone is classified as a progestin. Brand-name contraceptives using drospirenone include Yaz, Yasmine, Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda and Zarah.

Australia to doctors: tell diabetics of ‘small absolute increased risk’ of bladder cancer from pioglitazone

(Oct. 7, 2011) Australian health officials – concerned over published reports in British and U.S. medical journals – now believe the country’s physicians should avoid prescribing pioglitazone for diabetics who had or have bladder cancer.

“Until there is a better understanding of the link between bladder cancer and pioglitazone, it is prudent to avoid pioglitazone in patients with bladder cancer or a history of bladder cancer,” said the Therapeutic Goods Administration (Australia’s version of the U.S. Food and Drug Administration) in a recent newsletter.

Additionally, the TGA advises doctors to tell other diabetic patients taking pioglitazone that they face a “small absolute increased risk of bladder cancer” with continued use of the drug.

However, the TGA said its advice “is based on assumptions rather than clinical evidence.”

The TGA’s concern was sparked by two medical journal articles. The first appeared in the prestigious British medical The Lancet. Published six years ago, the article raised the possibility that pioglitazone use for longer than 12 months may lead to an increased risk of bladder cancer. In considering cardiovascular outcomes of patients with type 2 diabetes, investigators observed 14 cases of pioglitazone takers who developed bladder cancer.

Pioglitazone is used to treat type 2 diabetes mellitus when diet and exercise prove insufficient to control the disease.

The second article was published in 2011 in the journal Diabetes Care. It described a pair of recent observational cohort studies involving diabetic patients age 40 and older the found an association between pioglitazone and bladder cancer. One of those efforts calculated the adjusted hazard ratio for bladder cancer in pioglitazone users to be 1.2.

In the U.S., pioglitazone is available under the brand name Actos. It is made by Takeda Pharmaceutical Co., based in Osaka, Japan.

Cephalon changes product info after Australia takes closer look at modafinil

(Oct. 7, 2011) Pharmaceutical maker Cephalon recently updated the safety literature it packages with modafinil following a risk-benefit review of the drug by Australia’s Therapeutic Goods Administration (a counterpart to the U.S. Food and Drug Administration).

Australia conducted the review in the wake of reports that some modafinil users suffered cardiovascular, nervous system and psychologic problems. The analeptic drug is commonly prescribed to keep awake patients who suffer from narcolepsy or from obstructive sleep apnea-induced excessive daytime sleepiness.

Cephalon – the target of a 2002 FDA misleading-marketing probe that resulted in the company agreeing to pay penalties totaling $425 million – sells modafinil in Australia under the brand name Modavigil. In the U.S., the drug’s name is Provigil, and has been available here since 1998.

Because no one is sure exactly how modafinil works, there exists the possibility that more problems with it will surface in the years ahead.

For example, Cephalon’s current Provigil information recommends against prescribing it to children – this, after the FDA in 2006 held that modafinil was unsuitable for treatment of attention deficit hyperactivity disorder (ADHD) in youngsters (prior to that, the drug had shown promise as an ADHD therapy).

Cephalon, headquartered in West Chester, Pa., leases the rights to make and distribute modafinil from French pharmaceutical firm Lafon.